ClindaMax Side Effects

Please note - some side effects for ClindaMax 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 ClindaMax - for the Consumer

ClindaMax Cream

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 ClindaMax Cream:

Fungal infection; genital itching or burning; inflammation or pain; vaginal discharge.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood/mucus in stools; diarrhea; new or worsening vaginal or vulvar itching; painful sex; stomach cramps/pain; white vaginal discharge.

Clindamax Gel

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 Clindamax Gel:

Dryness; itching; oiliness or oily skin.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood or mucus in stools; bloody or severe diarrhea; stomach cramps or pain; swelling, redness, burning, or peeling of your skin.

ClindaMax Lotion

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 ClindaMax Lotion:

Dryness; itching; oiliness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood or mucus in stools; diarrhea; stomach cramps or pain; swelling, redness, burning, or peeling of your skin.

ClindaMax Side Effects - for the Professional

Clindamax

Clinical trials

Non-pregnant Women: In clinical trials involving non-pregnant women, 1.8% of 600 patients who received treatment with clindamycin phosphate vaginal cream 2% for 3 days and 2.7% of 1325 patients who received treatment for 7 days discontinued therapy due to drug-related adverse events. Medical events judged to be related, probably related, possibly related, or of unknown relationship to vaginally administered clindamycin phosphate vaginal cream 2%, were reported for 20.7% of the patients receiving treatment for 3 days and 21.3% of the patients receiving treatment for 7 days. Events occurring in ≥1% of patients receiving clindamycin phosphate vaginal cream 2% are shown in Table 1.

Table 1- Events Occurring in ≥1% of Non-pregnant Patients Receiving Clindamycin Phosphate Vaginal Cream 2%

Other events occurring in <1% of the clindamycin vaginal cream 2% groups include:

Urogenital system: vaginal discharge, metrorrhagia, urinary tract infection, endometriosis, menstrual disorder, vaginitis/vaginal infection, and vaginal pain.

Body as a whole: localized abdominal pain, generalized abdominal pain, abdominal cramps, halitosis, headache, bacterial infection, inflammatory swelling, allergic reaction, and fungal infection.

Digestive system: nausea, vomiting, constipation, dyspepsia, flatulence, diarrhea, and gastrointestinal disorder.

Endocrine system: hyperthyroidism.

Central nervous system: dizziness and vertigo.

Respiratory system: epistaxis.

Skin: pruritus (non-application site), moniliasis, rash, maculopapular rash, erythema, and urticaria.

Special senses: taste perversion.

Pregnant Women: In a clinical trial involving pregnant women during the second trimester, 1.7% of 180 patients who received treatment for 7 days discontinued therapy due to drug-related adverse events. Medical events judged to be related, probably related, possibly related, or of unknown relationship to vaginally administered clindamycin phosphate vaginal cream 2%, were reported for 22.8% of pregnant patients. Events occurring in ≥1% of patients receiving either clindamycin phosphate vaginal cream 2% or placebo are shown in Table 2.

Table 2- Events Occurring in ≥1% of Pregnant Patients Receiving Clindamycin Phosphate Vaginal Cream 2% or Placebo

Other events occurring in <1% of the clindamycin vaginal cream 2% group include:

Urogenital system: dysuria, metrorrhagia, vaginal pain, and trichomonal vaginitis.

Body as a whole: upper respiratory infection.

Skin: pruritus (topical application site) and erythema.

Clindamycin vaginal cream affords minimal peak serum levels and systemic exposure (AUCs) of clindamycin compared to 100 mg oral clindamycin dosing. Although these lower levels of exposure are less likely to produce the common reactions seen with oral clindamycin, the possibility of these and other reactions cannot be excluded presently. Data from well-controlled trials directly comparing clindamycin administered orally to clindamycin administered vaginally are not available.

The following adverse reactions and altered laboratory tests have been reported with the oral or parenteral use of clindamycin:

Gastrointestinal: Abdominal pain, esophagitis, nausea, vomiting, and diarrhea.

Hematopoietic: Transient neutropenia (leukopenia), eosinophilia, agranulocytosis, and thrombocytopenia have been reported. No direct etiologic relationship to concurrent clindamycin therapy could be made in any of these reports.

Hypersensitivity Reactions: Maculopapular rash and urticaria have been observed during drug therapy. Generalized mild to moderate morbilliform-like skin rashes are the most frequently reported of all adverse reactions. Rare instances of erythema multiforme, some resembling Stevens-Johnson syndrome, have been associated with clindamycin. A few cases of anaphylactoid reactions have been reported. If a hypersensitivity reaction occurs, the drug should be discontinued.

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

Musculoskeletal: Rare instances of polyarthritis have been reported.

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.

Side Effects by Body System

Gastrointestinal

Gastrointestinal side effects have included diarrhea in patients treated with topical clindamycin (less than 0.1% incidence), although in most cases it resolved despite continued therapy. Bloody diarrhea and colitis (including pseudomembranous colitis) have been reported rarely with topical clindamycin. In general, these cases involved extemporaneously prepared solutions of clindamycin hydrochloride. Rarely, heartburn, nausea, vomiting, constipation, and abdominal pain have been reported during vaginal use of clindamycin cream. Gastrointestinal disturbances have also been reported with the use of topical clindamycin.

Clindamycin has not been shown to have significant effects on colon flora. In one study, Clostridium difficile was detected in the stool of 4 of 19 patients receiving topical clindamycin for eight weeks. No Clostridium difficile was detected in the stool of patients receiving placebo. However, the difference was not statistically significant. Diarrhea was not reported in any patient.

Local

Local side effects have been frequently reported with the use of topical clindamycin. These have included transient drying, followed by erythema, burning, peeling, and itching. Contact dermatitis has been reported infrequently. Oiliness or oily skin has also been reported.

The foam, gel, and lotion formulations are less drying than the solution formulation, which contains alcohol.

Genitourinary

Genitourinary side effects have included vulvar irritation during use of vaginal clindamycin cream. Yeast overgrowth resulting in the development of fungal vaginitis has been reported. Symptomatic vaginal candida infection has also been reported in approximately 10% of women treated with intravaginal clindamycin.

Nervous system

Nervous system side effects have been reported rarely. Headache, dizziness, and vertigo have been reported with the use of clindamycin vaginal cream.

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