Salsalate side effects: what 939 FDA adverse event reports show
Drug class
Not stated in label
Who reports
939 reports · 63% serious · 82 with death outcome · 59% female
Used for
Carefully consider the potential benefits and risks of Salsalate tablets, USP and other treatment options before deciding to use Salsalate tablets, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Salsalate, USP is indicated for relief of the signs and symptoms of rheumatoid arthritis, osteoarthritis and related rheumatic disorder.
What it is
DESCRIPTION Salsalate USP, is a nonsteroidal anti-inflammatory agent for oral administration.
Boxed warning
Cardiovascular Risk NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk (see WARNINGS and CLINICAL TRIALS).
Causality screen of the 23 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 flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 11 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 |
|---|---|---|---|---|---|---|
| Vitamin d deficiency | 7 | 16.0 7.7–33.6ROR 16.2 · χ² 84 / p 2e-20 | 13.3 EB05 5.4 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 15.3 | no trial data cached |
| International normalised ratio increased | 20 | 15.5 10.1–23.9ROR 15.8 · χ² 258 / p 3e-58 | 15.0 EB05 9.8 · IC025 +2.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 14.3 · 100% clinician | no trial data cached |
| Economic problem | 10 | 14.5 7.8–26.9ROR 14.6 · χ² 113 / p 1e-26 | 12.7 EB05 6.3 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | serious PRR 14.6 | no trial data cached |
| Intervertebral disc degeneration | 6 | 14.4 6.5–32.0ROR 14.5 · χ² 62 / p 2e-15 | 10.8 EB05 4.2 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 15.2 | no trial data cached |
| Hereditary angioedema | 6 | 12.8 5.7–28.3ROR 12.8 · χ² 54 / p 1e-13 | 9.2 EB05 3.7 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 14.0 | no trial data cached |
| Bone disorder | 10 | 12.2 6.6–22.5ROR 12.3 · χ² 92 / p 5e-22 | 10.1 EB05 5.1 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 12.3 | no trial data cached |
| Type 2 diabetes mellitus | 17 | 11.2 7.0–18.0ROR 11.4 · χ² 149 / p 2e-34 | 10.1 EB05 6.2 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 10.9 | no trial data cached |
| Intervertebral disc protrusion | 11 | 11.2 6.2–20.2ROR 11.3 · χ² 92 / p 4e-22 | 9.3 EB05 5.0 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 11.0 | no trial data cached |
| Drug toxicity | 6 | 9.7 4.4–21.5ROR 9.8 · χ² 39 / p 3e-10 | 6.6 EB05 3.0 · IC025 +1.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 9.3 | no trial data cached |
| Gastric haemorrhage | 5 | 9.6 4.0–23.1ROR 9.7 · χ² 31 / p 2e-8 | 6.1 EB05 2.6 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious PRR 9.2 | no trial data cached |
| Rotator cuff syndrome | 5 | 8.7 3.6–20.8ROR 8.7 · χ² 27 / p 1e-7 | 5.5 EB05 2.4 · IC025 +0.8 3/3 methods agree | Not in label — unassessed | serious PRR 7.4 | no trial data cached |
| Cytokine release syndrome | 7 | 8.2 3.9–17.2ROR 8.3 · χ² 37 / p 5e-10 | 5.8 EB05 2.9 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 7.6 | no trial data cached |
| Multiple fractures | 6 | 8.1 3.6–18.0ROR 8.1 · χ² 31 / p 2e-8 | 5.5 EB05 2.6 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 6.6 | no trial data cached |
| Intentional drug misuse | 6 | 6.3 2.8–14.0ROR 6.4 · χ² 22 / p 1e-6 | 4.5 EB05 2.2 · IC025 +0.7 3/3 methods agree | Reporting / coding artifact | serious PRR 10.4 | no trial data cached |
| Diabetes mellitus inadequate control | 5 | 6.3 2.6–15.1ROR 6.3 · χ² 17 / p 2e-5 | 4.3 EB05 2.0 · IC025 +0.5 3/3 methods agree | Not in label — unassessed | serious PRR 6.8 | no trial data cached |
| Serotonin syndrome | 5 | 5.8 2.4–14.0ROR 5.9 · χ² 16 / p 4e-5 | 4.0 EB05 1.9 · IC025 +0.5 | Not in label — unassessed | serious PRR 5.4 | no trial data cached |
| Rheumatoid arthritis | 29 | 5.7 4.0–8.2ROR 5.9 · χ² 109 / p 8e-26 | 5.3 EB05 3.9 · IC025 +1.8 3/3 methods agree | Likely indication confounding term in indications | serious PRR 4.4 | no trial data cached |
| Tardive dyskinesia (persistent involuntary movements) | 7 | 5.5 2.6–11.5ROR 5.5 · χ² 21 / p 2e-6 | 4.2 EB05 2.2 · IC025 +0.8 3/3 methods agree | Not in label — unassessed | serious PRR 5.2 | no trial data cached |
| Bone density decreased | 7 | 4.9 2.4–10.3ROR 5.0 · χ² 18 / p 1e-5 | 3.9 EB05 2.1 · IC025 +0.7 3/3 methods agree | Lab value / disease marker | serious PRR 4.9 | no trial data cached |
| Extrapyramidal disorder | 5 | 4.5 1.9–10.7ROR 4.5 · χ² 10 / p 7e-4 | 3.4 EB05 1.6 · IC025 +0.2 | Not in label — unassessed | serious PRR 4.6 | no trial data cached |
| Injection site rash | 5 | 3.7 1.5–8.8ROR 3.7 · χ² 7 / p 0.004 | 2.9 EB05 1.4 · IC025 +0.0 | Labeled (related wording) related wording | serious n=1 | no trial data cached |
| Wrong technique in drug usage process | 6 | 3.6 1.6–8.1ROR 3.7 · χ² 9 / p 0.001 | 3.0 EB05 1.5 · IC025 +0.2 | Reporting / coding artifact | serious PRR 5.6 | no trial data cached |
| Injection site pruritus | 8 | 2.7 1.3–5.4ROR 2.7 · χ² 7 / p 0.004 | 2.4 EB05 1.4 · IC025 +0.1 | Not in label — unassessed | serious PRR 2.2 | 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 |
|---|---|---|---|---|---|---|
| Rheumatoid arthritis | 29 | 5.7 4.0–8.2ROR 5.9 · χ² 109 / p 8e-26 | 5.3 EB05 3.9 · IC025 +1.8 3/3 methods agree | Likely indication confounding term in indications | serious PRR 4.4 | no trial data cached |
| International normalised ratio increased | 20 | 15.5 10.1–23.9ROR 15.8 · χ² 258 / p 3e-58 | 15.0 EB05 9.8 · IC025 +2.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 14.3 · 100% clinician | no trial data cached |
| Type 2 diabetes mellitus | 17 | 11.2 7.0–18.0ROR 11.4 · χ² 149 / p 2e-34 | 10.1 EB05 6.2 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 10.9 | no trial data cached |
| Intervertebral disc protrusion | 11 | 11.2 6.2–20.2ROR 11.3 · χ² 92 / p 4e-22 | 9.3 EB05 5.0 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 11.0 | no trial data cached |
| Bone disorder | 10 | 12.2 6.6–22.5ROR 12.3 · χ² 92 / p 5e-22 | 10.1 EB05 5.1 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 12.3 | no trial data cached |
| Economic problem | 10 | 14.5 7.8–26.9ROR 14.6 · χ² 113 / p 1e-26 | 12.7 EB05 6.3 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | serious PRR 14.6 | no trial data cached |
| Completed suicide (death by suicide) | 8 | 2.1 1.1–4.2ROR 2.1 · χ² 4 / p 0.027 | 2.0 EB05 1.1 · IC025 -0.2 PRR-only: not supported by EBGM or IC | Outcome field, not a reaction boxed warning mentions mortality | serious PRR 2.0 | no trial data cached |
| Injection site pruritus | 8 | 2.7 1.3–5.4ROR 2.7 · χ² 7 / p 0.004 | 2.4 EB05 1.4 · IC025 +0.1 | Not in label — unassessed | serious PRR 2.2 | no trial data cached |
| Bone density decreased | 7 | 4.9 2.4–10.3ROR 5.0 · χ² 18 / p 1e-5 | 3.9 EB05 2.1 · IC025 +0.7 3/3 methods agree | Lab value / disease marker | serious PRR 4.9 | no trial data cached |
| Tardive dyskinesia (persistent involuntary movements) | 7 | 5.5 2.6–11.5ROR 5.5 · χ² 21 / p 2e-6 | 4.2 EB05 2.2 · IC025 +0.8 3/3 methods agree | Not in label — unassessed | serious PRR 5.2 | no trial data cached |
| Cytokine release syndrome | 7 | 8.2 3.9–17.2ROR 8.3 · χ² 37 / p 5e-10 | 5.8 EB05 2.9 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 7.6 | no trial data cached |
| Vitamin d deficiency | 7 | 16.0 7.7–33.6ROR 16.2 · χ² 84 / p 2e-20 | 13.3 EB05 5.4 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 15.3 | no trial data cached |
| Wrong technique in drug usage process | 6 | 3.6 1.6–8.1ROR 3.7 · χ² 9 / p 0.001 | 3.0 EB05 1.5 · IC025 +0.2 | Reporting / coding artifact | serious PRR 5.6 | no trial data cached |
| Intentional drug misuse | 6 | 6.3 2.8–14.0ROR 6.4 · χ² 22 / p 1e-6 | 4.5 EB05 2.2 · IC025 +0.7 3/3 methods agree | Reporting / coding artifact | serious PRR 10.4 | no trial data cached |
| Multiple fractures | 6 | 8.1 3.6–18.0ROR 8.1 · χ² 31 / p 2e-8 | 5.5 EB05 2.6 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 6.6 | no trial data cached |
Unlabeled candidate signals
Every screened signal with n ≥ 20 was either labeled, an indication term, or an artifact pattern — no unlabeled candidate stood out in the top signals.
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 Salsalate?
In FDA FAERS, the most frequently co-reported reaction terms for Salsalate are rheumatoid arthritis, international normalised ratio increased, type 2 diabetes mellitus, intervertebral disc protrusion, bone disorder, injection site pruritus. 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 Salsalate have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: Cardiovascular Risk NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk (see WARNINGS and CLINICAL TRIALS).
Do FAERS signals prove that Salsalate 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 24815546-658b-4b01-ac11-de7fbd0ebd16, effective 20240208; matched on
openfda.generic_name.exact:"SALSALATE") - 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, 34 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.