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) »

A A A

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.


Women's Health

Find out what women really need.


NIH talks about Ebola on WebMD