Lamisil Side Effects

Generic Name: terbinafine

Note: This page contains information about the side effects of terbinafine. Some of the dosage forms included on this document may not apply to the brand name Lamisil.

Not all side effects for Lamisil may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to terbinafine: oral packet, oral tablet

In addition to its needed effects, some unwanted effects may be caused by terbinafine (the active ingredient contained in Lamisil). In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when 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
  • shortness of breath or troubled breathing
  • 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
  • wheezing

Some of the side effects that can occur with terbinafine may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common
  • Stomach pain (mild)
  • stuffy nose
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, terbinafine (the active ingredient contained in Lamisil) 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.[Ref]

Nervous system

Very common (10% or more): Headache (12.9%)
Frequency not reported: Dizziness, insomnia
Postmarketing reports: Taste disturbance (including taste loss; some cases severe enough to cause decreased food intake, weight loss, anxiety, depressive symptoms), smell disturbance (including loss of smell), paresthesia, hypoesthesia, tinnitus, hearing impairment, vertigo[Ref]

Gastrointestinal

Common (1% to 10%): Diarrhea (5.6%), dyspepsia (4.3%), taste disturbance (2.8%), nausea (2.6%), abdominal pain (2.4%), flatulence (2.2%)
Rare (less than 0.1%): Severe sialadenitis (at least 1 case)
Frequency not reported: 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, metallic taste
Postmarketing reports: Vomiting, pancreatitis[Ref]

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.[Ref]

Dermatologic

Common (1% to 10%): Rash (5.6%), pruritus (2.8%), urticaria (1.1%)
Rare (less than 0.1%): Reversible alopecia areata of the scalp, pustular psoriasis, acrodermatitis continua of Hallopeau (at least 1 case)
Frequency not reported: Erythema multiforme
Postmarketing reports: Serious skin reactions (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, exfoliative dermatitis, bullous dermatitis, drug reaction with eosinophilia and systemic symptoms [DRESS] syndrome), psoriasiform eruptions or exacerbation of psoriasis, acute generalized exanthematous pustulosis, hair loss, photosensitivity reactions, precipitation and exacerbation of cutaneous and systemic lupus erythematosus[Ref]

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.[Ref]

Hepatic

A 57-year-old male with chronic hepatitis B virus (HBV) infection developed terbinafine-induced acute autoimmune hepatitis coincident with terbinafine (the active ingredient contained in Lamisil) 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.[Ref]

Common (1% to 10%): Liver enzyme abnormalities (2 times ULN or greater; 3.3%)
Rare (less than 0.1%): Terbinafine-induced autoimmune hepatitis (at least 1 case)
Frequency not reported: Transient elevations in serum liver enzymes, development of idiosyncratic and symptomatic hepatobiliary dysfunction
Postmarketing reports: Idiosyncratic and symptomatic hepatic injury, cases of liver failure (some leading to death or liver transplantation), hepatitis, cholestasis, increased hepatic enzymes[Ref]

Hematologic

Frequency not reported: Leukopenia, lymphopenia
Postmarketing reports: Pancytopenia, anemia, thrombocytopenia, agranulocytosis, severe neutropenia, altered prothrombin time (prolonged and reduced) with concomitant warfarin[Ref]

Ocular

Common (1% to 10%): Visual disturbance (1.1%)
Frequency not reported: Changes in ocular lens and retina, dyschromatopsia, photopsia
Postmarketing reports: Reduced visual acuity, visual field defect[Ref]

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]

Metabolic

Frequency not reported: Hypoglycemia, hypotriglyceridemia[Ref]

Renal

Rare (less than 0.1%): Renal function test impairment[Ref]

Genitourinary

Rare (less than 0.1%): Hematuria, transient erectile dysfunction in male patients (extremely rare)[Ref]

Hypersensitivity

Rare (less than 0.1%): Anaphylaxis, hypersensitivity reactions
Postmarketing reports: Serious hypersensitivity reactions (e.g., angioedema, allergic reactions [including anaphylaxis]), serum sickness-like reaction[Ref]

Musculoskeletal

Postmarketing reports: Arthralgia, myalgia, rhabdomyolysis, increased blood creatine phosphokinase[Ref]

Cardiovascular

Postmarketing reports: Vasculitis

Other

Postmarketing reports: Malaise, fatigue, influenza-like illness, pyrexia

Psychiatric

Postmarketing reports: Anxiety (independent of taste disturbance), depressive symptoms (independent of taste disturbance)

References

1. "Product Information. Lamisil (terbinafine)." Sandoz Pharmaceuticals Corporation, East Hanover, NJ.

2. Villars VV, Jones TC "Special features of the clinical use of oral terbinafine in the treatment of fungal diseases." Br J Dermatol 126(suppl (1992): 61-9

3. Shear NH, Gupta AK "Terbinafine for the treatment of pedal onychomycosis: a foot closer to the promised land of cured nails?" Arch Dermatol 131 (1995): 937-42

4. Amichai B, Grunwald MH "Adverse drug reactions of the new oral antifungal agents - terbinafine, fluconazole, and itraconazole." Int J Dermatol 37 (1998): 410-5

5. del Palacio Hernandez A, Lopez Gomez S, Gonzalez Lastra F, Moreno Palancar P, Iglesias Diez L "A comparative double-blind study of terbinafine (Lamisil) and griseofulvin in tinea corporis and tinea cruris." Clin Exp Dermatol 15 (1990): 210-6

6. Ottervanger JP, Stricker BH "Loss of taste and terbinafine." Lancet 340 (1992): 728

7. Beutler M, Hartmann K, Kuhn M, Gartmann J "Taste disorders and terbinafine." BMJ 307 (1993): 26

8. Abecassis S, Roujeau JC, Bocquet H, et al. "Severe sialadenitis: a new complication of drug reaction with eosinophilia and systemic symptoms." J Am Acad Dermatol 51 (2004): 827-30

9. Stricker BHC, Vanriemsdijk MM, Sturkenboom MCJM, Ottervanger JP "Taste loss to terbinafine: a case-control study of potential risk factors." Br J Clin Pharmacol 42 (1996): 313-8

10. Juhlin L "Loss of taste and terbinafine." Lancet 339 (1992): 1483

11. Balfour JA, Faulds D "Terbinafine. A review of its pharmacodynamic and pharmacokinetic properties, and therapeutic potential in superficial mycoses [published erratum appears in Drugs 1992 May;43(5):699]." Drugs 43 (1992): 259-84

12. Wilson NJE, Evans S "Severe pustular psoriasis provoked by oral terbinafine." Br J Dermatol 139 (1998): 168

13. Carstens J, Wendelboe P, Sogaard H, Thestrup-Pedersen K "Toxic epidermal necrolysis and erythema multiforme following therapy with terbinafine." Acta Derm Venereol 74 (1994): 391-2

14. Bennett ML, Jorizzo JL, White WL "Generalized pustular eruptions associated with oral terbinafine." Int J Dermatol 38 (1999): 596-600

15. Bonsmann G, Schiller M, Luger TA, Stander S "Terbinafine-induced subacute cutaneous lupus erythematosus." J Am Acad Dermatol 44 (2001): 925-31

16. Condon CA, Downs AMR, Archer CB "Terbinafine-induced acute generalized exanthematous pustulosis." Br J Cancer 138 (1998): 709-10

17. Verros CD, Rallis E "The role of terbinafine in induction and/or exacerbation of psoriasis." Int J Dermatol 52 (2012): 1155-6

18. Rzany B, Mockenhaupt M, Gehring W, Schopf E "Stevens-Johnson syndrome after terbinafine therapy." J Am Acad Dermatol 30 (1994): 509

19. Nishiwaki F, Matsumura Y, Morita N, Kore-Eda S, Miyachi Y, Omoto M "Acrodermatitis continua of Hallopeau due to oral terbinafine." Br J Dermatol 157 (2007): 1073-4

20. Wach F, Stolz W, Hein R, Landthaler M "Severe erythema anulare centrifugum-like psoriatic drug eruption induced by terbinafine." Arch Dermatol 131 (1995): 960-1

21. Papa CA, Miller OF "Pustular psoriasiform eruption with leukocytosis associated with terbinafine." J Am Acad Dermatol 39 (1998): 115-7

22. Todd P, Halpern S, Munro DD "Oral terbinafine and erythema multiforme." Clin Exp Dermatol 20 (1995): 247-8

23. Lazaros GA, Papatheodoridis GV, Delladetsima JK, Tassopoulos NC "Terbinafine-induced cholestatic liver disease." J Hepatol 24 (1996): 753-6

24. Fernandes NF, Geller SA, Fong TL "Terbinafine hepatotoxicity: Case report and review of the literature." Am J Gastroenterol 93 (1998): 459-60

25. "Itracanazole, terbinafine possibly linked to liver failure." Am J Health Syst Pharm 58 (2001): 1076

26. Paredes AH, Lewis JH "Terbinafine-induced acute autoimmune hepatitis in the setting of hepatitis B virus infection." Ann Pharmacother 41 (2007): 880-4

27. Gupta AK, DelRosso JQ, Lynde CW, Brown GH, Shear NH "Hepatitis associated with terbinafine therapy: three case reports and a review of the literature." Clin Exp Dermatol 23 (1998): 64-7

28. Lowe G, Green C, Jennings P "Hepatitis associated with terbinafine treatment." BMJ 306 (1993): 248

29. Gupta AK, Soori GS, DelRosso JQ, Bartos PB, Shear NH "Severe neutropenia associated with oral terbinafine therapy." J Am Acad Dermatol 38 (1998): 765-7

30. Shapiro M, Li LJ, Miller J "Terbinafine-induced neutropenia." Br J Dermatol 140 (1999): 1196-7

31. Kovacs MJ, Alshammari S, Guenther L, Bourcier M "Neutropenia and pancytopenia associated with oral terbinafine." J Am Acad Dermatol 31 (1994): 806

32. Grunwald MH, Amichai B "Thrombocytopenia associated with oral terbinafine." Int J Dermatol 37 (1998): 634

33. Gupta AK, Gonder JR, Shear NH, Dilworth GR "The development of green vision in association with terbinafine therapy." Arch Dermatol 132 (1996): 845-6

34. Hull PR, Vismer HF "Treatment of cutaneous sporotrichosis with terbinafine." Br J Dermatol 126 Suppl (1992): 51-5

35. Rossetti G, Livio F, Roulet E, Hofer MF "Anaphylactic reaction and unrelated, subsequent, known side effects during therapy with thiethylperazine." Pediatr Allergy Immunol 16 (2005): 453-5

36. Beltraminelli HS, Lerch M, Arnold A, Bircher AJ, Haeusermann P "Acute generalized exanthematous pustulosis induced by the antifungal terbinafine: case report and review of the literature." Br J Dermatol 152 (2005): 780-3

37. Gupta AK, Kopstein JB, Shear NH "Hypersensitivity reaction to terbinafine." J Am Acad Dermatol 36 (1997): 1018-9

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