Metrogel

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 Metrogel (metronidazole) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

Oral metronidazole has been reported to potentiate the anticoagulant effect of coumarin and warfarin, resulting in a prolongation of prothrombin time. Drug interactions should be kept in mind when METROGEL (metronidazole) is prescribed for patients who are receiving anticoagulant treatment, although they are less likely to occur with topical metronidazole administration because of low absorption.

Last reviewed on RxList: 3/29/2010
This monograph has been modified to include the generic and brand name in many instances.

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