What the label lists and what reports show
Benzoyl peroxide and clindamycin side effects
Benzoyl peroxide and clindamycin's FDA label: “During clinical trials, the most frequently reported adverse event in the clindamycin and benzoyl peroxide gel treatment group was dry skin (12%).” FAERS holds 598 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is erythema (43 reports).
- Generic listed
Check it at the source: the benzoyl peroxide and clindamycin FDA label on DailyMed (effective January 31, 2026, Glenmark Pharmaceuticals Inc., USA); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are possible side effects of ONEXTON Gel?ONEXTON Gel can cause serious side effects including: • Inflammation of the colon (colitis). Stop using ONEXTON Gel and call your doctor right away if you have severe stomach (abdominal) cramps watery diarrhea, or bloody diarrhea during treatment, and within several weeks after treatment with ONEXTON Gel. • Allergic reactions. Stop using ONEXTON Gel, call your doctor and get help right away if you have any of the following symptoms during treatment with ONEXTON Gel: • severe itching • swelling of your face, eyes, lips, tongue or throat • trouble breathing The most common side effects of ONEXTON Gel include burning sensation, skin redness or swelling, itching and rash. Stop using ONEXTON Gel and call your doctor if you have a skin rash or your skin becomes very red, itchy or swollen. Talk to your doctor about any side effect that bothers you or that does not go away. […]
Source: FDA drug label (ONEXTON), Bausch Health US, LLC, effective July 23, 2025 (SPL set 697e760a-c206-4565-8f4e-a8085e215827), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsDuring clinical trials, the most frequently reported adverse event in the clindamycin and benzoyl peroxide gel treatment group was dry skin (12%).
Table 1: Percent of Subjects with Local Skin Reactions. Results from the Phase 3 Trial (N = 243)
This table is printed in the ONEXTON label published by Bausch Health US, LLC of July 23, 2025; the label quoted above does not print one.
| Reaction | Mild | Mod. * | Severe | Mild | Mod. * | Severe | Mild | Mod. * | Severe |
|---|---|---|---|---|---|---|---|---|---|
| Erythema | 20 | 6 | 0 | 28 | 5 | <1 | 15 | 2 | 0 |
| Scaling | 10 | 1 | 0 | 19 | 3 | 0 | 10 | <1 | 0 |
| Itching | 14 | 3 | <1 | 15 | 3 | 0 | 7 | 2 | 0 |
| Burning | 5 | <1 | <1 | 7 | 1 | <1 | 3 | <1 | 0 |
| Stinging | 5 | <1 | 0 | 7 | 0 | <1 | 3 | 0 | <1 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedDuring clinical trials, the most frequently reported adverse event in the clindamycin and benzoyl peroxide gel treatment group was dry skin (12%). The Table below lists local adverse events reported by at least 1% of patients in the clindamycin and benzoyl peroxide gel and vehicle groups. Local Adverse Events – all causalities in >/= 1% of patients Clindamycin and Benzoyl Peroxide n=420 Vehicle n=168 Application site reaction 13 (3%) 1 (<1%) Dry skin 50 (12%) 10 (6%) Pruritus 8 (2%) 1 (<1%) Peeling 9 (2%) - Erythema 6 (1%) 1 (<1%) Sunburn 5 (1%) - The actual incidence of dry skin might have been greater were it not for the use of a moisturizer in these studies. Anaphylaxis, as well as allergic reactions leading to hospitalization, have been reported during post-marketing use of clindamycin/benzoyl peroxide products. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Source: FDA drug label, Glenmark Pharmaceuticals Inc., USA, effective January 31, 2026 (SPL set 76795d1b-e1f2-4d1d-b42a-f1d4448c63c0), via openFDA; the full label on DailyMed
What do FAERS reports show?
598 reports list benzoyl peroxide and clindamycin among the medicines taken, each a report of something that happened, not proof the medicine caused it; 3 are coded as a death and 43 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 18 reactions below, 6 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Benzoyl peroxide and clindamycin: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions