Topical Clindamycin For Acne Vulgaris: Pharmacovigilance Safety Review and Retrospective Analysis of Gastrointestinal Events

Main Article Content

Natalia Pelet del Toro
Andrew Strunk
Jashin Wu
Linda Stein Gold
James Del Rosso
Robert Brodell
George Han


clindamycin phosphate, inflammatory bowel disease, colitis, safety, topical, acne vulgaris


Background: Clindamycin, a lincosamide antibiotic, was the 125th most prescribed medicine in the US in 2020. Topical formulations that combine clindamycin with benzoyl peroxide or a retinoid are commonly used for acne vulgaris (AV) treatment. While oral and topical clindamycin carry warnings/contraindications regarding the development of gastrointestinal (GI) adverse events (AEs), the real-world incidence of these AEs with topical clindamycin is unknown. The objective is to provide an overview of safety data for topical clindamycin when used for AV treatment.

Methods: Safety data from published literature on PubMed® (case reports, clinical trials data, retrospective data), previously unpublished worldwide pharmacovigilance data (from January 1, 1900-December 31, 2022), and two unpublished retrospective cohort studies of US electronic medical records (EMR; January 1, 2011 to January 31, 2019) were reviewed, with a focus on inflammatory bowel disease (IBD) and GI AEs following topical clindamycin monotherapy or combination treatment

Results: There have been only 4 published case reports of topical clindamycin-associated GI AEs, which were all published between the years 1981-1997. In 8 published pivotal phase 3 clinical trials of topical clindamycin monotherapy or combination treatment for AV, GI-related AEs were reported in 1.4% of clindamycin-treated participants (38/2,672; safety populations). According to the pharmacovigilance data, the rate of GI-related adverse drug reactions with topical clindamycin-containing products was 0.000045% (64/141,084,533). In 1 published retrospective report, there were 0 reports of colitis from the 1,124 patients estimated to have received topical clindamycin prescriptions in the years 1977-1980. In the first retrospective EMR study, results indicate that physicians prescribe topical clindamycin for AV treatment equally to patients with a history of IBD (19.0%; 98/515) or without (20.7%; 14,495/70,151). The second retrospective EMR study showed that among patients with AV and an initial prescription for topical clindamycin (monotherapy or combination; n=18,012), there were 3 (0.02%) incident cases of pseudomembranous colitis within 30 days; none of these cases had a history of IBD.

Conclusions: A review of published case reports, clinical trials safety data, worldwide pharmacovigilance data, and retrospective US prescription data demonstrate that GI events—including colitis or pseudomembranous colitis—in patients exposed to topical clindamycin is extremely low, regardless of IBD history.

Support: Ortho Dermatologics


1. Del Rosso JQ & Schmidt NF. Cutis. 2010;85(1):15-24.

2. ClinCalc DrugStats database.

3. Drugs@FDA.

4. Zaenglein AL et al. J Am Acad Dermatol. 2016;74(5):945-973.

5. CLEOCIN HCl® [package insert]. Pfizer. 2022.

6. CLEOCIN-T® [monograph]. Pfizer. 2019.

7. CLINDAGEL® [monograph]. Clindagel, LLC. 2000.

8. EVOCLIN® [package insert]. Mylan Pharmaceuticals. 2010.

9. Parry MF & Rha CK. Arch Dermatol. 1986;122(5):583-584.

10. Milstone EB, et al. Arch Dermatol. 1981;117(3):154-155.

11. Schiedermayer DL & Loo FD. Wis Med J. 1987;86(3):29-30.

12. Gallerani M, et al. Clin Drug Investigation. 1997;14:243-245.

13. Stergachis A, et al. West J Med. 1984;140(2):217-219.

14. Pariser DM, et al. J Drugs Dermatol. 2014;13(9):1083-1089.

15. US FDA. NDA-050-741. 2002.

16. US FDA. NDA-050-803. 2010.

17. US FDA. NDA-050-801. 2004.

18. Data on file, Bausch Health Americas, Inc. Studies V01-126A-301and V01-126A-302.

Similar Articles

You may also start an advanced similarity search for this article.

Most read articles by the same author(s)

1 2 3 4 5 6 7 8 9 10 > >>