Clindamycin Hydrochloride side effects: what 3,409 FDA adverse event reports show
Drug class
Not stated in label
Who reports
3,409 reports · 77% serious · 224 with death outcome · 65% female
Used for
CLINICAL STUDIES In one 12-week multicenter, randomized, evaluator-blind, vehicle-controlled, parallel comparison clinical trial in which patients used CLINDAGEL (clindamycin phosphate topical gel, 1%) once daily or the vehicle gel once daily, in the treatment of acne vulgaris of mild to moderate severity, CLINDAGEL applied once daily was more effective than the vehicle applied once daily.
What it is
DESCRIPTION CLINDAGEL (clindamycin phosphate) topical gel, 1%, a topical antibiotic, contains clindamycin phosphate, USP, at a concentration equivalent to 10 mg clindamycin per gram in a gel v.
Boxed warning
None in the current label
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.
- 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. 291 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 |
|---|---|---|---|---|---|---|
| Toxic skin eruption | 39 | 22.7 16.6–31.0ROR 22.9 · χ² 783 / p 1e-172 | 22.3 EB05 17.0 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 17.7 · 95% clinician | no trial data cached |
| Rash maculo-papular | 80 | 21.2 17.1–26.3ROR 21.6 · χ² 1,514 / p <1e-300 | 21.0 EB05 17.4 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 18.1 · 100% clinician | no trial data cached |
| Hepatic cytolysis | 44 | 21.1 15.7–28.4ROR 21.4 · χ² 821 / p 7e-181 | 20.9 EB05 16.2 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 16.5 · 100% clinician | no trial data cached |
| Hepatic steatosis | 56 | 17.6 13.6–22.9ROR 17.9 · χ² 861 / p 1e-189 | 17.5 EB05 13.9 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 15.2 · ♀ 94% (drug 65%) | no trial data cached |
| Drug reaction with eosinophilia and systemic symptoms | 72 | 16.5 13.1–20.8ROR 16.8 · χ² 1,033 / p 7e-227 | 16.4 EB05 13.4 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 12.9 · 100% clinician | no trial data cached |
| Clostridium difficile colitis | 28 | 15.5 10.7–22.4ROR 15.6 · χ² 363 / p 2e-81 | 15.1 EB05 10.7 · IC025 +3.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 11.9 | no trial data cached |
| Tooth abscess | 22 | 12.6 8.3–19.1ROR 12.7 · χ² 223 / p 8e-51 | 11.9 EB05 7.9 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 10.6 | no trial data cached |
| Osteomyelitis | 35 | 11.3 8.1–15.8ROR 11.4 · χ² 319 / p 1e-71 | 10.8 EB05 7.9 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 7.5 | no trial data cached |
| Toxic epidermal necrolysis (severe skin peeling reaction) | 27 | 10.5 7.2–15.3ROR 10.6 · χ² 222 / p 2e-50 | 9.7 EB05 6.8 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 8.2 · 92% clinician | no trial data cached |
| Cholestasis (bile flow blockage) | 34 | 10.4 7.5–14.6ROR 10.5 · χ² 280 / p 3e-63 | 9.8 EB05 7.2 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 8.3 · 100% clinician | no trial data cached |
| Eosinophilia | 30 | 10.1 7.0–14.4ROR 10.1 · χ² 235 / p 2e-53 | 9.4 EB05 6.7 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 8.2 · 100% clinician | no trial data cached |
| Seasonal allergy | 23 | 9.5 6.3–14.3ROR 9.6 · χ² 167 / p 1e-38 | 8.6 EB05 5.8 · IC025 +2.3 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=17 · 74% consumer | no trial data cached |
| End stage renal disease | 30 | 9.5 6.7–13.6ROR 9.6 · χ² 221 / p 3e-50 | 8.8 EB05 6.3 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 7.5 | no trial data cached |
| Contraindicated product administered | 47 | 9.1 6.9–12.1ROR 9.2 · χ² 332 / p 2e-74 | 8.7 EB05 6.7 · IC025 +2.6 3/3 methods agree | Reporting / coding artifact | serious PRR 8.9 | no trial data cached |
| Tubulointerstitial nephritis | 29 | 9.1 6.3–13.0ROR 9.1 · χ² 200 / p 1e-45 | 8.3 EB05 5.9 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 7.1 · 100% clinician | no trial data cached |
| Tooth infection | 20 | 8.9 5.7–13.7ROR 8.9 · χ² 132 / p 8e-31 | 7.8 EB05 5.2 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 9.8 | no trial data cached |
| Cellulitis (skin infection) | 74 | 8.6 6.9–10.8ROR 8.7 · χ² 489 / p 1e-108 | 8.3 EB05 6.8 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 6.5 | no trial data cached |
| Oesophagitis | 16 | 8.6 5.3–14.0ROR 8.6 · χ² 99 / p 1e-23 | 7.3 EB05 4.6 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 5.1 | no trial data cached |
| Dental caries | 16 | 8.5 5.2–13.8ROR 8.5 · χ² 98 / p 2e-23 | 7.2 EB05 4.6 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 6.4 | no trial data cached |
| Dermatitis contact | 16 | 8.2 5.1–13.5ROR 8.3 · χ² 95 / p 1e-22 | 7.0 EB05 4.5 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious n=11 | no trial data cached |
| Clostridium difficile infection | 29 | 7.8 5.5–11.3ROR 7.9 · χ² 166 / p 3e-38 | 7.1 EB05 5.1 · IC025 +2.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.8 · ♀ 85% (drug 65%) | no trial data cached |
| Hyperlipidaemia | 16 | 7.8 4.8–12.7ROR 7.8 · χ² 88 / p 3e-21 | 6.6 EB05 4.2 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 5.1 | no trial data cached |
| Infusion site pain | 17 | 7.8 4.8–12.5ROR 7.8 · χ² 94 / p 2e-22 | 6.7 EB05 4.3 · IC025 +1.9 3/3 methods agree | Labeled (related wording) related wording | serious n=12 | no trial data cached |
| Stevens-johnson syndrome (severe blistering skin reaction) | 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 | Not in label — unassessed | serious PRR 5.8 | no trial data cached |
| Chronic kidney disease | 94 | 7.2 5.9–8.8ROR 7.3 · χ² 495 / p 6e-110 | 7.0 EB05 5.8 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 | no trial data cached |
| Diarrhoea haemorrhagic | 11 | 6.9 3.8–12.4ROR 6.9 · χ² 49 / p 1e-12 | 5.5 EB05 3.3 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 5.2 | no trial data cached |
| Tooth disorder | 25 | 6.5 4.4–9.7ROR 6.6 · χ² 112 / p 2e-26 | 5.9 EB05 4.2 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 5.3 | no trial data cached |
| Staphylococcal infection | 37 | 6.5 4.7–9.0ROR 6.6 · χ² 168 / p 9e-39 | 6.1 EB05 4.6 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.7 | no trial data cached |
| Therapeutic product effect decreased | 49 | 6.5 4.9–8.5ROR 6.5 · χ² 221 / p 3e-50 | 6.1 EB05 4.8 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | serious PRR 9.4 · ♀ 95% (drug 65%) | no trial data cached |
| Tooth extraction | 13 | 6.1 3.6–10.5ROR 6.1 · χ² 51 / p 6e-13 | 5.1 EB05 3.2 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 5.1 | no trial data cached |
| Localised infection | 25 | 6.0 4.1–8.9ROR 6.1 · χ² 100 / p 7e-24 | 5.5 EB05 3.9 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 5.2 · ♀ 43% (drug 65%) | no trial data cached |
| Atelectasis | 10 | 6.0 3.2–11.2ROR 6.0 · χ² 37 / p 6e-10 | 4.8 EB05 2.8 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 2.9 | no trial data cached |
| Bacterial infection | 19 | 6.0 3.8–9.4ROR 6.0 · χ² 74 / p 4e-18 | 5.3 EB05 3.6 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 4.8 | no trial data cached |
| Renal tubular necrosis | 10 | 6.0 3.2–11.1ROR 6.0 · χ² 36 / p 8e-10 | 4.8 EB05 2.8 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.7 | no trial data cached |
| Drug hypersensitivity | 194 | 5.8 5.1–6.7ROR 6.1 · χ² 781 / p 4e-172 | 5.8 EB05 5.1 · IC025 +2.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.0 | no trial data cached |
| Liver disorder | 42 | 5.5 4.1–7.5ROR 5.6 · χ² 152 / p 3e-35 | 5.2 EB05 4.0 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 | no trial data cached |
| Gastric disorder | 33 | 5.5 3.9–7.8ROR 5.6 · χ² 119 / p 7e-28 | 5.2 EB05 3.8 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 8.5 · ♀ 94% (drug 65%) | no trial data cached |
| Toothache | 17 | 5.5 3.4–8.8ROR 5.5 · χ² 58 / p 1e-14 | 4.8 EB05 3.2 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 4.8 | no trial data cached |
| Agranulocytosis (severe loss of white cells) | 17 | 5.4 3.3–8.6ROR 5.4 · χ² 56 / p 3e-14 | 4.7 EB05 3.1 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.2 | no trial data cached |
| Drug eruption | 16 | 5.3 3.3–8.7ROR 5.3 · χ² 52 / p 3e-13 | 4.7 EB05 3.0 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 3.9 | 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 |
|---|---|---|---|---|---|---|
| Rash | 271 | 3.7 3.3–4.1ROR 3.9 · χ² 531 / p 9e-118 | 3.6 EB05 3.3 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.8 | no trial data cached |
| Drug hypersensitivity | 194 | 5.8 5.1–6.7ROR 6.1 · χ² 781 / p 4e-172 | 5.8 EB05 5.1 · IC025 +2.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.0 | no trial data cached |
| Pruritus (itching) | 170 | 2.6 2.3–3.0ROR 2.7 · χ² 173 / p 7e-40 | 2.6 EB05 2.3 · IC025 +1.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.4 | no trial data cached |
| Cough | 142 | 3.0 2.5–3.5ROR 3.0 · χ² 186 / p 1e-42 | 2.9 EB05 2.6 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 3.7 | no trial data cached |
| Abdominal pain upper | 122 | 3.5 2.9–4.1ROR 3.6 · χ² 214 / p 7e-49 | 3.4 EB05 3.0 · IC025 +1.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.3 | no trial data cached |
| Acute kidney injury (sudden kidney damage) | 115 | 4.4 3.7–5.3ROR 4.5 · χ² 303 / p 4e-68 | 4.3 EB05 3.7 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 3.5 · 90% clinician | no trial data cached |
| Erythema (skin redness) | 108 | 3.1 2.6–3.7ROR 3.1 · χ² 151 / p 6e-35 | 3.0 EB05 2.6 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.4 | no trial data cached |
| Hypersensitivity (allergic reaction) | 101 | 3.2 2.6–3.9ROR 3.3 · χ² 151 / p 6e-35 | 3.1 EB05 2.7 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.6 | no trial data cached |
| Renal failure (kidney failure) | 95 | 4.2 3.4–5.1ROR 4.2 · χ² 226 / p 3e-51 | 4.1 EB05 3.4 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 3.1 | no trial data cached |
| Abdominal discomfort | 94 | 3.3 2.7–4.0ROR 3.4 · χ² 149 / p 2e-34 | 3.2 EB05 2.7 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 5.2 · ♀ 86% (drug 65%) | no trial data cached |
| Chronic kidney disease | 94 | 7.2 5.9–8.8ROR 7.3 · χ² 495 / p 6e-110 | 7.0 EB05 5.8 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 | no trial data cached |
| Product dose omission issue | 93 | 1.9 1.6–2.3ROR 1.9 · χ² 40 / p 1e-10 | 1.9 EB05 1.6 · IC025 +0.6 | Reporting / coding artifact | serious PRR 3.3 | no trial data cached |
| Sinusitis | 86 | 4.9 4.0–6.0ROR 5.0 · χ² 264 / p 1e-59 | 4.8 EB05 4.0 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 5.6 | no trial data cached |
| Covid-19 | 80 | 2.6 2.1–3.3ROR 2.7 · χ² 81 / p 1e-19 | 2.6 EB05 2.2 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 2.8 · ♀ 86% (drug 65%) · 73% consumer | no trial data cached |
| Rash maculo-papular | 80 | 21.2 17.1–26.3ROR 21.6 · χ² 1,514 / p <1e-300 | 21.0 EB05 17.4 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 18.1 · 100% clinician | 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.
- Toxic skin eruption — n=39, PRR 22.7
- Rash maculo-papular — n=80, PRR 21.2
- Hepatic cytolysis — n=44, PRR 21.1
- Hepatic steatosis — n=56, PRR 17.6
- Drug reaction with eosinophilia and systemic symptoms — n=72, PRR 16.5
- Tooth abscess — n=22, PRR 12.6
- Osteomyelitis — n=35, PRR 11.3
- Toxic epidermal necrolysis — n=27, PRR 10.5
- Cholestasis — n=34, PRR 10.4
- Eosinophilia — n=30, PRR 10.1
✓ A hand-written Bradford Hill causality assessment exists for this drug: Clindamycin ↔ Clostridioides difficile colitis.
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 Clindamycin?
In FDA FAERS, the most frequently co-reported reaction terms for Clindamycin are rash, drug hypersensitivity, pruritus, cough, abdominal pain upper, acute kidney injury. 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 Clindamycin have an FDA boxed warning?
No. The FDA label retrieved for Clindamycin has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Clindamycin 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 f7b4e985-719a-4547-b624-94612d520991, effective 20200101; matched on
openfda.generic_name.exact:"CLINDAMYCIN") - 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, 331 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.