Medications · October 3, 2026 · Memios · 25 min read

Ketorolac tromethamine

For short-term severe acute pain the evidence is reasonably good: pooled single-dose trials give a number-needed-to-treat of about 3 for at least half the pain relieved.

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Photograph for Ketorolac tromethamine: plain unmarked tablets in a dish beside a glass of water on pale linen.

TLDR

  • Boxed warning: These events can occur at any time during use and without warning symptoms.
  • Well established. For short-term severe acute pain the evidence is reasonably good: pooled single-dose trials give a number-needed-to-treat of about 3 for at least half the pain relieved, and in the emergency department a 10 mg intravenous dose worked as well as 30 mg.
  • What it is: Ketorolac tromethamine is a synthetic non-steroidal anti-inflammatory drug given by injection into a vein or muscle, by mouth as a short continuation course, as a nasal spray, and as eye drops.
  • Main use: Short-term management of moderately severe acute pain requiring analgesia at the opioid level (well supported).
  • Off-label uses (not on the FDA label): Acute migraine attack (limited evidence); Acute renal colic (limited evidence); Acute pain in children in the emergency department (limited evidence).
  • Recommended dose (official position): Dosing is set by the prescriber, not by the reader. As a position, the US label (SPL effective 2026-09-29) gives single-dose intramuscular 60 mg and intravenous 30 mg for patients under 65, and 30 mg intramuscular or 15 mg intravenous for patients 65 or older, renally impaired, or under 50 kg.
  • Studied dose (a trial dose, not a recommendation): A randomised emergency-department trial gave single intravenous doses of 10, 15 and 30 mg. Findings citing that trial: 1 against.
  • Upper limit: As a position, the same label caps ketorolac tablets at 40 mg a day and ketorolac injection at 120 mg a day for adults generally, and separately caps injection at 60 mg total per day in patients 65 years or older.
  • What goes wrong: 5 findings on harm. Compared with parenteral opiates, parenteral ketorolac was associated with more gastrointestinal bleeding, and the excess roughly doubled once treatment ran beyond five days.
  • Interactions: 7 recorded, including Aspirin and other NSAIDs, Aspirin (effect on free ketorolac in the blood), Warfarin and other anticoagulants, Probenecid.
  • Common myth: A bigger dose of ketorolac is a stronger painkiller, so it is worth asking for more.

What it is

Ketorolac tromethamine is a synthetic non-steroidal anti-inflammatory drug given by injection into a vein or muscle, by mouth as a short continuation course, as a nasal spray, and as eye drops. It is a racemic mixture, and the pain-relieving activity sits in the S-enantiomer. It is eliminated mainly by the kidneys. Unlike an opioid it has no sedative or anxiolytic effect.

What the research says

For short-term severe acute pain the evidence is reasonably good: pooled single-dose trials give a number-needed-to-treat of about 3 for at least half the pain relieved, and in the emergency department a 10 mg intravenous dose worked as well as 30 mg. The problems are harms, not efficacy. A 20,000-course cohort study found more gastrointestinal bleeding than with opiates, and the risk roughly doubled once treatment passed five days. A separate 11,245-patient randomised trial found it no more dangerous than diclofenac or ketoprofen. Its US label carries a long boxed warning and a hard five-day limit.

Evidence grade: Well established.

How it works

Drug class: Nonsteroidal anti-inflammatory drug (NSAID); non-selective inhibitor of prostaglandin synthesis

Ketorolac blocks the enzymes that make prostaglandins, the local signalling molecules that amplify pain and inflammation and that also protect the stomach lining, maintain blood flow in the kidney and help platelets clump. Blocking them relieves pain, and the same block explains the stomach bleeding, kidney and bleeding risks. The label states the mechanism is not completely understood. (Source 1)

Boxed warning

Ketorolac tromethamine, a nonsteroidal anti-inflammatory drug (NSAID), is indicated for the short-term (up to 5 days in adults) management of moderately severe acute pain that requires analgesia at the opioid level. Oral ketorolac tromethamine is indicated only as continuation treatment following intravenous or intramuscular dosing of ketorolac tromethamine, if necessary. The total combined duration of use of oral ketorolac tromethamine and ketorolac tromethamine injection should not exceed 5 days.

(Source 2)

What it is used for

  • Pooled single-dose trials show real analgesia (oral 10 mg NNT 2.6; intramuscular 30 mg NNT 3.4). A randomised emergency-department trial found no extra benefit above 10 mg intravenously. Evidence: established. (Source 3)
  • A crossover randomised trial found ketorolac nasal spray beat placebo for two-hour pain relief (72.5% vs 38.3%). A systematic review of 13 trials found no significant difference from phenothiazines or metoclopramide and called the evidence base inadequate. Evidence: limited. (Source 4)
  • In a network meta-analysis of 12 randomised trials, ketorolac ranked highest for pain reduction at 30 and 60 minutes and morphine ranked lowest and had the highest odds of adverse events. Ranking statistics are not absolute effect sizes. Evidence: limited. (Source 5)
  • The US label states ketorolac is not indicated for paediatric patients. A systematic review of eight randomised trials found no significant difference between ketorolac and other analgesics including opioids. Evidence: limited. (Source 6)

Interactions

  • Aspirin and other NSAIDs (label): The label contraindicates taking ketorolac at the same time as aspirin or another NSAID, because the NSAID-related harms add up. (Source 2)
  • Aspirin (effect on free ketorolac in the blood) (label): Aspirin reduces how much ketorolac is bound to plasma protein, although the label says the clearance of the free drug is not altered and the clinical significance of this is not known. In the label's laboratory work, therapeutic salicylate concentrations cut ketorolac protein binding from about 99.2% to 97.5%, which it describes as a potential two-fold increase in unbound ketorolac. (Source 7)
  • Warfarin and other anticoagulants (pharmacokinetic study): Single-dose studies found no pharmacokinetic interaction, but the bleeding risks combine: the label says the effect of warfarin and NSAIDs on gastrointestinal bleeding is synergistic. In the 11,245-patient trial, anticoagulants after surgery roughly tripled surgical-site bleeding whichever NSAID was used. (Source 7)
  • Probenecid (pharmacokinetic study): Probenecid roughly tripled ketorolac exposure and doubled its half-life, so the combination is contraindicated. (Source 8)
  • Lithium (label): NSAIDs reduce the kidney’s clearance of lithium and raise its blood level, which matters because lithium has a narrow safety margin. (Source 8)
  • Methotrexate (theoretical): NSAIDs may block methotrexate clearance and increase its toxicity. The evidence cited on the label is laboratory work in rabbit kidney slices, not human trials. (Source 8)
  • Alcohol (label): Alcohol use is one of the factors the label lists as increasing gastrointestinal bleeding risk on NSAID therapy. No rate is given. (Source 9)

Stopping it

  • There is no taper. The label requires the course to stop at five days, and the risk of gastrointestinal complications rises with how long it is taken, which is why the limit exists rather than a weaning schedule. (Source 9)
  • The approved use is explicitly short-term with a switch to other analgesics as soon as possible. The injection SPL we parsed carries no drug-abuse-and-dependence section, and we found no literature on ketorolac dependence or a withdrawal syndrome. (Source 10)

What goes wrong

Compared with parenteral opiates, parenteral ketorolac was associated with more gastrointestinal bleeding, and the excess roughly doubled once treatment ran beyond five days. (Source 11)

  • Cohort study, Moderate certainty.
  • Size: 10,272 ketorolac courses vs 10,247 matched parenteral opiate courses.
  • Who: hospital inpatients at 35 Philadelphia-region hospitals, 1991 to 1993.
  • How long: course of analgesic therapy, 5 days or fewer versus longer.
  • Result: GI bleeding adjusted OR 1.30 (95% CI 1.11 to 1.52); operative site bleeding OR 1.02 (0.95 to 1.10); age 75+ GI bleeding OR 1.66 (1.23 to 2.25); therapy beyond 5 days OR 2.20 (1.36 to 3.57); dose-response trend test P < .001.
  • Funding: not stated; postmarketing surveillance study.

Limit of this finding: This is a postmarketing surveillance cohort, not a randomised trial: the doctors chose who got ketorolac and who got an opiate, so some of the difference may reflect who was given which drug rather than the drug itself. The odds ratios are associations.

The multivariate adjusted odds ratio (OR) comparing ketorolac with opiates for gastrointestinal bleeding was 1.30 (95% confidence interval [CI], 1.11 to 1.52); for operative site bleeding, the OR was 1.02 (95% CI, 0.95 to 1.10). The OR was elevated further in subjects 75 years of age or older for both gastrointestinal bleeding (OR = 1.66; 95% CI, 1.23 to 2.25) and operative site bleeding (OR = 1.12; 95% CI, 0.94 to 1.35). A dose-response relationship was evident between average daily ketorolac dose and both gastrointestinal bleeding and operative site bleeding (trend test P < .001 for both). When analgesic therapy lasted 5 or fewer days, ketorolac was associated with only a small increased risk of gastrointestinal bleeding (OR = 1.17; 95% CI, 0.99 to 1.30); when therapy was prolonged beyond 5 days, the OR was 2.20 (95% CI, 1.36 to 3.57). The association of ketorolac with operative site bleeding was not affected by duration of therapy.

Oral ketorolac 10 mg caused significantly more adverse effects than placebo in pooled single-dose trials. (Source 3)

  • Meta-analysis, Moderate certainty.
  • Size: 14 ketorolac reports.
  • Who: adults with moderate to severe postoperative pain.
  • How long: single dose.
  • Result: number-needed-to-harm for any adverse effect 7.3 (95% CI 4.7 to 17) for oral ketorolac 10 mg.
  • Funding: not stated.

Limit of this finding: Like the benefit figure from the same review, this is a single-dose postoperative estimate and does not describe a course of treatment.

Only with oral ketorolac 10 mg were there significantly more adverse effects than with placebo, with an NNH for any adverse effect of 7.3 (4.7-17).

The label lists gastrointestinal and other adverse experiences occurring in approximately 1% to 10% of patients, and footnotes nausea and headaches as occurring in more than 10%. (Source 12)

  • Official position, Certainty not rated.
  • Size: not stated.
  • Who: patients given ketorolac or other NSAIDs in clinical trials.
  • How long: up to 5 days of licensed use.
  • Result: reactions listed at approximately 1% to 10% include GI ulcers (gastric/duodenal), gross bleeding/perforation, abnormal renal function, anemia and increased bleeding time; nausea and headaches carry the footnote "* Incidence greater than 10%"
  • Funding: not stated (FDA-approved labelling)

In patients taking ketorolac tromethamine or other NSAIDs in clinical trials, the most frequently reported adverse experiences in approximately 1% to 10% of patients are: Gastrointestinal (GI) experiences including: abdominal pain constipation/diarrhea dyspepsia flatulence GI fullness GI ulcers (gastric/duodenal) gross bleeding/perforation heartburn nausea* stomatitis vomiting Other experiences: abnormal renal function anemia dizziness drowsiness edema elevated liver enzymes headaches* hypertension increased bleeding time injection site pain pruritus purpura rashes tinnitus sweating * Incidence greater than 10%

Alcohol and smoking are listed on the label among the factors that increase gastrointestinal bleeding risk during NSAID treatment, and even short courses carry risk. (Source 9)

  • Official position, Certainty not rated.
  • Size: not stated.
  • Who: patients treated with NSAIDs.
  • How long: short-term and longer therapy.
  • Result: no rate given; risk factors listed are corticosteroids or anticoagulants, longer therapy, smoking, alcohol, older age, poor general health.
  • Funding: not stated (FDA-approved labelling)

In addition to past history of ulcer disease, other factors that increase the risk for GI bleeding in patients treated with NSAIDs include concomitant use of oral corticosteroids, or anticoagulants, longer duration of NSAID therapy, smoking, use of alcohol, older age, and poor general health status.

The tablet boxed warning states its 40 mg daily maximum for adults and, in the same warning, requires the dose to be adjusted for people 65 or older, under 50 kg, or with moderately raised serum creatinine. (Source 13)

  • Official position, Certainty not rated.
  • Size: not stated.
  • Who: adults prescribed ketorolac tromethamine tablets as continuation of an injected course.
  • How long: combined injection-plus-tablet course not to exceed 5 days.
  • Result: 40 mg a day given as the adult maximum for tablets; dosage adjustment required for age 65 or older, body weight under 50 kg (110 lbs) and moderately elevated serum creatinine.
  • Funding: not stated.

SPECIAL POPULATIONS Dosage should be adjusted for patients 65 years or older, for patients under 50 kg (110 lbs) of body weight (see DOSAGE AND ADMINISTRATION ) and for patients with moderately elevated serum creatinine (see WARNINGS ).

What the evidence supports

Pooled single-dose trials show oral ketorolac 10 mg gives at least half the pain relieved in roughly one of every 2.6 patients treated after surgery. (Source 3)

  • Meta-analysis, Moderate certainty.
  • Size: 14 ketorolac reports (six intramuscular, eight oral); most intramuscular information in 176 patients at 30 mg.
  • Who: adults with moderate to severe postoperative pain.
  • How long: single dose, pain outcomes summed over 4-6 hours.
  • Result: Oral ketorolac 10 mg NNT 2.6 (95% CI 2.3-3.1) and intramuscular 30 mg NNT 3.4 (2.5-4.9) for at least 50% pain relief over 4-6 hours after one dose; the review states oral 10 mg was consistently at least as effective as 30 mg intramuscular.
  • Funding: not stated.

Limit of this finding: These numbers are for ONE dose given for moderate to severe pain after surgery, and "works" means at least half the pain relieved over the next four to six hours. They say nothing about repeated dosing, about migraine or about any other kind of pain. Oddly, the oral 10 mg dose came out better than the 30 mg injection, which is what the review reports rather than an error.

For ketorolac, 14 reports met the inclusion criteria (six i.m. and eight oral). Most i.m. information (176 patients) was available for the 30 mg dose, which had an NNT of 3.4 (2.5-4.9). Most oral information was available for the 10 mg dose, which had an NNT of 2.6 (2.3-3.1). Oral ketorolac 10 mg was consistently at least as effective as ketorolac 30 mg i.m.

Ketorolac nasal spray beat placebo for two-hour pain relief in a crossover randomised migraine trial. (Source 4)

  • Randomized trial, Low certainty.
  • Size: 72 randomised, 54 treated at least one attack, 152 treated attacks.
  • Who: adults with episodic migraine, 2 or more attacks a month.
  • How long: three attacks, crossover; outcomes at 2 and 24 hours.
  • Result: 2-hour pain relief 72.5% ketorolac vs 38.3% placebo (P < .001); 2-hour pain freedom 43.1% vs 18.4% (P = .004); 24-hour sustained pain freedom 35.3% vs 12.2% (P = .003)
  • Funding: not stated.

Both ketorolac NS (72.5%, P < .001) and sumatriptan NS (69.4%, P = .001) were more effective than placebo (38.3%) for 2-hour pain relief and 2-hour pain freedom (ketorolac: 43.1%, P = .004; sumatriptan: 36.7%, P = .046; placebo: 18.4%).

In a network meta-analysis of renal colic trials ketorolac ranked best for pain at 30 and 60 minutes while morphine ranked worst and had the most adverse events. (Source 5)

  • Meta-analysis, Low certainty.
  • Size: 12 randomised controlled trials.
  • Who: adults with acute renal colic.
  • How long: 15 to 60 minutes after a single analgesic.
  • Result: ketorolac ranked first for pain at 30 and 60 minutes with P-scores of 0.84 and 0.99, which the abstract does not match to individual time points; morphine ranked last for pain (P-score 0.07) and had the highest odds of adverse events (0.89)
  • Funding: not stated.

Limit of this finding: The abstract prints two ranking scores for ketorolac, 0.84 and 0.99, for the 30 and 60 minute time points without saying which score belongs to which point, so do not read either figure as tied to a particular time. These P-scores are ranking probabilities, not effect sizes: they say which drug came out on top, not by how much.

As per the P-scores, acetaminophen was the most effective in reducing pain score at 15 min (P-score = 0.74). Ketorolac was the most effective in reducing the pain score at 30 and 60 min (P-score = 0.84) (P-score = 0.99), whereas morphine was the least effective (P-score = 0.07). Moreover, morphine was correlated with the highest odds of adverse events after treatment (P-score = 0.89).

What the evidence does not support

Intravenous ketorolac at 10 mg relieved acute pain as well as 15 mg or 30 mg, so higher doses added no analgesia. (Source 14)

  • Randomized trial, Moderate certainty.
  • Size: 240 patients, 80 per dose group.
  • Who: emergency-department patients aged 18 to 65 with pain score 5 or more.
  • How long: single dose, outcomes to 120 minutes.
  • Result: mean pain score fell from 7.7, 7.5 and 7.8 at baseline to 5.1, 5.0 and 4.8 at 30 minutes for 10, 15 and 30 mg; no between-group difference.
  • Funding: not stated.

Limit of this finding: The three ranges the trial reports (4.5 to 5.7, 4.5 to 5.6, 4.2 to 5.4) are confidence intervals around the average pain score at 30 minutes in each dose group. They are not intervals around a difference between doses, so do not read them as an effect size.

We enrolled 240 subjects (80 in each dose group). At 30 minutes, substantial pain reduction was demonstrated without any differences between the groups (95% confidence intervals 4.5 to 5.7 for the 10-mg group, 4.5 to 5.6 for the 15-mg group, and 4.2 to 5.4 for the 30-mg group). The mean numeric rating scale pain scores at baseline were 7.7, 7.5, and 7.8 and improved to 5.1, 5.0, and 4.8, respectively, at 30 minutes.

The label itself states the peak analgesic effect does not differ significantly across the recommended dose range, and that larger doses mainly lengthen the duration; it gives two different times to peak effect in two different sections. (Source 1)

  • Official position, Certainty not rated.
  • Size: not stated.
  • Who: adults given ketorolac tromethamine.
  • How long: not stated.
  • Result: peak analgesic effect stated as 2 to 3 hours in CLINICAL PHARMACOLOGY and as a maximum effect 1 to 2 hours after intravenous or intramuscular dosing in DOSAGE AND ADMINISTRATION; not statistically significantly different over the recommended dose range.
  • Funding: not stated (FDA-approved labelling)

Limit of this finding: This label contradicts itself on timing. The CLINICAL PHARMACOLOGY section quoted here says the peak analgesic effect comes within 2 to 3 hours, while the same label's DOSAGE AND ADMINISTRATION section says the maximum effect comes 1 to 2 hours after an injected dose. Treat the exact time to peak effect as unsettled by this document. What both sections agree on is that a bigger dose does not give a bigger peak effect.

The peak analgesic effect of ketorolac tromethamine occurs within 2 to 3 hours and is not statistically significantly different over the recommended dosage range of ketorolac tromethamine. The greatest difference between large and small doses of ketorolac tromethamine by either route is in the duration of analgesia.

In children treated in the emergency department, ketorolac was not better than other analgesics including opioids. (Source 6)

  • Systematic review, Low certainty.
  • Size: 8 randomised controlled trials.
  • Who: children with acute pain in the emergency department.
  • How long: acute, single-episode treatment.
  • Result: no significant differences in analgesic performance between ketorolac and other drugs; review states the evidence remains insufficient.
  • Funding: not stated.

The meta-analysis revealed no significant differences in analgesic performance between ketorolac and other drugs, including opioids and other NSAIDs. The risk of bias across the studies was evaluated. However, the evidence remains insufficient to confidently recommend a specific intervention, highlighting the need for further research to guide clinical decision-making.

Where the evidence is mixed

For acute migraine, injected (parenteral) ketorolac was not significantly different from phenothiazines or metoclopramide on one-hour pain reduction. (Source 15)

  • Systematic review, Low certainty.
  • Size: 13 trials, 944 participants.
  • Who: patients presenting to hospital with acute migraine headache, treated with parenteral (injected) ketorolac.
  • How long: single attack, outcomes at 1 and 24 hours.
  • Result: pain intensity at 1 h: ketorolac vs phenothiazines SMD 0.09, p = 0.74; vs metoclopramide SMD 0.02, p = 0.95; adverse-effect frequency vs metoclopramide RR 1.07, p = 0.82.
  • Funding: not stated.

Limit of this finding: The review looked only at ketorolac given by injection, so it does not tell you about ketorolac tablets for migraine. It reports p-values with no confidence intervals, so each "no significant difference" rests on a single p-value from a small number of trials, and the review itself says the number of trials available was inadequate.

There were no significant differences in the reduction of pain intensity at 1 h under the comparisons between ketorolac and phenothiazines (standard mean difference [SMD] = 0.09, p = 0.74) or metoclopramide (SMD = 0.02, p = 0.95).

In a randomised trial of 11,245 surgical patients, serious adverse outcomes were uncommon and no more frequent with ketorolac than with diclofenac or ketoprofen. (Source 16)

  • Randomized trial, Moderate certainty.
  • Size: 11,245 patients (5,634 ketorolac, 5,611 comparator) at 49 European hospitals.
  • Who: adults after elective major surgery.
  • How long: 30 days of follow-up.
  • Result: 155 patients (1.38%) had a serious adverse outcome: 19 deaths (0.17%), 117 surgical site bleeds (1.04%), 12 allergic reactions (0.12%), 10 acute renal failure (0.09%), 4 GI bleeds (0.04%); postoperative anticoagulants raised surgical site bleeding equally with ketorolac (OR 2.65, 95% CI 1.51-4.67) and comparators (OR 3.58, 1.93-6.70)
  • Funding: not stated in the abstract; trial run in response to two European regulatory reviews.

Limit of this finding: The abstract counts 155 patients with a serious adverse outcome but lists 162 individual events, which only adds up if some patients had more than one event; the abstract does not say so. It also prints "0. 17%" with a stray space, meaning 0.17%. This trial was designed to compare safety, not to measure how well the drugs relieved pain.

A total of 11,245 patients completed the trial at 49 European hospitals. Of these, 5634 patients received ketorolac and 5611 patients received one of the comparators. 155 patients (1.38%) had a serious adverse outcome, with 19 deaths (0. 17%), 117 patients with surgical site bleeding (1.04%), 12 patients with allergic reactions (0.12%), 10 patients with acute renal failure (0.09%), and four patients with gastrointestinal bleeding (0.04%). There were no differences between ketorolac and ketoprofen or diclofenac. Postoperative anticoagulants increased the risk of surgical site bleeding equally with ketorolac (odds ratio=2.65, 95% CI=1.51-4.67) and the comparators (odds ratio=3.58, 95% CI=1.93-6.70).

Where the research disagrees

Whether ketorolac is more dangerous than other injectable NSAIDs

  • Strom and colleagues, postmarketing inception cohort of 20,519 analgesic courses, cohort study with opiate comparator: The multivariate adjusted odds ratio (OR) comparing ketorolac with opiates for gastrointestinal bleeding was 1.30 (95% confidence interval [CI], 1.11 to 1.52) (Source 11)
  • Forrest and colleagues, randomised multicentre trial of 11,245 surgical patients, randomised controlled trial with active NSAID comparators: There were no differences between ketorolac and ketoprofen or diclofenac. (Source 16)

Which boxed warning applies - the injection, the tablet and the ophthalmic solution carry different label text

  • Ketorolac tromethamine injection SPL (ANTHEA PHARMA, effective 2026-09-29), FDA-approved labelling, boxed warning section LOINC 34066-1: Doses of ketorolac tromethamine injection are not to exceed 60 mg (total dose per day) in these patients. (Source 2)
  • Ketorolac tromethamine tablets SPL (REMEDYREPACK, effective 2026-08-28), FDA-approved labelling, boxed warning section LOINC 34066-1; the same boxed warning requires the dose to be adjusted for patients 65 years or older, for patients under 50 kg (110 lbs) and for patients with moderately elevated serum creatinine, so the 40 mg figure is not a universal adult ceiling: Increasing the dose of ketorolac tromethamine beyond a daily maximum of 40 mg in adults will not provide better efficacy but will increase the risk of developing serious adverse events. (Source 13)

How much

  • Reference intake: Dosing is set by the prescriber, not by the reader. As a position, the US label (SPL effective 2026-09-29) gives single-dose intramuscular 60 mg and intravenous 30 mg for patients under 65, and 30 mg intramuscular or 15 mg intravenous for patients 65 or older, renally impaired, or under 50 kg. (Source 17)
  • Upper limit: As a position, the same label caps ketorolac tablets at 40 mg a day and ketorolac injection at 120 mg a day for adults generally, and separately caps injection at 60 mg total per day in patients 65 years or older, patients under 50 kg (110 lbs) and patients with moderately elevated serum creatinine, for whom it says the dose must be adjusted. It is not indicated for children, and it limits the combined injection-plus-tablet course to 5 days. (Source 2)
  • Studied: A randomised emergency-department trial gave single intravenous doses of 10, 15 and 30 mg. (Source 14)
  • Studied: Pooled single-dose trials used oral ketorolac 10 mg and intramuscular ketorolac 30 mg. (Source 3)
  • Studied: A randomised migraine trial used ketorolac nasal spray 31.5 mg. (Source 4)

A common belief, and what the research shows

The belief: A bigger dose of ketorolac is a stronger painkiller, so it is worth asking for more.

What the research shows: Two independent sources say otherwise. A randomised trial of 240 emergency-department patients found 10 mg intravenously worked as well as 30 mg: "Rates of rescue analgesia were similar, and there were no serious adverse events." The label agrees that peak analgesia does not rise with dose: "The peak analgesic effect of ketorolac tromethamine occurs within 2 to 3 hours and is not statistically significantly different over the recommended dosage range of ketorolac tromethamine." Harms, by contrast, do rise with dose and duration: Strom and colleagues found "A dose-response relationship was evident between average daily ketorolac dose and both gastrointestinal bleeding and operative site bleeding (trend test P < .001 for both)."

Questions and answers

What is it?

Ketorolac tromethamine is a prescription non-steroidal anti-inflammatory drug used for short bursts of severe pain, usually after surgery. It is given into a vein or muscle, with tablets only as a short continuation, and also exists as a nasal spray and as eye drops. It is a mirror-image mixture and only the S-form does the pain relief. (Source 1)

What does it do in the body?

It blocks the making of prostaglandins, the local messengers that amplify pain. The label says the mechanism is not completely understood but is probably prostaglandin synthetase inhibition. Unlike an opioid it does not sedate or calm you, and its peak effect does not get stronger with a bigger dose. (Source 1)

Is it good or bad for you?

Good in a narrow window, bad outside it. For a few days of severe acute pain the trial evidence supports it, and a randomised trial of 11,245 surgical patients found serious harms uncommon and no worse than other injectable NSAIDs. Beyond five days a 20,000-course cohort study found gastrointestinal bleeding risk roughly doubled, and the boxed warning lists ulcers, bleeding, heart attack, stroke and kidney failure. (Source 11)

How do you get more of it?

This is a prescription-only drug, not something you top up. Treatment has to start with an injection into a vein or muscle and tablets are only a continuation of that course. The combined course must not exceed five days. Reporting how studied doses were given is not advice to take them. (Source 10)

If it is harmful, what reduces it?

Stopping the drug is what clears it; there is no antidote and no taper. About 92% of a dose leaves in the urine, so clearance depends on the kidneys, which is also why the label contraindicates it in advanced kidney impairment. (Source 18)

Why might someone be low in it or missing it?

Does not apply in the nutrient sense: ketorolac is a manufactured drug, not something the body makes or stores, so nobody is "low" in it. Someone may be unable to have it because the label contraindicates it in active ulcer disease, prior gastrointestinal bleeding, advanced kidney impairment, bleeding risk, before major surgery, in labour, in children, and with aspirin or another NSAID. (Source 2)

Which whole foods contain it or feed it?

No whole food contains ketorolac. Food matters in the other direction: alcohol is one of the factors the label names as raising gastrointestinal bleeding risk on NSAID treatment, alongside smoking, older age and anticoagulants. (Source 9)

What happens if you do not have it?

Nothing happens from not having it, because the body does not need it. The question for a person in severe acute pain is what else is used instead. In renal colic a network meta-analysis found acetaminophen and ketorolac the most effective and morphine the least, with morphine carrying the highest odds of adverse events. (Source 5)

How can you test for it?

There is no routine blood test for ketorolac and no target level. What gets monitored is harm, not drug level: kidney function, signs of stomach bleeding and bleeding time. Plasma concentrations are described in pharmacokinetic studies on the label, where ketorolac is 99.2% bound to plasma protein, but these are research measures rather than a clinical test. (Source 12)

References

  1. DailyMed / US FDA Structured Product Label (ANTHEA PHARMA, SPL effective 2026-09-29). Ketorolac Tromethamine Injection, USP - CLINICAL PHARMACOLOGY. 2026. Read the source
  2. DailyMed / US FDA Structured Product Label (ANTHEA PHARMA, SPL effective 2026-09-29). Ketorolac Tromethamine Injection, USP - FDA prescribing information (Structured Product Label, boxed warning section, LOINC 34066-1). 2026. Read the source
  3. British Journal of Anaesthesia. Single-dose ketorolac and pethidine in acute postoperative pain: systematic review with meta-analysis.. 2000. PMID 10740547, DOI 10.1093/oxfordjournals.bja.a013381. Read the source
  4. Headache. A Randomized Trial of Ketorolac vs. Sumatripan vs. Placebo Nasal Spray (KSPN) for Acute Migraine.. 2016. PMID 26840902, DOI 10.1111/head.12767. Read the source
  5. American Journal of Emergency Medicine. Comparison of acetaminophen, ketamine, or ketorolac versus morphine in the treatment of acute renal colic: A network meta-analysis.. 2023. PMID 37679264, DOI 10.1016/j.ajem.2023.08.029. Read the source
  6. European Journal of Pediatrics. Ketorolac use in the emergency department in children: a systematic review and meta-analysis.. 2025. PMID 40229463, DOI 10.1007/s00431-025-06128-2. Read the source
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