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MetroGel-Vaginal Side Effects

Generic Name: metronidazole topical

Note: This document contains side effect information about metronidazole topical. Some of the dosage forms listed on this page may not apply to the brand name MetroGel-Vaginal.

In Summary

More frequent side effects include: cervical candidiasis and vaginitis. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to metronidazole topical: vaginal cream, vaginal gel/jelly, vaginal suppository

Other dosage forms:

Along with its needed effects, metronidazole topical (the active ingredient contained in MetroGel-Vaginal) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking metronidazole topical:

More Common

  • Itching in the vagina
  • pain during sexual intercourse
  • thick, white vaginal discharge with no odor or with a mild odor

Less Common

  • Abdominal or stomach cramping or pain
  • burning on urination or need to urinate more often
  • burning or irritation of penis of sexual partner
  • itching, stinging, or redness of the genital area

Some side effects of metronidazole topical may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less Common

Metronidazole may cause your urine to become dark. This is harmless and will go away when you stop using this medicine.

After you stop using this medicine, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:

  • Any vaginal or genital irritation or itching
  • pain during sexual intercourse
  • thick, white vaginal discharge not present before treatment, with no odor or with a mild odor

For Healthcare Professionals

Applies to metronidazole topical: topical cream, topical gel, topical kit, topical lotion, vaginal gel with applicator

General

Topical: The most frequently reported side effects were nasopharyngitis, upper respiratory tract infection, and headache.

Vaginal: The most frequently reported side effects were fungal infection, vulvovaginal candidiasis, headache, vulvovaginal pruritus, nausea, diarrhea, metrorrhagia, breast pain, infection, rash, pharyngitis, abdominal pain, pruritus, and dysmenorrhea.[Ref]

Local

Very common (10% or more): Mild dryness (17.1%), mild scaling (16.2%)

Common (1% to 10%): Moderate dryness, moderate scaling, mild pruritus, moderate pruritus, severe pruritus, mild stinging/burning, moderate stinging/burning, severe stinging/burning, local allergic reaction

Uncommon (0.1% to 1%): Severe dryness, severe scaling

Frequency not reported: Application site reaction, condition aggravated, transient redness[Ref]

Genitourinary

Common (1% to 10%): Dysmenorrhea, breast pain, metrorrhagia, vulvovaginal candidiasis, vulvovaginal pruritus, urinary tract infection, vaginal itching/irritation/burning/numbness, pelvic discomfort, vaginal discharge

Uncommon (0.1% to 1%): Vaginal mycosis, urine discolored, vulva edema, menstrual discomfort/irregularities, vaginal spotting/bleeding

Frequency not reported: Breast enlargement, dysuria, female lactation, labial edema, leucorrhoea, menorrhagia, salpingitis, urinary frequency, vaginitis, vulvovaginal disorder[Ref]

Gastrointestinal

Common (1% to 10%): Abdominal pain, nausea, diarrhea, gastritis, tooth disorder, gastrointestinal discomfort, abdominal cramps, vomiting

Uncommon (0.1% to 1%): Constipation, dry mouth, abdominal bloating/noise

Frequency not reported: Dyspepsia, flatulence, gingivitis[Ref]

Nervous system

Common (1% to 10%): Headache, dizziness

Uncommon (0.1% to 1%): Tingling/numb extremities, taste metallic, dysgeusia, paresthesia, hypothesia

Frequency not reported: Peripheral neuropathy, ataxia

Postmarketing reports: Taste perversion[Ref]

Respiratory

Common (1% to 10%): Pharyngitis, bronchitis, nasopharyngitis, sinusitis, upper respiratory tract infection, nasal congestion

Frequency not reported: Asthma, rhinitis[Ref]

Cardiovascular

Common (1% to 10%): Hypertension[Ref]

Dermatologic

Common (1% to 10%): Pruritus, rash, contact dermatitis, dry skin, skin discomfort, burning/stinging, erythema, worsening of rosacea, skin irritation

Frequency not reported: Acne, sweating, urticaria, skin exfoliation, facial edema, zoster lesion, nose pustule, vesicular bullous eruption

Postmarketing reports: Hyperpigmentation, pigmentation disorder, hypertrichosis[Ref]

Other

Very common (10% or more): Fungal infection (12%), flu syndrome (up to 11%)

Common (1% to 10%): Infection, influenza, abscess, pain

Uncommon (0.1% to 1%): Fatigue

Frequency not reported: Mucous membrane disorder[Ref]

Psychiatric

Uncommon (0.1% to 1%): Depression, difficult sleep, irritability

Frequency not reported: Insomnia[Ref]

Musculoskeletal

Uncommon (0.1% to 1%): Back pain, cramp[Ref]

Oncologic

Uncommon (0.1% to 1%): Basal cell carcinoma

Frequency not reported: Skin cancer[Ref]

Ocular

Frequency not reported: Eye irritation, watery eye

Postmarketing reports: Eyelid edema[Ref]

Hepatic

Frequency not reported: Liver function test abnormal[Ref]

Immunologic

Frequency not reported: Allergic reaction[Ref]

Metabolic

Common (1% to 10%): Appetite decreased

Frequency not reported: Anorexia, hypomagnesemia[Ref]

Renal

Frequency not reported: Pyelonephritis[Ref]

References

1. "Product Information. MetroLotion (metroNIDAZOLE topical)." Galderma Laboratories Inc, Cranbury, NJ.

2. "Product Information. Noritate (metroNIDAZOLE topical)." sanofi-aventis, Bridgewater, NJ.

3. "Product Information. MetroNIDAZOLE Vaginal (metroNIDAZOLE topical)." Oceanside Pharmaceuticals, Bridgewater, NJ.

4. Cerner Multum, Inc. "Australian Product Information." O 0

5. "Product Information. Rosadan (metroNIDAZOLE topical)." Medimetriks Pharmaceuticals Inc, Fairfield, NJ.

6. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

7. "Product Information. MetroNIDAZOLE Topical (metroNIDAZOLE topical)." G & W Laboratories Inc, South Plainfield, NJ.

8. "Product Information. Metrogel (metronidazole)." Galderma Laboratories Inc, Fort Worth, TX.

9. "Product Information. Vandazole (metroNIDAZOLE topical)." Upsher-Smith Laboratories Inc, Minneapolis, MN.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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