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Aminosalicylic Side Effects

The most commonly reported side effects of aminosalicylic include off label use, condition aggravated, and weight decreased, based on 4,704 FDA adverse event reports from 2004 to 2025. 14.8% of reports found the drug to be ineffective.

Aminosalicylic side effects

Percentages show how often each reaction appears relative to total reports for aminosalicylic.

1
Off Label Use17.8%837
2
Drug Ineffective14.8%695
3
Condition Aggravated14.4%677
4
Weight Decreased12.8%600
5
Headache12.6%594
6
Colitis Ulcerative11.9%561
7
Pain11.8%554
8
Pyrexia11.7%549
9
Fatigue11.2%527
10
Rash10.7%503
11
Diarrhoea10.1%477
12
Abdominal Discomfort9.9%467
13
Nausea9.9%465
14
Frequent Bowel Movements9.8%463
15
Vomiting9.8%461

These are voluntary reports and do not establish that aminosalicylic caused these reactions.

Report severity

93.8%Serious4,414 reports
38.0%Hospitalizations1,788 reports
26.6%Fatal1,253 reports

Seriousness is determined by the reporter, not by OpenClaim.

Aminosalicylic drug interactions

Other drugs that appear in adverse event reports alongside aminosalicylic. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Infliximab27.1%1,274
2
Prednisone23.0%1,081
3
Adalimumab21.8%1,025
4
Mesalamine21.3%1,002
5
Vedolizumab19.6%920
6
Methotrexate19.1%897
7
Acetaminophen18.4%867
8
Hydrocortisone17.4%819
9
Oxycodone16.8%788
10
Linezolid16.3%767
11
Sulfasalazine15.8%742
12
Abatacept15.6%736
13
Pantoprazole-sodium15.6%733
14
Diclofenac14.5%684
15
Azathioprine14.4%677

Taken alongside

1
Acetaminophen13.2%620
2
Prednisone11.2%527
3
Ergocalciferol9.8%459
4
Folic-acid7.8%368
5
Methotrexate7.6%357
6
Pantoprazole-sodium7.5%351
7
Mesalamine7.4%348
8
Lansoprazole7.3%344
9
Hydrocortisone6.9%323
10
Pregabalin6.2%293
11
Lorazepam6.1%289
12
Tofacitinib6.0%283
13
Sulfasalazine5.8%271
14
Cetirizine-hydrochloride5.7%268
15
Atorvastatin-calcium5.6%262

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports aminosalicylic side effects

50.5% of aminosalicylic adverse event reports involve female patients and 36.0% involve male patients. The largest age group is adult at 74%. These figures reflect who reports side effects, not underlying risk.

Sex

Female50.5%
Male36.0%
Unknown13.5%

Age group

< 21.3%
2–112.4%
12–172.7%
18–6474.1%
65+19.5%

What is aminosalicylic used for

Conditions and purposes for which patients were taking aminosalicylic when the adverse event was reported.

AcarodermatitisAccidental ExposureAcneAcne CysticAcute Myocardial InfarctionAdjustment DisorderAlopecia ScarringAmyloidosisAnalgesic TherapyAngina PectorisAntibiotic ProphylaxisAntiinflammatory TherapyAntiplatelet TherapyArrhythmiaAsteatosis

Showing 15 of 223 indications

Aminosalicylic brand names and reporting trend

Aminosalicylic is sold under brand names including Neopasalate, Rezipas.

Brand names

Neopasalate3,946
Rezipas1,969

Quarterly reports (20042025)

20052010201520202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking aminosalicylic with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.