Vandazole Side Effects

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

Vandazole Side Effects - for the Professional

Vandazole

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 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 was discontinued in 5 patients (2.3%) due to adverse reactions.

The incidence of all adverse reactions in Vandazole-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. Approximately 10% of patients treated with Vandazole developed Candida vaginitis during or immediately after therapy.

Additional uncommon events, reported by < 1% of those women treated with Vandazole included:

General:	allergic reaction, back pain, flu syndrome, mucous membrane disorder, pain
Gastrointestinal:	anorexia, constipation, dyspepsia, flatulence, gingivitis, vomiting
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 appetite.

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 tracings.

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 (5.1)]

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 libido, proctitis.

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 (4.1)].

Renal: Dysuria, cystitis, polyuria, incontinence, a sense of pelvic pressure, darkened urine.

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Side Effects by Body System - for Healthcare Professionals

Local

Local side effects associated with topical use have included skin irritation, dryness, transient redness, burning, and stinging. Dryness (mild: 17.1%; moderate: 7.7%; severe: 0.6%), scaling (mild: 16.2%; moderate: 7.9%; severe: 0.6%), pruritus (mild: 9.7%; moderate: 5%; severe: 1.1%), and stinging/burning (mild: 7.2%; moderate: 1.3%; severe: 1.8%) have been reported with the 1% gel. Application site reaction and local allergic reaction have been reported with the 1% cream and 0.75% lotion, respectively. At times, the local effects of metronidazole may be difficult to distinguish from the clinical characteristics of acne rosacea.

Genitourinary

Genitourinary side effects associated with the 0.75% vaginal gel have included vaginal discharge (12%), symptomatic Candida cervicitis/vaginitis (10%), vulva/vaginal irritative symptoms (9%), pelvic discomfort (3%), uterine cramping, and vaginal or vulvar burning, irritation, or itching. Urinary tract infection (1.1%) and vaginal mycosis (0.2%) have been reported with the 1% gel. Dyspareunia, dysuria, cystitis, polyuria, incontinence, darkened urine, and overgrowth of Candida in the vagina have been reported with oral or parenteral administration of metronidazole.

Gastrointestinal

Gastrointestinal side effects associated with the 0.75% vaginal gel have included gastrointestinal discomfort (7%), nausea and/or vomiting (4%), unusual taste (2%), diarrhea/loose stools (1%), decreased appetite (1%), abdominal bloating/gas (less than 1%), dry mouth (less than 1%), abdominal cramping, cramps/pain, and metallic or bad taste. Nausea and dry mouth have been reported with the 1% cream. Nausea and metallic taste have been reported with topical administration of metronidazole. Abdominal discomfort, nausea, vomiting, diarrhea, unpleasant metallic taste, anorexia, epigastric distress, abdominal cramping, constipation, "furry" tongue, glossitis, stomatitis, pancreatitis, proctitis, and modified taste of alcoholic beverages have been reported with oral or parenteral administration of metronidazole.

Nervous system

Nervous system side effects associated with the 0.75% vaginal gel have included headache (5%) and dizziness (2%). Headache (2.2%) has been reported with the 1% gel. Tingling or numbness of extremities and headache have been reported with the 1% cream. Tingling or numbness of extremities has been reported with topical administration of metronidazole. Headache, dizziness, syncope, ataxia, convulsive seizures, peripheral neuropathy, vertigo, incoordination, weakness, and insomnia have been reported with oral or parenteral administration of metronidazole. Peripheral neuropathy has been associated with the 1% gel during postmarketing experience.

Respiratory

Respiratory side effects associated with the 1% gel have included nasopharyngitis (3.1%), upper respiratory tract infection (2.5%), sinusitis (1.4%), bronchitis (1.1%), and nasal congestion (1.1%).

Hematologic

A 58-year-old female with possible vaginal infection experienced TTP coincident with metronidazole therapy. She presented to the hospital with chest pain and blood in her urine three days after she was administered metronidazole 0.75% vaginal gel. She was diagnosed with TTP based on her laboratory and clinical findings. Her condition resolved after treatment.

Hematological side effects associated with the 0.75% vaginal gel have included increased/decreased white blood cell counts (1.7%) and at least one case of thrombotic thrombocytopenic purpura (TTP). Reversible neutropenia and reversible thrombocytopenia have been reported with oral or parenteral administration of metronidazole.

Cardiovascular

Cardiovascular side effects associated with the 1% gel have included hypertension (1.1%). Flattening of the T-wave may be seen in electrocardiographic tracings during oral or parenteral administration of metronidazole.

Dermatologic

Dermatologic side effects associated with the 0.75% vaginal gel have included generalized itching or rash (less than 1%). Contact dermatitis (1.3%) and dry skin (1.1%) have been reported with the 1% gel. Condition aggravated, acne, severe flare of comedonal acne, rosacea aggravated, skin irritation, and rash have been reported with the 1% cream. Skin discomfort (burning and stinging), erythema, skin irritation, pruritus, and worsening of rosacea have been reported in less than 3% of patients using the 0.75% cream. Erythema (6%), contact dermatitis (3%), pruritus (1%), skin discomfort (burning and stinging; 1%), and worsening of rosacea (1%) have been reported with the 0.75% lotion. Skin irritation, transient skin erythema, and mild skin dryness have been reported with topical administration of metronidazole.

Other

Other side effects associated with the 0.75% vaginal gel have included unspecified cramping (1%), thirsty (less than 1%), fatigue (less than 1%), and darkened urine (less than 1%). Influenza (1.4%) has been reported with the 1% gel. A sense of pelvic pressure has been reported with oral or parenteral administration of metronidazole.

Psychiatric

Psychiatric side effects associated with the 0.75% vaginal gel have included depression (less than 1%). Confusion, irritability, depression, and decreased libido have been reported with oral or parenteral administration of metronidazole.

Musculoskeletal

Musculoskeletal side effects associated with the 1% gel have included back pain (0.5%).

Oncologic

Oncologic side effects associated with the 1% gel have included basal cell carcinoma (0.2%).

Hypersensitivity

Hypersensitivity side effects associated with the 1% cream have included allergic reactions. Hypersensitivity reactions associated with oral or parenteral administration of metronidazole have included urticaria, erythematous rash, flushing, nasal congestion, fever, pruritus, fleeting joint pains, and dryness of the mouth, vagina, or vulva.

Ocular

Ocular side effects associated with the 1% cream have included eye irritation. Watering or tearing may occur when metronidazole topical is applied too close to the eyes.

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