Adverse reactions reported among 426 patients who received miconazole 2% cream base in 21 double-blind clinical trials are presented in Table A below.
Based on pooled safety data from these clinical trials, the most commonly reported adverse reaction was Application site irritation (0.7%).
Including the above-mentioned adverse reaction, Table A displays adverse reactions that have been reported with the use of topical, non-gynaecological, miconazole nitrate/miconazole from either clinical trial or postmarketing experiences.
The displayed frequency categories use the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); and very rare (< 1/10,000, including isolated reports) and Not Known (cannot be estimated from the available data).
Table A: Adverse Reactions Reported in Clinical Trials and Post-marketing Experience
System Organ Class
|
Adverse Drug Reactions
|
Frequency Category
|
Uncommon
(≥1/1,000 to <1/100)
|
Not Known
|
Immune System Disorders
|
|
Anaphylactic reaction, Hypersensitivity
|
Skin and Subcutaneous Tissue Disorders
|
Skin burning sensation
Skin inflammation
|
Angioedema
Urticaria
Contact dermatitis
Rash
Erythema
Pruritus
|
General Disorders and Administration Site Conditions
|
Application site reactions (including application site irritation, burning, pruritus, reaction NOS and warmth)
|
|
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store