FDA label b88a7597-62f2-41ac-b20d-d698042aab47

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

SPL set ID
fce3e59e-8e08-47f1-947f-5a6d141ba1b2
SPL ID
b88a7597-62f2-41ac-b20d-d698042aab47
Version
6
Effective date
2025-01-15
Source export date
2026-10-12
Source partition
12
Source file
https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/edd23646015c9adc800cdbe2b778398a2d2b70e90dce5721ef2b191499a0397f/drug-label-0012-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:57:54

Adverse reactions cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Adverse reactions sections page 1 of 1 · 1 matching rows.

adverse reactions

ADVERSE REACTIONS In a controlled clinical trial, safety data from 141 patients who used Metronidazole Topical Lotion (n=71), or the lotion vehicle (n=70), twice daily and experienced a local cutaneous adverse event which may or may not have been related to the treatments include: local allergic reaction, Metronidazole Topical Lotion 2 (3%), lotion vehicle 0; contact dermatitis, Metronidazole Topical Lotion 2 (3%), lotion vehicle 1 (1%); pruritus, Metronidazole Topical Lotion 1 (1%), lotion vehicle 0; skin discomfort (burning and stinging), Metronidazole Topical Lotion 1 (1%), lotion vehicle 2 (3%); erythema, Metronidazole Topical Lotion 4 (6%), lotion vehicle 0; dry skin, MetronidazoleTopical Lotion 0, lotion vehicle 1 (1%); and worsening of rosacea, Metronidazole Topical Lotion 1 (1%), lotion vehicle 7 (10%). 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.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.