Benzoylside effects

benzoyl peroxide 0.025 MG/MG / clindamycin phosphate 0.012 MG/MG Topical Gel

Adverse reactions

The following selected adverse reactions occurred in less than 0.2% of patients: application site pain (0.1%); application site exfoliation (0.1%); and application site irritation (0.1%). To report SUSPECTED ADVERSE REACTIONS, contact Perrigo at 1-866-634-9120 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

6.1 Clinical

Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reactions observed in the clinical trials of a drug cannot always be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The following selected adverse reactions occurred in less than 0.2% of subjects treated with clindamycin phosphate and benzoyl peroxide gel, 1.2%/2.5%: application site pain (0.1%); application site exfoliation (0.1%); and application site irritation (0.1%). During clinical trials, subjects were assessed for local cutaneous signs and symptoms of erythema, scaling, itching, burning and stinging. Most local skin reactions increased and peaked around Week 4 and continually decreased over time reaching near baseline levels by Week 12. The percentage of subjects that had symptoms present before treatment, the maximum value recorded during treatment, and the percent with symptoms present at Week 12 are shown in Table 1.

Table 1: Percent of Subjects with Local Skin Reactions. Combined Results from the Two Phase 3 Trials (N = 773) Combined Results from the Two Phase 3 Trials (N=773) Before Treatment (Baseline) Maximum During Treatment End of Treatment (Week 12) Mild Mod.* Severe Mild Mod.* Severe Mild Mod.* Severe Erythema 22 4 0 25 5 <1 15 2 0 Scaling 8 <1 0 18 3 0 8 1 0 Itching 10 2 0 15 2 0 6 <1 0 Burning 3 <1 0 8 2 0 2 <1 0 Stinging 2 <1 0 6 1 0 1 <1 0 *Mod. = Moderate

6.2 Postmarketing

Experience 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. Anaphylaxis, as well as allergic reactions leading to hospitalizations, has been reported in postmarketing use of products containing clindamycin/benzoyl peroxide.

Text above is quoted in full from the FDA-approved drug label published by openFDA, effective October 18, 2024. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.

Contraindications

Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% is contraindicated in:

Patients who have demonstrated hypersensitivity (e.g., anaphylaxis) to clindamycin, benzoyl peroxide, any components of the formulation, or lincomycin.

Patients with a history of regional enteritis, ulcerative colitis, or antibiotic-associated colitis.

4.1 Hypersensitivity

Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% is contraindicated in those individuals who have shown hypersensitivity to clindamycin, benzoyl peroxide, any components of the formulation, or lincomycin. Anaphylaxis, as well as allergic reactions leading to hospitalization, has been reported in postmarketing use with clindamycin phosphate and benzoyl peroxide gel, 1.2%/2.5%.

4.2 Colitis/Enteritis

Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% is contraindicated in patients with a history of regional enteritis, ulcerative colitis, or antibiotic-associated colitis.

This page reproduces regulatory text for reference. It is not medical advice, and KenyRx is not a pharmacy or a prescriber. Talk to a doctor or pharmacist about whether a medicine is right for you.

See what it costs — price without insurance