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% | Clindamycin Phosphate Vaginal Cream |
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Event | 3 Day n=600 | 7 Day n=1325 |
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Urogenital | | |
Vaginal moniliasis | 7.7 | 10.4 |
Vulvovaginitis | 6.0 | 4.4 |
Vulvovaginal disorder | 3.2 | 5.3 |
Trichomonal vaginitis | 0 | 1.3 |
Body as a Whole | | |
Moniliasis (body) | 1.3 | 0.2 |
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 | Clindamycin Phosphate Vaginal Cream | Placebo |
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Event | 7 DAY n=180 | 7 Day n=184 |
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Urogenital | | |
Vaginal moniliasis | 13.3 | 7.1 |
Vulvovaginal disorder | 6.7 | 7.1 |
Abnormal labor | 1.1 | 0.5 |
Body as a Whole | | |
Fungal infection | 1.7 | 0 |
Skin | | |
Pruritus, non-application site | 1.1 | 0 |
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.