MetroGel

Last updated on RxList: 4/19/2021
MetroGel Side Effects 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:

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.

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.

QUESTION

Rosacea usually first appears on the ________. See Answer
MetroGel Consumer Information

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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)

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MetroGel Professional Information

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)

SLIDESHOW

Rosacea, Acne, Shingles, Covid-19 Rashes: Common Adult Skin Diseases See Slideshow

© MetroGel Patient Information is supplied by Cerner Multum, Inc. and MetroGel Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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