ADVERSE REACTIONS

In the one well-controlled clinical study comparing CLINDAGEL and its vehicle, the incidence of skin and appendages adverse events occurring in ≥1% of the patients in either group is presented in the following table:

	Number (%) of Patients
Body System/Adverse Event	CLINDAGEL QD N=168	Vehicle Gel QD N=84
Skin and Appendages Disorders
Dermatitis	0 (0.0)	1 (1.2)
Dermatitis contact	0 (0.0)	1 (1.2)
Dermatitis fungal	0 (0.0)	1 (1.2)
Folliculitis	0 (0.0)	1 (1.2)
Photosensitivity reaction	0 (0.0)	1 (1.2)
Pruritus	1 (0.6)	1 (1.2)
Rash erythematous	0 (0.0)	0 (0.0)
Skin dry	0 (0.0)	0 (0.0)
Peeling	1 (0.6)	0 (0.0)

Orally and parenterally administered clindamycin has been associated with severe colitis, which may end fatally.

Cases of diarrhea, bloody diarrhea, and colitis (including pseudomembranous colitis) have been reported as adverse reactions in patients treated with oral and parenteral formulations of clindamycin and rarely with topical clindamycin (see WARNINGS). Abdominal pain and gastrointestinal disturbances, as well as gram-negative folliculitis, have also been reported in association with the use of topical formulations of clindamycin.

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.