Vandazole

Last updated on RxList: 10/22/2020
Vandazole Side Effects Center

What Is Vandazole?

Vandazole (metronidazole) is an antimicrobial vaginal gel used to treat bacterial vaginosis in women who are not pregnant.

What Are Side Effects of Vandazole?

Side effects of Vandazole include:

  • headache,
  • nausea,
  • loss of appetite,
  • constipation,
  • upset stomach,
  • vomiting rash,
  • infection,
  • diarrhea,
  • abdominal pain,
  • burning or stinging when the medication is applied,
  • pelvic pain or cramps,
  • dizziness,
  • sleep problems (insomnia),
  • runny nose,
  • urinating more than usual,
  • acne,
  • increased sweating, or
  • breast discharge or enlargement.

Tell your doctor if you have rare but serious side effects of Vandazole including:

  • seizure (convulsions), or
  • numbness, burning, pain, or tingly feeling in your hands or feet.

Dosage for Vandazole

The recommended dose is one applicator full of Vandazole administered intravaginally once a day for 5 days at bedtime. It is not necessary for a health-care provider to administer Vandazole. Patients should not consume alcoholic beverages and/or preparations containing ethanol or propylene glycol during treatment and for at least 3 days after treatment. Vandazole is for vaginal use only and should not be put in the eyes, mouth or on the skin.

What Drugs, Substances, or Supplements Interact with Vandazole?

Vandazole may interact with disulfiram, cimetidine, lithium, or blood thinners. The use of other vaginal products and vaginal intercourse should be avoided during treatment with Vandazole. Tell your doctor all medications and supplements you use.

Vandazole During Pregnancy and Breastfeeding

Women should consider discontinuing breastfeeding and discard their milk during treatment and for 24 hours after the last dose of Vandazole. Vandazole should be used during pregnancy only if clearly needed.

Additional Information

Our Vandazole (hydroxyprogesterone caproate) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Vandazole Consumer Information

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Get emergency medical help if you have signs of an allergic reaction (hives, itching, warmth or tingling; fever, joint pain; dry mouth, dry vagina; stuffy nose, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Rare but serious side effects may include:

  • seizure (convulsions); or
  • numbness, burning, pain, or tingly feeling in your hands or feet.

Call your doctor at once if you have new or worsening vaginal symptoms.

Common side effects may include:

  • vaginal itching or discharge;
  • menstrual pain, heavy bleeding;
  • breast pain;
  • headache;
  • rash, itching;
  • stomach pain, nausea, diarrhea; or
  • cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Vandazole (Metronidazole Vaginal Gel)

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Pelvic Pain: What's Causing Your Pelvic Pain? See Slideshow
Vandazole Professional Information

SIDE EFFECTS

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 reactions.

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 therapy.

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 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]

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].

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

Read the entire FDA prescribing information for Vandazole (Metronidazole Vaginal Gel)

© Vandazole Patient Information is supplied by Cerner Multum, Inc. and Vandazole Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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