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Sulindac Side Effects

The most commonly reported side effects of sulindac include pain, drug hypersensitivity, and fatigue, based on 3,085 FDA adverse event reports from 2004 to 2025. 6.6% of reports found the drug to be ineffective.

Sulindac side effects

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

1
Drug Ineffective6.6%203
2
Pain5.6%173
3
Drug Hypersensitivity4.7%144
4
Fatigue4.3%132
5
Arthralgia4.1%126
6
Pain In Extremity3.5%107
7
Nausea3.4%105
8
Diarrhoea3.2%98
9
Asthenia2.9%89
10
Chronic Kidney Disease2.8%86
11
Back Pain2.7%83
12
Headache2.7%82
13
Dyspnoea2.5%77
14
Pneumonia2.5%77
15
Pruritus2.4%73

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

Report severity

61.2%Serious1,888 reports
29.6%Hospitalizations913 reports
6.5%Fatal202 reports

Seriousness is determined by the reporter, not by OpenClaim.

Sulindac drug interactions

Other drugs that appear in adverse event reports alongside sulindac. 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
Adalimumab15.0%464
2
Etanercept7.6%236
3
Methotrexate5.2%160
4
Infliximab4.1%125
5
Esomeprazole2.8%87
6
Tofacitinib2.8%87
7
Diclofenac2.7%83
8
Omeprazole2.6%79
9
Sodium-oxybate2.5%76
10
Naproxen2.2%69
11
Prednisone2.0%62
12
Pantoprazole-sodium1.8%54
13
Pregabalin1.8%54
14
Secukinumab1.8%54
15
Ibuprofen1.7%52

Taken alongside

1
Acetaminophen17.0%524
2
Methotrexate15.6%480
3
Folic-acid15.5%478
4
Prednisone14.7%455
5
Omeprazole14.2%439
6
Levothyroxine-sodium13.3%409
7
Gabapentin12.7%393
8
Aspirin12.5%386
9
Ergocalciferol12.4%384
10
Furosemide9.7%300
11
Amlodipine9.4%289
12
Lisinopril9.2%285
13
Metformin9.2%283
14
Hydrochlorothiazide9.1%282
15
Atorvastatin-calcium8.8%272

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 sulindac side effects

67.5% of sulindac adverse event reports involve female patients and 27.9% involve male patients. The largest age group is adult at 61%. These figures reflect who reports side effects, not underlying risk.

Sex

Female67.5%
Male27.9%
Unknown4.6%

Age group

< 20.2%
2–110.5%
12–170.9%
18–6461.3%
65+37.0%

What is sulindac used for

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

Abdominal PainAdenomatous Polyposis ColiAnalgesiaAnalgesic EffectAnalgesic Intervention Supportive TherapyAnalgesic TherapyAnkylosing SpondylitisAntiinflammatory TherapyArthralgiaArthritisArthropathyAtrial FibrillationAdenomatous Polyposis ColiAnalgesic TherapyAnkylosing Spondylitis

Showing 15 of 140 indications

Sulindac brand names and reporting trend

Sulindac is sold under the brand name Sulindac.

Brand names

Sulindac2,512

Quarterly reports (20042025)

20052010201520202025

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

Taking sulindac with another medication?

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