Mesalamine side effects: what 55,824 FDA adverse event reports show
Drug class
Aminosalicylate
Who reports
55,824 reports · 75% serious · 2,749 with death outcome · 57% female
Used for
Mesalamine delayed-release tablets are indicated for the treatment of moderately active ulcerative colitis in adults. Limitations of Use : Safety and effectiveness of mesalamine delayed-release tablets beyond 6 weeks have not been established. Mesalamine delayed-release tablets are an aminosalicylate indicated for the treatment of moderately active ulcerative colitis in adults.
What it is
Each mesalamine delayed-release tablet, USP for oral administration contains 800 mg of mesalamine, USP, an aminosalicylate. Mesalamine delayed-release tablets, USP have an outer protective coat consisting of a combination of acrylic based resins, methacrylic acid copolymer type A and methacrylic acid copolymer type B.
Boxed warning
None in the current label
Causality screen of the 40 strongest signals
What the badges mean
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only (and, for the 300 most-reported drugs, adjusted for age band), and flags pairs whose reports are unusually skewed by sex or come mostly from consumers. Each row also shows the PRR against the other drugs of the same FDA class, which removes most confounding by the condition being treated, and a calibrated p-value: on validation, known non-causes average an ROR of about 2, so significance is judged against that empirical null (✓ = p < 0.05 after calibration). 1,220 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Vaginal flatulence | 214 | 898.8 701.4–1,151.9ROR 902.3 · calibrated p 2e-16 ✓ | 256.6 EB05 229.0 · IC025 +7.1 3/3 methods agree | Not in label — unassessed | serious n=214 · ♀ 100% (drug 57%) | not reported in cached trials |
| Congenital hiatus hernia | 144 | 709.7 536.9–938.0ROR 711.5 · calibrated p 4e-15 ✓ | 236.1 EB05 205.4 · IC025 +6.8 3/3 methods agree | Not in label — unassessed | serious n=144 · ♀ 0% (drug 57%) · 92% clinician | not reported in cached trials |
| Grip strength | 106 | 318.5 245.7–413.0ROR 319.1 · calibrated p 1e-11 ✓ | 166.5 EB05 141.5 · IC025 +6.3 3/3 methods agree | Not in label — unassessed | serious n=106 · ♀ 100% (drug 57%) · 100% clinician | not reported in cached trials |
| Antacid therapy | 42 | 201.6 138.4–293.6ROR 201.8 · calibrated p 1e-9 ✓ | 123.6 EB05 95.3 · IC025 +5.2 3/3 methods agree | Reporting / coding artifact | serious n=42 · ♀ 0% (drug 57%) · 100% clinician | not reported in cached trials |
| Malignant melanoma stage 0 | 62 | 195.9 144.0–266.5ROR 196.1 · calibrated p 1e-9 ✓ | 123.6 EB05 99.8 · IC025 +5.6 3/3 methods agree | Not in label — unassessed | serious n=62 · ♀ 0% (drug 57%) · 100% clinician | not reported in cached trials |
| Steroid dependence | 207 | 121.1 103.5–141.6ROR 121.5 · calibrated p 3e-8 ✓ | 90.7 EB05 80.8 · IC025 +6.0 3/3 methods agree | Not in label — unassessed | serious n=207 · ♀ 18% (drug 57%) | not reported in cached trials |
| Lupus vulgaris | 281 | 116.2 101.6–132.8ROR 116.8 · calibrated p 4e-8 ✓ | 88.1 EB05 79.8 · IC025 +6.1 3/3 methods agree | Not in label — unassessed | serious n=281 · ♀ 100% (drug 57%) · 96% clinician | not reported in cached trials |
| Sleep disorder therapy | 44 | 116.2 82.8–163.0ROR 116.3 · calibrated p 8e-8 ✓ | 85.4 EB05 66.3 · IC025 +5.0 3/3 methods agree | Reporting / coding artifact | serious n=44 · ♀ 0% (drug 57%) · 100% clinician | not reported in cached trials |
| Swollen joint count | 53 | 103.1 76.0–139.8ROR 103.2 · calibrated p 2e-7 ✓ | 78.6 EB05 62.4 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious n=53 · ♀ 100% (drug 57%) · 100% clinician | not reported in cached trials |
| Anti-cyclic citrullinated peptide antibody | 137 | 97.0 80.4–117.1ROR 97.2 · calibrated p 2e-7 ✓ | 76.3 EB05 66.1 · IC025 +5.6 3/3 methods agree | Lab value / disease marker | serious n=137 · ♀ 100% (drug 57%) · 100% clinician | not reported in cached trials |
| Catarrh | 162 | 83.6 70.5–99.2ROR 83.9 · calibrated p 5e-7 ✓ | 67.9 EB05 59.5 · IC025 +5.6 3/3 methods agree | Not in label — unassessed | serious n=162 · ♀ 20% (drug 57%) · 91% clinician | not reported in cached trials |
| Retinitis | 290 | 78.9 69.6–89.6ROR 79.3 · calibrated p 7e-7 ✓ | 65.0 EB05 58.9 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious n=290 · ♀ 100% (drug 57%) · 93% clinician | not reported in cached trials |
| Myopericarditis | 120 | 75.9 62.4–92.4ROR 76.1 · calibrated p 1e-6 ✓ | 62.6 EB05 53.7 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious n=120 · ♀ 21% (drug 57%) · 100% clinician | not reported in cached trials |
| Anticoagulant therapy | 42 | 66.9 48.2–92.9ROR 67.0 · calibrated p 4e-6 ✓ | 55.5 EB05 42.8 · IC025 +4.6 3/3 methods agree | Reporting / coding artifact | serious n=42 · ♀ 0% (drug 57%) · 100% clinician | not reported in cached trials |
| Colitis ulcerative | 6,708 | 66.5 64.8–68.1ROR 75.4 · calibrated p 9e-7 ✓ | 56.5 EB05 55.4 · IC025 +5.8 3/3 methods agree | Likely indication confounding term in indications; also in warnings | age-adj. PRR 62.1 · serious PRR 44.5 | NCT01124149: 1/461 (0.2%) on Mesalamine (serious AE) |
| Female genital tract fistula | 258 | 66.2 58.0–75.5ROR 66.5 · calibrated p 2e-6 ✓ | 56.1 EB05 50.5 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious n=257 · ♀ 100% (drug 57%) | not reported in cached trials |
| Proctitis | 419 | 65.9 59.4–73.1ROR 66.4 · calibrated p 2e-6 ✓ | 56.0 EB05 51.6 · IC025 +5.6 3/3 methods agree | Not in label — unassessed | serious n=410 · ♀ 79% (drug 57%) | not reported in cached trials |
| Therapeutic reaction time decreased | 432 | 64.6 58.3–71.5ROR 65.1 · calibrated p 3e-6 ✓ | 55.0 EB05 50.8 · IC025 +5.5 3/3 methods agree | Lab value / disease marker | serious n=419 | not reported in cached trials |
| Deep vein thrombosis postoperative | 276 | 61.5 54.1–69.8ROR 61.8 · calibrated p 4e-6 ✓ | 52.7 EB05 47.6 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious n=276 · ♀ 100% (drug 57%) · 92% clinician | not reported in cached trials |
| Seronegative arthritis | 155 | 60.1 50.7–71.2ROR 60.3 · calibrated p 5e-6 ✓ | 51.5 EB05 45.1 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious n=154 · ♀ 100% (drug 57%) · 100% clinician | not reported in cached trials |
| Analgesic therapy | 41 | 57.8 41.6–80.4ROR 57.9 · calibrated p 9e-6 ✓ | 49.1 EB05 37.7 · IC025 +4.5 3/3 methods agree | Reporting / coding artifact | serious n=41 · ♀ 0% (drug 57%) · 100% clinician | not reported in cached trials |
| Adjustment disorder with depressed mood | 267 | 57.3 50.4–65.1ROR 57.5 · calibrated p 6e-6 ✓ | 49.6 EB05 44.8 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious n=267 · ♀ 100% (drug 57%) · 94% clinician | not reported in cached trials |
| Overlap syndrome | 91 | 57.0 45.7–71.1ROR 57.1 · calibrated p 7e-6 ✓ | 49.0 EB05 41.2 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious n=91 · ♀ 100% (drug 57%) · 100% clinician | not reported in cached trials |
| Faecal calprotectin increased | 399 | 55.1 49.6–61.2ROR 55.5 · calibrated p 7e-6 ✓ | 48.0 EB05 44.1 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious n=394 | not reported in cached trials |
| Dislocation of vertebra | 270 | 51.8 45.6–58.8ROR 52.1 · calibrated p 1e-5 ✓ | 45.4 EB05 41.1 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious n=269 · ♀ 100% (drug 57%) · 92% clinician | not reported in cached trials |
| Mucous stools | 591 | 51.2 47.0–55.7ROR 51.7 · calibrated p 1e-5 ✓ | 45.0 EB05 42.0 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious n=553 | not reported in cached trials |
| Drug therapy | 35 | 46.0 32.4–65.4ROR 46.1 · calibrated p 4e-5 ✓ | 40.2 EB05 30.2 · IC025 +4.2 3/3 methods agree | Reporting / coding artifact | serious n=35 · ♀ 0% (drug 57%) · 100% clinician | NCT01124149: 22/461 (4.8%) on Mesalamine |
| Porphyria acute | 144 | 43.7 36.7–51.9ROR 43.8 · calibrated p 3e-5 ✓ | 39.0 EB05 33.9 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=144 · ♀ 100% (drug 57%) · 92% clinician | not reported in cached trials |
| Hepatosplenic t-cell lymphoma | 38 | 42.6 30.4–59.5ROR 42.6 · calibrated p 6e-5 ✓ | 37.6 EB05 28.6 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=38 · ♀ 0% (drug 57%) · 100% clinician | not reported in cached trials |
| Rectal tenesmus | 120 | 40.5 33.6–48.9ROR 40.6 · calibrated p 6e-5 ✓ | 36.4 EB05 31.3 · IC025 +4.7 3/3 methods agree | Labeled (related wording) related wording | serious n=115 | not reported in cached trials |
| Burns second degree | 166 | 39.3 33.5–46.1ROR 39.4 · calibrated p 6e-5 ✓ | 35.5 EB05 31.2 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=166 · ♀ 18% (drug 57%) · 91% clinician | not reported in cached trials |
| Frequent bowel movements | 2,516 | 38.7 37.2–40.3ROR 40.5 · calibrated p 5e-5 ✓ | 35.1 EB05 34.0 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | age-adj. PRR 37.4 · serious PRR 38.4 | not reported in cached trials |
| Subcutaneous drug absorption impaired | 50 | 37.9 28.3–50.7ROR 37.9 · calibrated p 1e-4 ✓ | 34.0 EB05 26.8 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=50 · ♀ 100% (drug 57%) · 100% clinician | not reported in cached trials |
| Swollen joint count increased | 274 | 36.1 31.9–40.9ROR 36.3 · calibrated p 1e-4 ✓ | 32.9 EB05 29.8 · IC025 +4.8 3/3 methods agree | Lab value / disease marker | serious n=274 · ♀ 100% (drug 57%) · 100% clinician | not reported in cached trials |
| Crohn's disease | 602 | 35.6 32.7–38.6ROR 35.9 · calibrated p 1e-4 ✓ | 32.5 EB05 30.4 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious n=499 | not reported in cached trials |
| Radiculopathy | 228 | 35.5 31.0–40.6ROR 35.6 · calibrated p 1e-4 ✓ | 32.4 EB05 29.0 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=228 · ♀ 100% (drug 57%) | NCT01124149: 1/461 (0.2%) on Mesalamine (serious AE) |
| Loss of therapeutic response | 261 | 35.4 31.2–40.2ROR 35.6 · calibrated p 1e-4 ✓ | 32.4 EB05 29.2 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=256 | not reported in cached trials |
| Terminal ileitis | 52 | 35.4 26.6–47.0ROR 35.4 · calibrated p 1e-4 ✓ | 32.0 EB05 25.4 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=52 · ♀ 100% (drug 57%) | not reported in cached trials |
| Proctitis ulcerative | 52 | 35.3 26.5–46.9ROR 35.3 · calibrated p 1e-4 ✓ | 31.9 EB05 25.3 · IC025 +4.2 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=46 | not reported in cached trials |
| Faecal calprotectin abnormal | 35 | 35.2 24.9–49.9ROR 35.3 · calibrated p 2e-4 ✓ | 31.8 EB05 23.9 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=32 | not reported in cached trials |
Clinical concept groups
MedDRA splits one clinical problem across several terms (e.g. "neutropenia", "neutrophil count decreased", "agranulocytosis"), which dilutes term-level signals. These rows count reports with any term in a concept group (an exact union, not a sum), compared with all other drugs. Groups are hand-built and listed in the methods.
| Concept | Reports | PRR 95% CI | Reading |
|---|---|---|---|
| Pancreatitis | 975 | 4.64.3–4.9 | signal |
| Gi bleeding | 2,205 | 4.64.4–4.8 | signal |
| Interstitial lung disease | 748 | 2.92.7–3.2 | signal |
| Opportunistic infection | 776 | 2.12.0–2.3 | raised |
| Anaemia | 1,671 | 2.12.0–2.2 | signal |
| Serious infection | 3,426 | 1.71.6–1.7 | raised |
| Liver injury | 1,336 | 1.71.6–1.8 | raised |
| Venous thromboembolism | 947 | 1.61.5–1.8 | raised |
| Depression | 1,121 | 1.51.4–1.6 | raised |
| Tendon disorder | 110 | 1.10.9–1.3 | no difference |
| Hyponatraemia | 209 | 1.00.9–1.1 | no difference |
| Hyperglycaemia / diabetes | 870 | 0.90.9–1.0 | no difference |
| Anaphylaxis / angioedema | 307 | 0.90.8–1.0 | no difference |
| Arrhythmia / qt | 418 | 0.80.7–0.9 | lower than other drugs |
| Kidney injury | 982 | 0.80.8–0.9 | lower than other drugs |
| Stroke | 525 | 0.80.7–0.9 | lower than other drugs |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Mesalamine as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (3 of 40 signal terms matched).
- NCT00505778 — A Comparison of Once a Day Dose Compared to 2 Doses/Day (N=1027, PHASE3; 36 AE terms posted; arms: Mesalamine Once-Daily; Mesalamine Twice-Daily)
- NCT01124149 — Ability to Maintain or Achieve Clinical and Endoscopic Remission With MMX Mesalamine Once Daily in Adults With (N=759, PHASE4; 34 AE terms posted; arms: MMX Mesalamine/ Mesalazine (Acute Phase); MMX Mesalamine/ Mesalazine (Maintenance )
Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Off label use (used outside approved label) | 9,143 | 4.0 3.9–4.1ROR 4.6 · calibrated p 0.286 | 4.0 EB05 3.9 · IC025 +1.9 3/3 methods agree | Reporting / coding artifact | age-adj. PRR 4.1 · serious PRR 5.3 | not reported in cached trials |
| Drug ineffective (drug did not work) | 7,146 | 2.0 2.0–2.1ROR 2.2 · calibrated p 0.953 | 2.0 EB05 2.0 · IC025 +1.0 | Reporting / coding artifact | age-adj. PRR 2.2 · serious PRR 3.5 | NCT01124149: 22/461 (4.8%) on Mesalamine |
| Colitis ulcerative | 6,708 | 66.5 64.8–68.1ROR 75.4 · calibrated p 9e-7 ✓ | 56.5 EB05 55.4 · IC025 +5.8 3/3 methods agree | Likely indication confounding term in indications; also in warnings | age-adj. PRR 62.1 · serious PRR 44.5 | NCT01124149: 1/461 (0.2%) on Mesalamine (serious AE) |
| Diarrhoea (diarrhea) | 4,922 | 2.9 2.8–3.0ROR 3.1 · calibrated p 0.604 | 2.9 EB05 2.8 · IC025 +1.5 3/3 methods agree | Labeled adverse reaction exact term | age-adj. PRR 2.8 · serious PRR 3.2 | NCT01124149: 3/461 (0.7%) on Mesalamine (serious AE) |
| Condition aggravated | 4,591 | 5.8 5.6–5.9ROR 6.2 · calibrated p 0.137 | 5.7 EB05 5.6 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | age-adj. PRR 4.3 · serious PRR 6.2 | not reported in cached trials |
| Fatigue (tiredness) | 3,839 | 1.9 1.8–1.9ROR 1.9 · calibrated p 0.902 | 1.9 EB05 1.8 · IC025 +0.8 | Labeled (related wording) related wording | age-adj. PRR 1.8 · serious PRR 2.1 | not reported in cached trials |
| Abdominal pain | 3,745 | 6.1 5.9–6.3ROR 6.5 · calibrated p 0.121 | 6.0 EB05 5.9 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | age-adj. PRR 5.3 · serious PRR 5.4 | NCT00505778: 1/511 (0.2%) on Mesalamine (serious AE) |
| Haematochezia (blood in stool) | 3,666 | 26.7 25.9–27.6ROR 28.5 · calibrated p 3e-4 ✓ | 25.0 EB05 24.3 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | age-adj. PRR 23.5 · serious PRR 19.9 | not reported in cached trials |
| Nausea | 3,318 | 1.6 1.5–1.6ROR 1.6 · calibrated p 0.718 | 1.6 EB05 1.5 · IC025 +0.6 | Labeled adverse reaction exact term | age-adj. PRR 1.4 · serious PRR 1.9 | not reported in cached trials |
| Headache | 3,139 | 1.9 1.8–2.0ROR 1.9 · calibrated p 0.911 | 1.9 EB05 1.8 · IC025 +0.9 | Labeled adverse reaction exact term | age-adj. PRR 1.6 · serious PRR 2.3 | not reported in cached trials |
| Arthralgia (joint pain) | 2,941 | 2.7 2.6–2.8ROR 2.8 · calibrated p 0.705 | 2.7 EB05 2.6 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | age-adj. PRR 2.3 · serious PRR 3.0 | not reported in cached trials |
| Pyrexia (fever) | 2,922 | 3.2 3.1–3.3ROR 3.3 · calibrated p 0.534 | 3.2 EB05 3.1 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | age-adj. PRR 2.6 · serious PRR 2.7 | NCT01124149: 1/461 (0.2%) on Mesalamine (serious AE) |
| Weight decreased (weight loss) | 2,756 | 3.7 3.6–3.9ROR 3.9 · calibrated p 0.401 | 3.7 EB05 3.6 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | age-adj. PRR 3.5 · serious PRR 4.0 | not reported in cached trials |
| Pain | 2,692 | 1.6 1.6–1.7ROR 1.7 · calibrated p 0.756 | 1.6 EB05 1.6 · IC025 +0.7 | Labeled adverse reaction exact term | age-adj. PRR 1.6 · serious PRR 1.6 | NCT00505778: 1/511 (0.2%) on Mesalamine (serious AE) |
| Malaise (feeling unwell) | 2,524 | 2.2 2.1–2.2ROR 2.2 · calibrated p 0.942 | 2.2 EB05 2.1 · IC025 +1.0 3/3 methods agree | Labeled adverse reaction exact term | age-adj. PRR 2.1 · serious PRR 2.5 | not reported in cached trials |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Vaginal flatulence — n=214, PRR 898.8
- Congenital hiatus hernia — n=144, PRR 709.7
- Grip strength — n=106, PRR 318.5
- Malignant melanoma stage 0 — n=62, PRR 195.9
- Steroid dependence — n=207, PRR 121.1
- Lupus vulgaris — n=281, PRR 116.2
- Swollen joint count — n=53, PRR 103.1
- Catarrh — n=162, PRR 83.6
- Retinitis — n=290, PRR 78.9
- Myopericarditis — n=120, PRR 75.9
✓ A hand-written Bradford Hill causality assessment exists for this drug: Mesalamine ↔ Pancreatitis.
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Mesalamine?
In FDA FAERS, the most frequently co-reported reaction terms for Mesalamine are colitis ulcerative, diarrhoea, fatigue, abdominal pain, haematochezia, nausea. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Mesalamine have an FDA boxed warning?
No. The FDA label retrieved for Mesalamine has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Mesalamine causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 00f77203-3615-47e8-ae25-6e1cf8a2a00a, effective 20240523; matched on
openfda.generic_name.exact:"MESALAMINE") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 1,260 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath - ClinicalTrials.gov API v2 (query
MESALAMINE, results-bearing studies sorted by enrollment)
Page generated 2026-10-14. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.