Note: This document contains side effect information about terbinafine. Some of the dosage forms listed on this page may not apply to the brand name Lamisil.
Common side effects of Lamisil include: headache. Other side effects include: diarrhea, dyspepsia, and skin rash. See below for a comprehensive list of adverse effects.
Applies to terbinafine: oral tablet
Along with its needed effects, terbinafine (the active ingredient contained in Lamisil) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking terbinafine:
Incidence not known
Some side effects of terbinafine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Incidence not known
Applies to terbinafine: oral granule, oral tablet
In general, side effects have been mild to moderate and transient; however, this drug has been associated with serious life-threatening events such as hepatic failure, anaphylaxis, and severe neutropenia. Unless otherwise specified, the listed side effects were reported with the tablets.
Taste disturbances were typically noticed 5 to 8 weeks after starting therapy and returned to normal within several 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.
Hypogeusia (including ageusia) usually recovered within several weeks after this drug was stopped. Isolated cases of prolonged hypogeusia have been reported.
Taste disturbance (including taste loss), paresthesia, hypoesthesia, tinnitus, and vertigo have also been reported during postmarketing experience. Some cases of taste disturbance were severe enough to cause decreased food intake, weight loss, anxiety, and depressive symptoms.
Very common (10% or more): Headache (12.9%)
Common (1% to 10%): Taste disturbance/dysgeusia (including taste loss/ageusia), dizziness
Uncommon (0.1% to 1%): Hypogeusia, ageusia, paresthesia, hypoesthesia, tinnitus
Very rare (less than 0.01%): Vertigo, sedation, lightheadedness
Frequency not reported: Taste alteration
Postmarketing reports: Smell disturbance (including loss of smell), paresthesia, hypoesthesia, hearing impairment, hypoacusis, anosmia (including permanent anosmia), hyposmia
Very common (10% or more): Gastrointestinal symptoms, feeling of fullness, abdominal distension, diarrhea, dyspepsia/gastritis, nausea, abdominal pain, flatulence, vomiting, mild abdominal discomfort, abdominal cramps, belching
Common (1% to 10%): Upper abdominal pain
Uncommon (0.1% to 1%): Toothache
Very rare (less than 0.01%): Parotid swelling
Frequency not reported: Mild to moderate gastrointestinal discomfort, gastritis, gastric fullness, nausea and vomiting, discoloration of the tongue, hypogeusia, ageusia, metallic taste, severe sialadenitis
Postmarketing reports: Pancreatitis
Vomiting, upper abdominal pain, and toothache have been reported with the oral granules. Vomiting has also been reported during postmarketing experience with the tablets.
An 81-year-old male who had been treated with topical antifungal agents for tinea pedis started this drug (125 mg orally 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. This drug 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.
An 80-year-old female experienced DRESS secondary to severe sialadenitis coincident with this drug. 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 therapy 14 days before onset of the generalized rash, for a nonspecific squamous plaque of the trunk. DRESS induced by this drug was diagnosed and therapy 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.
A 68-year-old male experienced acute generalized exanthematous pustulosis coincident with this drug. He presented with a symmetrical maculopapular eruption on both lower anterior legs. Within 2 days, the rash generalized with facial involvement. He developed the rash 20 days after initiating oral therapy for onychomycosis. After withdrawal of this drug, the exanthema abated within 10 days under topical therapy with corticosteroids.
Serious skin reactions (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, exfoliative dermatitis, bullous dermatitis), psoriasiform eruptions or exacerbation of psoriasis, acute generalized exanthematous pustulosis, hair loss, and photosensitivity reactions have also been reported during postmarketing experience.
Very common (10% or more): Nonserious forms of skin reactions, rash, urticaria
Common (1% to 10%): Pruritus, erythema
Uncommon (0.1% to 1%): Photosensitivity reactions
Very rare (less than 0.01%): Serious skin reactions (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, exfoliative dermatitis, bullous dermatitis), photosensitivity (e.g., photodermatosis, photosensitivity allergic reaction, polymorphic light eruption), alopecia/hair loss, psoriasiform eruptions or exacerbation of psoriasis, acute generalized exanthematous pustulosis, toxic skin eruption
Frequency not reported: Reversible alopecia areata of the scalp, pustular psoriasis, acrodermatitis continua of Hallopeau
Postmarketing reports: Serious skin reactions (e.g., drug reaction with eosinophilia and systemic symptoms [DRESS] syndrome)
Very common (10% or more): Decreased appetite/anorexia
Frequency not reported: Hypoglycemia, decreased food intake (due to taste disturbance)
Arthralgia and myalgia have also been reported during postmarketing experience.
Very common (10% or more): Musculoskeletal reactions, arthralgia, myalgia
Very rare (less than 0.01%): Cutaneous and systemic lupus erythematosus
Postmarketing reports: Rhabdomyolysis, increased blood creatine phosphokinase, precipitation and exacerbation of cutaneous and systemic lupus erythematosus
Liver enzyme abnormalities (at least 2 times the upper limit of normal) have been reported in 3.3% of patients.
In most liver failure cases, patients had serious underlying systemic conditions; causal association with this drug was unclear.
A 57-year-old male with chronic hepatitis B virus (HBV) infection developed drug-induced acute autoimmune hepatitis coincident with this drug. He was given 250 mg once daily over a 12-week period for dermatophyte toenail onychomycosis. He developed the side effect 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 this drug was discontinued.
Cases of liver failure (some leading to death or liver transplant), hepatitis, cholestasis, and increased hepatic enzymes have also been reported during postmarketing experience.
Common (1% to 10%): Liver enzyme abnormalities
Rare (0.01% to 0.1%): Serious liver dysfunction (including hepatic failure, increased hepatic enzymes, jaundice, cholestasis, liver decompensation, hepatitis), transient increases in liver enzymes, hepatobiliary dysfunction, cholestatic jaundice, liver failure (some cases leading to death or liver transplant)
Frequency not reported: Development of idiosyncratic and symptomatic hepatobiliary dysfunction, drug-induced autoimmune hepatitis
Postmarketing reports: Idiosyncratic and symptomatic hepatic injury
Common (1% to 10%): Depression
Very rare (less than 0.01%): Anxiety
Frequency not reported: Insomnia
Postmarketing reports: Anxiety (independent of taste disturbance), depressive symptoms (independent of taste disturbance), anxiety (secondary to taste disturbances), depressive symptoms (secondary to taste disturbances)
Common (1% to 10%): Pyrexia, tiredness/fatigue
Uncommon (0.1% to 1%): Weight decreased
Rare (0.01% to 0.1%): Malaise (secondary to dysgeusia)
Very rare (less than 0.01%): Chest pain
Frequency not reported: Weight loss (due to taste disturbance), weight decreased (secondary to hypogeusia)
Postmarketing reports: Influenza-like illness
Pyrexia has been reported with the oral granules; it has also been reported during postmarketing experience with the tablets.
Malaise and fatigue have also been reported during postmarketing experience.
Common (1% to 10%): Nasopharyngitis, cough, upper respiratory tract infection, influenza, pharyngolaryngeal pain, rhinorrhea, nasal congestion
Nasopharyngitis, cough, upper respiratory tract infection, influenza, pharyngolaryngeal pain, rhinorrhea, and nasal congestion have been reported with the oral granules.
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 3 weeks of therapy. This problem resolved within 1 week of discontinuing the drug.
Common (1% to 10%): Visual disturbance
Frequency not reported: Changes in ocular lens and retina, dyschromatopsia, photopsia
Postmarketing reports: Reduced visual acuity, visual field defect, blurred vision
Agranulocytosis, thrombocytopenia, anemia, and pancytopenia have also been reported during postmarketing experience.
Uncommon (0.1% to 1%): Anemia
Very rare (less than 0.01%): Neutropenia, agranulocytosis, thrombocytopenia, pancytopenia
Frequency not reported: Leukopenia, lymphopenia, transient decreases in hematocrit, transient decreases in hemoglobin, transient decreases in leukocytes
Postmarketing reports: Severe neutropenia, altered prothrombin time (prolonged and reduced) with concomitant warfarin
Very rare (less than 0.01%): Anaphylactoid reactions (including angioedema)
Frequency not reported: Anaphylaxis, hypersensitivity reactions
Postmarketing reports: Serious hypersensitivity reactions (e.g., angioedema, allergic reactions [including anaphylaxis]), anaphylactic reaction, serum sickness-like reaction
Frequency not reported: Renal function test impairment, transient increases in serum urea, transient increases in serum creatinine
Frequency not reported: Hematuria, transient erectile dysfunction in male patients
Postmarketing reports: Vasculitis
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Lamisil Af Defense (www.drugs.com/lamisil.html).
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