Terbinafine Side Effects

Some side effects of terbinafine may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to terbinafine: oral granule, oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking terbinafine: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Some people taking terbinafine have developed severe liver damage leading to liver transplant or death. It is not clear whether terbinafine actually caused the liver damage in these patients. In most cases, the patient had a serious medical condition before taking terbinafine.

Call your doctor at once if you have symptoms of liver damage, such as nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes). These events can occur whether or not you have ever had liver problems before.

Stop taking terbinafine and call your doctor at once if you have a serious side effect such as:

• fever, chills, body aches, flu symptoms, sores in your mouth and throat;

• joint pain or swelling, swollen glands, patchy skin color, or a butterfly-shaped skin rash over your cheeks and nose;

• changes in mood or behavior;

• hearing problems;

• weight loss due to taste changes;

• raised, silvery flaking of the skin; or

• severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Less serious side effects of terbinafine may include:

• upset stomach, gas, diarrhea, mild nausea or stomach pain;

• headache, dizziness or spinning sensation;

• mild skin rash or itching; or

• unusual or unpleasant taste in your mouth.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to terbinafine: oral granule, oral tablet

General

In general, terbinafine side effects have been mild and transient. However, the drug has been associated with serious life threatening events such as hepatic failure, anaphylaxis, and severe neutropenia.

Gastrointestinal

Gastrointestinal side effects have included diarrhea (5.6%), dyspepsia (4.3%), taste disturbance (2.8%), nausea (2.6%), abdominal pain (2.4%), and flatulence (2.2%). Mild to moderate gastrointestinal discomfort, gastritis, gastric fullness, nausea and vomiting, taste alteration (rarely accompanied by discoloration of the tongue and/or disturbance in the sense of smell), hypogeusia, ageusia, and a metallic taste have been reported. At least one case of a drug reaction with eosinophilia and systemic symptoms associated with severe sialadenitis induced by terbinafine has been reported. Vomiting and pancreatitis have been reported during postmarketing experience.

Patients with hiatal hernia or gastric duodenal ulcer disease may be more likely to experience mild to moderate gastrointestinal discomfort, diarrhea, dyspepsia, nausea and vomiting, gastritis, gastric fullness, and flatulence.

Taste disturbances were typically noticed 5 to 8 weeks after starting therapy and returned to normal 2 to 5 weeks after stopping the medication. The taste alteration has been rarely accompanied by a discoloration of the tongue and/or a disturbance in the sense of smell.

An 80-year-old female experienced a drug reaction with eosinophilia and systemic symptoms (DRESS) secondary to severe sialadenitis coincident with terbinafine therapy. The patient was admitted with a generalized pruriginous eruption. She presented with erythematous and edematous widespread confluent plaques, with a scaly annular border. She had initiated terbinafine therapy 14 days before onset of the generalized rash, for a nonspecific squamous plaque of the trunk. DRESS induced by terbinafine was diagnosed and terbinafine intake was discontinued. Topical therapy was started with 0.5% clobetasol propionate cream applied to the whole body. The rash progressively improved and blood eosinophilia decreased.

Dermatologic

An 81-year-old male who had been treated with topical antifungal agents for tinea pedis started oral terbinafine 125 mg daily as the lesions did not respond to topical therapy. He was not taking any other medications and had no history of skin disease. No other skin lesions were observed at that time. Two weeks later, he developed erythematous and pustular lesions on his fingers and toes, and an erythematous macular eruption on the limbs. Oral terbinafine therapy was discontinued, but the eruptions continued to worsen. Histopathology of a punch biopsy from his toe showed intraepidermal sterile pustules containing neutrophils, so-called Kogoj's spongiform pustules. He was then diagnosed with having acrodermatitis continua of Hallopeau and was treated with corticosteroids therapy.

A 68-year-old male experienced acute generalized exanthematous pustulosis coincident with terbinafine therapy. He presented with a symmetrical maculopapular eruption on both lower anterior legs. Within two days, the rash generalized with facial involvement. He developed the rash 20 days after initiating oral terbinafine for onychomycosis. After withdrawal of terbinafine, the exanthema abated within 10 days under topical therapy with corticosteroids.

Dermatologic side effects have included rash (5.6%), pruritus (2.8%), urticaria (1.1%), and eczema. Reversible alopecia areata of the scalp and pustular psoriasis have been rarely reported. Erythema multiforme and at least one case of acrodermatitis continua of Hallopeau have been reported. Serious skin reactions (e.g., Stevens-Johnson syndrome and toxic epidermal necrolysis), psoriasiform eruptions or exacerbation of psoriasis, acute generalized exanthematous pustulosis, hair loss, photosensitivity reactions, and precipitation and exacerbation of cutaneous and systemic lupus erythematosus have been reported during postmarketing experience.

Nervous system

Nervous system side effects have included headache (12.9%), dizziness, and insomnia. Taste disturbance (including taste loss), smell disturbance (including loss of smell), tinnitus, hearing impairment, and vertigo have been reported during postmarketing experience. Some cases of taste disturbance were severe enough to cause decreased food intake, weight loss, and depressive symptoms.

Hepatic

A 57-year-old male with chronic hepatitis B virus (HBV) infection developed terbinafine-induced acute autoimmune hepatitis coincident with terbinafine therapy. He was given 250 mg of terbinafine once daily over a 12-week period for dermatophyte toenail onychomycosis. He developed the adverse event just prior to completing the course of therapy. He was not taking any other drugs or herbal supplements, did not drink alcohol, and did not appear to suffer a flare of HBV infection. Liver function studies began to normalize 6 weeks after terbinafine was discontinued.

Hepatic side effects have included liver enzyme abnormalities (greater than or equal to 2 times ULN; 3.3%). Transient elevations in serum liver enzymes, the development of idiosyncratic and symptomatic hepatobiliary dysfunction, and at least one case of terbinafine-induced autoimmune hepatitis have been reported. Idiosyncratic and symptomatic hepatic injury and rare cases of liver failure (some leading to death or liver transplantation) have been reported during postmarketing experience.

Hematologic

Hematologic side effects have included leukopenia and lymphopenia. Pancytopenia, anemia, thrombocytopenia, agranulocytosis, and severe neutropenia have been reported during postmarketing experience.

Ocular

Ocular side effects have included visual disturbance (1.1%). Changes in the ocular lens and retina have been reported; however, the clinical significance is unknown. Dyschromatopsia, whereby the patient reported a greenish hue in her vision, and photopsia have occurred in a patient after three weeks of therapy. This problem resolved within 1 week of discontinuing the drug. Reduced visual acuity and visual field defect have been reported during postmarketing experience.

Metabolic

Metabolic side effects have included hypoglycemia and hypotriglyceridemia.

Genitourinary

Genitourinary side effects have included transient erectile dysfunction in male patients (extremely rare).

Renal

Renal side effects have been uncommonly reported. These have included a case of renal function test impairment and rare cases of hematuria.

Hypersensitivity

Hypersensitivity side effects have included rare cases of anaphylaxis and hypersensitivity reactions. Angioedema, allergic reactions (including anaphylaxis), and serum sickness-like reaction have been reported during postmarketing experience.

Musculoskeletal

Musculoskeletal side effects have included arthralgia, myalgia, rhabdomyolysis, and increased blood creatine phosphokinase during postmarketing experience.

Cardiovascular

Cardiovascular side effects have included vasculitis during postmarketing experience.

Other

Other side effects have included malaise, fatigue, influenza-like illness, and pyrexia during postmarketing experience.

Psychiatric

Psychiatric side effects have included depressive symptoms (independent of taste disturbance) during postmarketing experience.

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