Ciprofloxacin 0.3% / dexamethasone 0.1% otic suspension

What it is

This is an ear drop, not a tablet or an injection. Each mL of the suspension carries ciprofloxacin hydrochloride equivalent to 3 mg of ciprofloxacin base plus 1 mg of dexamethasone. In the United States it is approved only for two ear infections: acute otitis media in children aged 6 months and older who have tympanostomy tubes, and acute otitis externa. The label states plainly that the product is for the ear only and not for the eye or for injection.

What the research says

The evidence for this product is a set of randomised trials in children with discharging ears through tympanostomy tubes and in adults and children with outer-ear infection. In those trials it cleared discharge faster than ofloxacin drops, faster than ciprofloxacin drops without the steroid, and faster than oral amoxicillin/clavulanate. Against neomycin/polymyxin B/hydrocortisone drops in outer-ear infection the advantage was small and most of it had disappeared by the final visit. A Cochrane review of outer-ear infection found that topical drops work but that the choice between topical drops usually does not change the outcome, and rated the overall quality of the trials as low.

Evidence grade: Well established.

How it works

Drug class: Fixed combination of a fluoroquinolone antibacterial (ciprofloxacin) and a corticosteroid (dexamethasone), formulated as a sterile suspension for instillation into the ear

Ciprofloxacin kills bacteria by blocking DNA gyrase, an enzyme the bacterium needs to copy its own DNA. Dexamethasone is a corticosteroid that damps down the inflammatory response, which is why the combination clears discharge faster than the antibiotic on its own. Very little of either drug reaches the bloodstream when the drops are used in the ear. (Source 1)

What it is used for

• Three randomised trials found faster resolution of ear discharge with this combination than with ofloxacin drops, ciprofloxacin drops alone, or oral amoxicillin/clavulanate. The advantage over ciprofloxacin alone was present at days 3 and 8 but had gone by day 14. Evidence: established. (Source 2)
• One randomised trial found a higher cure rate than neomycin/polymyxin B/hydrocortisone drops, but a pooled analysis of two trials found almost all patients in both groups cured by day 18 and only about half a day's difference in mean time to cure. Evidence: established. (Source 3)
• A pre-specified analysis inside one of the tympanostomy tube trials found more resolution of granulation tissue than with ofloxacin drops, but it rests on the 90 children who had granulation tissue at baseline. Evidence: limited. (Source 4)
• A narrative review of topical antibiotic ear drops in chronic suppurative otitis media found the available information scant and low quality, could not say whether quinolones are better or worse than aminoglycosides, and said negative effects were generally underreported. Its stated method was a search for reported cases of ototoxicity, which cannot settle whether the drops work. Evidence: unknown. (Source 5)

Interactions

• Milk, yogurt and other dairy products (pharmacokinetic study): This matters for ciprofloxacin swallowed as a tablet, not for the ear drops. In seven healthy volunteers, milk and yogurt cut the peak blood level of a 500 mg oral dose by 36% and 47% and reduced total absorption by 30% to 36%. Because the ear drops put only trace amounts into the blood, the same interaction has no practical meaning for the drops. (Source 6)
• Calcium, iron, magnesium and zinc supplements, and antacids (pharmacokinetic study): Divalent and trivalent cations bind oral ciprofloxacin in the gut and reduce its absorption. We found no study of this with the otic suspension, and the label's own pharmacokinetic data explain why it is not expected to matter: measurable plasma levels were found in only a minority of children at 6 hours after a dose. (Source 7)
• Alcohol (label): We found no trial, pharmacokinetic study or case series describing an interaction between alcohol and this otic suspension. The negligible systemic exposure recorded in the label is the reason none would be expected, but that is an inference rather than a tested finding. (Source 7)
• Other quinolone antibacterials (label): Cross-resistance has been documented between ciprofloxacin and other fluoroquinolones, so a failure on one is likely to mean a failure on another. The label records no cross-resistance with beta-lactams or aminoglycosides. (Source 1)

Stopping it

• The courses studied were short and fixed. There is no withdrawal syndrome described for this product in the literature we searched; the label simply says to discard what is left when the seven days are finished. (Source 8)
• If the discharge has not stopped after a full course, or if it comes back twice within six months, the label calls for further evaluation rather than another course of drops. (Source 9)
• Treatment should be stopped at once, not tapered, if a rash or any other sign of hypersensitivity appears. (Source 10)

What goes wrong

In the manufacturer's phase II and III programme of 937 treated patients, the commonest side effects were local: ear discomfort in 3% and ear pain in 2.3% of the 400 children treated for tube otorrhoea. (Source 11)

• Official position, Certainty not rated.
• Size: 937 patients treated across phases II and III; 400 with tympanostomy tube otitis media and 537 with otitis externa.
• Who: children, adults and elderly people treated in the registration trials.
• How long: not stated in this section of the label; the dosage section gives twice daily for seven days.
• Result: tube otorrhoea group (N = 400): ear discomfort 3%, ear pain 2.3%, ear precipitate 0.5%, irritability 0.5%, taste perversion 0.5%; otitis externa group (N=537): ear pruritus 1.5%, ear debris 0.6%, superimposed ear infection 0.6%, ear congestion 0.4%, ear pain 0.4%, erythema 0.4%.
• Funding: manufacturer data reproduced in the FDA-approved label; no placebo arm is reported for these rates.

In Phases II and III clinical trials, a total of 937 patients were treated with ciprofloxacin and dexamethasone otic suspension. This included 400 patients with acute otitis media with tympanostomy tubes (AOMT) and 537 patients with AOE.

In the otitis externa trials, treatment-related side effect rates were the same for the combination and the comparator, at 3.8% overall. (Source 12)

• Meta-analysis, Low certainty.
• Size: 1072 patients.
• Who: adults and children with acute otitis externa.
• How long: 7 days of treatment with assessment to day 18.
• Result: treatment-related adverse events in 3.8% of patients and similar between groups; otic pruritus 2.1%, otic congestion 0.6%, otic debris 0.5%, otic pain 0.3%, superimposed ear infection 0.3%, erythema 0.1%.
• Funding: not stated in the abstract.

Treatment-related adverse event rates were similar between the 2 groups and occurred in 3.8% of the patients. The most common adverse events included otic pruritus (2.1%), otic congestion (0.6%), otic debris (0.5%), otic pain (0.3%), superimposed ear infection (0.3%), and erythema (0.1%).

Side effects differed in kind between the drops and the oral antibiotic: ear pain with the drops, diarrhoea and skin reactions with oral amoxicillin/clavulanate. (Source 13)

• Randomized trial, Low certainty.
• Size: 80 children randomised.
• Who: children aged 6 months to 12 years with tympanostomy tube otorrhoea.
• How long: 7 days of drops versus 10 days of oral suspension.
• Result: ear pain 5.1% with the drops; diarrhoea 19.5%, dermatitis 7.3% and gastroenteritis 4.9% with oral amoxicillin/clavulanate.
• Funding: not stated in the abstract.

Frequent adverse events (> 3%) related to ciprofloxacin/dexamethasone otic suspension included ear pain (5.1%) and related to amoxicillin/clavulanic acid suspension included diarrhea (19.5%), dermatitis (7.3%), and gastroenteritis (4.9%).

Prolonged use can let non-susceptible bacteria and fungi overgrow, and the label tells prescribers to take cultures if the infection has not improved after a week. (Source 14)

• Official position, Certainty not rated.
• Size: not applicable.
• Who: anyone using the drops beyond a short course.
• How long: beyond one week.
• Result: no rate is given; the label describes the risk qualitatively.
• Funding: FDA-approved labelling, effective 2 April 2026.

Prolonged use of ciprofloxacin and dexamethasone otic suspension may result in overgrowth of non-susceptible, bacteria and fungi.

Serious and sometimes fatal allergic reactions have been reported with systemic quinolones, and the label instructs stopping the drops at the first sign of hypersensitivity. (Source 10)

• Official position, Certainty not rated.
• Size: not applicable.
• Who: people receiving quinolones; the serious reactions described were reported with systemic, not otic, use.
• How long: some reactions followed the first dose.
• Result: no rate is given; reactions described include cardiovascular collapse, loss of consciousness, angioedema, airway obstruction, dyspnoea, urticaria and itching.
• Funding: FDA-approved labelling, effective 2 April 2026.

Serious and occasionally fatal hypersensitivity (anaphylactic) reactions, some following the first dose, have been reported in patients receiving systemic quinolones.

The boxed warning that fluoroquinolones carry belongs to the oral and injectable forms of ciprofloxacin, not to these ear drops, which have no boxed warning. (Source 15)

• Official position, Certainty not rated.
• Size: not applicable.
• Who: people taking ciprofloxacin by mouth or by vein.
• How long: not stated.
• Result: the oral tablet label carries a boxed warning covering tendinitis and tendon rupture, peripheral neuropathy, central nervous system effects and worsening of myasthenia gravis; the otic suspension label carries no boxed warning.
• Funding: FDA-approved labelling for ciprofloxacin tablets, effective 6 October 2026.

Limit of this finding: This warning is quoted from the label for ciprofloxacin TABLETS, which is a systemic medicine. The product described in this entry is an ear drop, and its own FDA label carries no boxed warning. The otic label records ciprofloxacin blood levels after a dose in the ear as on average approximately 0.1% of those reached after a 250-mg dose by mouth, so the tendon, nerve and central nervous system warnings that belong to the tablets and the injection are not being attributed to the drops here.

Fluoroquinolones, including ciprofloxacin, have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together

The same review searched the literature for reported human cases of ototoxicity from topical antibiotic ear drops and recorded the dose, duration and type of preparation involved. (Source 5)

• Expert review, not systematic, Very low certainty.
• Size: not stated; a case search with no reported count of retrieved cases.
• Who: humans with reported ototoxicity after topical antibiotic ear drops.
• How long: not stated.
• Result: no incidence can be calculated from a search for case reports, because the number of people exposed is unknown.
• Funding: not stated.

Limit of this finding: A search for published case reports cannot give a rate of harm, and it cannot say anything about whether the drops work. It is a list of what has been reported, nothing more.

An electronic search of the literature was performed for reported cases of ototoxicity associated with the use of topical antibiotic ear drops in humans. The dosage, duration, and type of ototoxic preparations involved were recorded.

The only review of ear-drop ototoxicity in chronic suppurative otitis media we could reach said negative effects were generally underreported and that the trials it included gave too few data to compare the harm profiles of quinolones and aminoglycosides. (Source 5)

• Expert review, not systematic, Very low certainty.
• Size: not stated; the review reports no count of included studies or cases.
• Who: people with chronic suppurative otitis media using topical antibiotic ear drops.
• How long: not stated.
• Result: no rates, no denominators and no pooled estimate are given; the review reports only that harms were underreported and that the data were insufficient to compare the two antibiotic classes.
• Funding: not stated.

Limit of this finding: This is a narrative review with no stated eligibility criteria, no quality appraisal and no synthesis method, and it gives no number of included studies. It can tell you that harm reporting is poor; it cannot tell you how often harm happens.

Although the adverse impact profiles of these two classes of chemicals varied, there are not enough data from the included trials to draw any conclusions about them. Negative effects were generally underreported.

What the evidence supports

As a regulatory position, the FDA has approved this product for exactly two conditions and named the bacteria it covers in each. (Source 16)

• Official position, Certainty not rated.
• Size: not applicable.
• Who: children aged 6 months and older with tympanostomy tubes for acute otitis media; children, adults and elderly people for acute otitis externa.
• How long: not stated in this section.
• Result: approved for acute otitis media with tympanostomy tubes due to Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis and Pseudomonas aeruginosa, and for acute otitis externa due to Staphylococcus aureus and Pseudomonas aeruginosa.
• Funding: FDA-approved labelling, effective 2 April 2026.

Acute Otitis Externa (AOE) in pediatric (age 6 months and older), adult and elderly patients due to Staphylococcus aureus and Pseudomonas aeruginosa.

In children with otorrhoea through tympanostomy tubes, ciprofloxacin/dexamethasone drops produced more clinical cures and fewer treatment failures than ofloxacin drops. (Source 2)

• Randomized trial, Moderate certainty.
• Size: 599 children at 39 sites.
• Who: children aged 6 months to 12 years with acute otitis media with otorrhoea through tympanostomy tubes of up to 3 weeks' duration.
• How long: 7 days of ciprofloxacin/dexamethasone versus 10 days of ofloxacin, followed to day 18.
• Result: clinical cure 90% versus 78%; microbiologic success 92% versus 81.8%; treatment failures 4.4% versus 14.1%; median time to cessation of otorrhoea 4 days versus 6 days.
• Funding: not stated in the abstract; the product was developed by Alcon and the trial was multicentre industry-sponsored in design.

Ciprofloxacin/dexamethasone is superior to ofloxacin for clinical cure (90% vs 78%) and microbiologic success (92% vs 81.8%) at the test-of-cure visit, produces fewer treatment failures (4.4% vs 14.1%), and results in a shorter median time to cessation of otorrhea (4 days vs 6 days).

That same trial enrolled 599 children at 39 sites and gave the drops twice daily, with the comparator given for 10 days rather than 7. (Source 17)

• Randomized trial, Moderate certainty.
• Size: 599 children.
• Who: children aged 6 months to 12 years with an episode of up to 3 weeks' duration.
• How long: 7 days versus 10 days.
• Result: 4 drops of ciprofloxacin 0.3%/dexamethasone 0.1% twice daily for 7 days versus 5 drops of ofloxacin 0.3% twice daily for 10 days.
• Funding: not stated.

This multicenter, prospective, randomized, observer-masked, parallel-group study was conducted at 39 sites in 599 children aged >or=6 months to 12 years with an AOMT episode of <or=3 weeks' duration.

Adding dexamethasone to ciprofloxacin drops shortened the time to the discharge stopping by about one day. (Source 18)

• Randomized trial, Moderate certainty.
• Size: 167 culture-positive children out of 201 randomised.
• Who: children aged 6 months to 12 years with acute otitis media with tympanostomy tubes and visible otorrhoea.
• How long: twice daily for 7 days, assessed to day 14.
• Result: mean time to cessation of otorrhoea 4.22 versus 5.31 days (P =.004); better clinical responses on days 3 and 8 (P <.0001 and P =.0499)
• Funding: not stated.

The mean time to cessation of otorrhea in the microbiologically culture-positive patient population (n = 167) was significantly shorter with topical ciprofloxacin/dexamethasone than with ciprofloxacin alone (4.22 vs. 5.31 days; P =.004).

The trial comparing the combination with ciprofloxacin alone randomised 201 children and masked the patients rather than the assessors. (Source 19)

• Randomized trial, Moderate certainty.
• Size: 201 children.
• Who: children aged 6 months to 12 years with visible otorrhoea through tympanostomy tubes.
• How long: 3 weeks' duration or less at entry.
• Result: randomised, patient-masked, parallel-group, multicentre design.
• Funding: not stated.

Randomized, patient-masked, parallel-group, multicenter trial of topical otic ciprofloxacin/dexamethasone versus topical ciprofloxacin alone in 201 children aged 6 months to 12 years with acute otitis media with tympanostomy tubes (AOMT) of less than or equal to 3 weeks' duration and visible otorrhea.

In an observer-masked trial that gave the combination twice daily against a comparator given three times daily, more culture-positive patients with acute otitis externa were cured by Day 18. (Source 3)

• Randomized trial, Low certainty.
• Size: 468 patients enrolled, 396 culture-positive and eligible.
• Who: people older than 1 year with mild, moderate or severe acute otitis externa and intact eardrums.
• How long: a one-week course in both arms, with the test-of-cure assessment at Day 18.
• Result: clinical cure at day 18 90.9% versus 83.9% (p = 0.0375); microbiologic eradication 94.7% versus 86.0% (p = 0.0057)
• Funding: not stated in the abstract.

Limit of this finding: The two arms were not given on the same schedule: the combination was used twice a day and the comparator three times a day, so some of the difference may be down to how easy each was to keep up with rather than to the drug. The trial was observer-masked, not double-blind - the assessors did not know which treatment a patient was on, but the patients could tell from the dosing schedule.

In culture-positive patients who met the inclusion criteria (N = 396), clinical cure rates at Day 18 were significantly higher with CIP/DEX than with N/P/H (90.9% vs. 83.9%; p = 0.0375), as were microbiologic eradication rates (94.7% vs. 86.0%; p = 0.0057).

That otitis externa trial was observer-masked rather than double-blind, and the two arms were given on different schedules. (Source 20)

• Randomized trial, Low certainty.
• Size: not stated in this section of the abstract.
• Who: patients with acute otitis externa randomised in a parallel-group multicentre study.
• How long: 7 days of treatment in both arms.
• Result: ciprofloxacin/dexamethasone 3-4 drops twice daily versus neomycin/polymyxin B/hydrocortisone 3-4 drops three times daily.
• Funding: not stated in the abstract.

Limit of this finding: Unequal dosing frequency between the arms, and masking of the observers only, both weaken this comparison. A difference in cure rates here is not the same as a difference between the two drugs given on identical schedules.

Randomized, observer-masked, parallel-group, multicenter study. Patients were randomized to 7 days treatment with either CIP/DEX 3-4 drops twice daily or N/P/H 3-4 drops three times daily.

In children with tube otorrhoea, the drops beat oral amoxicillin/clavulanate on both speed and cure rate. (Source 13)

• Randomized trial, Low certainty.
• Size: 80 children randomised, 79 in the time-to-cessation analysis.
• Who: children aged 6 months to 12 years with visible otorrhoea through tympanostomy tubes.
• How long: 7 days of drops versus 10 days of oral suspension, assessed to day 18.
• Result: median time to cessation of otorrhoea 4.0 versus 7.0 days; clinical cures at test-of-cure 85% versus 59%.
• Funding: not stated in the abstract.

The median time to cessation of otorrhea was significantly shorter with ciprofloxacin/dexamethasone otic suspension than with amoxicillin/clavulanic acid suspension (4.0 vs 7.0 days; n = 79). This resulted in significantly more clinical cures at the test-of-cure visit (85% vs 59%, respectively).

That comparison against oral amoxicillin/clavulanate was observer-masked and gave the drops for 7 days against 10 days of the oral suspension. (Source 21)

• Randomized trial, Low certainty.
• Size: 80 children aged 6 months to 12 years.
• Who: children with acute otitis media with otorrhoea through tympanostomy tubes of 3 weeks' duration or less.
• How long: 4 drops twice daily for 7 days versus oral amoxicillin/clavulanic acid every 12 hours for 10 days, assessed on days 1, 3, 11 and 18.
• Result: 4 drops of ciprofloxacin 0.3%/dexamethasone 0.1% twice daily for 7 days versus 600 mg of amoxicillin with 42.9 mg of clavulanic acid every 12 hours for 10 days.
• Funding: not stated in the abstract.

Limit of this finding: Observer-masked and only 80 children, with the two treatments given by different routes for different lengths of time, so patients could not be blinded.

Patients were randomly assigned to receive either 4 drops of topical ciprofloxacin 0.3%/dexamethasone 0.1% (Ciprodex Sterile Otic Suspension) into the affected ear(s) twice daily for 7 days or 600 mg of amoxicillin/42.9 mg of clavulanic acid oral suspension (Augmentin ES-600 Oral Suspension) every 12 hours for 10 days.

Granulation tissue, present in 15.0% of children at baseline, resolved more often with the combination than with ofloxacin drops. (Source 4)

• Randomized trial, Low certainty.
• Size: 90 of 599 children had granulation tissue at baseline.
• Who: children aged 6 months to 12 years with tympanostomy tube otorrhoea.
• How long: assessed at days 11 and 18.
• Result: reduction of granulation tissue 81.3% versus 56.1% at day 11 (P = 0.0067) and 91.7% versus 73.2% at day 18 (P = 0.0223)
• Funding: not stated in the abstract.

Granulation tissue was present in 90 of 599 AOMT patients (15.0%) at baseline. CIP/DEX treatment was superior to OFL for reduction of granulation tissue at the day 11 visit (81.3% compared with 56.1%, P = 0.0067) and the day 18 visit (91.7% compared with 73.2%, P = 0.0223).

In a chinchilla model, seven days of these drops produced a transient hearing threshold shift that was no longer significantly different from the saline-treated ear by day 60; this is an animal result and says nothing directly about human hearing. (Source 22)

• Animal study, Low certainty.
• Size: 15 chinchillas, each acting as its own control (one ear drug, one ear saline)
• Who: chinchillas after ventilation tube insertion.
• How long: twice daily for 7 days, with auditory brainstem responses to day 60.
• Result: transient 8.11 dB nHL rise in the treated ears at day 4; at day 60 mean thresholds 16.33 +/- 6.93 dB nHL treated versus 13.66 +/- 6.65 dB nHL control, reported as not significant, with the confidence interval printed in the paper as "3.12, -8.02" (bounds in reverse order; read as -8.02 to 3.12)
• Funding: not stated in the abstract.

Limit of this finding: Two things to hold in mind. First, this is a chinchilla experiment in 15 animals, not a human safety study, so it cannot show the drops are safe for people's hearing. Second, the paper prints its own confidence interval backwards, as "3.12, -8.02", with the upper bound first and no "to"; read in the normal order it is -8.02 to 3.12. Because that range includes zero, the reasonable reading is that no difference was shown at day 60 in these animals - not that a difference was ruled out, and not that the published figures as printed make arithmetic sense.

An initial transient increase of 8.11 dB nHL was noted in the mean thresholds of the experimental ears at day 4. On the last ABR evaluation (day 60), the mean thresholds were 16.33 +/- 6.93 dB nHL in the experimental ears and 13.66 +/- 6.65 dB nHL in the control ears. The difference in the mean thresholds between the experimental and control ears at day 60 was not significant (95% confidence interval, 3.12, -8.02).

That ototoxicity experiment was an animal study: ventilation tubes were placed in 15 chinchillas and one ear of each animal was randomised to the drops while the other received a saline control solution. (Source 23)

• Animal study, Low certainty.
• Size: 15 chinchillas, one ear treated and the contralateral ear given 0.45% NaCl.
• Who: chinchillas after ventilation tube insertion.
• How long: twice daily for 7 consecutive days, with auditory brainstem responses at baseline and on days 4, 8, 15, 22 and 60.
• Result: four drops of ciprofloxacin/dexamethasone in the randomised ear against a 0.45% NaCl control solution in the other ear.
• Funding: not stated in the abstract.

Limit of this finding: An animal model. Nothing in this study was measured in a human ear, so it cannot be reported as a human safety finding.

Ventilation tubes were inserted in the ears of 15 chinchillas. One ear was randomized to receive four drops of ciprofloxacin/dexamethasone. A control solution (0.45% NaCl) was applied in the contralateral ear. The eardrops were delivered twice daily for 7 consecutive days.

Very little of either drug reaches the blood after the drops are used in the ear, which is why systemic fluoroquinolone and corticosteroid problems are not expected. (Source 7)

• Blood level study, Low certainty.
• Size: 9 paediatric patients.
• Who: children given a single bilateral 4-drop dose after tympanostomy tube insertion.
• How long: single dose, sampled to 6 hours.
• Result: mean peak plasma ciprofloxacin 1.39 ± 0.880 ng/mL, about 0.1% of the peak after an oral 250 mg dose; mean peak plasma dexamethasone 1.14 ± 1.54 ng/mL, about 14% of the peak reported after an oral 0.5 mg tablet.
• Funding: manufacturer data reproduced in the FDA-approved label.

Peak plasma concentrations ranged from 0.543 ng/mL to 3.45 ng/mL and were on average approximately 0.1% of peak plasma concentrations achieved with an oral dose of 250-mg.

What the evidence does not support

By day 14 the steroid-containing drops and the antibiotic-only drops were no different on either clinical response or bacterial eradication. (Source 18)

• Randomized trial, Moderate certainty.
• Size: 201 children randomised.
• Who: children aged 6 months to 12 years with acute otitis media with tympanostomy tubes.
• How long: assessed at day 14 (test-of-cure)
• Result: no significant difference between the two treatment groups in clinical response or microbial eradication rate at day 14.
• Funding: not stated.

However, there were no significant differences between the two treatment groups in either the clinical response or the microbial eradication rate by day 14.

The same Cochrane review found no clinically meaningful difference in cure rates between the different topical drops, including quinolone versus non-quinolone antibiotics. (Source 24)

• Systematic review, Low certainty.
• Size: 19 trials, 3382 participants.
• Who: people with uncomplicated acute otitis externa.
• How long: to three weeks.
• Result: no clinically meaningful differences in clinical cure rates between topical interventions; one low-quality trial comparing quinolone with non-quinolone antibiotics found no difference in clinical cure rate.
• Funding: Cochrane review; funding not stated in the abstract.

In general, no clinically meaningful differences were noted in clinical cure rates between the various topical interventions reviewed.

Where the evidence is mixed

Pooling both otitis externa trials, nearly everyone in both groups was cured by day 18 and the difference in mean time to cure was about half a day. (Source 12)

• Meta-analysis, Low certainty.
• Size: 1072 patients (1242 ears); 537 on the combination and 535 on the comparator.
• Who: adults and children aged 1 year and older with acute otitis externa, treated at 76 US sites between April 1998 and July 1999.
• How long: 7 days of treatment, assessed on days 3, 8 and 18.
• Result: proportions cured at days 3, 8 and 18 were 0.14 and 0.10, 0.75 and 0.72, 0.98 and 0.97; mean time to cure 9.7 versus 10.3 days; log-rank P = 0.038.
• Funding: not stated in the abstract.

Limit of this finding: This is a pooled re-analysis of patient-level data from two trials, not a conventional meta-analysis of published effect estimates, and the patients in those trials were not blinded because the two preparations were given at different frequencies. The honest summary is that almost everyone in both groups was cured by day 18 and the average difference in time to cure was about half a day.

The proportions cured in the AOE at-risk groups at the day-3, -8, and -18 assessments in the CD and PNH treatment groups were 0.14 and 0.10, 0.75 and 0.72, and 0.98 and 0.97, respectively. The Kaplan-Meier summary statistics indicated that the mean time to cure was 0.6 day less with CD compared with PNH (9.7 vs 10.3 days).

The otitis externa 'pooled analysis' combined patient-level data from two observer-masked non-inferiority trials, and the patients in them were not blinded because the two preparations were given at different frequencies. (Source 25)

• Meta-analysis, Low certainty.
• Size: two randomised non-inferiority trials conducted at 76 institutions.
• Who: patients aged 1 year and older with acute otitis externa, recruited in the United States between April 1998 and July 1999.
• How long: 7 days of treatment in both arms.
• Result: the combination given as 3 drops in children and 4 drops from age 12 twice daily; the comparator at the same drop count three times daily.
• Funding: not stated in the abstract.

Limit of this finding: Pooling two trials after the fact is weaker than a single trial designed to answer the question, and because the dosing frequencies differed the patients knew which treatment they were on. Treat the cure-rate difference as suggestive, not settled.

Data from 2 institutional review board-approved, multicenter, observer-masked, parallel-group, randomized, noninferiority clinical trials conducted at 76 institutions across the United States between April 1998 and July 1999 were pooled together for this analysis.

A Cochrane review of nineteen trials in acute otitis externa found that topical antimicrobial plus steroid drops beat placebo drops, but that the various topical options generally did not differ from one another and that the trials were of low quality. (Source 24)

• Systematic review, Low certainty.
• Size: 19 randomised controlled trials with a total of 3382 participants.
• Who: people with uncomplicated acute otitis externa.
• How long: follow-up to two and three weeks in the trials that reported it.
• Result: topical antimicrobials containing steroids versus placebo drops OR 11 (95% CI 2.00 to 60.57, one trial); acetic acid versus antibiotic/steroid OR 0.29 (95% CI 0.13 to 0.62) at two weeks and OR 0.25 (95% CI 0.11 to 0.58) at three weeks; quinolone versus non-quinolone antibiotic no difference in clinical cure rate.
• Funding: Cochrane review; funding not stated in the abstract.

Nineteen randomised controlled trials with a total of 3382 participants were included. Three meta-analyses were possible. The overall quality of studies was low.

Cochrane's authors concluded that for most people the choice between topical treatments may come down to ototoxicity risk, sensitisation, resistance, availability, cost and dosing rather than to efficacy. (Source 26)

• Systematic review, Low certainty.
• Size: 19 trials, 3382 participants.
• Who: people with uncomplicated acute otitis externa.
• How long: not applicable.
• Result: no consistent efficacy difference; choice driven by other factors.
• Funding: Cochrane review; funding not stated in the abstract.

Given that most topical treatments are equally effective, it would appear that in most cases the preferred choice of topical treatment may be determined by other factors, such as risk of ototoxicity, risk of contact sensitivity, risk of developing resistance, availability, cost and dosing schedule.

That review also judged the information on topical antibiotics in chronic suppurative otitis media scant and low quality, and could not say whether quinolones are better or worse than aminoglycosides. (Source 5)

• Expert review, not systematic, Very low certainty.
• Size: not stated; no count of included studies is reported.
• Who: people with chronic suppurative otitis media.
• How long: not stated.
• Result: no pooled estimate; the review reports uncertainty about whether topical antibiotics speed resolution of ear discharge, some data that they may be useful against placebo or added to a systemic antibiotic, and no ability to rank quinolones against aminoglycosides.
• Funding: not stated.

Limit of this finding: These statements about whether the drops work sit in the review's single unstructured abstract paragraph, alongside the only method the review states for itself: a search for reported cases of ototoxicity. A case search of harm reports cannot establish efficacy, so this passage should be read as the authors echoing other reviews, not as a finding of their own work.

Additionally, there is ambiguity regarding the relative efficacy of various kinds of antibiotics; it is impossible to say with absolute certainty whether quinolones are superior to or inferior to aminoglycosides.

Where the research disagrees

Whether ciprofloxacin/dexamethasone is meaningfully better than the older neomycin/polymyxin B/hydrocortisone drops for acute otitis externa

• Roland and colleagues, in the individual randomised trial, single randomised, observer-masked, multicentre trial of 468 patients: In culture-positive patients who met the inclusion criteria (N = 396), clinical cure rates at Day 18 were significantly higher with CIP/DEX than with N/P/H (90.9% vs. 83.9%; p = 0.0375) (Source 3)
• The pooled analysis of both trials, pooled analysis of two randomised non-inferiority trials, 1072 patients: The proportions cured in the AOE at-risk groups at the day-3, -8, and -18 assessments in the CD and PNH treatment groups were 0.14 and 0.10, 0.75 and 0.72, and 0.98 and 0.97, respectively. (Source 12)
• Cochrane review of interventions for acute otitis externa, systematic review of 19 randomised trials, 3382 participants, rated low quality overall: In general, no clinically meaningful differences were noted in clinical cure rates between the various topical interventions reviewed. (Source 24)

How much

• Reference intake: Dosing is set by the prescriber. As a position, the current FDA-approved label states four drops into the affected ear twice daily for seven days, for both approved uses. (Source 8)
• Upper limit: The label sets no maximum beyond the approved regimen: four drops (0.14 mL, containing 0.42 mg ciprofloxacin and 0.14 mg dexamethasone) twice daily for seven days, with the unused portion discarded after therapy. There is no stated upper limit for longer courses; the label instead says to take cultures if the infection has not improved after one week. (Source 8)
• Studied: 4 drops of ciprofloxacin 0.3%/dexamethasone 0.1% twice daily for 7 days, compared with 5 drops of ofloxacin 0.3% twice daily for 10 days, in 599 children. (Source 17)
• Studied: Three drops of either ciprofloxacin 0.3%/dexamethasone 0.1% or ciprofloxacin 0.3% into the affected ear or ears twice daily for 7 days. (Source 27)
• Studied: 3 to 4 drops twice daily for 7 days in acute otitis externa, against neomycin/polymyxin B/hydrocortisone given three times daily. (Source 20)

A common belief, and what the research shows

The belief: Ciprofloxacin ear drops carry the same tendon-rupture and nerve-damage warnings as ciprofloxacin tablets.

What the research shows: The boxed warning belongs to the systemic forms. The oral ciprofloxacin label states that "Fluoroquinolones, including ciprofloxacin, have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together", and lists tendinitis, tendon rupture, peripheral neuropathy and central nervous system effects. The otic suspension label has no boxed warning at all; its own warnings section covers hypersensitivity, microbial overgrowth and persistent otorrhoea, and the measured blood levels after a dose in the ear were "approximately 0.1% of peak plasma concentrations achieved with an oral dose of 250-mg".

Questions and answers

What is it?

It is a sterile suspension of two drugs put into the ear canal. Each mL contains ciprofloxacin hydrochloride at 0.3 %, equivalent to 3 mg of ciprofloxacin base, plus dexamethasone at 0.1 %, equivalent to 1 mg of dexamethasone. Ciprofloxacin is a fluoroquinolone antibacterial and dexamethasone is a corticosteroid. It is for the ear only, not the eye and not injection. (Source 28)

What does it do in the body?

Ciprofloxacin kills bacteria by interfering with DNA gyrase, the enzyme a bacterium needs to copy its DNA. Dexamethasone is there to settle the inflammation that comes with the infection, which is what makes the discharge stop sooner than with the antibiotic alone. Only traces of either drug reach the bloodstream when the drops are used in the ear. (Source 1)

Is it good or bad for you?

For the two infections it is approved for, randomised trials show it works and is well tolerated: in the pivotal paediatric trial of discharge through tympanostomy tubes it cured 90% against 78% for ofloxacin drops. It is not a general-purpose ear drop. It is contraindicated in viral and fungal ear infections and in anyone allergic to quinolones, and long use can let fungi and resistant bacteria take over. (Source 2)

How do you get more of it?

This is not something a person needs more of. It is a prescription-only ear drop and the quantity is fixed by the approved regimen: four drops into the affected ear twice daily for seven days. The label also describes warming the bottle in the hand and pumping the tragus to get the drops into the middle ear. (Source 8)

If it is harmful, what reduces it?

If it is causing harm, the response is to stop it, not to taper it. The label says to discontinue at the first sign of a rash or other hypersensitivity, and to stop and switch treatment if a resistant bacterial or fungal overgrowth develops. There is no antidote, and because systemic absorption is minimal there is nothing to clear from the body. (Source 14)

Why might someone be low in it or missing it?

The question does not apply in the usual sense: this is a manufactured medicine, not something the body makes or stores. The situations in which a person would not be given it are set out in the label: previous reaction to ciprofloxacin or another quinolone, and viral or fungal infection of the ear canal, including herpes simplex. (Source 29)

Which whole foods contain it or feed it?

No food contains it and no food is needed with it, because it is not swallowed. The food interaction that matters for ciprofloxacin, with milk and yogurt, applies to the oral tablet. In the ear, peak blood levels of ciprofloxacin are around 0.1% of what a 250 mg tablet produces, so diet is not a factor. (Source 7)

What happens if you do not have it?

Not treating an acute ear canal infection at all is worse than treating it with drops: in the Cochrane review, topical antimicrobial-plus-steroid drops beat placebo drops with an odds ratio of 11, though that rested on a single trial with a very wide confidence interval. Going without this particular product is a different matter, because the same review found the various topical drops largely interchangeable. (Source 24)

How can you test for it?

There is no blood test for this drug in routine use. What is tested is the infection: a swab of the ear discharge for culture and susceptibility tells you whether the bacteria present are ones ciprofloxacin covers. The registration trial cultured middle ear fluid before treatment and found Streptococcus pneumoniae in 16.8% and Pseudomonas aeruginosa in 12.7% of children. (Source 17)

References

1. DailyMed, U.S. National Library of Medicine (Sun Pharmaceutical Industries, Inc.). CIPROFLOXACIN AND DEXAMETHASONE suspension/ drops - FDA prescribing information (section: 12.4 Microbiology). 2026. Read the source
2. Pediatrics. Topical ciprofloxacin/dexamethasone otic suspension is superior to ofloxacin otic solution in the treatment of children with acute otitis media with otorrhea through tympanostomy tubes — abstract, Results. 2004. PMID 14702493, DOI 10.1542/peds.113.1.e40. Read the source
3. Current Medical Research and Opinion. Efficacy and safety of topical ciprofloxacin/dexamethasone versus neomycin/polymyxin B/hydrocortisone for otitis externa — abstract, Results. 2004. PMID 15324520, DOI 10.1185/030079902125004312. Read the source
4. Otolaryngology-Head and Neck Surgery. Topical ciprofloxacin/dexamethasone otic suspension is superior to ofloxacin otic solution in the treatment of granulation tissue in children with acute otitis media with otorrhea through tympanostomy tubes (Results). 2004. PMID 15195060, DOI 10.1016/j.otohns.2004.02.037. Read the source
5. Cureus. Ototoxicity of Topical Antibiotic Ear Drops in Chronic Suppurative Otitis Media in Humans: A Review of the Literature — abstract. 2022. PMID 36686080, DOI 10.7759/cureus.32780. Read the source
6. Clinical Pharmacology and Therapeutics. Interference of dairy products with the absorption of ciprofloxacin. 1991. PMID 1934862, DOI 10.1038/clpt.1991.174. Read the source
7. DailyMed, U.S. National Library of Medicine (Sun Pharmaceutical Industries, Inc.). CIPROFLOXACIN AND DEXAMETHASONE suspension/ drops - FDA prescribing information (section: 12.3 Pharmacokinetics). 2026. Read the source
8. DailyMed, U.S. National Library of Medicine (Sun Pharmaceutical Industries, Inc.). CIPROFLOXACIN AND DEXAMETHASONE suspension/ drops - FDA prescribing information (section: 2.2 Dosage). 2026. Read the source
9. DailyMed, U.S. National Library of Medicine (Sun Pharmaceutical Industries, Inc.). CIPROFLOXACIN AND DEXAMETHASONE suspension/ drops - FDA prescribing information (section: 5.3 Continued or Recurrent Otorrhea). 2026. Read the source
10. DailyMed, U.S. National Library of Medicine (Sun Pharmaceutical Industries, Inc.). CIPROFLOXACIN AND DEXAMETHASONE suspension/ drops - FDA prescribing information (section: 5.1 Hypersensitivity Reactions). 2026. Read the source
11. DailyMed, U.S. National Library of Medicine (Sun Pharmaceutical Industries, Inc.). CIPROFLOXACIN AND DEXAMETHASONE suspension/ drops - FDA prescribing information (section: 6.1 Clinical Trials Experience). 2026. Read the source
12. Clinical Therapeutics. Pooled analysis of two clinical trials comparing the clinical outcomes of topical ciprofloxacin/dexamethasone otic suspension and polymyxin B/neomycin/hydrocortisone otic suspension for the treatment of acute otitis externa in adults and children — abstract, Results. 2007. PMID 18035194, DOI 10.1016/j.clinthera.2007.09.005. Read the source
13. Pediatrics. Topical ciprofloxacin/dexamethasone superior to oral amoxicillin/clavulanic acid in acute otitis media with otorrhea through tympanostomy tubes — abstract, Results. 2006. PMID 16880248, DOI 10.1542/peds.2005-2033. Read the source
14. DailyMed, U.S. National Library of Medicine (Sun Pharmaceutical Industries, Inc.). CIPROFLOXACIN AND DEXAMETHASONE suspension/ drops - FDA prescribing information (section: 5.2 Potential for Microbial Overgrowth with Prolonged Use). 2026. Read the source
15. DailyMed, U.S. National Library of Medicine (Hikma Pharmaceuticals USA Inc.). CIPROFLOXACIN tablet, film coated - FDA prescribing information (boxed warning). 2026. Read the source
16. DailyMed, U.S. National Library of Medicine (Sun Pharmaceutical Industries, Inc.). CIPROFLOXACIN AND DEXAMETHASONE suspension/ drops - FDA prescribing information (section: 1 INDICATIONS AND USAGE). 2026. Read the source
17. Pediatrics. Topical ciprofloxacin/dexamethasone otic suspension is superior to ofloxacin otic solution in the treatment of children with acute otitis media with otorrhea through tympanostomy tubes — abstract, Methods. 2004. PMID 14702493, DOI 10.1542/peds.113.1.e40. Read the source
18. The Laryngoscope. Topical ciprofloxacin/dexamethasone is superior to ciprofloxacin alone in pediatric patients with acute otitis media and otorrhea through tympanostomy tubes — abstract, Results. 2003. PMID 14660913, DOI 10.1097/00005537-200312000-00011. Read the source
19. The Laryngoscope. Topical ciprofloxacin/dexamethasone is superior to ciprofloxacin alone in pediatric patients with acute otitis media and otorrhea through tympanostomy tubes — abstract, Study design. 2003. PMID 14660913, DOI 10.1097/00005537-200312000-00011. Read the source
20. Current Medical Research and Opinion. Efficacy and safety of topical ciprofloxacin/dexamethasone versus neomycin/polymyxin B/hydrocortisone for otitis externa — abstract, Study design. 2004. PMID 15324520, DOI 10.1185/030079902125004312. Read the source
21. Pediatrics. Topical ciprofloxacin/dexamethasone superior to oral amoxicillin/clavulanic acid in acute otitis media with otorrhea through tympanostomy tubes — abstract, Methods. 2006. PMID 16880248, DOI 10.1542/peds.2005-2033. Read the source
22. Otolaryngology-Head and Neck Surgery. Ototoxicity of topical ciprofloxacin/dexamethasone otic suspension in a chinchilla animal model — abstract, Results. 2008. PMID 19041513, DOI 10.1016/j.otohns.2008.08.005. Read the source
23. Otolaryngology-Head and Neck Surgery. Ototoxicity of topical ciprofloxacin/dexamethasone otic suspension in a chinchilla animal model — abstract, Methods. 2008. PMID 19041513, DOI 10.1016/j.otohns.2008.08.005. Read the source
24. Cochrane Database of Systematic Reviews. Interventions for acute otitis externa — abstract, Main results. 2010. PMID 20091565, DOI 10.1002/14651858.cd004740.pub2. Read the source
25. Clinical Therapeutics. Pooled analysis of two clinical trials comparing the clinical outcomes of topical ciprofloxacin/dexamethasone otic suspension and polymyxin B/neomycin/hydrocortisone otic suspension for the treatment of acute otitis externa in adults and children — abstract, Methods. 2007. PMID 18035194, DOI 10.1016/j.clinthera.2007.09.005. Read the source
26. Cochrane Database of Systematic Reviews. Interventions for acute otitis externa — abstract, Authors' conclusions. 2010. PMID 20091565, DOI 10.1002/14651858.cd004740.pub2. Read the source
27. The Laryngoscope. Topical ciprofloxacin/dexamethasone is superior to ciprofloxacin alone in pediatric patients with acute otitis media and otorrhea through tympanostomy tubes — abstract, Methods. 2003. PMID 14660913, DOI 10.1097/00005537-200312000-00011. Read the source
28. DailyMed, U.S. National Library of Medicine (Sun Pharmaceutical Industries, Inc.). CIPROFLOXACIN AND DEXAMETHASONE suspension/ drops - FDA prescribing information (section: 3 DOSAGE FORMS AND STRENGTHS). 2026. Read the source
29. DailyMed, U.S. National Library of Medicine (Sun Pharmaceutical Industries, Inc.). CIPROFLOXACIN AND DEXAMETHASONE suspension/ drops - FDA prescribing information (section: 4 CONTRAINDICATIONS). 2026. Read the source