Clindesse Side Effects

Generic Name: clindamycin topical

Please note - some side effects for Clindesse may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Clindesse - for the Consumer

Clindesse 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 Clindesse Cream:

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

Seek medical attention right away if any of these SEVERE side effects occur when using Clindesse Cream:

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; new or worsening vaginal or vulvar itching; painful sex; stomach cramps or pain; white vaginal discharge.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Top

Clindesse Side Effects - for the Professional

Clindesse

Clinical Study Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The data described below reflect exposure to Clindesse in 368 patients. Clindesse was studied in three clinical studies: placebo-controlled (n=85), active-controlled (n=263), and single-arm (n=20). The population was female, aged 18 to 78, who were diagnosed with bacterial vaginosis. Patient demographics in the trials were 51% Caucasian, 36% Black, 10% Hispanic, and 3% Asian, other or unknown. All patients received 100 mg clindamycin phosphate cream intravaginally in a single dose.

Of the 368 women treated with a single dose of Clindesse, 1.6% of the patients discontinued therapy due to adverse reactions. Adverse reactions occurred in 126 of 368 patients (34%) treated with Clindesse and in 32 of 85 patients (38%) treated with placebo.

Adverse reactions occurring in ≥1% of patients receiving Clindesse in the three clinical studies are shown in Table 1.

Table 1. Adverse Reactions Occurring in ≥1% of Clindesse-Treated Patients and at a Higher Rate than Placebo-Treated Patients
N = number of patients in intent-to-treat population n (%) = number and percentage of patients with reported adverse reaction NOS = not otherwise specified * The use of clindamycin may result in the overgrowth of non-susceptible fungal organisms in the vagina and may require antifungal treatment
Adverse Event	Clindesse N=368 n (%)	Placebo N=85 n (%)
Vaginosis fungal NOS*	52 (14)	7 (8)
Headache NOS	10 (3)	2 (2)
Back pain	6 (2)	1 (1)
Constipation	4 (1)	0 (0)
Urinary tract infection NOS	4 (1)	0 (0)

Other reactions reported by <1% of those women treated with Clindesse include:

Dermatologic: Pruritic rash

Gastrointestinal: Diarrhea, vomiting

General: Fatigue

Immune System: Hypersensitivity

Nervous System: Dizziness

Reproductive System: Dysfunctional uterine bleeding, dysmennorrhea, intermenstrual bleeding, pelvic pain, vaginal burning, vaginal irritation, vulvar erythema, vulvitis, vulvovaginal discomfort, vulvovaginal dryness, vulvovaginitis

Other Clindamycin Formulations

Clindesse affords minimal peak serum levels and systemic exposure (AUCs) of clindamycin compared to an oral or intravenous dose of clindamycin [see Clinical Pharmacology (12.1)]. 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, Clostridium difficile-associated diarrhea [see Warnings and Precautions (5.1)]

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, vesiculobullous 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. Cases of erythema multiforme, some resembling Stevens-Johnson syndrome, have been associated with clindamycin. A few cases of anaphylactoid reactions have been reported.

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

Musculoskeletal: Cases 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.

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of Clindesse. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Dermatologic: Rash

Gastrointestinal: Hematochezia

Reproductive System: Vaginal erythema, vulvovaginal pruritis, vaginal discharge, vaginal swelling, vaginal bleeding, vaginal pain

Top

Side Effects by Body System - for Healthcare Professionals

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.

Other

Other side effects have included one case of ringing in the ear and partial hearing loss believed to be caused by clindamycin.

A 14-year-old boy developed reproducible ringing in his right ear and hearing loss while using topical clindamycin and after discontinuing use. He underwent a complete physical exam and labs which failed to find a cause for his symptoms. The patient was restarted on benzoyl peroxide/clindamycin topical and the ringing in his ear increased. He was told to stop all medications and was started on methylprednisolone. The tinnitus decreased in 1 to 2 days with no improvement in the hearing deficit. After the third time he was restarted on benzoyl peroxide/clindamycin gel, the tinnitus returned at an increased level together with right-sided headaches within 1 to 2 days. The patient again stopped using the benzoyl peroxide and clindamycin gel and the tinnitus returned to a low level over 1 to 2 days. It is believed that the clindamycin component played a part in this patient's tinnitus and hearing loss.

Top

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This information does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug of drug combination is safe, effective, or appropriate for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of information provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.