Local symptoms such as pruritus, skin exfoliation, application site pain, application site irritation, pigmentation disorder, skin burning sensation, erythema and scab may occur at the site of application.
These minor symptoms must be distinguished from hypersensitivity reactions such as widespread pruritus, rash, bullous eruptions and hives, which are reported in sporadic cases and require discontinuation.
In case of accidental contact with the eyes terbinafine hydrochloride may be irritating to the eyes. In rare cases the underlying fungal infection may be aggravated.
Adverse reactions are listed as follows by system organ class and frequency. Frequencies are defined as: 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); very rare (<1/10,000), or not known (cannot be estimated from available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Immune system disorders: Not known: Hypersensitivity.
Eye disorders: Rare: Eye irritation.
Skin and subcutaneous tissue disorders: Common: Skin exfoliation, pruritus.
Uncommon: Skin lesion, scab, skin disorder, pigmentation disorder, erythema, skin burning sensation.
Rare: Dry skin, dermatitis contact, eczema.
Not known: Rash.
General disorders and administration site conditions: Uncommon: Pain, application site pain, application site irritation.
Rare: Condition aggravated.
Any adverse drug reactions should be immediately reported to the physician or pharmacist.
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