Lamisil (Terbinafine) Adverse Reactions
- abdominal pain
- acute generalized exanthematous pustulosis (AGEP)
- agranulocytosis
- anaphylactoid reactions
- anorexia
- cholestasis
- diarrhea
- dizziness
- dysgeusia
- dyspepsia
- elevated hepatic enzymes
- fatigue
- headache
- hepatic failure
- hepatitis
- jaundice
- nausea/vomiting
- neutropenia
- pruritus
- rash (unspecified)
- skin discoloration
- skin irritation
- Stevens-Johnson syndrome
- thrombocytopenia
- toxic epidermal necrolysis
- urticaria
Lamisil (Terbinafine) Adverse Reactions
Topical formulations of terbinafine are well tolerated. In clinical trials for terbinafine topical cream, the manufacturer reported that only 6 of 2265 patients discontinued terbinafine therapy due to adverse effects. Only 52 of 2265 reported adverse effects that could have at least possibly been associated with therapy. The most common adverse effect was irritation or urticaria, occuring in about 1% of patients. Terbinafine dermal gel is associated with pruritus, skin irritation, burning at the application site, and skin discoloration in 1-2% of patients.
Adverse reactions associated with oral terbinafine have been assessed in both clinical trials and post-marketing surveillance. Approximately 17% of patients experience side effects with oral terbinafine. The most frequently reported adverse effects observed in clinical trials with oral terbinafine were gastrointestinal symptoms such as abdominal pain, diarrhea, nausea/vomiting, and dyspepsia. Also observed in 2-3% of patients were headache, dizziness, elevated hepatic enzymes (>= 2 times the upper limit of the normal), rash (unspecified), urticaria and pruritus. Dysgeusia occurs in 2% of patients; rare cases of prolonged (> 1 year) loss of taste have been reported. Rarely taste disturbances associated with oral terbinafine have been reported to be severe enough to result in decreased food intake leading to significant and unwanted weight loss. Most reactions have resolved within several weeks of drug discontinuation.
Rare but serious adverse events observed with oral terbinafine treatment include serious skin reactions (e.g., Stevens-Johnson syndrome and toxic epidermal necrolysis). Severe allergic events including anaphylactoid reactions have also been reported. If irritation, skin rash, or sensitivity occurs during use of terbinafine, treatment should be discontinued and appropriate therapy administered.
Terbinafine has been associated with acute generalized exanthematous pustulosis (AGEP). The nonfollicular, pustular, erythematous rash starts suddenly, is associated with fever above 38 degrees C, and is distinct from pustular psoriasis, although biopsy results in each reveal spongiform subcorneal pustules. Drugs are the main cause of AGEP. A period of 2-3 weeks after an inciting drug exposure appears necessary for a first episode of AGEP. Unintentional reexposure may cause a second episode within 2 days. Clinical presentation is diverse with cutaneous lesions beyond erythema and pustules present in half of the cases. For example, bullous lesions, edema, purpura, pruritus, and mucosal erosions are possible. The mean duration of the pustules is 9.7 days followed by an annular desquamation, as long as the causative drug or factor is discontinued. The physiopathological mechanisms of AGEP have not been determined but the pathological criteria of edema, leukocytoclastic vasculitis, eosinophil exocytosis, and keratinocyte focal necrosis are distinctive. Pustule confluence or very small pustules may lead a clinician to make an incorrect diagnosis of TEN, of drug-induced erythroderma, or of staphylococcal scalded skin syndrome.
Rare cases of blood dyscrasias have been reported. Severe neutropenia, lymphopenia, thrombocytopenia, and agranulocytosis have all been reported with oral terbinafine use. In placebo controlled trials, 1-2% of patients treated with oral terbinafine developed absolute lymphocyte counts < 1000/mm3 on one or more occasions. Case reports suggest that these hematologic adverse events are reversible on drug discontinuation.
Rare cases of hepatic failure, some leading to death or liver transplantation, have occurred with use of oral terbinafine. In the majority of cases, patients had serious underlying systemic conditions and an uncertain casual relationship to terbinafine. The severity of hepatotoxicity and/or outcome may be worse in patients with active or chronic hepatic disease (see Contraindications and Precautions). Treatment with oral terbinafine should be discontinued if biochemical or clinical evidence of hepatic injury develops (e.g., anorexia, hyperbilirubinemia, cholestasis, jaundice, or hepatitis).
Other side effects reported with terbinafine treatment include malaise, fatigue, arthralgia, myalgia, and alopecia; a causal relationship with terbinafine has not been established for these side effects.
[ Last revised: 8/10/2004 12:35:00 PM ]
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