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Clindagel (Clindamycin Phosphate Topical) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

In the one well-controlled clinical study comparing Clindagel® and its vehicle, the incidence of skin and appendages adverse events occuring in ≥1% of the patients in either group is presented below:

 Body System/Adverse Event   Number(%) of Patients/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 formulation of clindamycin.

To report SUSPECTED ADVERSE REACTIONS,

contact Onset Dermatologics, LLC at 1-800-978-5060 and/or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

Drug label data at the top of this Page last updated: 2013-12-04

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