MetroGel
- Generic Name: metronidazole
- Brand Name: Metrogel
Metrogel (Metronidazole) side effects drug center
What Is MetroGel?
MetroGel (metronidazole) Topical gel is a topical (for the skin) antibiotic used to treat skin lesions caused by rosacea. MetroGel is available in generic form.
What Are Side Effects of MetroGel?
Common side effects of MetroGel include:
- skin stinging/burning/irritation/dryness/ redness/scaling/itching,
- metallic taste,
- nausea,
- headache,
- numbness or tingly feeling in your hands or feet,
- cough,
- stuffy nose,
- sore throat,
- cold symptoms, or
- vaginal itching or discharge.
Dosage for MetroGel
Apply and rub in a thin film dose of Metrogel once daily to affected area(s).
What Drugs, Substances, or Supplements Interact with MetroGel?
Metrogel may interact with blood thinners such as warfarin (Coumadin). It is not likely that other drugs you take orally or inject will have an effect on topically applied Metrogel. Tell your doctor all medications and supplements you use.
MetroGelDuring Pregnancy or Breastfeeding
Metrogel should be used only when prescribed during pregnancy. Metrogel passes into breast milk. Consult your doctor before breastfeeding.
Additional Information
Our Metrogel (metronidazole) Drug Center provides a comprehensive view of available drug information as well as related drugs, user reviews, supplements, and diseases and conditions articles.
Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
- numbness, tingling, or burning pain in your hands or feet; or
- stinging or burning when you apply metronidazole topical.
Common side effects may include:
- burning or stinging;
- skin redness or irritation;
- dry, scaly, or itchy skin; or
- cold symptoms such as stuffy nose, sneezing, sore throat.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for MetroGel (Metronidazole)
SIDE EFFECTS
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% N= 557 |
Gel Vehicle 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
Sign/Symptom | Metronidazole Gel, 1% N= 544 |
Gel Vehicle 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.
Read the entire FDA prescribing information for MetroGel (Metronidazole)
IMAGES
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