What the label lists and what reports show
Clindamycin and tretinoin side effects
Clindamycin and tretinoin's FDA label: “Other most commonly reported adverse events (≥1% in patients treated with ZIANA Gel) were nasopharyngitis, pharyngolaryngeal pain, dry skin, cough, and sinusitis.” FAERS holds 154 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 headache (8 reports).
- Generic listed
Check it at the source: the clindamycin and tretinoin FDA label on DailyMed (effective May 15, 2026, Bausch Health US, LLC); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are possible side effects with ZIANA Gel?Skin irritation. ZIANA Gel may cause skin irritation such as dryness, redness, peeling, burning, or stinging. Stop ZIANA Gel and call your doctor if your skin becomes very red, swollen, blistered, or crusted. • Change in skin color. ZIANA Gel may cause a temporary skin color change (lighter or darker). • Colitis. This occurs rarely. Stop ZIANA Gel and call your doctor if you develop severe watery diarrhea, or bloody diarrhea. Talk to your doctor about any side effect that bothers you or that does not go away. These are not all the side effects with ZIANA Gel. Ask your doctor or pharmacist for more information.
Source: FDA drug label, Bausch Health US, LLC, effective May 15, 2026 (SPL set 78c329f9-f0c9-486d-9e54-0123699fb9e1), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsOther most commonly reported adverse events (≥1% in patients treated with ZIANA Gel) were nasopharyngitis, pharyngolaryngeal pain, dry skin, cough, and sinusitis.
Table 1: Adverse Reactions Reported in at Least 1% of Patients Treated with ZIANA Gel: 12-Week Studies
| Reaction | ZIANA Gel N=1853 N (%) | Clindamycin N=1428 N (%) | Tretinoin N=846 N (%) | Vehicle N=423 N (%) |
|---|---|---|---|---|
| PATIENTS WITH AT LEAST ONE AR | 497 (27) | 342 (24) | 225 (27) | 91 (22) |
| Nasopharyngitis | 65 (4) | 64 (5) | 16 (2) | 5 (1) |
| Pharyngolaryngeal pain | 29 (2) | 18 (1) | 5 (1) | 7 (2) |
| Dry skin | 23 (1) | 7 (1) | 3 (<1) | 0 (0) |
| Cough | 19 (1) | 21 (2) | 9 (1) | 2 (1) |
| Sinusitis | 19 (1) | 19 (1) | 15 (2) | 4 (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, continuedObserved local adverse reactions in patients treated with ZIANA Gel were skin erythema, scaling, itching, burning, and stinging. Other most commonly reported adverse events (≥1% in patients treated with ZIANA Gel) were nasopharyngitis, pharyngolaryngeal pain, dry skin, cough, and sinusitis. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Bausch Health US, LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Studies Experience Because clinical trials are conducted under prescribed conditions, adverse reaction rates observed in the clinical trial may not reflect the rates observed in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse reactions that appear to be related to drug use for approximating rates. The safety data presented in Table 1 (below) reflects exposure to ZIANA Gel in 1853 patients with acne vulgaris. Patients were 12 years and older and were treated once daily for 12 weeks.
Source: FDA drug label, Bausch Health US, LLC, effective May 15, 2026 (SPL set 78c329f9-f0c9-486d-9e54-0123699fb9e1), via openFDA; the full label on DailyMed
What do FAERS reports show?
154 reports list clindamycin and tretinoin among the medicines taken, each a report of something that happened, not proof the medicine caused it; 3 are coded as a death and 25 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 19 reactions below, 3 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.
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?
- Clindamycin and tretinoin: 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