Summary

Commonly reported side effects of terbinafine include: headache. Other side effects include: diarrhea, dyspepsia, and skin rash. Continue reading for a comprehensive list of adverse effects.

Applies to terbinafine: oral tablet.

Serious side effects of Terbinafine

Along with its needed effects, terbinafine 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:

More common

• Fever

Less common

• Body aches or pain
• chills
• cough
• diarrhea
• difficulty with breathing
• ear congestion
• general feeling of discomfort or illness
• headache
• joint pain
• loss of appetite
• loss of voice
• nasal congestion
• nausea
• runny nose
• shivering
• skin rash or itching
• sneezing
• sore throat
• sweating
• trouble with sleeping
• unusual tiredness or weakness
• upper abdominal or stomach pain
• vomiting

Rare

• Dark urine
• difficulty with swallowing
• pale skin
• pale stools
• redness, blistering, peeling, or loosening of the skin
• stomach pain
• unusual bleeding or bruising
• yellow skin or eyes

Incidence not known

• Black, tarry stools
• bleeding gums
• bloating
• blood in the urine or stools
• chest pain
• constipation
• cough or hoarseness
• dizziness
• fast heartbeat
• feeling of discomfort
• flu-like symptoms
• general feeling of tiredness or weakness
• hair loss
• high fever
• hives
• indigestion
• inflammation of the joints
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• light-colored stools
• lower back or side pain
• muscle aches
• painful or difficult urination
• pains in the stomach, side, or abdomen, possibly radiating to the back
• persistent loss of appetite
• pinpoint red spots on the skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• red skin lesions, often with a purple center
• red, irritated eyes
• red, scaling, or crusted skin
• sores, ulcers, or white spots on the lips or in the mouth
• sores, welting, or blisters
• stomach pain, continuing
• swollen glands
• swollen lymph glands
• tightness in the chest
• troubled breathing with exertion
• ulcers, sores, or white spots in the mouth
• unexplained bleeding or bruising

Other side effects of Terbinafine

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:

More common

• Stomach pain (mild)

Less common

• Acid or sour stomach
• bad, unusual, or unpleasant (after) taste
• belching
• change of taste or loss of taste
• heartburn
• toothache

Incidence not known

• Decreased vision
• difficulty with moving
• discouragement
• feeling sad or empty
• irritability
• lack of appetite
• loss of interest or pleasure
• loss of sense of smell
• muscle cramps or spasms
• muscle stiffness
• tiredness
• trouble concentrating

For Healthcare Professionals

Applies to terbinafine: oral granule, oral tablet.

General

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.^[Ref]

Nervous system

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.^[Ref]

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^[Ref]

Gastrointestinal

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^[Ref]

Vomiting, upper abdominal pain, and toothache have been reported with the oral granules. Vomiting has also been reported during postmarketing experience with the tablets.^[Ref]

Dermatologic

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.^[Ref]

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)^[Ref]

Metabolic

Very common (10% or more): Decreased appetite/anorexia

Frequency not reported: Hypoglycemia, decreased food intake (due to taste disturbance)^[Ref]

Arthralgia and myalgia have also been reported during postmarketing experience.^[Ref]

Musculoskeletal

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^[Ref]

Hepatic

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.^[Ref]

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^[Ref]

Psychiatric

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)^[Ref]

Other

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.

Respiratory

Nasopharyngitis, cough, upper respiratory tract infection, influenza, pharyngolaryngeal pain, rhinorrhea, and nasal congestion have been reported with the oral granules.

Common (1% to 10%): Nasopharyngitis, cough, upper respiratory tract infection, influenza, pharyngolaryngeal pain, rhinorrhea, nasal congestion

Ocular

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.^[Ref]

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^[Ref]

Hematologic

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^[Ref]

Agranulocytosis, thrombocytopenia, anemia, and pancytopenia have also been reported during postmarketing experience.^[Ref]

Hypersensitivity

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^[Ref]

Renal

Frequency not reported: Renal function test impairment, transient increases in serum urea, transient increases in serum creatinine^[Ref]

Genitourinary

Frequency not reported: Hematuria, transient erectile dysfunction in male patients^[Ref]

Cardiovascular

Postmarketing reports: Vasculitis