ADVERSE REACTIONS
Clinical Trials
In clinical trials totaling 368 women treated with a single dose of Clindesse™, 1.6% of the patients discontinued therapy due to adverse events. Medical events judged to be definitely related, probably related, or possibly drug-related were reported for 10.6% of the patients after receiving a single dose of Clindesse™ and in 17.6% of patients treated with placebo. Adverse events occurred in 126 of 368 patients (34.2%) treated with Clindesse™ and in 32 of 85 patients (37.6%) treated with placebo. Events occurring in ≥1% of patients receiving Clindesse™ in 3 clinical studies are shown in Table 1.
Table 1. All Adverse Events Reported in ≥1% of Patients Receiving Clindesse™ in Clinical Studies | Adverse Event | Clindesse™
N=368
n (%) | Placebo
N=85
n (%) |
N = number of patients in intent-to-treat Population
n (%) = number and percentage of patients with reported adverse event
NOS = not otherwise specified |
| Any adverse event | 126 (34.2) | 32 (37.6) |
| Vaginosis fungal NOS | 52 (14.1) | 7 (8.2) |
| Vulvovaginal pruritus | 12 (3.3) | 3 (3.5) |
| Headache NOS | 10 (2.7) | 2 (2.4) |
| Constipation | 4 (1.1) | 0 (0) |
| Nasopharyngitis | 4 (1.1) | 0 (0) |
| Back pain | 6 (1.6) | 1 (1.2) |
| Nausea | 5 (1.4) | 3 (3.5) |
| Urinary tract infection NOS | 4 (1.1) | 0 (0) |
| Vaginal discharge | 4 (1.1) | 2 (2.4) |
Other events not necessarily related to Clindesse™ but reported by < 1% of those women treated with Clindesse™:
Dermatologic: dermatitis, dry skin, pruritic rash
Gastrointestinal: diarrhea, dyspepsia, flatulence, hemorrhoids, vomiting
General: fatigue, pain, pyrexia, increased tendency to bruise, palpable lymph node
Immune System: hypersensitivity, food allergy
Infections: bladder infection, fungal infection, Herpes simplex, influenza, papilloma virus infection, sinusitis, tooth abscess, upper respiratory tract infection, vaginal infection, vulvovaginal trichomoniasis
Musculoskeletal: arthralgia, myalgia, neck pain, sciatica
Nervous System: dizziness, hypoesthesia
Psychiatric: anxiety disorder
Renal and Urinary Tract: bladder spasm
Reproductive System: pregnancy, cervical dysplasia, dysfunctional uterine bleeding, dysmennorrhea, intermenstrual bleeding, pelvic pain, uterine cervical disorder, uterine spasm, vaginal burning, vaginal irritation, atrophic vaginitis, vulvar erythema, vulvar laceration, vulvitis, vulvovaginal discomfort, vulvovaginal dryness, vulvovaginitis
Respiratory Tract: cough, epistaxis, pharyngitis, rhinorrhea, sinusitis, wheezing
Other Clindamycin Formulations
Clindesse™ Vaginal Cream affords minimal peak serum levels and systemic exposure (AUCs) of clindamycin compared to an oral or intravenous dose of clindamycin (see CLINICAL PHARMACOLOGY). 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, diarrhea, pseudomembranous colitis (see WARNINGS)
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. Rare instances 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: 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.
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