CLEOCIN T® Adverse Reactions

(clindamycin)

ADVERSE REACTIONS

In 18 clinical studies of various formulations of CLEOCIN T using placebo vehicle and/or active comparator drugs as controls, patients experienced a number of treatment emergent adverse dermatologic events [see table below].

Number of Patients Reporting Events
Treatment Emergent
Adverse Event
Solution
n=553(%)
Gel
n=148(%)
Lotion
n=160(%)
# not recorded
*
of 126 subjects
Burning62 (11)15 (10)17 (11)
Itching36 ( 7)15 (10)17 (11)
Burning/Itching60 (11)# ( – )# ( – )
Dryness105 (19)34 (23)29 (18)
Erythema86 (16)10 ( 7)22 (14)
Oiliness/Oily Skin8 ( 1)26 (18)12* (10)
Peeling61 (11)# ( – )11 ( 7)

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, gastrointestinal disturbances, gram-negative folliculitis, eye pain and contact dermatitis have also been reported in association with the use of topical formulations of clindamycin.

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Adverse Reactions

ADVERSE REACTIONS

In 18 clinical studies of various formulations of CLEOCIN T using placebo vehicle and/or active comparator drugs as controls, patients experienced a number of treatment emergent adverse dermatologic events [see table below].

Number of Patients Reporting Events
Treatment Emergent
Adverse Event
Solution
n=553(%)
Gel
n=148(%)
Lotion
n=160(%)
# not recorded
*
of 126 subjects
Burning62 (11)15 (10)17 (11)
Itching36 ( 7)15 (10)17 (11)
Burning/Itching60 (11)# ( – )# ( – )
Dryness105 (19)34 (23)29 (18)
Erythema86 (16)10 ( 7)22 (14)
Oiliness/Oily Skin8 ( 1)26 (18)12* (10)
Peeling61 (11)# ( – )11 ( 7)

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, gastrointestinal disturbances, gram-negative folliculitis, eye pain and contact dermatitis have also been reported in association with the use of topical formulations of clindamycin.

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