Veltin
Veltin Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Veltin (clindamycin phosphate and tretinoin) Gel is an antibiotic used to treat acne. Common side effects of Veltin include skin irritation, dryness, peeling, burning, and itching.
The recommended dosage of Veltin is a pea-sized amount applied once daily in the evening. Erythromycin and neuromuscular blocking agents can interact with Veltin. Tell your doctor all medications you take. Do not get Veltin in your mouth, eyes, or vagina. Do not use Veltin if you have Crohn's disease, ulcerative colitis, or had colitis with past antibiotic use. If you are pregnant, talk to your doctor about using Veltin. Exercise caution if you are breastfeeding and taking Veltin.
Our Veltin (clindamycin phosphate and tretinoin) Gel 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.
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Veltin FDA Prescribing Information: Side Effects
(Adverse Reactions)
SIDE EFFECTS
Adverse Reactions in Clinical Studies
Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in clinical practice.
The safety data reflect exposure to VELTIN (clindamycin phosphate and tretinoin gel) Gel in 1,104 patients with acne vulgaris. Patients were 12 years or older and were treated once daily in the evening for 12 weeks. Adverse reactions that were reported in ≥ 1% of patients treated with VELTIN (clindamycin phosphate and tretinoin gel) Gel are presented in Table 1.
Table 1: Treatment-Related Adverse Reactions Reported by
≥ 1% of Subjects
| VELTIN (clindamycin phosphate and tretinoin gel) Gel N=1104 n (%) |
ClindamycinGel N=1091 n (%) |
TretinoinGel N=1084 n(%) |
VehicleGel N=552 n (%) |
|
| Patients with at least one adverse reaction | 140(13) | 38(3) | 141 (13) | 17(3) |
| Application site dryness | 64(6) | 12(1) | 62(6) | 3(1) |
| Application site irritation | 50(5) | 4( < 1) | 57(5) | 5(1) |
| Application site exfoliation | 50(5) | 2( < 1) | 56(5) | 2( < 1) |
| Application site erythema | 40(4) | 6(1) | 39(4) | 3(1) |
| Application site pruritus | 26(2) | 7(1) | 23(2) | 6(1) |
| Sunburn | 11(1) | 6(1) | 7(1) | 3(1) |
| Application site dermatitis | 6(1) | 0(0) | 8(1) | 1( < 1) |
Local skin reactions actively assessed at baseline and end of treatment with a score > 0 are presented in Table 2.
Table 2: VELTIN (clindamycin phosphate and tretinoin gel) GEL-Treated Patients with Local Skin Reactions
| VELTIN GEL | VEHICLE GEL | |||
| Local Reaction | Baseline N=476 N(%) |
End of Treatment N=409 N(%) |
Baseline N=219 N(%) |
End of Treatment N=209 N(%) |
| Erythema | 24% | 21% | 31% | 35% |
| Scaling | 8% | 19% | 14% | 12% |
| Dryness | 11% | 22% | 18% | 13% |
| Burning | 8% | 13% | 8% | 4% |
| Itching | 17% | 15% | 22% | 14% |
During the twelve weeks of treatment, each local skin reaction peaked at week 2 and gradually reduced thereafter.
Read the entire FDA prescribing information for Veltin (Clindamycin Phosphate and Tretinoin Gel) »
Additional Veltin Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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