Medications · October 3, 2026 · Memios · 23 min read

Mesalamine

The evidence is strongest, and of high certainty, for ulcerative colitis: oral 5-ASA beats placebo both for getting mild-to-moderate disease into remission and for keeping it there.

Mesalamine (5-aminosalicylic acid, 5-ASA)mesalazine5-ASA5-aminosalicylic acidmedicine research
Photograph for Mesalamine: plain unmarked tablets in a dish beside a glass of water on pale linen.

TLDR

  • Well established. The evidence is strongest, and of high certainty, for ulcerative colitis: oral 5-ASA beats placebo both for getting mild-to-moderate disease into remission and for keeping it there.
  • What it is: Mesalamine is 5-aminosalicylic acid, a small anti-inflammatory molecule, formulated so that it is released in the colon or lower small bowel rather than absorbed in the stomach.
  • Main use: Induction of remission in mildly to moderately active ulcerative colitis (adults) (well supported).
  • Other approved uses: Maintenance of remission in quiescent ulcerative colitis (well supported); Mildly to moderately active ulcerative colitis in children weighing at least 24 kg (limited evidence); Distal / left-sided ulcerative colitis, rectal (enema or suppository) 5-ASA (well supported).
  • Off-label uses (not on the FDA label): Chemoprevention of colorectal cancer in inflammatory bowel disease (disputed).
  • Uses NOT supported by research: Crohn's disease - maintenance of medically induced remission; Crohn's disease - induction of remission.
  • Recommended dose (official position): Dosing is set by the prescriber.
  • Studied dose (a trial dose, not a recommendation): As reported in section 14.1 Clinical Studies of the label, the two placebo-controlled induction trials gave 2.4 g or 4.8 g once daily for 8 weeks (in Study 1 the 2.4 g dose was split as 1.2 g twice daily). Findings citing that trial: 1 for.
  • Upper limit: The highest adult dosage stated in section 2 of the LIALDA Highlights of Prescribing Information is 4.8 g once daily, used for induction only; no separate toxicological upper limit is set.
  • What goes wrong: 6 findings on harm. In the induction trials of the 1.2 g tablet, headache was the commonest adverse reaction and pancreatitis occurred in under 1% but led to stopping the drug.
  • Interactions: 4 recorded, including Non-steroidal anti-inflammatory drugs and other nephrotoxic drugs, Azathioprine and 6-mercaptopurine, Food, in particular a high-fat meal, Urinary normetanephrine laboratory test.
  • Common myth: Mesalamine is an inflammatory bowel disease drug, so it should work for Crohn's disease as well as ulcerative colitis.

What it is

Mesalamine is 5-aminosalicylic acid, a small anti-inflammatory molecule, formulated so that it is released in the colon or lower small bowel rather than absorbed in the stomach. LIALDA's 1.2 g delayed-release tablet, for example, is coated with a pH-dependent polymer that breaks down at or above pH 6.8. It is also given rectally as an enema or suppository. It is the active anti-inflammatory part of the older drug sulfasalazine, separated from the sulfapyridine carrier.

What the research says

The evidence is strongest, and of high certainty, for ulcerative colitis: oral 5-ASA beats placebo both for getting mild-to-moderate disease into remission and for keeping it there. For Crohn's disease the same reviews find essentially nothing: oral 5-ASA is no better than placebo for maintaining remission, and low- and high-dose mesalamine are not superior to placebo for inducing it. Rectal 5-ASA works well for disease limited to the left colon and rectum. Its mechanism is still not fully explained.

Evidence grade: Well established.

How it works

Drug class: Aminosalicylate (5-aminosalicylic acid); topically acting intestinal anti-inflammatory

Mesalamine acts on the lining of the colon itself rather than through the bloodstream. The label says the mechanism is not fully understood, but that it appears to damp inflammation locally, possibly by blocking cyclooxygenase and reducing prostaglandin production in the colon. (Source 1)

What it is used for

  • High-certainty Cochrane evidence from 11 placebo-controlled trials: 71% of 5-ASA participants failed to enter clinical remission versus 83% on placebo, i.e. roughly 29% versus 17% did enter remission. In the two LIALDA registration trials remission at week 8 was 34% and 41% on 2.4 g/day versus 13% and 22% on placebo. Evidence: established. (Source 2)
  • High-certainty Cochrane evidence: about 37% of 5-ASA participants relapsed at six to 12 months versus 55% on placebo. The same review found 5-ASA inferior to sulfasalazine for this purpose. Evidence: established. (Source 3)
  • The label states that effectiveness in children weighing at least 24 kg rests on the adult trials plus one multicentre randomised double-blind trial in 105 paediatric patients aged 5 to 17, with additional pharmacokinetic analyses, and that effectiveness has not been established below 24 kg. That is a much smaller evidence base than the adult one. Evidence: limited. (Source 4)
  • A Cochrane review of 38 trials found rectal 5-ASA superior to placebo for symptomatic, endoscopic and histological improvement and remission, and superior to rectal corticosteroids. Results are given as pooled odds ratios, not absolute rates. Evidence: established. (Source 5)
  • Twelve placebo-controlled trials, 2,146 participants: 53% of 5-ASA patients relapsed at 12 months versus 54% on placebo. The review concluded additional randomised trials may not be justified. Evidence: not-supported. (Source 6)
  • Low-dose mesalamine (1-2 g/day) was not superior to placebo (23% vs 15% remission at week 6), and high-dose controlled-release mesalamine 4 g/day produced a clinically non-significant CDAI reduction of 19.8 points. Evidence: not-supported. (Source 7)
  • A meta-analysis restricted to non-referral populations found no protective association (pooled adjusted OR 0.95, 95% CI 0.66-1.38), while nine clinic-based studies pooled to OR 0.58. The authors called the results inconsistent and dependent on which populations were included. All of it is observational. Evidence: disputed. (Source 8)

Interactions

  • Non-steroidal anti-inflammatory drugs and other nephrotoxic drugs (label): Taking mesalamine together with drugs that are hard on the kidneys may add to the risk of kidney damage; the label advises monitoring kidney function. (Source 9)
  • Azathioprine and 6-mercaptopurine (label): Combining mesalamine with these immunosuppressants may increase the risk of blood disorders and bone marrow failure; blood counts are monitored. (Source 10)
  • Food, in particular a high-fat meal (pharmacokinetic study): A high-fat meal delays absorption of the 1.2 g delayed-release tablet but increases how much drug reaches the bloodstream - peak levels by 91% and total exposure by 16%. The clinical trials gave the tablet with food. (Source 11)
  • Urinary normetanephrine laboratory test (label): Mesalamine's main metabolite looks like normetanephrine on one common laboratory method, so results can be spuriously high - relevant if someone is being investigated for a phaeochromocytoma. (Source 12)

Stopping it

  • In a territory-wide Hong Kong cohort of 1,408 ulcerative colitis patients who had been in corticosteroid-free remission for at least a year, stopping 5-ASA was not associated with a higher risk of flare over a median 41.8 months. This is retrospective observational data, not a randomised withdrawal trial, and the authors call for prospective trials. (Source 13)
  • The same cohort's authors framed the conclusion cautiously, saying prospective trials are still needed before stopping is treated as established practice. (Source 14)
  • Mesalamine is not a drug of dependence and no withdrawal syndrome is described. The label's only stopping instructions are about stopping for harm: stop promptly if acute intolerance syndrome is suspected, and discontinue if kidney function deteriorates. (Source 15)

What goes wrong

Mesalamine can cause an acute intolerance syndrome that mimics a colitis flare, reported in about 3% of patients in controlled trials of mesalamine or sulfasalazine. (Source 15)

  • Official position, Low certainty.
  • Size: Not stated; pooled across controlled clinical trials.
  • Who: Patients treated with mesalamine or sulfasalazine.
  • How long: Not stated.
  • Result: Approximately 3% of patients; symptoms include cramping, acute abdominal pain and bloody diarrhoea, sometimes fever, headache and rash.
  • Funding: Manufacturer label (Takeda), FDA-approved labelling.

Although the exact frequency of occurrence has not been determined, it has occurred in 3% of patients in controlled clinical trials of mesalamine or sulfasalazine.

Kidney injury, including interstitial nephritis and rarely renal failure, is a recognised harm of mesalamine-containing products. (Source 16)

  • Official position, Low certainty.
  • Size: Not quantified.
  • Who: Patients given mesalamine or drugs converted to mesalamine.
  • How long: Any.
  • Result: Minimal change disease, acute and chronic interstitial nephritis and, rarely, renal failure; in animal studies the kidney was the principal organ of mesalamine toxicity.
  • Funding: Manufacturer label (Takeda), FDA-approved labelling.

Renal impairment, including minimal change disease, acute and chronic interstitial nephritis, and, rarely, renal failure, has been reported in patients given products such as LIALDA that contain mesalamine or are converted to mesalamine.

Biopsy-confirmed interstitial nephritis has been reported in individual patients on 5-ASA, in one report leaving chronic renal failure. (Source 17)

  • Case report, Very low certainty.
  • Size: 2 patients.
  • Who: Patients with inflammatory bowel disease treated with 5-ASA.
  • How long: Not stated.
  • Result: Both had a trial of steroid therapy; one had partial recovery of renal function, the other was in chronic renal failure and likely approaching dialysis.
  • Funding: Not stated.

We report two cases of biopsy-confirmed interstitial nephritis in patients being treated with 5-ASA.

In the induction trials of the 1.2 g tablet, headache was the commonest adverse reaction and pancreatitis occurred in under 1% but led to stopping the drug. (Source 18)

  • Randomized trial, Moderate certainty.
  • Size: LIALDA 2.4 g n=177, 4.8 g n=179, placebo n=179.
  • Who: Adults with mildly to moderately active ulcerative colitis.
  • How long: 8 weeks.
  • Result: Headache 6% (2.4 g) and 3% (4.8 g) vs <1% placebo; flatulence 4% and 3% vs 3%; abnormal liver function test <1% and 2% vs 1%.
  • Funding: Manufacturer trials reported in the FDA label.

Headache 6% 3% <1% Flatulence 4% 3% 3%

Rare but serious harms reported after marketing include pancreatitis, myocarditis and pericarditis, liver failure, blood dyscrasias and severe skin reactions. (Source 19)

  • Case series, Very low certainty.
  • Size: Spontaneous reports from a population of uncertain size.
  • Who: Users of LIALDA or other mesalamine-containing products.
  • How long: Post-approval.
  • Result: Frequency cannot be reliably estimated; reports include pericarditis, myocarditis, hepatitis, liver failure, agranulocytosis, aplastic anaemia, interstitial lung disease, renal failure and interstitial nephritis.
  • Funding: Manufacturer label (Takeda), FDA-approved labelling.

Hematologic: agranulocytosis, aplastic anemia

Mesalamine can form kidney stones made entirely of the drug, which do not show up on standard X-ray or CT. (Source 20)

  • Official position, Very low certainty.
  • Size: Not quantified.
  • Who: Patients taking mesalamine.
  • How long: Any.
  • Result: Stones with 100% mesalamine content reported; radiotransparent and undetectable by standard radiography or CT.
  • Funding: Manufacturer label (Takeda), FDA-approved labelling.

Cases of nephrolithiasis have been reported with the use of mesalamine, including stones with a 100% mesalamine content.

What the evidence supports

Oral 5-ASA is better than placebo for inducing remission in active ulcerative colitis, with high-certainty evidence and a modest absolute difference. (Source 2)

  • Systematic review, High certainty.
  • Size: 2,387 participants, 11 studies (54 studies and 9,612 participants in the whole review)
  • Who: Adults aged 18 or over with active ulcerative colitis.
  • How long: Induction trials, typically 8 weeks.
  • Result: Failure to enter clinical remission 71% (1107/1550) on 5-ASA vs 83% (695/837) on placebo; RR 0.86, 95% CI 0.82 to 0.89.
  • Funding: Cochrane review; the senior author discloses extensive pharmaceutical industry payments and authored one included study.

Seventy-one per cent (1107/1550) of 5-ASA participants failed to enter clinical remission compared to 83% (695/837) of placebo participants (RR 0.86, 95% CI 0.82 to 0.89; 2387 participants, 11 studies; high-certainty evidence).

Oral 5-ASA is better than placebo for keeping ulcerative colitis in remission. (Source 3)

  • Systematic review, High certainty.
  • Size: 1,555 participants, 8 studies (44 studies and 9,967 participants in the whole review)
  • Who: Adults with quiescent ulcerative colitis.
  • How long: Six to 12 months.
  • Result: Relapse 37% (335/907) on 5-ASA vs 55% (355/648) on placebo; RR 0.68, 95% CI 0.61 to 0.76.
  • Funding: Cochrane review; same author group as the induction review, with industry disclosures.

About 37% (335/907) of 5-ASA participants relapsed at six to 12 months compared to 55% (355/648) of placebo participants (RR 0.68, 95% CI 0.61 to 0.76; 8 studies, 1555 participants; high-certainty evidence).

In the two registration trials of the 1.2 g delayed-release tablet, remission at week 8 was reached by about a third to two-fifths of patients versus 13% to 22% on placebo. (Source 21)

  • Randomized trial, Moderate certainty.
  • Size: 517 adults across two trials (Study 1 n=262, Study 2 n=255)
  • Who: Adults with mildly to moderately active ulcerative colitis, mean age 42, 80% Caucasian.
  • How long: 8 weeks.
  • Result: Remission at week 8: 2.4 g/day 30/88 (34%) and 34/84 (41%); 4.8 g/day 26/89 (29%) and 35/85 (41%); placebo 11/85 (13%) and 19/86 (22%)
  • Funding: Manufacturer trials reported in the FDA label (NCT00503243, NCT00548574)

LIALDA 2.4 g/day 30/88 (34) 34/84 (41) LIALDA 4.8 g/day 26/89 (29) 35/85 (41) Placebo 11/85 (13) 19/86 (22)

Rectal 5-ASA is superior to placebo and to rectal corticosteroids for active distal ulcerative colitis, reported as pooled odds ratios rather than absolute rates. (Source 5)

  • Systematic review, Moderate certainty.
  • Size: 38 studies.
  • Who: Patients with mild to moderately active distal ulcerative colitis.
  • How long: Induction trials.
  • Result: Peto OR for symptomatic improvement 8.87 (95% CI 5.30 to 14.83); symptomatic remission 8.30 (95% CI 4.28 to 16.12); vs rectal corticosteroids OR 1.56 and 1.65.
  • Funding: Cochrane review, funding not stated in the abstract.

Rectal 5-ASA was superior to placebo for inducing symptomatic, endoscopic and histological improvement and remission, with POR for symptomatic improvement 8.87 (8 trials, 95% CI: 5.30 to 14.83; P < 0.00001)

What the evidence does not support

Oral 5-ASA does not keep Crohn's disease in remission: relapse rates at 12 months were the same as placebo. (Source 6)

  • Systematic review, Moderate certainty.
  • Size: 2,014 patients across 11 studies (12 studies, 2,146 participants in the review)
  • Who: Patients with Crohn's disease in medically induced remission.
  • How long: 12 months.
  • Result: Relapse 53% (526/998) on 5-ASA (1.6 to 4 g/day) vs 54% (544/1016) on placebo; RR 0.98, 95% CI 0.91 to 1.07.
  • Funding: Cochrane review, funding not stated in the abstract.

Fifty-three per cent (526/998) of 5-ASA patients (dose 1.6 g to 4 g/day) relapsed at 12 months compared to 54% (544/1016) of placebo patients (RR 0.98, 95% CI 0.91 to 1.07; 11 studies; 2014 patients; moderate-quality evidence).

The Crohn's maintenance reviewers concluded that further trials of 5-ASA for this purpose may not be justified. (Source 22)

  • Systematic review, Moderate certainty.
  • Size: 12 studies, 2,146 participants.
  • Who: Crohn's disease in medically induced remission.
  • How long: 12 to 24 months.
  • Result: No evidence of superiority over placebo on any efficacy outcome.
  • Funding: Cochrane review, funding not stated in the abstract.

We found no evidence in this review to suggest that oral 5-ASA preparations are superior to placebo for the maintenance of medically-induced remission in patients with Crohn's disease.

Mesalamine is not superior to placebo for inducing remission in active Crohn's disease, at either low or high dose. (Source 7)

  • Systematic review, Low certainty.
  • Size: 302 patients (low dose) and 615 patients (high dose controlled-release); 20 studies, 2,367 patients in the review.
  • Who: Patients with mildly to moderately active Crohn's disease.
  • How long: 6 to 18 weeks.
  • Result: Low dose: remission 23% (43/185) vs 15% (18/117) placebo, RR 1.46, 95% CI 0.89 to 2.40. High dose controlled-release 4 g/day: CDAI mean difference -19.8 points, 95% CI -46.2 to 6.7.
  • Funding: Cochrane review; two authors disclose industry payments outside the review.

Twenty-three per cent (43/185) of low dose mesalamine patients entered remission at week 6 compared to 15% (18/117) of placebo patients (RR = 1.46, 95% CI 0.89 to 2.40; n = 302).

In non-referral populations, 5-ASA use was not associated with a lower risk of colorectal cancer in inflammatory bowel disease. (Source 8)

  • Meta-analysis, Low certainty.
  • Size: Four observational studies (plus a separate pool of nine clinic-based studies)
  • Who: People with inflammatory bowel disease using 5-ASA for at least one year.
  • How long: Observational follow-up, varies by study.
  • Result: Pooled adjusted OR 0.95, 95% CI 0.66 to 1.38, I2 = 58.2%; clinic-based studies pooled OR 0.58, 95% CI 0.45 to 0.75.
  • Funding: Not stated in the abstract.

The pooled adjusted odds ratio (aOR) was 0.95 (95% confidence interval (CI): 0.66-1.38), but there was moderate heterogeneity (I2 = 58.2%; P = 0.07).

Where the evidence is mixed

Across placebo-controlled induction trials, overall adverse event rates on 5-ASA did not differ from placebo, but sulfasalazine was clearly worse tolerated than 5-ASA. (Source 23)

  • Systematic review, Moderate certainty.
  • Size: 909 participants, 12 studies for the sulfasalazine comparison.
  • Who: Adults with active ulcerative colitis.
  • How long: Induction trials.
  • Result: Any AE 29% (118/411) on sulfasalazine vs 15% (72/498) on 5-ASA; RR 0.48, 95% CI 0.36 to 0.63.
  • Funding: Cochrane review, author industry disclosures as above.

Twenty-nine per cent (118/411) of SASP participants experienced an AE compared to 15% (72/498) of 5-ASA participants (RR 0.48, 95% CI 0.36 to 0.63; 909 participants, 12 studies; moderate-certainty evidence).

In Crohn's disease trials, adverse events, withdrawals for adverse events and serious adverse events were all no different from placebo. (Source 24)

  • Systematic review, Moderate certainty.
  • Size: 1,814 patients, 10 studies (AEs); 576 patients, 3 studies (serious AEs)
  • Who: Patients with Crohn's disease in remission.
  • How long: 12 to 24 months.
  • Result: Any AE 34% (307/900) vs 33% (301/914), RR 1.05, 95% CI 0.95 to 1.17; serious AE 1% (3/293) vs 0.7% (2/283), RR 1.43, 95% CI 0.24 to 2.83.
  • Funding: Cochrane review, funding not stated in the abstract.

Limit of this finding: The serious-adverse-event figure in this review's abstract does not hold together. It is printed as "RR 1.43, 95% CI 0.24 to 2.83", but a risk ratio of 1.43 cannot sit inside that interval the way risk ratios are calculated, and the published full review gives a much wider upper limit. The counts behind it (3 of 293 on 5-ASA against 2 of 283 on placebo) do give a ratio of about 1.45, so the estimate looks right and the interval looks wrong. The quote reproduces the abstract as printed. Read this as showing that serious adverse events were rare in both groups and that 576 patients is far too few to rule a difference in or out; do not use the printed interval to judge how precise that comparison is.

Thirty-four per cent (307/900) of 5-ASA patients had at least one adverse event compared to 33% (301/914) of placebo patients (RR 1.05, 95% CI 0.95 to 1.17; 10 studies; 1814 patients).

Where the research disagrees

Whether 5-ASA protects against colorectal cancer in inflammatory bowel disease

  • Nguyen, Loftus and colleagues, restricting to non-referral populations, meta-analysis of observational studies: The pooled adjusted odds ratio (aOR) was 0.95 (95% confidence interval (CI): 0.66-1.38), but there was moderate heterogeneity (I2 = 58.2%; P = 0.07). (Source 8)
  • The same authors, pooling clinic-based studies instead, meta-analysis of observational studies: We conducted a separate meta-analysis of nine clinic-based studies, which, in contrast, yielded a pooled OR of 0.58 (95% CI: 0.45-0.75). (Source 8)

Whether 5-ASA or the older sulfasalazine is the better choice

  • Cochrane induction review, systematic review: There is high-certainty evidence that 5-ASA is superior to placebo, and moderate-certainty evidence that 5-ASA is not more effective than SASP. (Source 25)
  • Cochrane maintenance review, systematic review: There is high-certainty evidence that 5-ASA is inferior compared to SASP. (Source 26)

How much

  • Reference intake: Dosing is set by the prescriber. As a position, section 2 of the Highlights of Prescribing Information of the FDA-approved LIALDA label (Takeda, label version dated 2026) states a recommended adult dosage of 2.4 g to 4.8 g once daily for induction of remission and 2.4 g once daily for maintenance, taken with food. (Source 27)
  • Upper limit: The highest adult dosage stated in section 2 of the LIALDA Highlights of Prescribing Information is 4.8 g once daily, used for induction only; no separate toxicological upper limit is set. (Source 27)
  • Studied: As reported in section 14.1 Clinical Studies of the label, the two placebo-controlled induction trials gave 2.4 g or 4.8 g once daily for 8 weeks (in Study 1 the 2.4 g dose was split as 1.2 g twice daily). (Source 21)
  • Studied: The 6-month maintenance comparator trial gave 2.4 g once daily versus another mesalamine delayed-release product at 0.8 g twice daily, in 826 adults. (Source 28)
  • Studied: Crohn's disease maintenance trials pooled by Cochrane used 1.6 g to 4 g/day in adults and 50 mg/kg/day in children. (Source 6)

A common belief, and what the research shows

The belief: Mesalamine is an inflammatory bowel disease drug, so it should work for Crohn's disease as well as ulcerative colitis.

What the research shows: It largely does not. The Cochrane maintenance review found "Fifty-three per cent (526/998) of 5-ASA patients (dose 1.6 g to 4 g/day) relapsed at 12 months compared to 54% (544/1016) of placebo patients", and the induction review found "Twenty-three per cent (43/185) of low dose mesalamine patients entered remission at week 6 compared to 15% (18/117) of placebo patients". The authors wrote: "We found no evidence in this review to suggest that oral 5-ASA preparations are superior to placebo for the maintenance of medically-induced remission in patients with Crohn's disease."

Questions and answers

What is it?

Mesalamine is 5-aminosalicylic acid, a small anti-inflammatory molecule used for ulcerative colitis. It is made in forms designed to release the drug in the gut rather than be absorbed early: the 1.2 g delayed-release tablet is coated with a polymer that only breaks down at or above pH 6.8, normally in the last part of the small bowel. There are also enemas and suppositories for disease confined to the rectum and left colon. (Source 29)

What does it do in the body?

It acts on the lining of the colon itself rather than through the bloodstream. The manufacturer's own label admits the mechanism is not fully worked out, but describes a topical anti-inflammatory effect on colonic epithelial cells, possibly through blocking cyclooxygenase and reducing prostaglandin production in the colon. (Source 1)

Is it good or bad for you?

It depends entirely on the condition. For ulcerative colitis the benefit is real and of high certainty: 37% relapsed on 5-ASA versus 55% on placebo over six to 12 months. For Crohn's disease the same body of evidence shows no benefit. Harms are usually mild, but the drug can cause an acute intolerance syndrome that looks like a flare, and rarely kidney injury, pancreatitis or blood disorders. (Source 3)

How do you get more of it?

Mesalamine is a prescription medicine, not a nutrient; there is no way to get more of it other than a prescriber increasing the dose or changing the formulation. As a position, the label's adult range is 2.4 g to 4.8 g once daily for induction and 2.4 g once daily for maintenance. Taking it with food raises how much reaches the bloodstream: a high-fat meal increased peak levels by 91%. (Source 11)

If it is harmful, what reduces it?

If mesalamine is causing harm, the response described in the literature is to stop it. The label says to discontinue promptly if the acute intolerance syndrome is suspected, to discontinue if kidney function deteriorates, and to stop at the first sign of severe skin reactions. In the two reported cases of biopsy-confirmed interstitial nephritis, early withdrawal of the drug allowed partial or complete reversal of kidney dysfunction. (Source 17)

Why might someone be low in it or missing it?

Someone may be off mesalamine because it did not work for their disease, because they could not tolerate it, or because their condition is Crohn's disease, where the evidence does not support it. Roughly 3% of patients in controlled trials of mesalamine or sulfasalazine developed an acute intolerance syndrome that forces the drug to be stopped, and in Crohn's maintenance trials 14% of patients on 5-ASA withdrew because of adverse events. (Source 24)

Which whole foods contain it or feed it?

No whole food contains mesalamine. Food matters only in that it changes absorption: the delayed-release tablet was given with food in the controlled clinical trials, and a high-fat meal both delays absorption and increases total exposure. The label also tells patients to drink an adequate amount of fluids, because mesalamine can form kidney stones. (Source 11)

What happens if you do not have it?

For someone with ulcerative colitis in remission, not taking 5-ASA is associated with a higher relapse rate: 55% relapsed on placebo versus 37% on 5-ASA over six to 12 months. For someone with Crohn's disease the evidence suggests nothing changes - relapse was 54% on placebo and 53% on 5-ASA. One large retrospective cohort found that in people already in steroid-free remission for a year, stopping was not associated with more flares. (Source 13)

How can you test for it?

There is no routine blood level test for mesalamine. What is monitored is harm, not drug level: the label says to evaluate kidney function before starting and periodically during therapy, and to monitor complete blood cell counts if the drug is combined with azathioprine or 6-mercaptopurine. One caution: mesalamine's metabolite interferes with a common urinary normetanephrine assay and can give falsely high results. (Source 16)

References

  1. Takeda Pharmaceuticals America, Inc. / DailyMed (U.S. National Library of Medicine). LIALDA (mesalamine) tablet, delayed release - Full Prescribing Information, section 12.1 Mechanism of Action. 2026. Read the source
  2. Cochrane Database of Systematic Reviews. Oral 5-aminosalicylic acid for induction of remission in ulcerative colitis.. 2020. PMID 32786164, DOI 10.1002/14651858.CD000543.pub5. Read the source
  3. Cochrane Database of Systematic Reviews. Oral 5-aminosalicylic acid for maintenance of remission in ulcerative colitis.. 2020. PMID 32856298, DOI 10.1002/14651858.CD000544.pub5. Read the source
  4. Takeda Pharmaceuticals America, Inc. / DailyMed. LIALDA (mesalamine) tablet, delayed release - Full Prescribing Information, section 8.4 Pediatric Use. 2026. Read the source
  5. Cochrane Database of Systematic Reviews. Rectal 5-aminosalicylic acid for induction of remission in ulcerative colitis.. 2010. PMID 20091560, DOI 10.1002/14651858.CD004115.pub2. Read the source
  6. Cochrane Database of Systematic Reviews. Oral 5-aminosalicylic acid for maintenance of medically-induced remission in Crohn's disease.. 2016. PMID 27681657, DOI 10.1002/14651858.CD003715.pub3. Read the source
  7. Cochrane Database of Systematic Reviews. Aminosalicylates for induction of remission or response in Crohn's disease.. 2016. PMID 27372735, DOI 10.1002/14651858.CD008870.pub2. Read the source
  8. The American Journal of Gastroenterology. 5-aminosalicylic acid is not protective against colorectal cancer in inflammatory bowel disease: a meta-analysis of non-referral populations.. 2012. PMID 22751467, DOI 10.1038/ajg.2012.198. Read the source
  9. Takeda Pharmaceuticals America, Inc. / DailyMed. LIALDA (mesalamine) tablet, delayed release - Full Prescribing Information, section 7.1 Nephrotoxic Agents, Including Non-Steroidal Anti-Inflammatory Drugs. 2026. Read the source
  10. Takeda Pharmaceuticals America, Inc. / DailyMed. LIALDA (mesalamine) tablet, delayed release - Full Prescribing Information, section 7.2 Azathioprine and 6-Mercaptopurine. 2026. Read the source
  11. Takeda Pharmaceuticals America, Inc. / DailyMed. LIALDA (mesalamine) tablet, delayed release - Full Prescribing Information, section 12.3 Pharmacokinetics (Food Effects). 2026. Read the source
  12. Takeda Pharmaceuticals America, Inc. / DailyMed. LIALDA (mesalamine) tablet, delayed release - Full Prescribing Information, section 5.9 Interference with Laboratory Tests. 2026. Read the source
  13. Journal of Gastroenterology and Hepatology. No increased risk of flare in ulcerative colitis patients in corticosteroid-free remission after stopping 5-aminosalicylic acid: A territory-wide population-based study. (Results). 2022. PMID 35338526, DOI 10.1111/jgh.15838. Read the source
  14. Journal of Gastroenterology and Hepatology. No increased risk of flare in ulcerative colitis patients in corticosteroid-free remission after stopping 5-aminosalicylic acid: A territory-wide population-based study. (Conclusion). 2022. PMID 35338526, DOI 10.1111/jgh.15838. Read the source
  15. Takeda Pharmaceuticals America, Inc. / DailyMed. LIALDA (mesalamine) tablet, delayed release - Full Prescribing Information, section 5.2 Mesalamine-Induced Acute Intolerance Syndrome. 2026. Read the source
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  17. Journal of Clinical Gastroenterology. Interstitial nephritis in patients with inflammatory bowel disease treated with mesalamine.. 2001. PMID 11205659, DOI 10.1097/00004836-200102000-00019. Read the source
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