Drug · FAERS side-effect profile with label screen
Clindamycin Gel and 1% side effects: what 3,453 FDA adverse event reports show
Drug class
Not stated in label
Label matched
Clindamycin Phosphate Gel Usp, 1% (Clindamycin Phosphate)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
3,453 reports · 64% serious · 263 with death outcome · 64% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Clindamycin phosphate gel USP, 1% is indicated in the treatment of acne vulgaris. In view of the potential for diarrhea, bloody diarrhea and pseudomembranous colitis, the physician should consider whether other agents are more appropriate (see CONTRAINDICATIONS , WARNINGS and ADVERSE REACTIONS ).
FDA label, Indications and Usage
What it is
DESCRIPTION Clindamycin phosphate gel USP, 1% contains clindamycin phosphate, USP, at a concentration equivalent to 10 mg clindamycin per gram. Clindamycin phosphate is a water soluble ester o.
FDA label, Description section
Boxed warning
None in the current label
How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation.
Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)?
That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.
Causality screen of the 40 strongest signals
Labeled adverse reaction 1Labeled (related wording) 4Likely indication confounding 1Reporting / coding artifact 4Lab value / disease marker 1Not in label — unassessed 29
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. 167 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Toxic skin eruption | 25 | 15.0 10.2–22.2ROR 15.1 · χ² 313 / p 2e-70 | 14.6 EB05 10.1 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 13.5 · 92% clinician | no trial data cached |
| Toxic epidermal necrolysis (severe skin peeling reaction) | 31 | 12.5 8.8–17.7ROR 12.6 · χ² 316 / p 5e-71 | 12.0 EB05 8.6 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 11.2 · 100% clinician | no trial data cached |
| Sleep apnoea syndrome | 34 | 10.8 7.7–15.1ROR 10.9 · χ² 292 / p 7e-66 | 10.2 EB05 7.5 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 10.8 · ♀ 94% (drug 64%) | no trial data cached |
| Drug eruption | 31 | 10.7 7.5–15.2ROR 10.8 · χ² 262 / p 3e-59 | 10.1 EB05 7.2 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 11.0 · 94% clinician | no trial data cached |
| Clostridium difficile infection | 37 | 10.4 7.5–14.3ROR 10.5 · χ² 304 / p 2e-68 | 9.8 EB05 7.3 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 9.8 · ♀ 88% (drug 64%) | no trial data cached |
| Scar | 27 | 9.6 6.6–13.9ROR 9.6 · χ² 198 / p 2e-45 | 8.8 EB05 6.1 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 10.7 | no trial data cached |
| Drug reaction with eosinophilia and systemic symptoms | 39 | 9.3 6.8–12.7ROR 9.4 · χ² 280 / p 5e-63 | 8.7 EB05 6.5 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 8.3 · ♀ 23% (drug 64%) · 100% clinician | no trial data cached |
| Rash maculo-papular | 33 | 9.0 6.4–12.7ROR 9.1 · χ² 228 / p 8e-52 | 8.4 EB05 6.1 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 8.4 · ♀ 43% (drug 64%) · 100% clinician | no trial data cached |
| Folliculitis | 15 | 8.8 5.3–14.6ROR 8.9 · χ² 96 / p 5e-23 | 7.5 EB05 4.6 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.6 | no trial data cached |
| Clostridium difficile colitis | 14 | 8.0 4.7–13.5ROR 8.0 · χ² 79 / p 3e-19 | 6.7 EB05 4.1 · IC025 +1.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.3 | no trial data cached |
| Eosinophilia | 22 | 7.6 5.0–11.6ROR 7.7 · χ² 121 / p 2e-28 | 6.8 EB05 4.6 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 7.2 · 100% clinician | no trial data cached |
| Drug hypersensitivity | 228 | 7.1 6.3–8.1ROR 7.6 · χ² 1,205 / p 2e-264 | 7.0 EB05 6.3 · IC025 +2.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.0 · ♀ 89% (drug 64%) | no trial data cached |
| Skin reaction | 16 | 6.9 4.2–11.3ROR 6.9 · χ² 75 / p 2e-18 | 5.9 EB05 3.8 · IC025 +1.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.2 | no trial data cached |
| Skin lesion | 30 | 6.7 4.7–9.6ROR 6.7 · χ² 140 / p 2e-32 | 6.1 EB05 4.5 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 6.5 · ♀ 100% (drug 64%) | no trial data cached |
| Application site pain | 24 | 6.6 4.4–9.9ROR 6.7 · χ² 109 / p 8e-26 | 5.9 EB05 4.2 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious n=7 · ♀ 86% (drug 64%) | no trial data cached |
| Product packaging issue | 10 | 6.5 3.5–12.2ROR 6.6 · χ² 42 / p 6e-11 | 5.2 EB05 3.0 · IC025 +1.3 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Cyst | 13 | 6.4 3.7–10.9ROR 6.4 · χ² 53 / p 1e-13 | 5.3 EB05 3.3 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 5.8 | no trial data cached |
| Pharyngeal swelling | 10 | 6.3 3.4–11.8ROR 6.4 · χ² 40 / p 1e-10 | 5.1 EB05 2.9 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious n=7 | no trial data cached |
| Drug ineffective for unapproved indication | 57 | 6.2 4.8–8.0ROR 6.3 · χ² 244 / p 2e-55 | 5.9 EB05 4.7 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | serious PRR 5.0 | no trial data cached |
| Product odour abnormal | 10 | 5.8 3.1–10.9ROR 5.9 · χ² 35 / p 1e-9 | 4.7 EB05 2.8 · IC025 +1.2 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Oesophagitis | 10 | 5.6 3.0–10.3ROR 5.6 · χ² 33 / p 5e-9 | 4.5 EB05 2.6 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 5.5 | no trial data cached |
| Tooth fracture | 10 | 5.5 3.0–10.2ROR 5.5 · χ² 33 / p 6e-9 | 4.5 EB05 2.6 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 7.5 | no trial data cached |
| Acute respiratory distress syndrome | 16 | 5.5 3.4–9.0ROR 5.5 · χ² 54 / p 8e-14 | 4.8 EB05 3.1 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 | no trial data cached |
| Premature delivery | 14 | 5.3 3.1–9.0ROR 5.3 · χ² 45 / p 1e-11 | 4.6 EB05 2.9 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 | no trial data cached |
| Renal failure acute | 36 | 5.1 3.7–7.0ROR 5.1 · χ² 114 / p 7e-27 | 4.8 EB05 3.6 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 4.6 · ♀ 36% (drug 64%) · 100% clinician | no trial data cached |
| Hepatic steatosis | 15 | 4.9 3.0–8.1ROR 4.9 · χ² 43 / p 3e-11 | 4.3 EB05 2.8 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.0 | no trial data cached |
| Cholestasis (bile flow blockage) | 15 | 4.8 2.9–7.9ROR 4.8 · χ² 41 / p 8e-11 | 4.2 EB05 2.7 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.3 | no trial data cached |
| Skin ulcer | 20 | 4.7 3.0–7.3ROR 4.7 · χ² 55 / p 7e-14 | 4.3 EB05 2.9 · IC025 +1.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.8 | no trial data cached |
| Acute hepatic failure | 10 | 4.5 2.4–8.3ROR 4.5 · χ² 24 / p 6e-7 | 3.8 EB05 2.2 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious PRR 4.0 | no trial data cached |
| Gingival bleeding | 10 | 4.4 2.4–8.2ROR 4.4 · χ² 23 / p 7e-7 | 3.8 EB05 2.2 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious PRR 6.0 | no trial data cached |
| Stevens-johnson syndrome (severe blistering skin reaction) | 16 | 4.4 2.7–7.1ROR 4.4 · χ² 38 / p 3e-10 | 3.9 EB05 2.6 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 3.9 | no trial data cached |
| Localised infection | 17 | 4.3 2.7–6.9ROR 4.3 · χ² 39 / p 2e-10 | 3.9 EB05 2.6 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 | no trial data cached |
| Abscess | 11 | 4.2 2.3–7.6ROR 4.2 · χ² 24 / p 6e-7 | 3.6 EB05 2.2 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious PRR 3.8 | no trial data cached |
| Foot fracture | 13 | 4.2 2.4–7.1ROR 4.2 · χ² 28 / p 6e-8 | 3.7 EB05 2.3 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 | no trial data cached |
| Acne | 51 | 4.1 3.1–5.3ROR 4.1 · χ² 115 / p 4e-27 | 3.9 EB05 3.1 · IC025 +1.5 3/3 methods agree | Likely indication confounding term in indications | serious PRR 6.7 | no trial data cached |
| Therapy partial responder | 10 | 4.0 2.2–7.5ROR 4.0 · χ² 20 / p 4e-6 | 3.5 EB05 2.1 · IC025 +0.7 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Anaphylactic reaction (severe allergic reaction) | 35 | 3.9 2.8–5.4ROR 3.9 · χ² 72 / p 1e-17 | 3.7 EB05 2.8 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 3.4 · 91% clinician | no trial data cached |
| Obesity | 10 | 3.8 2.0–7.1ROR 3.8 · χ² 18 / p 1e-5 | 3.3 EB05 2.0 · IC025 +0.7 | Not in label — unassessed | serious PRR 4.0 | no trial data cached |
| Cellulitis (skin infection) | 31 | 3.7 2.6–5.3ROR 3.8 · χ² 59 / p 7e-15 | 3.6 EB05 2.6 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 3.5 | no trial data cached |
| Blood pressure systolic increased | 12 | 3.7 2.1–6.5ROR 3.7 · χ² 21 / p 2e-6 | 3.3 EB05 2.1 · IC025 +0.8 3/3 methods agree | Lab value / disease marker | serious PRR 3.6 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).
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 | 251 | 3.5 3.1–4.0ROR 3.7 · χ² 458 / p 6e-102 | 3.5 EB05 3.1 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 4.0 | no trial data cached |
| Drug hypersensitivity | 228 | 7.1 6.3–8.1ROR 7.6 · χ² 1,205 / p 2e-264 | 7.0 EB05 6.3 · IC025 +2.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.0 · ♀ 89% (drug 64%) | no trial data cached |
| Pruritus (itching) | 157 | 2.5 2.2–2.9ROR 2.6 · χ² 145 / p 1e-33 | 2.5 EB05 2.2 · IC025 +1.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.9 | no trial data cached |
| Erythema (skin redness) | 101 | 3.0 2.5–3.6ROR 3.0 · χ² 133 / p 5e-31 | 3.0 EB05 2.5 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.6 | no trial data cached |
| Dry skin | 60 | 2.8 2.2–3.6ROR 2.8 · χ² 66 / p 2e-16 | 2.7 EB05 2.2 · IC025 +1.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.1 | no trial data cached |
| Drug ineffective for unapproved indication | 57 | 6.2 4.8–8.0ROR 6.3 · χ² 244 / p 2e-55 | 5.9 EB05 4.7 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | serious PRR 5.0 | no trial data cached |
| Acne | 51 | 4.1 3.1–5.3ROR 4.1 · χ² 115 / p 4e-27 | 3.9 EB05 3.1 · IC025 +1.5 3/3 methods agree | Likely indication confounding term in indications | serious PRR 6.7 | no trial data cached |
| Product quality issue | 42 | 1.9 1.4–2.6ROR 1.9 · χ² 17 / p 2e-5 | 1.9 EB05 1.4 · IC025 +0.4 | Reporting / coding artifact | serious PRR 0.8 | no trial data cached |
| Psoriasis | 42 | 1.9 1.4–2.6ROR 2.0 · χ² 19 / p 8e-6 | 1.9 EB05 1.5 · IC025 +0.4 | Not in label — unassessed | serious PRR 2.6 | no trial data cached |
| Suicidal ideation (thoughts of suicide) | 39 | 2.6 1.9–3.5ROR 2.6 · χ² 36 / p 8e-10 | 2.5 EB05 1.9 · IC025 +0.8 | Not in label — unassessed | serious PRR 2.4 | no trial data cached |
| Drug reaction with eosinophilia and systemic symptoms | 39 | 9.3 6.8–12.7ROR 9.4 · χ² 280 / p 5e-63 | 8.7 EB05 6.5 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 8.3 · ♀ 23% (drug 64%) · 100% clinician | no trial data cached |
| Burning sensation | 37 | 3.2 2.3–4.4ROR 3.2 · χ² 54 / p 1e-13 | 3.1 EB05 2.4 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 3.1 · ♀ 87% (drug 64%) · 71% consumer | no trial data cached |
| Clostridium difficile infection | 37 | 10.4 7.5–14.3ROR 10.5 · χ² 304 / p 2e-68 | 9.8 EB05 7.3 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 9.8 · ♀ 88% (drug 64%) | no trial data cached |
| Renal failure acute | 36 | 5.1 3.7–7.0ROR 5.1 · χ² 114 / p 7e-27 | 4.8 EB05 3.6 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 4.6 · ♀ 36% (drug 64%) · 100% clinician | no trial data cached |
| Anaphylactic reaction (severe allergic reaction) | 35 | 3.9 2.8–5.4ROR 3.9 · χ² 72 / p 1e-17 | 3.7 EB05 2.8 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 3.4 · 91% 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=25, PRR 15.0
- Toxic epidermal necrolysis — n=31, PRR 12.5
- Sleep apnoea syndrome — n=34, PRR 10.8
- Drug eruption — n=31, PRR 10.7
- Clostridium difficile infection — n=37, PRR 10.4
- Scar — n=27, PRR 9.6
- Drug reaction with eosinophilia and systemic symptoms — n=39, PRR 9.3
- Rash maculo-papular — n=33, PRR 9.0
- Eosinophilia — n=22, PRR 7.6
- Skin lesion — n=30, PRR 6.7
✓ 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 Gel and 1%?
In FDA FAERS, the most frequently co-reported reaction terms for Clindamycin Gel and 1% are rash, drug hypersensitivity, pruritus, erythema, dry skin, acne. 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 Gel and 1% have an FDA boxed warning?
No. The FDA label retrieved for Clindamycin Gel and 1% has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Clindamycin Gel and 1% 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 ac21d7ad-f94e-4d57-95e3-1648add7ad0b, effective 20260225; matched on
openfda.generic_name.exact:"CLINDAMYCIN PHOSPHATE GEL USP, 1%") - 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, 207 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.