MetroGel Side Effects

Please note - some side effects for MetroGel may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of MetroGel - for the Consumer

MetroGel Cream

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using MetroGel Cream:

Mild burning, dryness, itching, scaling, or stinging.

Seek medical attention right away if any of these SEVERE side effects occur when using MetroGel Cream:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); severe burning, dryness, irritation, itching, scaling, or stinging; tingling or numbness of the hands or feet.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

MetroGel Vaginal Gel

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using MetroGel Vaginal Gel:

Headache; minor vaginal irritation; pelvic discomfort; stomach upset.

Seek medical attention right away if any of these SEVERE side effects occur when using MetroGel Vaginal Gel:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); numbness, tingling, or burning of your arms, hands, legs, or feet; seizures; severe or persistent vaginal irritation; stomach pain; unusual vaginal odor, itching, or discharge.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

MetroGel Gel

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using MetroGel Gel:

Mild burning, dryness, itching, scaling, or stinging.

Seek medical attention right away if any of these SEVERE side effects occur when using MetroGel Gel:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); severe burning, dryness, irritation, itching, scaling, or stinging; tingling or numbness in hands and feet.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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MetroGel Side Effects - for the Professional

MetroGel

Clinical Studies 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.

In a controlled clinical trial, 557 patients used metronidazole gel, 1% and 189 patients used the gel vehicle once daily for up to 10 weeks. The following table summarizes selected adverse reactions that occurred at a rate of ≥1%:

Table 1: Adverse Reactions That Occurred at a Rate of≥1%

System Organ Class/Preferred Term	Metronidazole Gel, 1%	Gel Vehicle
	N= 557	N= 189
Patients with at least one AE        Number (%) of Patients	186 (33.4)	51 (27.0)
Infections and infestations	76 (13.6)	28 (14.8)
Bronchitis	6 (1.1)	3 (1.6)
Influenza	8 (1.4)	1 (0.5)
Nasopharyngitis	17 (3.1)	8 (4.2)
Sinusitis	8 (1.4)	3 (1.6)
Upper respiratory tract infection	14 (2.5)	4 (2.1)
Urinary tract infection	6 (1.1)	1 (0.5)
Vaginal mycosis	1 (0.2)	2 (1.1)
Musculoskeletal and connective tissue disorders	19 (3.4)	5 (2.6)
Back pain	3 (0.5)	2 (1.1)
Neoplasms	4 (0.7)	2 (1.1)
Basal cell carcinoma	1 (0.2)	2 (1.1)
Nervous system disorders	18 (3.2)	3 (1.6)
Headache	12 (2.2)	1 (0.5)
Respiratory, thoracic and mediastinal disorders	22 (3.9)	5 (2.6)
Nasal congestion	6 (1.1)	3 (1.6)
Skin and subcutaneous tissue disorders	36 (6.5)	12 (6.3)
Contact dermatitis	7 (1.3)	1 (0.5)
Dry skin	6 (1.1)	3 (1.6)
Vascular disorders	8 (1.4)	1 (0.5)
Hypertension	6 (1.1)	1 (0.5)

Table 2: Local Cutaneous Signs and Symptoms of Irritation That Were Worse Than Baseline

	Metronidazole Gel, 1%	Gel Vehicle
Sign/Symptom	N= 544	N= 184
Dryness	138 (25.4)	63 (34.2)
Mild	93 (17.1)	41 (22.3)
Moderate	42 (7.7)	20 (10.9)
Severe	3 (0.6)	2 (1.1)
Scaling	134 (24.6)	60 (32.6)
Mild	88 (16.2)	32 (17.4)
Moderate	43 (7.9)	27 (14.7)
Severe	3 (0.6)	1 (0.5)
Pruritus	86 (15.8)	35 (19.0)
Mild	53 (9.7)	21 (11.4)
Moderate	27 (5.0)	13 (7.1)
Severe	6 (1.1)	1 (0.5)
Stinging/burning	56 (10.3)	28 (15.2)
Mild	39 (7.2)	18 (9.8)
Moderate	7 (1.3)	9 (4.9)
Severe	10 (1.8)	1 (0.5)

The following additional adverse experiences have been reported with the topical use of metronidazole: skin irritation, transient redness, metallic taste, tingling or numbness of extremities, and nausea.

Post Marketing Experience

The following adverse reaction has been identified during post approval use of topical metronidazole: peripheral neuropathy.  Because this reaction is reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate the frequency or establish a causal relationship to drug exposure.

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Side Effects by Body System - for Healthcare Professionals

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, and mild skin dryness 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 is applied too close to the eyes.

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