Probenecid side effects: what 1,173 FDA adverse event reports show
Drug class
Not stated in label
Who reports
1,173 reports · 70% serious · 167 with death outcome · 32% female
Used for
Probenecid tablets are indicated for the treatment of the hyperuricemia associated with gout and gouty arthritis. As an adjuvant to therapy with penicillin or with ampicillin, methicillin, oxacillin, cloxacillin, or nafcillin, for elevation and prolongation of plasma levels by whatever route the antibiotic is given.
What it is
DESCRIPTION Probenecid is a uricosuric and renal tubular transport blocking agent. Probenecid is the generic name for 4-[(dipropyl-amino)sulfonyl] benzoic acid. It has the following structural formula: C 13 H 19 NO 4 S M.W. 285.36 Probenecid USP is a white or practically white, fine, crystalline powder.
Boxed warning
None in the current label
Causality screen of the 18 strongest signals
What the badges mean
- 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.
- 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.
- Outcome field, not a reaction Death is a report outcome, not a reaction term. It is dominated by the underlying illness; see the seriousness profile and the boxed warning instead.
- 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. 3 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 |
|---|---|---|---|---|---|---|
| Gout | 23 | 22.9 15.3–34.4ROR 23.4 · χ² 460 / p 2e-102 | 22.5 EB05 15.7 · IC025 +3.3 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 13.5 | no trial data cached |
| Pancreatitis acute | 21 | 16.8 11.0–25.7ROR 17.1 · χ² 297 / p 6e-67 | 16.4 EB05 11.0 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 13.8 | no trial data cached |
| Nephropathy toxic | 10 | 16.1 8.7–29.8ROR 16.2 · χ² 127 / p 1e-29 | 14.5 EB05 7.2 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 13.5 | no trial data cached |
| Cytomegalovirus infection | 13 | 14.0 8.1–24.0ROR 14.1 · χ² 144 / p 2e-33 | 12.7 EB05 7.1 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 11.6 | no trial data cached |
| Bacterial infection | 12 | 11.6 6.6–20.3ROR 11.7 · χ² 105 / p 5e-25 | 9.9 EB05 5.4 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 10.0 | no trial data cached |
| Renal tubular necrosis | 6 | 10.9 4.9–24.2ROR 11.0 · χ² 45 / p 1e-11 | 7.5 EB05 3.3 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 9.0 | no trial data cached |
| Hepatomegaly | 6 | 10.9 4.9–24.1ROR 10.9 · χ² 44 / p 1e-11 | 7.5 EB05 3.3 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 9.7 | no trial data cached |
| Pneumocystis jirovecii pneumonia | 6 | 10.7 4.8–23.9ROR 10.8 · χ² 44 / p 2e-11 | 7.4 EB05 3.2 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 8.8 | no trial data cached |
| Squamous cell carcinoma | 5 | 9.5 4.0–22.8ROR 9.5 · χ² 30 / p 2e-8 | 6.0 EB05 2.6 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious PRR 8.0 | no trial data cached |
| Lymphopenia | 7 | 8.9 4.3–18.6ROR 8.9 · χ² 41 / p 6e-11 | 6.3 EB05 3.1 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 7.9 | no trial data cached |
| Renal failure acute | 21 | 8.7 5.7–13.3ROR 8.9 · χ² 136 / p 9e-32 | 7.7 EB05 5.2 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 7.2 | no trial data cached |
| Fluid overload | 7 | 8.5 4.1–17.8ROR 8.5 · χ² 39 / p 2e-10 | 6.0 EB05 3.0 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 9.0 | no trial data cached |
| Red blood cell sedimentation rate increased | 5 | 8.1 3.4–19.3ROR 8.1 · χ² 24 / p 4e-7 | 5.2 EB05 2.3 · IC025 +0.7 3/3 methods agree | Lab value / disease marker | serious PRR 6.0 | no trial data cached |
| Uveitis | 5 | 6.6 2.8–15.9ROR 6.6 · χ² 19 / p 8e-6 | 4.4 EB05 2.1 · IC025 +0.6 3/3 methods agree | Not in label — unassessed | serious PRR 5.8 | no trial data cached |
| Neoplasm progression | 10 | 5.1 2.7–9.4ROR 5.1 · χ² 29 / p 4e-8 | 4.2 EB05 2.5 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 5.8 | no trial data cached |
| Activities of daily living impaired | 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 4.9 | no trial data cached |
| Myelosuppression | 7 | 3.7 1.8–7.7ROR 3.7 · χ² 11 / p 4e-4 | 3.1 EB05 1.7 · IC025 +0.3 | Not in label — unassessed | serious PRR 3.0 | no trial data cached |
| Completed suicide (death by suicide) | 11 | 2.3 1.3–4.2ROR 2.3 · χ² 7 / p 0.004 | 2.2 EB05 1.3 · IC025 +0.1 | Outcome field, not a reaction | serious PRR 1.9 | 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 |
|---|---|---|---|---|---|---|
| Gout | 23 | 22.9 15.3–34.4ROR 23.4 · χ² 460 / p 2e-102 | 22.5 EB05 15.7 · IC025 +3.3 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 13.5 | no trial data cached |
| Renal failure acute | 21 | 8.7 5.7–13.3ROR 8.9 · χ² 136 / p 9e-32 | 7.7 EB05 5.2 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 7.2 | no trial data cached |
| Pancreatitis acute | 21 | 16.8 11.0–25.7ROR 17.1 · χ² 297 / p 6e-67 | 16.4 EB05 11.0 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 13.8 | no trial data cached |
| Cytomegalovirus infection | 13 | 14.0 8.1–24.0ROR 14.1 · χ² 144 / p 2e-33 | 12.7 EB05 7.1 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 11.6 | no trial data cached |
| Bacterial infection | 12 | 11.6 6.6–20.3ROR 11.7 · χ² 105 / p 5e-25 | 9.9 EB05 5.4 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 10.0 | no trial data cached |
| Completed suicide (death by suicide) | 11 | 2.3 1.3–4.2ROR 2.3 · χ² 7 / p 0.004 | 2.2 EB05 1.3 · IC025 +0.1 | Outcome field, not a reaction | serious PRR 1.9 | no trial data cached |
| Neoplasm progression | 10 | 5.1 2.7–9.4ROR 5.1 · χ² 29 / p 4e-8 | 4.2 EB05 2.5 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 5.8 | no trial data cached |
| Nephropathy toxic | 10 | 16.1 8.7–29.8ROR 16.2 · χ² 127 / p 1e-29 | 14.5 EB05 7.2 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 13.5 | no trial data cached |
| Myelosuppression | 7 | 3.7 1.8–7.7ROR 3.7 · χ² 11 / p 4e-4 | 3.1 EB05 1.7 · IC025 +0.3 | Not in label — unassessed | serious PRR 3.0 | no trial data cached |
| Fluid overload | 7 | 8.5 4.1–17.8ROR 8.5 · χ² 39 / p 2e-10 | 6.0 EB05 3.0 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 9.0 | no trial data cached |
| Lymphopenia | 7 | 8.9 4.3–18.6ROR 8.9 · χ² 41 / p 6e-11 | 6.3 EB05 3.1 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 7.9 | no trial data cached |
| Pneumocystis jirovecii pneumonia | 6 | 10.7 4.8–23.9ROR 10.8 · χ² 44 / p 2e-11 | 7.4 EB05 3.2 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 8.8 | no trial data cached |
| Hepatomegaly | 6 | 10.9 4.9–24.1ROR 10.9 · χ² 44 / p 1e-11 | 7.5 EB05 3.3 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 9.7 | no trial data cached |
| Renal tubular necrosis | 6 | 10.9 4.9–24.2ROR 11.0 · χ² 45 / p 1e-11 | 7.5 EB05 3.3 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 9.0 | no trial data cached |
| Activities of daily living impaired | 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 4.9 | 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.
- Pancreatitis acute — n=21, PRR 16.8
- Renal failure acute — n=21, PRR 8.7
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 Probenecid?
In FDA FAERS, the most frequently co-reported reaction terms for Probenecid are gout, renal failure acute, pancreatitis acute, cytomegalovirus infection, bacterial infection, neoplasm progression. 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 Probenecid have an FDA boxed warning?
No. The FDA label retrieved for Probenecid has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Probenecid 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 65b4888c-d49a-433f-9bfd-17880ae40069, effective 20260429; matched on
openfda.generic_name.exact:"PROBENECID") - 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, 21 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.