metronidazole topical

Name: metronidazole topical — FDA Drug Safety & Adverse Event Data
Creator: PlainMeds
License: https://creativecommons.org/publicdomain/zero/1.0/

Reviewed byPlainmeds Editorial, Drug Information Editorial Team · June 5, 2026

Verify with FDA → · CMS NADAC pricing →

Brand names: MetroGel

Topical Antibiotic (Rosacea) Rx

Metronidazole gel is a medicine that you put on your skin. It helps treat rosacea.

Drug Pricing (NADAC)

Generic Price

$0.38/unit

Generic Available

Yes (1 manufacturer)

Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →

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What it does

This medicine treats rosacea.

Common side effects

Burning, Skin irritation, Dryness

Key warnings

You should not use this medicine if you are allergic to metronidazole, parabens, or any of the other ingredients.

How It Works

Metronidazole is an antiprotozoal and antibacterial medicine. It's not fully known how it works for rosacea. It may reduce inflammation and kill certain germs.

How to Take It

Apply a thin layer of the gel to the affected areas. Do this twice a day, once in the morning and once in the evening. Make sure to wash the area before you put the gel on. You can use makeup after applying the gel.

Pregnancy & Breastfeeding

It is not known if this medicine will harm an unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant. It is also not known if this medicine passes into breast milk.

Missed Dose

Apply the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular schedule.

Storage

Store the gel at room temperature, between 68° to 77°F.

Side Effects (from patient reports)

Based on 25,880 FDA adverse event reports.

The medicine did not work

4,364

Feeling sick to your stomach

3,317

Using the medicine for something it's not approved for

3,130

Loose, watery stools

2,622

Throwing up

2,212

Fever

2,205

Head pain

2,127

General pain

2,047

Stomach pain

2,008

Feeling tired

1,848

FDA Adverse Event Report Analysis

Detailed analysis of 45,816 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 1999–2025.

Total Reports

45,816

Death-Related Reports

5,167

Hospitalization Reports

18,836

Top Indication

Product Used For Unknown Indication

Gender Distribution

Female 25,143 (61%)

Male 15,907 (39%)

Age Distribution

0–17 2,457

18–44 9,898

45–64 10,392

65–74 6,291

75+ 4,854

Most Reported Adverse Reactions (FAERS)

#	Reaction	Reports
1	DRUG INEFFECTIVE	4,365
2	NAUSEA	3,318
3	OFF LABEL USE	3,130
4	DIARRHOEA	2,621
5	VOMITING	2,211
6	PYREXIA	2,205
7	HEADACHE	2,127
8	PAIN	2,047
9	ABDOMINAL PAIN	2,009
10	FATIGUE	1,847
11	DIZZINESS	1,611
12	ACUTE KIDNEY INJURY	1,501
13	CONDITION AGGRAVATED	1,495
14	DYSPNOEA	1,493
15	MALAISE	1,430

Reactions in Death Reports

DEATH 780

DRUG INEFFECTIVE 768

SEPSIS 654

MULTIPLE ORGAN DYSFUNCTION SYNDROME 618

OFF LABEL USE 501

SEPTIC SHOCK 430

GENERAL PHYSICAL HEALTH DETERIORATION 416

VOMITING 411

ABDOMINAL PAIN 407

NAUSEA 397

Reactions in Hospitalization Reports

DRUG INEFFECTIVE 1,884

OFF LABEL USE 1,455

NAUSEA 1,450

PYREXIA 1,378

DIARRHOEA 1,367

ABDOMINAL PAIN 1,230

VOMITING 1,197

PAIN 1,107

ANAEMIA 905

ACUTE KIDNEY INJURY 884

Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation

Serious Warnings

You should not use this medicine if you are allergic to metronidazole, parabens, or any of the other ingredients.

Known Drug Interactions

minor warfarin

Drug interactions Oral metronidazole has been reported to potentiate the anticoagulant effect of coumarin and warfarin resulting in a prolongation of prothrombin time.

Mechanism: Metronidazole can increase the blood-thinning effects of warfarin. This makes your blood take longer to clot and increases your risk of bleeding.

What to do: Your doctor should check your blood clotting levels more often while you are using these medicines together.

minor metronidazole

Drug interactions Oral metronidazole has been reported to potentiate the anticoagulant effect of coumarin and warfarin resulting in a prolongation of prothrombin time. The effect of topical metronidazole on prothrombin time is not known.

Mechanism: While the oral version of this medicine is known to thin the blood, it is not yet known if the skin cream version has the same effect.

What to do: Talk to your doctor about using both forms of this medicine to ensure they are safe for you.

Common Questions

Can I use other skincare products with this gel?

Yes, you can use cosmetics after applying the gel.

How long will it take to see results?

It may take several weeks to see improvement in your rosacea. Continue using the gel as directed by your doctor.

What should I do if my skin becomes very irritated?

If your skin becomes severely irritated, stop using the gel and contact your doctor.

Can I use this gel on other parts of my body?

This gel is only for use on the skin affected by rosacea. Do not use it on other areas unless your doctor tells you to.

What if I accidentally swallow some of the gel?

If you accidentally swallow the gel, contact your doctor or poison control center right away.

Can I go out in the sun after applying this?

Yes, but it's always a good idea to protect your skin from the sun. Wear sunscreen and protective clothing.

Is it okay to drink alcohol while using this medicine?

This medicine is applied to the skin, so drinking alcohol should not affect it. However, check with your doctor.

What do I do if I get the gel in my eyes?

Rinse your eyes thoroughly with water. If irritation persists, contact your doctor.

How long should I use this gel?

Use this gel for as long as your doctor tells you to.

Can I buy this over the counter?

No, you need a prescription from your doctor to get this medicine.

What are the common side effects of metronidazole topical?

The most commonly reported side effects of metronidazole topical include Burning, Skin irritation, Dryness, Temporary redness. Based on 25,880 FDA adverse event reports. Always consult your healthcare provider about potential side effects.

Does metronidazole topical interact with other medications?

Yes, metronidazole topical has 2 known drug interactions. Notable interactions include warfarin, metronidazole. Always inform your doctor about all medications you are taking.

What drug class is metronidazole topical?

metronidazole topical belongs to the Topical Antibiotic (Rosacea) drug class. It requires a prescription (Rx). This medicine treats rosacea.

Is metronidazole topical safe during pregnancy?

It is not known if this medicine will harm an unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant. Always consult your healthcare provider before using any medication during pregnancy or breastfeeding.

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What the FDA Data Shows for metronidazole topical

The FDA label for metronidazole topical (sold under brand names such as MetroGel) classifies it as a prescription-only medication in the Topical Antibiotic (Rosacea) class. This medicine treats rosacea. Official labeling lists 4 commonly reported side effects, including Burning, Skin irritation, Dryness.

Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 25,880 voluntary reports. The database also lists 2 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated minor severity. NADAC pricing from CMS shows a generic unit cost of $0.38.

Report counts do not establish causation — a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice — always consult a licensed healthcare provider before starting, stopping, or changing any medication.

Data Sources

Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).

FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.

Last updated: September 12, 2025

Read our methodology — how this data is sourced, computed, and verified.

All federal data sources used on this page

FDA Orange Book — approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
FDA DailyMed — NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
FDA Adverse Event Reporting System (FAERS) — post-marketing safety surveillance. fda.gov/drugs/faers
NLM RxNorm — standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
CMS Medicare Part B Drug Average Sales Price Files — federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
FDA Drug Shortages Database — current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages