Sulindac side effects: what 2,402 FDA adverse event reports show
Drug class
Nonsteroidal Anti-inflammatory Drug
Who reports
2,402 reports · 58% serious · 132 with death outcome · 70% female
Used for
Carefully consider the potential benefits and risks of sulindac tablets and other treatment options before deciding to use sulindac tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ).
What it is
DESCRIPTION Sulindac is a non-steroidal, anti-inflammatory indene derivative designated chemically as (Z)-5-fluoro-2-methyl-1-[[ p -(methylsulfinyl)phenyl]methylene]-1 H -indene-3-acetic acid. It is not a salicylate, pyrazolone or propionic acid derivative.
Boxed warning
Cardiovascular Thrombotic Events Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use [see Warnings and Precautions ].
Causality screen of the 40 strongest signals
What the badges mean
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- 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 flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 109 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 |
|---|---|---|---|---|---|---|
| Musculoskeletal chest pain | 27 | 15.2 10.5–22.2ROR 15.4 · χ² 345 / p 3e-77 | 14.9 EB05 10.5 · IC025 +3.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 21.5 | no trial data cached |
| Musculoskeletal discomfort | 28 | 14.2 9.8–20.6ROR 14.4 · χ² 331 / p 3e-74 | 13.8 EB05 9.8 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 24.1 · ♀ 92% (drug 70%) | no trial data cached |
| Intervertebral disc degeneration | 14 | 13.1 7.8–22.2ROR 13.2 · χ² 145 / p 1e-33 | 11.9 EB05 6.8 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 12.8 | no trial data cached |
| Tenderness | 14 | 11.7 6.9–19.8ROR 11.8 · χ² 127 / p 1e-29 | 10.3 EB05 6.0 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Osteopenia | 18 | 10.3 6.5–16.3ROR 10.4 · χ² 142 / p 5e-33 | 9.2 EB05 5.8 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 9.4 | no trial data cached |
| Gastric haemorrhage | 13 | 9.8 5.7–16.9ROR 9.9 · χ² 94 / p 1e-22 | 8.2 EB05 4.8 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 10.1 | no trial data cached |
| Osteoarthritis | 46 | 9.5 7.1–12.6ROR 9.6 · χ² 340 / p 3e-76 | 9.0 EB05 6.9 · IC025 +2.6 3/3 methods agree | Likely indication confounding term in indications | serious PRR 10.1 | no trial data cached |
| Chronic kidney disease | 78 | 8.9 7.1–11.1ROR 9.2 · χ² 540 / p 1e-119 | 8.6 EB05 7.1 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 8.9 | no trial data cached |
| Ankylosing spondylitis | 13 | 8.7 5.1–15.0ROR 8.8 · χ² 81 / p 1e-19 | 7.2 EB05 4.3 · IC025 +1.8 3/3 methods agree | Likely indication confounding term in indications | serious PRR 7.6 | no trial data cached |
| Carpal tunnel syndrome | 14 | 8.7 5.2–14.7ROR 8.8 · χ² 88 / p 3e-21 | 7.3 EB05 4.4 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 9.9 | no trial data cached |
| End stage renal disease | 17 | 8.1 5.0–13.0ROR 8.1 · χ² 98 / p 2e-23 | 6.9 EB05 4.5 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 8.0 | no trial data cached |
| Sciatica | 14 | 7.7 4.6–13.0ROR 7.8 · χ² 75 / p 2e-18 | 6.4 EB05 4.0 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 10.3 | no trial data cached |
| Rotator cuff syndrome | 11 | 7.5 4.1–13.4ROR 7.5 · χ² 55 / p 6e-14 | 5.9 EB05 3.5 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 7.0 | no trial data cached |
| Economic problem | 13 | 7.4 4.3–12.7ROR 7.4 · χ² 65 / p 3e-16 | 6.1 EB05 3.7 · IC025 +1.6 3/3 methods agree | Reporting / coding artifact | serious PRR 8.0 | no trial data cached |
| Skin disorder | 28 | 7.4 5.1–10.6ROR 7.4 · χ² 147 / p 3e-34 | 6.7 EB05 4.8 · IC025 +2.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 10.3 · ♀ 100% (drug 70%) | no trial data cached |
| Neck pain | 47 | 7.3 5.5–9.7ROR 7.5 · χ² 251 / p 6e-57 | 6.9 EB05 5.4 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 9.2 | no trial data cached |
| Localised infection | 20 | 7.2 4.7–11.2ROR 7.3 · χ² 101 / p 4e-24 | 6.3 EB05 4.3 · IC025 +1.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.9 | no trial data cached |
| Psoriatic arthropathy | 33 | 7.2 5.1–10.1ROR 7.3 · χ² 169 / p 5e-39 | 6.6 EB05 4.9 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 8.7 · ♀ 93% (drug 70%) | no trial data cached |
| Staphylococcal infection | 27 | 7.1 4.9–10.4ROR 7.2 · χ² 136 / p 9e-32 | 6.5 EB05 4.6 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 7.2 | no trial data cached |
| Seasonal allergy | 11 | 6.8 3.8–12.3ROR 6.8 · χ² 49 / p 1e-12 | 5.5 EB05 3.2 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious n=5 | no trial data cached |
| Musculoskeletal stiffness | 65 | 6.5 5.1–8.2ROR 6.6 · χ² 297 / p 9e-67 | 6.2 EB05 5.0 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 8.1 | no trial data cached |
| Sleep apnoea syndrome | 14 | 6.4 3.8–10.8ROR 6.4 · χ² 58 / p 1e-14 | 5.4 EB05 3.4 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 7.0 | no trial data cached |
| Intervertebral disc protrusion | 16 | 6.4 3.9–10.4ROR 6.4 · χ² 67 / p 1e-16 | 5.5 EB05 3.6 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 7.4 | no trial data cached |
| Multiple fractures | 12 | 6.3 3.6–11.1ROR 6.4 · χ² 49 / p 2e-12 | 5.2 EB05 3.2 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 6.7 | no trial data cached |
| Synovitis | 13 | 6.3 3.7–10.8ROR 6.3 · χ² 53 / p 2e-13 | 5.3 EB05 3.3 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 6.0 | no trial data cached |
| Renal injury | 21 | 6.1 4.0–9.4ROR 6.2 · χ² 85 / p 2e-20 | 5.4 EB05 3.7 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.1 | no trial data cached |
| Tendonitis | 10 | 5.6 3.0–10.4ROR 5.6 · χ² 33 / p 4e-9 | 4.6 EB05 2.7 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 6.4 | no trial data cached |
| Scar | 11 | 5.6 3.1–10.1ROR 5.6 · χ² 37 / p 6e-10 | 4.6 EB05 2.8 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 6.2 | no trial data cached |
| Knee arthroplasty | 13 | 5.4 3.2–9.4ROR 5.5 · χ² 43 / p 3e-11 | 4.6 EB05 2.9 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 5.6 | no trial data cached |
| Arthritis | 49 | 5.4 4.1–7.2ROR 5.5 · χ² 173 / p 7e-40 | 5.2 EB05 4.1 · IC025 +1.9 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 5.3 | no trial data cached |
| Kidney infection | 11 | 4.9 2.7–8.8ROR 4.9 · χ² 30 / p 2e-8 | 4.1 EB05 2.5 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 5.4 | no trial data cached |
| Osteoporosis | 23 | 4.9 3.2–7.3ROR 4.9 · χ² 67 / p 1e-16 | 4.5 EB05 3.1 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 5.1 | no trial data cached |
| Upper limb fracture | 11 | 4.8 2.7–8.7ROR 4.8 · χ² 29 / p 3e-8 | 4.1 EB05 2.5 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 5.4 | no trial data cached |
| Bone disorder | 10 | 4.8 2.6–8.8ROR 4.8 · χ² 26 / p 2e-7 | 4.0 EB05 2.3 · IC025 +0.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.2 | no trial data cached |
| Cellulitis (skin infection) | 27 | 4.7 3.2–6.8ROR 4.7 · χ² 74 / p 3e-18 | 4.3 EB05 3.1 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 4.5 | no trial data cached |
| Injection site warmth | 11 | 4.7 2.6–8.4ROR 4.7 · χ² 28 / p 6e-8 | 4.0 EB05 2.4 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious n=3 | no trial data cached |
| Joint stiffness | 14 | 4.7 2.8–7.9ROR 4.7 · χ² 37 / p 7e-10 | 4.1 EB05 2.6 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 2.4 | no trial data cached |
| Blood cholesterol increased | 24 | 4.5 3.0–6.7ROR 4.5 · χ² 62 / p 2e-15 | 4.2 EB05 3.0 · IC025 +1.4 3/3 methods agree | Lab value / disease marker | serious PRR 5.9 | no trial data cached |
| Disability | 10 | 4.4 2.4–8.2ROR 4.4 · χ² 23 / p 8e-7 | 3.7 EB05 2.2 · IC025 +0.8 3/3 methods agree | Not in label — unassessed | serious PRR 4.5 | no trial data cached |
| Pruritus generalised | 11 | 4.4 2.4–7.9ROR 4.4 · χ² 25 / p 2e-7 | 3.8 EB05 2.3 · IC025 +0.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.1 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
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 |
|---|---|---|---|---|---|---|
| Drug hypersensitivity | 92 | 4.1 3.4–5.1ROR 4.3 · χ² 218 / p 1e-49 | 4.1 EB05 3.4 · IC025 +1.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 1.9 | no trial data cached |
| Chronic kidney disease | 78 | 8.9 7.1–11.1ROR 9.2 · χ² 540 / p 1e-119 | 8.6 EB05 7.1 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 8.9 | no trial data cached |
| Musculoskeletal stiffness | 65 | 6.5 5.1–8.2ROR 6.6 · χ² 297 / p 9e-67 | 6.2 EB05 5.0 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 8.1 | no trial data cached |
| Injection site pain (pain where injected) | 64 | 1.8 1.4–2.3ROR 1.9 · χ² 24 / p 5e-7 | 1.8 EB05 1.5 · IC025 +0.5 | Likely indication confounding term in indications; also in warnings | serious PRR 2.0 · 76% consumer | no trial data cached |
| Rheumatoid arthritis | 55 | 4.2 3.3–5.5ROR 4.3 · χ² 134 / p 3e-31 | 4.1 EB05 3.3 · IC025 +1.6 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 4.0 | no trial data cached |
| Sinusitis | 50 | 4.2 3.2–5.6ROR 4.3 · χ² 121 / p 1e-28 | 4.1 EB05 3.2 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 3.4 | no trial data cached |
| Joint swelling | 49 | 3.6 2.7–4.7ROR 3.6 · χ² 88 / p 4e-21 | 3.5 EB05 2.7 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 3.7 | no trial data cached |
| Arthritis | 49 | 5.4 4.1–7.2ROR 5.5 · χ² 173 / p 7e-40 | 5.2 EB05 4.1 · IC025 +1.9 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 5.3 | no trial data cached |
| Neck pain | 47 | 7.3 5.5–9.7ROR 7.5 · χ² 251 / p 6e-57 | 6.9 EB05 5.4 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 9.2 | no trial data cached |
| Osteoarthritis | 46 | 9.5 7.1–12.6ROR 9.6 · χ² 340 / p 3e-76 | 9.0 EB05 6.9 · IC025 +2.6 3/3 methods agree | Likely indication confounding term in indications | serious PRR 10.1 | no trial data cached |
| Drug dose omission | 43 | 2.2 1.7–3.0ROR 2.3 · χ² 28 / p 5e-8 | 2.2 EB05 1.7 · IC025 +0.6 | Reporting / coding artifact | serious PRR 3.1 | no trial data cached |
| Psoriasis | 43 | 2.9 2.1–3.9ROR 2.9 · χ² 51 / p 5e-13 | 2.8 EB05 2.2 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 6.1 | no trial data cached |
| Psoriatic arthropathy | 33 | 7.2 5.1–10.1ROR 7.3 · χ² 169 / p 5e-39 | 6.6 EB05 4.9 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 8.7 · ♀ 93% (drug 70%) | no trial data cached |
| Skin disorder | 28 | 7.4 5.1–10.6ROR 7.4 · χ² 147 / p 3e-34 | 6.7 EB05 4.8 · IC025 +2.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 10.3 · ♀ 100% (drug 70%) | no trial data cached |
| Musculoskeletal discomfort | 28 | 14.2 9.8–20.6ROR 14.4 · χ² 331 / p 3e-74 | 13.8 EB05 9.8 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 24.1 · ♀ 92% (drug 70%) | no trial data cached |
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.
- Musculoskeletal discomfort — n=28, PRR 14.2
- Chronic kidney disease — n=78, PRR 8.9
- Neck pain — n=47, PRR 7.3
- Psoriatic arthropathy — n=33, PRR 7.2
- Staphylococcal infection — n=27, PRR 7.1
- Musculoskeletal stiffness — n=65, PRR 6.5
- Osteoporosis — n=23, PRR 4.9
- Cellulitis — n=27, PRR 4.7
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 Sulindac?
In FDA FAERS, the most frequently co-reported reaction terms for Sulindac are drug hypersensitivity, chronic kidney disease, musculoskeletal stiffness, injection site pain, rheumatoid arthritis, sinusitis. 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 Sulindac have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: Cardiovascular Thrombotic Events Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use [see Warnings and Precautions ].
Do FAERS signals prove that Sulindac 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 1fffe88d-50c8-45cf-ac7c-a62b665c89a8, effective 20250404; matched on
openfda.generic_name.exact:"SULINDAC") - 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, 149 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
Page generated 2026-10-08. 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.