Medical Editor: John P. Cunha, DO, FACOEP
Ziana Gel (clindamycin phosphate, tretinoin) is a combination of an antibiotic and a form of vitamin A used to treat severe nodular acne in adults and children who are at least 12 years old. Common side effects of Ziana Gel include:
- skin redness,
- mild burning/stinging,
- temporary lightening or darkening of treated skin, or
- worsening of acne during the first 2 to 4 weeks of using the medication.
These side effects usually decrease with continued use of Ziana Gel. Other side effects of Ziana Gel include stuffy nose, sore throat, cough. Tell your doctor if you have serious side effects of of Ziana Gel including:
- blistering, crusting, severe redness, burning, stinging, or peeling of treat skin areas; or
- diarrhea that is watery or bloody.
At bedtime, squeeze a pea-sized dose of Ziana Gel onto one fingertip, dot onto the chin, cheeks, nose, and forehead, then gently rub over the entire face. Keep away from the eyes, the mouth, angles of the nose, and mucous membranes. Ziana Gel may interact with erythromycin topical (for the skin), or oral erythromycin. Other drugs may affect Ziana Gel topical. Tell your doctor all prescription and over-the-counter medications and supplements you use. During pregnancy, Ziana Gel should be used only when prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.
Our Ziana Gel (clindamycin phosphate, tretinoin) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using this medicine and call your doctor at once if you have any of these serious side effects:
- severe redness, burning, stinging, or peeling of treat skin areas; or
- diarrhea that is watery or bloody.
Continue using this medicine and talk with your doctor if you have any of these less serious side effects:
- mild itching, stinging, or dryness of treated skin;
- temporary lightening or darkening of treated skin; or
- stuffy nose, sore throat, cough.
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Ziana Gel (Clindamycin Phosphate, Tretinoin)
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 (clindamycin phosphate, tretinoin) in 1,853 patients with acne vulgaris. Patients were 12 years and older and were treated once daily for 12 weeks. Adverse reactions that were reported in ≥1% of patients treated with ZIANA Gel (clindamycin phosphate, tretinoin) were compared to adverse reactions in patients treated with clindamycin phosphate 1.2% in vehicle gel, tretinoin 0.025% in vehicle gel, and the vehicle gel alone:
Table 1: Adverse Reactions Reported in at Least 1% of Patients
Treated with ZIANA Gel (clindamycin phosphate, tretinoin) : 12-Week Studies
|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)|
|Note: Formulations used in all treatment arms were in the ZIANA vehicle gel.|
Table 2: ZIANA Gel (clindamycin phosphate, tretinoin) -Treated Patients with Local Skin Reactions
End of Treatment
|Erythema||636 (35)||416 (26)|
|Scaling||237 (13)||280 (17)|
|Itching||189 (10)||70 (4)|
|Burning||38 (2)||56 (4)|
|Stinging||33 (2)||27 (2)|
At each study visit, application site reactions on a scale of 0 (none), 1 (mild), 2 (moderate), and 3 (severe), and the mean scores were calculated for each of the local skin reactions. In Studies 1 and 2, 1277 subjects enrolled with moderate to severe acne, 854 subjects treated with ZIANA Gel (clindamycin phosphate, tretinoin) and 423 treated with vehicle. Analysis over the twelve week period demonstrated that cutaneous irritation scores for erythema, scaling, itching, burning, and stinging peaked at two weeks of therapy, and were slightly higher for the ZIANA-treated group, decreasing thereafter.
One open-label 12-month safety study for ZIANA Gel (clindamycin phosphate, tretinoin) showed a similar adverse reaction profile as seen in the 12-week studies. Eighteen out of 442 subjects (4%) reported gastrointestinal symptoms.
Read the entire FDA prescribing information for Ziana Gel (Clindamycin Phosphate, Tretinoin)
© Ziana Gel Patient Information is supplied by Cerner Multum, Inc. and Ziana Gel Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.