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CLINDAMYCIN Palmitate Hydrochloride Oral Solution (GREENSTONE LLC) Adverse Reactions

ADVERSE REACTIONS

The following reactions have been reported with the use of clindamycin.

Infections and Infestations

Clostridium difficile colitis.

Gastrointestinal

Abdominal pain, pseudomembranous colitis, esophagitis, nausea, vomiting and diarrhea (see BOXED WARNING). The onset of pseudomembranous colitis symptoms may occur during or after antibacterial treatment (see WARNINGS). An unpleasant or metallic taste has been reported after oral administration.

Hypersensitivity Reactions

Generalized mild to moderate morbilliform-like (maculopapular) skin rashes are the most frequently reported adverse reactions. Vesiculobullous rashes, as well as urticaria, have been observed during drug therapy. Severe skin reactions such as Toxic Epidermal Necrolysis, some with fatal outcome, have been reported (see WARNINGS). Cases of Acute Generalized Exanthematous Pustulosis (AGEP), erythema multiforme, some resembling Stevens-Johnson syndrome, anaphylactic shock, anaphylactic reaction and hypersensitivity have also been reported.

Skin and Mucous Membranes

Pruritus, vaginitis, angioedema, and rare instances of exfoliative dermatitis have been reported (see Hypersensitivity Reactions).

Liver

Jaundice and abnormalities in liver function tests have been observed during clindamycin therapy.

Renal

Although no direct relationship of clindamycin to renal damage has been established, renal dysfunction as evidenced by azotemia, oliguria, and/or proteinuria has been observed.

Hematopoietic

Transient neutropenia (leukopenia) and eosinophilia have been reported. Reports of agranulocytosis and thrombocytopenia have been made. No direct etiologic relationship to concurrent clindamycin therapy could be made in any of the foregoing.

Immune system

Drug reaction with eosinophilia and systemic symptoms (DRESS) cases have been reported.

Musculoskeletal

Cases of polyarthritis have been reported.

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