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Metrogel Vaginal

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MetroGel Vaginal

Metrogel Vaginal Side Effects Center

Pharmacy Editor: Melissa Conrad Stöppler, MD

Metrogel vaginal (metronidazole) is an antibiotic used to treat bacterial vaginosis. The recommended dose is one applicator full of METROGEL-VAGINAL (metronidazole) (approximately 5 grams containing approximately 37.5 mg of metronidazole) intravaginally once or twice a day for 5 days. Side effects may include numbness, burning, mild pain or cramping, loss of appetite, or seizure. Other side effects may occur.

There has been no experience to date with the use of METROGEL-VAGINAL (metronidazole) in pregnant patients. Metronidazole crosses the placental barrier and enters the fetal circulation rapidly. There are, however, no well-controlled studies of this drug in pregnant women. Because metronidazole is a carcinogen in rodents, this drug should be used during pregnancy only if clearly needed. Metronidazole is secreted in human milk in concentrations similar to those found in plasma following oral administration of metronidazole.

Our Metrogel vaginal 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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Metrogel Vaginal in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Rare but serious side effects may include:

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

Less serious side effects may include:

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

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Metrogel Vaginal (Metronidazole) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Metrogel Vaginal Overview - Patient Information: Side Effects

SIDE EFFECTS: Dizziness, headache, nausea, diarrhea, unusual taste in the mouth, stomach cramps, or vaginal itching/burning/discharge may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: fainting, painful urination.

Tell your doctor immediately if any of these rare but very serious side effects occur: tingling or numbness of the hands and feet, seizures, signs of another infection (e.g., fever, persistent sore throat), mental/mood changes (e.g., depression).

Use of this medication for prolonged or repeated periods may result in a new vaginal yeast infection (vaginal fungal infection). Contact your doctor if you notice a change in vaginal discharge or other new symptoms.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Metrogel Vaginal (Metronidazole)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Metrogel Vaginal FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Clinical Trials

There were no deaths or serious adverse events related to drug therapy in clinical trials involving 800 non-pregnant women who received METROGEL-VAGINAL (metronidazole) .

In a randomized, single-blind clinical trial of 505 non-pregnant women who received METROGEL-VAGINAL (metronidazole) once or twice a day, 2 patients (one from each regimen) discontinued therapy early due to drug-related adverse events. One patient discontinued drug because of moderate abdominal cramping and loose stools, while the other patient discontinued drug because of mild vaginal burning. These symptoms resolved after discontinuation of drug.

Medical events judged to be related, probably related, or possibly related to administration of METROGEL-VAGINAL (metronidazole) once or twice a day were reported for 195/505 (39%) patients. The incidence of individual adverse reactions were not significantly different between the two regimens. Unless percentages are otherwise stipulated, the incidence of individual adverse reactions listed below was less than 1%:

Reproductive

Vaginal discharge (12%),
Symptomatic Candida cervicitis/vaginitis (10%),
Vulva/vaginal irritative symptoms (9%),
Pelvic discomfort (3%).

Gastrointestinal

Gastrointestinal discomfort (7%),
Nausea and/or vomiting (4%),
Unusual taste (2%),
Diarrhea/loose stools (1%),
Decreased appetite (1%),
Abdominal bloating/gas; thirsty, dry mouth.

Neurologic

Headache (5%),
Dizziness (2%),
Depression.

Dermatologic

Generalized itching or rash.

Other

Unspecified cramping (1%),
Fatigue,
Darkened urine.

In previous clinical trials submitted for approved labeling of METROGEL-VAGINAL (metronidazole) the following was also reported:

Laboratory

Increased/decreased white blood cell counts (1.7%).

Other Metronidazole Formulations

Other effects 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 events exceeded an incidence of 2% of patients.

METROGEL-VAGINAL (metronidazole) affords minimal peak serum levels and systemic exposure (AUC) of metronidazole compared to 500 mg oral metronidazole dosing. Although these lower levels of exposure are less likely to produce the common reactions seen with oral metronidazole, the possibility of these and other reactions cannot be excluded presently.

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.

Central Nervous System: (See WARNINGS.) Headache, dizziness, syncope, ataxia, confusion, convulsive seizures, peripheral neuropathy, vertigo, incoordination, irritability, depression, weakness, insomnia.

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; flushing; nasal congestion; dryness of the mouth, vagina, or vulva; fever; pruritus; fleeting joint pains.

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

Read the entire FDA prescribing information for Metrogel Vaginal (Metronidazole) »

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MetroGel Vaginal - User Reviews

MetroGel Vaginal User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication MetroGel Vaginal sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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