Noritate 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 Noritate.

Some side effects of Noritate may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to metronidazole topical: topical cream, topical gel, topical kit, topical lotion

Get emergency medical help if you have any of these signs of an allergic reaction while taking metronidazole topical (the active ingredient contained in Noritate) hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor if you have severe stinging or burning when you apply metronidazole topical.

Less serious side effects of metronidazole topical may include:

• mild burning or stinging when the medication is applied;

• numbness or tingly feeling in your hands or feet;

• cough, stuffy nose, sore throat, cold symptoms;

• vaginal itching or discharge;

• headache;

• dry, scaly, or itchy skin;

• nausea; or

• metallic taste in your mouth.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

For Healthcare Professionals

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

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, mild skin dryness, and bullous fixed drug eruption 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 (the active ingredient contained in Noritate) is applied too close to the eyes.

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