Clinical Trials 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 VANDAZOLE compared to another
formulation of vaginal metronidazole in 220 women in a single trial. The population
was non-pregnant females (age range 18 to 72 years, the mean was 33 years +/-
11 years) with bacterial vaginosis. The racial demographic of those enrolled
was 71 (32%) of White, 143 (65%) of Black, 3 (1%) of Hispanic, 2 (1%) of Asian,
and 1 (0%) of other. Patients administered an applicator full of VANDAZOLE (metronidazole vaginal gel) intravaginally
once daily at bedtime for 5 days.
There were no deaths or serious adverse reactions related to drug therapy in
the clinical trial. VANDAZOLE (metronidazole vaginal gel) was discontinued in 5 patients (2.3%) due to adverse
The incidence of all adverse reactions in VANDAZOLE (metronidazole vaginal gel) -treated patients was 42%
(92/220). Adverse reactions occurring in ≥ 1% of patients were: fungal infection*
(12%), headache (7%), pruritus (6%), abdominal pain (5%), nausea (3%), dysmenorrhea
(3%), pharyngitis (2%), rash (1%), infection (1%), diarrhea (1%), breast pain
(1%), and metrorrhagia (1%).
* Known or previously unrecognized vaginal candidiasis may present more prominent
symptoms during therapy with VANDAZOLE (metronidazole vaginal gel) . Approximately 10% of patients treated
with VANDAZOLE (metronidazole vaginal gel) developed Candida vaginitis during or immediately after
Additional uncommon events, reported by < 1% of those women treated with
VANDAZOLE (metronidazole vaginal gel) included:
General: allergic reaction, back pain, flu syndrome, mucous membrane
Gastrointestinal: anorexia, constipation, dyspepsia, flatulence, gingivitis,
Nervous System: depression, dizziness, insomnia
Respiratory System: asthma, rhinitis
Skin and Appendages: acne, sweating, urticaria
Urogenital System: breast enlargement, dysuria, female lactation, labial
edema, leucorrhea, menorrhagia, pyleonephritis, salpingitis, urinary frequency,
urinary tract infection, vaginitis, vulvovaginal disorder
Other Metronidazole Formulations
Other Vaginal Formulations
Other reactions that have been reported in association with the use of other
formulations of metronidazole vaginal gel include: unusual taste and decreased
Topical (Dermal) Formulations
Other reactions that have been reported in association with the use of topical
(dermal) formulations of metronidazole include skin irritation, transient skin
erythema, and mild skin dryness and burning. None of these adverse reactions
exceeded an incidence of 2% of patients.
Oral and Parenteral Formulations
The following adverse reactions and altered laboratory tests have been reported
with the oral or parenteral use of metronidazole:
Cardiovascular: Flattening of the T-wave may be seen in electrocardiographic
Nervous System: The most serious adverse reactions reported in patients
treated with metronidazole have been convulsive seizures, encephalopathy, aseptic
meningitis, optic and peripheral neuropathy, the latter characterized mainly
by numbness or paresthesia of an extremity. In addition, patients have reported
syncope, vertigo, incoordination, ataxia, confusion, dysarthria, irritability,
depression, weakness, and insomnia. [see WARNINGS AND PRECAUTIONS]
Gastrointestinal: Abdominal discomfort, nausea, vomiting, diarrhea,
an unpleasant metallic taste, anorexia, epigastric distress, abdominal cramping,
constipation, “furry” tongue, glossitis, stomatitis, pancreatitis,
and modification of taste of alcoholic beverages.
Genitourinary: Overgrowth of Candida in the vagina, dyspareunia, decreased
Hematopoietic: Reversible neutropenia, reversible thrombocytopenia.
Hypersensitivity Reactions: Urticaria; erythematous rash; Stevens-Johnson
Syndrome, toxic epidermal necrolysis, flushing; nasal congestion; dryness of
the mouth, vagina, or vulva; fever; pruritus; fleeting joint pains [see CONTRAINDICATIONS].
Renal: Dysuria, cystitis, polyuria, incontinence, a sense of pelvic
pressure, darkened urine.