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

Applies to metronidazole topical: topical cream, topical gel/jelly, topical lotion. Other dosage forms:

• vaginal gel/jelly

Serious side effects of MetroGel

Along with its needed effects, metronidazole topical (the active ingredient contained in MetroGel) 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:

Less common

• Bladder pain
• blistering, burning, crusting, dryness, or flaking of the skin
• bloody or cloudy urine
• blurred vision
• body aches or pain
• chest tightness
• chills
• cough producing mucus
• diarrhea
• difficult, burning, or painful urination
• difficulty breathing
• dizziness
• ear congestion
• fever
• frequent urge to urinate
• general feeling of discomfort or illness
• headache
• itching, scaling, severe redness, soreness, or swelling of the skin
• joint pain
• loss of appetite
• loss of voice
• lower back or side pain
• muscle aches and pains
• nausea
• pounding in the ears
• shivering
• slow or fast heartbeat
• sore throat
• stuffy or runny nose
• sweating
• trouble sleeping
• unusual tiredness or weakness
• vomiting

Incidence not known

• Burning, numbness, tingling, or painful sensations
• unsteadiness or awkwardness
• weakness in the arms, hands, legs, or feet

Other side effects of MetroGel

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:

Rare

• Back pain

For Healthcare Professionals

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

Local

Very common (10% or more): Dryness (up to 28.5%), scaling (up to 24.6%), itching (up to 16.3%), pruritus (up to 15.8%), stinging (up to 11%), stinging/burning (up to 10.3%)

Common (1% to 10%): Burning, local allergic reaction

Frequency not reported: Condition aggravated (rosacea or acne), transient redness, irritation

Postmarketing reports: Application site reaction, local irritation^[Ref]

Local cutaneous signs/symptoms of irritation that were worse than baseline included dryness (25.4% [mild: 17.1%; moderate: 7.7%; severe: 0.6%]), scaling (24.6% [mild: 16.2%; moderate: 7.9%; severe: 0.6%]), pruritus (15.8% [mild: 9.7%; moderate: 5%; severe: 1.1%]), and stinging/burning (10.3% [mild: 7.2%; moderate: 1.3%; severe: 1.8%]).^[Ref]

Genitourinary

Very common (10% or more): Vaginal discharge (up to 12%)

Common (1% to 10%): Candida cervicitis/vaginitis, yeast infection, dysmenorrhea, metrorrhagia, vulvovaginal candidiasis, vulvovaginal pruritus, urinary tract infection (UTI), vaginal itching/irritation/burning/numbness, vulva/vaginal irritative symptoms, pelvic discomfort

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

Frequency not reported: Breast enlargement, dysuria, female lactation, labial edema, menorrhagia, salpingitis, urinary frequency, vulvovaginal disorder, vulvovaginal discomfort, itching (vaginal and perianal), vulvar burning, vulvar lesions, uterine/menstrual/vaginal cramping, darkened urine

Postmarketing reports: Leukorrhea, vaginitis, vulvar disorder, genital pruritus

Oral or parenteral formulations:

-Frequency not reported: Yeast infection, darkened urine, vaginal discharge, vaginal itching, overgrowth of Candida in vagina, dyspareunia, proctitis, dysuria, cystitis, polyuria, incontinence, sense of pelvic pressure, vulva/vaginal irritative symptoms, itching (vaginal and perianal), vulvar burning, vulvar lesions, vaginal burning, pelvic discomfort, uterine/menstrual/vaginal cramping^[Ref]

Other

Very common (10% or more): Fungal infection (up to 12%)

Common (1% to 10%): Infection, breast pain, unspecified cramping, abscess, accidental injury

Uncommon (0.1% to 1%): Fatigue

Frequency not reported: Mucous membrane disorder, pain, thirst, surgical/medical procedure

Postmarketing reports: Swelling face, facial edema, treatment failure (worsening of rosacea)

Oral or parenteral formulations:

-Frequency not reported: Fatigue, weakness^[Ref]

Respiratory

Very common (10% or more): Influenza (up to 11%)

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

Frequency not reported: Asthma^[Ref]

Gastrointestinal

Common (1% to 10%): Abdominal pain, nausea, diarrhea/loose stools, gastritis, tooth disorder, gastrointestinal discomfort, abdominal cramps, vomiting, unpleasant taste/unusual feeling on tongue

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

Frequency not reported: Dyspepsia, flatulence, gingivitis, abdominal cramping, abdominal bloating/gas

Postmarketing reports: Abdominal pain, diarrhea, nausea

Oral or parenteral formulations:

-Frequency not reported: Nausea, unpleasant taste/feeling on tongue, diarrhea, constipation, abdominal cramping, abdominal discomfort, vomiting, epigastric distress, "furry" tongue, glossitis, stomatitis, pancreatitis, gastrointestinal discomfort, gastrointestinal disturbance^[Ref]

Nervous system

Common (1% to 10%): Headache, dizziness, unpleasant taste, hypertonia

Uncommon (0.1% to 1%): Metallic taste, dysgeusia/unusual taste, paresthesia, hypoesthesia

Frequency not reported: Ataxia, drowsiness

Postmarketing reports: Peripheral neuropathy, taste perversion, dizziness, headache, paresthesia, metallic taste, tingling/numbness of extremities

Oral or parenteral formulations:

-Frequency not reported: Unpleasant taste, dizziness, headache, convulsive seizures, encephalopathy, aseptic meningitis, peripheral neuropathy (characterized mainly by numbness/paresthesia of an extremity), syncope, vertigo, incoordination, ataxia, confusion, dysarthria, unpleasant metallic taste, taste of alcoholic beverages modified^[Ref]

Cardiovascular

Common (1% to 10%): Hypertension

Oral or parenteral formulations:

-Frequency not reported: Flattening of T-wave in ECG tracings^[Ref]

Dermatologic

Common (1% to 10%): Pruritus, rash, contact dermatitis, dry skin, skin discomfort (burning, pain of skin/stinging), erythema/transient skin erythema, worsening of rosacea, skin irritation, psoriasis, seborrhea, skin infection, sunburn, urticaria

Frequency not reported: Acne, sweating, generalized itching/rash, severe flare of comedonal acne, rosacea aggravated

Postmarketing reports: Hyperpigmentation, pigmentation disorder, hypertrichosis, rash, urticaria, contact dermatitis, skin exfoliation, erythema, pruritus, burning, dryness, tightness, discomfort, rash, zoster lesion, pustules on the nose, vesicular bullous eruption

Oral or parenteral formulations:

-Frequency not reported: Urticaria, angioedema^[Ref]

Metabolic

Common (1% to 10%): Decreased appetite

Frequency not reported: Anorexia, hypomagnesemia

Oral or parenteral formulations:

-Frequency not reported: Decreased appetite, anorexia^[Ref]

Musculoskeletal

Common (1% to 10%): Bursitis, myalgia, osteoporosis

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

Hematologic

Common (1% to 10%): Increased/decreased WBC counts

Oral or parenteral formulations:

-Frequency not reported: Reversible neutropenia, reversible thrombocytopenia

Ocular

Common (1% to 10%): Conjunctivitis

Frequency not reported: Eye irritation (watering/tearing)

Postmarketing reports: Eyelid edema, watery eyes

Oral or parenteral formulations:

-Frequency not reported: Optic neuropathy^[Ref]

Oncologic

Common (1% to 10%): Skin carcinoma

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

Frequency not reported: Skin cancer^[Ref]

Endocrine

Common (1% to 10%): Hypothyroidism

Hypersensitivity

Postmarketing reports: Allergic reaction

Oral or parenteral formulations:

-Frequency not reported: Allergic reaction, hypersensitivity reactions (including urticaria, erythematous rash, Stevens-Johnson syndrome, toxic epidermal necrolysis, flushing, nasal congestion, dryness of mouth/vagina/vulva, fever, pruritus, fleeting joint pains), anaphylaxis

Psychiatric

Uncommon (0.1% to 1%): Depression, difficulty sleeping, irritability

Frequency not reported: Insomnia

Oral or parenteral formulations:

-Frequency not reported: Trouble sleeping, irritability, depression, insomnia, decreased libido^[Ref]

Hepatic

Frequency not reported: Abnormal liver function test^[Ref]

Renal

Frequency not reported: Pyelonephritis^[Ref]