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Aminosalicylate Side Effects

The most commonly reported side effects of aminosalicylate include completed suicide, vomiting, and sciatica, based on 331 FDA adverse event reports from 2005 to 2025.

Aminosalicylate side effects

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

1
Completed Suicide32.9%109
2
Vomiting10.9%36
3
Sciatica10.9%36
4
Type 2 Diabetes Mellitus10.6%35
5
Upper Respiratory Tract Infection10.6%35
6
Joint Stiffness10.3%34
7
Systemic Lupus Erythematosus10.3%34
8
Rheumatoid Factor Positive10.0%33
9
Road Traffic Accident10.0%33
10
Sinusitis10.0%33
11
Wound Infection10.0%33
12
Visual Impairment9.7%32
13
Joint Dislocation9.7%32
14
Seronegative Arthritis9.7%32
15
Tachycardia9.4%31

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

Report severity

94.6%Serious313 reports
36.0%Hospitalizations119 reports
70.7%Fatal234 reports

Seriousness is determined by the reporter, not by OpenClaim.

Aminosalicylate drug interactions

Other drugs that appear in adverse event reports alongside aminosalicylate. 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
Acetaminophen29.9%99
2
Quetiapine-fumarate20.2%67
3
Abatacept20.2%67
4
Pregabalin18.7%62
5
Oxycodone18.4%61
6
Prednisone17.8%59
7
Mesalamine17.2%57
8
Ergocalciferol16.9%56
9
Methotrexate16.9%56
10
Naproxen16.9%56
11
Diclofenac16.9%56
12
Tocilizumab16.9%56
13
Ustekinumab16.9%56
14
Pseudoephedrine16.6%55
15
Sulfasalazine16.6%55

Taken alongside

1
Pyridoxine5.7%19
2
Acetaminophen5.7%19
3
Ergocalciferol5.1%17
4
Prednisone4.5%15
5
Folic-acid4.2%14
6
Aminosalicylic3.9%13
7
Methotrexate3.9%13
8
Pregabalin3.9%13
9
Pantoprazole-sodium3.9%13
10
Sulfasalazine3.9%13
11
Mesalamine3.6%12
12
Naproxen3.6%12
13
Pseudoephedrine3.6%12
14
Quetiapine-fumarate3.6%12
15
Moxifloxacin-hydrochloride3.3%11

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 aminosalicylate side effects

57.1% of aminosalicylate adverse event reports involve female patients and 32.9% involve male patients. The largest age group is adult at 77%. These figures reflect who reports side effects, not underlying risk.

Sex

Female57.1%
Male32.9%
Unknown10.0%

Age group

< 20.4%
2–112.0%
12–173.2%
18–6476.6%
65+17.9%

What is aminosalicylate used for

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

Ankylosing SpondylitisAntibiotic ProphylaxisBehcet^s SyndromeCardiac DisorderCardiac Failure CongestiveColitis UlcerativeDisseminated TuberculosisDrug Use For Unknown IndicationDyspepsiaFoetal Exposure During PregnancyInflammatory Bowel DiseaseMeningitis TuberculousProduct Used For Unknown IndicationPulmonary TuberculosisProctitis Ulcerative

Showing 15 of 25 indications

Aminosalicylate brand names and reporting trend

Aminosalicylate is sold under the brand name Sodium Aminosalicylate.

Brand names

Sodium Aminosalicylate332

Quarterly reports (20052025)

2005201520202025

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

Taking aminosalicylate with another medication?

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