Cleocin Pediatric Side Effects

Generic Name: clindamycin

Please note - some side effects for Cleocin Pediatric may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Cleocin Pediatric - for the Consumer

Cleocin Pediatric Suspension

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Cleocin Pediatric Suspension:

Mild diarrhea; nausea; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody or tarry stools; decreased urination; joint pain or swelling; red, swollen, blistered, or peeling skin; severe or persistent diarrhea; severe stomach cramps or pain; unusual vaginal discharge, itching, or odor; yellowing of the skin or eyes.

Cleocin Pediatric Side Effects - for the Professional

Cleocin Pediatric

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

Gastrointestinal: Abdominal pain, pseudomembraneous colitis, esophagitis, nausea, vomiting and diarrhea. The onset of pseudomembranous colitis symptoms may occur during or after antibacterial treatment.

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. Rare instances of erythema multiforme, some resembling Stevens-Johnson syndrome, and a few cases of anaphylactoid reactions have also been reported.

Skin and Mucous Membranes: Pruritus, vaginitis, and rare instances of exfoliative dermatitis have been reported.

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 in rare instances.

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.

Musculoskeletal: Rare instances of polyarthritis have been reported.

Side Effects by Body System

Gastrointestinal

The development of pseudomembranous colitis is associated with the presence of Clostridium difficile toxin in the stool. It appears as a pale plaque on direct visualization of the mucosa by endoscopy and is sensitive to oral vancomycin or metronidazole. Pseudomembranous colitis may be associated with toxic megacolon, which can be life-threatening.

Gastrointestinal side effects have included nausea, vomiting, abdominal pain, esophagitis, diarrhea (in as many as 20% of treated patients), and pseudomembranous colitis. Dry mouth, hairy tongue, upset stomach, gastrointestinal bleeding, and mouth irritation have also been reported.

Hypersensitivity

Hypersensitivity reactions have included generalized pruritic, maculopapular rash, vesiculobullous rash, urticaria, edema, erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, anaphylactoid reactions, and acute generalized exanthematous pustulosis. Rash is particularly common in AIDS patients.

Rare cases of leukocytoclastic angiitis, toxic epidermal necrolysis, erythema multiforme, and Stevens-Johnson syndrome associated with clindamycin hypersensitivity have been reported.

Cardiovascular

Cardiovascular side effects have included rare cases of high degree heart block, hypotension, and cardiopulmonary arrest after clindamycin was administered intravenously over several minutes. In these cases, the affected patients subsequently tolerated slow infusions of clindamycin.

Hematologic

Hematologic side effects have included rare cases of granulocytopenia, agranulocytosis, thrombocytopenia, transient neutropenia, and transient eosinophilia; however, causality could not be determined.

Neutropenia (ANC 945 cells/mm3) occurred in a 68 year old male 6 days after receiving a single 600 mg oral dose of clindamycin. The neutrophil count normalized after 2 weeks.

Dermatologic

A 47-year-old female patient with multiple comorbidities was diagnosed with Sweet's Syndrome. The patient's symptoms developed 2 days after initiating oral clindamycin therapy for a tooth infection. The patient's symptoms persisted despite tooth extraction and continuance of antibiotic treatment with IV, then oral, clindamycin. Following discontinuation of clindamycin, the patient's symptoms resolved over several days. Drug-induced Sweet's syndrome was determined based on the temporal relationship of the patient's symptoms, the beginning and end of clindamycin therapy, and the exclusion of other etiologies.

Dermatological side effects have included pruritus. At least one case of drug-induced Sweet's syndrome has been reported.

Musculoskeletal

Musculoskeletal side effects have included rare reports of polyarthritis.

Hepatic

Hepatic side effects have included jaundice and abnormalities in liver function tests. Cases of cholestatic liver disease with ductopenia have also been reported.

Renal

Renal side effects have included azotemia, oliguria, and proteinuria.

Genitourinary

Genitourinary side effects have included vaginitis.

Local

Local side effects have included pain induration, and sterile abscess after intramuscular administration and thrombophlebitis after intravenous administration.

Nervous system

Nervous system side effects have included taste perversion/disorders (including bitter taste, taste loss, bad taste, and taste alteration) and parosmia.

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