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 at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).
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:
Seek medical attention right away if any of these SEVERE side effects occur when using MetroGel Cream:Mild burning, dryness, itching, scaling, or stinging.
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.
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:
Seek medical attention right away if any of these SEVERE side effects occur when using MetroGel Vaginal Gel:Headache; minor vaginal irritation; pelvic discomfort; stomach upset.
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.
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:
Seek medical attention right away if any of these SEVERE side effects occur when using MetroGel Gel:Mild burning, dryness, itching, scaling, or stinging.
TopSevere 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.
MetroGel Side Effects - for the Professional
MetroGel
In a controlled clinical trial, 557 patients used MetroGel® (metronidazole gel), 1% and 189 patients used the gel vehicle once daily. The following table summarizes adverse reactions that occur at a rate of ≥1% in the clinical trials:
| 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) |
The following table summarizes the highest scores of 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.
Side Effects by Body System
Local
Local side effects have included skin irritation, dryness, redness, burning, and stinging. At times, the local effects of metronidazole may be difficult to distinguish from the clinical characteristics of acne rosacea. Watering or tearing may occur when metronidazole is applied too close to the eyes.
Genitourinary
Genitourinary side effects including vaginal or vulvar burning, irritation, or itching have been reported following administration of intravaginal metronidazole. In approximately 6% of patients, symptomatic vaginal candidiasis occurs during or immediately after metronidazole therapy. Uterine cramping has also been reported in less than 4% of patients.
Gastrointestinal
Gastrointestinal side effects including cramps/pain (3.4%), nausea (2.0%), and metallic or bad taste (1.7%) have been reported during vaginal administration of metronidazole.
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 have included a case of thrombotic thrombocytopenic purpura (TTP).
TopMore resources:
MetroGel Topical - Includes detailed dosage instructions.
MetroGel-Vaginal Vaginal - Includes detailed dosage instructions.
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