Skip Navigation

DRUG RECORD

 

TERBINAFINE

OVERVIEW
Terbinafine

 

Introduction

Terbinafine is an orally and topically active allylamine fungicidal. It is used to treat superficial fungal infections of the skin and nails and has been clearly linked to rare instances of acute liver injury that can be severe and fatal.

 

Background

Terbinafine is a synthetic allylamine derivative that has potent activity against many dermatophytes that affect skin and nails, including Epidermophyton floccosum, Trichophyton mentagrophytes and Trichophyton rubrum. The antifungal activity of terbinafine is believed to be due to the selective inhibition of fungal squalene epoxidase, which increases squalene to toxic levels, thus killing the fungal cell. Terbinafine was approved for use in the United States in a topical form in 1992 and as an oral antifungal agent in 1998. Terbinafine is available over-the-counter as a 1% cream or spray for treatment of dermatophyte infections of the skin (tinea pedis, crurus or corporis). Oral terbinafine is available by prescription only in tablets of 250 mg under the brand name of Lamisal. Oral terbinafine is used in the therapy of onychomycosis or fungal infections of the fingernails or toenails (tinea unguium) typically in a dose of 250 mg once daily for 6 (fingernails) or 12 (toenails) weeks. The most common side effects of terbinafine include gastrointestinal disturbances, headache, change in taste and rash.

 

Hepatotoxicity

Drug-induced liver injury due to terbinafine was identified shortly after its introduction into medical use. Oral therapy with terbinafine is associated with elevations in serum aminotransferases in less than 1% of patients and the elevations are generally asymptomatic and resolve without stopping therapy. The estimated probability of developing elevated serum aminotransferase levels requiring stopping treatment is about 0.31% for 2-6 week treatment and 0.44% for treatment longer than 8 weeks. Symptomatic liver injury from terbinafine occurs rarely (1 in 50,000 to 120,000 prescriptions). Liver injury usually arises within the first 6 weeks of therapy. The pattern of injury can be either hepatocellular or cholestatic initially, but typically evolves into a cholestatic pattern. Signs of hypersensitivity (rash, fever, eosinophilia) are not common and when present are generally mild to moderate in severity. Autoantibody formation is rare. Severe acute hepatocellular injury with acute liver failure has been described as has prolonged cholestatic hepatitis with a vanishing bile duct syndrome. Terbinafine has also been implicated in cases of Stevens-Johnson syndrome.

 

Mechanism of Injury

The acute hepatotoxicity caused by terbinafine appears to be part of a hypersensitivity reaction although the mechanism has not been defined.

 

Outcome and Management

The majority of cases of acute hepatic injury from terbinafine resolve within 3 to 6 months of stopping the medication. In some instances, however, the injury is severe and unremitting, leading to acute liver failure and either death or need for liver transplantation. A severe outcome is more likely if terbinafine is continued after the appearance of symptoms and signs of liver injury. Terbinafine has also been implicated in several cases of acute bile duct injury followed by prolonged cholestasis associated with vanishing bile duct syndrome.

 

Drug Class:Antifungal Agents

Other drugs within this class: Amphotericin B, Echinocandins, Fluconazole , Flucytosine , Griseofulvin, Itraconazole, Ketoconazole, Nystatin, Posaconazole, Voriconazole

 

Top of page


CASE REPORT
Terbinafine

 

Case 1. Prolonged cholestasis due to terbinafine.
[Modified from: Fernandes NF, Geller SA, Fong TL. Terbinafine hepatotoxicity: case report and review of the literature. Am J Gastroenterol 1998; 93: 459-60. PubMed Citation]

 

A 24 year old man developed progressive loss of appetite, pruritus and jaundice within days of stopping a 3½ week course of terbinafine (250 mg daily) for onychomycosis of the toe nails. On initial evaluation one week later he was jaundiced and had excoriations. There was no fever, urticaria or rash. Laboratory tests showed serum bilirubin of 6.6 mg/dL and elevations in both ALT (584 U/L) and alkaline phosphatase (222 U/L). Tests for hepatitis A, B and C were negative, he did not drink alcohol to excess and he took no other medications. Ultrasound of the abdomen showed no evidence of biliary obstruction. A liver biopsy showed intrahepatic cholestasis and injury to small bile ducts; with reduction in the number of ducts. Despite having stopped terbinafine, his symptoms and laboratory test abnormalities worsened over the next few weeks. Pruritus was treated with antihistamines and cholestyramine. Six weeks after stopping terbinafine his symptoms began to improve and 16 weeks after stopping his liver tests were normal (Table).

 

Key Points

 

Medication:Terbinafine (250 mg daily)
Pattern: Hepatocellular→Cholestatic (R=7.5→1.1)
Severity: 3+ (Jaundice, hospitalization)
Latency: 24 Days to symptoms, 32 days to jaundice
Recovery:Complete recovery after 12 weeks
Other medications:None

 

Laboratory Values

 

Days After Starting Days After Stopping ALT* (U/L) Alk* P (U/L) Bilirubin* (mg/dL) Other
32 8 584 222 6.6
35 11 420 370 12.0
45 21 210 530 20.5
51 27 190 550 25.0
53 29 205 525 30.9
58 34 310 490 28.0
66 42 250 490 21.0
72 48 175 400 10.0
79 55 40 670 5.0
88 64 200 1.4
96 70 40 110 0.5
Normal Values <42 <120

*Values estimated from Figure 2.

 

Comment

This was a typical case of terbinafine hepatotoxicity arising within 4 weeks of starting therapy and worsening for several weeks thereafter despite the prompt discontinuation. The initial laboratory results suggested a hepatocellular pattern of injury, but by the time of peak bilirubin elevation the serum enzyme pattern was clearly cholestatic. The prominence of jaundice and pruritus also argued for a cholestatic injury. A liver biopsy showed evidence of injury to bile ducts and ductopenia, which was clearly severe enough to cause prolonged jaundice, but not severe enough to call persistence of cholestatic features and qualify as vanishing bile duct syndrome.

 

 

Case 2. Terbinafine induced cholestatic hepatitis.
[DILIN 103-0030]

 

A 43 year old man with history of diabetes and onychomycosis developed fatigue and flu-like symptoms one month after starting treatment with terbinafine 10 mg taken orally once daily. He developed severe itching one week later and stopped terbinafine after a total of 40 days. Several days later he complained of nausea, vomiting and became jaundiced. Laboratory investigations (Table 1) revealed bilirubin of 6.8 mg/dL, ALT 269 U/L and alkaline phosphatase 433 U/L. Tests for hepatitis A, B and C were negative as were autoantibodies. Imaging of the liver showed no evidence of extrahepatic obstruction. Intravenous prednisone was given in tapering doses over 4 weeks (60 mg, 40 mg, 20 mg, 10 mg for one week each) five days after stopping terbinafine. The itching and jaundice improved and he became asymptomatic a month after initial presentation. Liver test abnormalities resolved over the next several months.

 

Key Points

 

Medication:Terbinafine (10 mg daily)
Pattern: Mixed (R=3.7)
Severity: 3+ (Jaundice, hospitalization)
Latency: 34 Days
Recovery:Symptomatic improvements after 4 weeks
Other medications:Milrinone lactate

 

Laboratory Values

 

Days After Starting Days After Stopping ALT (U/L) Alk P (U/L) Bilirubin (mg/dL) Other
Pre Normal Normal Normal
0 Terbinafine started
34 Fatigue, flu-like illness
40 0 Terbinafine stopped Severe itching and dark urine
43 3 269 443 6.8 Nausea and vomiting
46 6 234 489 6.2 Prednisone started
47 7 269 508 9.1
50 10 686 667 11.3
57 17 775 625 6.4
74 34 99 232 2.1 Prednisone stopped
Normal Values <41 115 <1.2

Comment

Symptoms arose approximately 5 weeks after starting terbinabine and jaundice appeared by week 7. The symptoms (itching) suggested a cholestatic hepatitis although the initial enzyme elevations were “mixed”. While corticosteroids may improve itching and jaundice, they have not been shown to ameliorate or shorten the course of illness. The patient became asymptomatic after 4 weeks, but was lost to follow up. Follow up is important, as chronic cholestasis and vanishing bile duct syndrome has been associated with terbinafine hepatotoxicity.

 

Top of page


PRODUCT INFORMATION
Terbinafine

 

REPRESENTATIVE TRADE NAMES
Lamisil®

DRUG CLASS
Antifungal Agents

COMPLETE LABELING

FDA product labeling at DailyMed, National Library of Medicine, NIH

Top of page


 

DRUG CAS REGISTRY NUMBER MOLECULAR FORMULA STRUCTURE
Terbinafine 91161-71-6 C21-H25-N Image of Terbinafine Chemical Structure

Top of page


REFERENCES
Terbinafine

 

References updated: 25 April 2010

  1. Zimmerman HJ. Antifungal agents. In, Zimmerman HJ. Hepatotoxicity: the adverse effects of drugs and other chemicals on the liver. 2nd ed. Philadelphia: Lippincott, 1999, pp. 609-11.  (Expert review of hepatotoxicity of antifungal agents published in 1999; reports that terbinafine has been implicated in at least 10 cases of hepatic injury, usually mixed pattern of enzyme elevations and 1 case of possible vanishing bile duct syndrome).

  2. Mosely RH. Antibacterial and antifungal agents. In, Kaplowitz N, DeLeve LD, eds. Drug-induced liver disease. 2nd ed. New York: Informa Healthcare USA, 2007, pp. 527-46.  (Review of hepatotoxicity of antifungal agents published in 2007; reports several case reports of terbinafine hepatotoxicity, usually mixed enzyme pattern; latency of 4 to 6 weeks, can cause bile duct injury).

  3. Bennett JE. Antimicrobial agents: antifungal agents. In, Brunton LL, Lazo JS, Parker KL, eds. Goodman & Gilman’s the pharmacological basis of therapeutics. 11th ed. New York: McGraw-Hill, 2006, pp. 1225-41.  (Textbook of pharmacology and therapeutics; terbinafine is a synthetic allylamine, a prolonged half-life in serum and at least as effective as itraconazole for onychomycosis).

  4. Lowe G, Green C, Jennings P. Hepatitis associated with terbinafine treatment. BMJ 1993; 306: 248. PubMed Citation  (52 year old developed abdominal pain and jaundice 2 weeks after starting terbinafine with bilirubin 1.7 mg/dL, ALT 470 U/L and AlkP 193 U/L, resolving within a month of stopping).

  5. Hay RJ. Risk/benefit ratio of modern antifungal therapy: focus on hepatic reactions. J Am Acad Dermatol 1993; 29: S50-4. PubMed Citation  (Review article on hepatotoxicity of antifungal agents, griseofulvin, ketoconazole, fluconazole, itraconazole and terbinafine; does not recommend routine monitoring but stresses need to discontinue agent for hepatic injury with symptoms).

  6. van ‘t Wout JW, Herrmann WA, de Vries RA, Stricker BHC. Terbinafine-associated hepatic injury. J Hepatology 1994; 21: 1115-7. PubMed Citation  (Two cases of hepatitis due to terbinafine; 63 and 52 year olds with jaundice arising 38 and 31 days after starting terbinafine, with bilirubin 10.6 and 7.3 mg/dL, ALT 194 and 446 U/L, and Alk P 201 and 296 U/L, resolving slowly but completely by 12 weeks).

  7. Ihre-Lundgren C, Frisell J, Bergman U. [A patient treated with terbinafine. Intrahepatic biliary stasis is a severe adverse effect]. Lakartidningen 1995; 92: 1112-3. Swedish. PubMed Citation  (43 year old developed fatigue and jaundice 6 weeks after starting terbinafine with 10.9 mg/dL, ALT 312 U/L, Alk P 690 U/L worsening for 4 weeks, found to have intrahepatic gallstones, resolving over 12 weeks).

  8. Lazaros GA, Papatheodoridis GV, Delladetsima JK, Tassopoulos NC. Terbinafine-induced cholestatic liver disease. J Hepatol 1996; 24: 753-6. PubMed Citation  (58 year old developed jaundice 7 weeks after starting terbinafine and presented 18 days later with bilirubin 16.7 mg/dL, ALT 470 U/L, Alk P 934 U/L with slow resolution over the following 6 months).

  9. Boldewijn OY, Ottervanger JP, Mostart CM, Janssens AR, Calame J, Jonkers GJ. [Hepatitis attributed to the use of terbinafine]. Ned Tijdschr Geneeskd 1996; 140: 669-72. Dutch. PubMed Citation  (71 year old developed severe cholestasis [bilirubin 7.9 mg/dL, ALT 321 U/L] and pruritus that persisted for 10 months after stopping 6 week course of terbinafine).

  10. Vantaux P, Grasset D, Nougue J, Lagier E, Seigneuric C. [Acute hepatitis related to the ingestion of terbinafine]. Gastroenterol Clin Biol 1996; 20: 402-3. French. PubMed Citation  (68 year old developed malaise and fever with bilirubin 1.8 mg/dL, ALT 9x ULN, Alk P 4x ULN with rapid improvement and resolution within 1 month).

  11. Dwyer CM, White MI, Sinclair TS. Cholestatic jaundice due to terbinafine. Br J Dermatol 1997; 136: 976-7. PubMed Citation  (40 year old developed jaundice and pruritus 6 weeks after starting terbinafine with bilirubin 5.6 mg/dL, ALT 165 U/L, Alk P 256 U/L; resolution in 10 weeks).

  12. Mallat A, Zafrani ES, Metreau JM, Dhumeaux D. Terbinafine-induced prolonged cholestasis with reduction of interlobular bile ducts. Dig Dis Sci 1997; 42: 1486-8. PubMed Citation  (75 year old developed weakness followed by jaundice several days after completing a 3 week course of terbinafine with bilirubin 5.2 mg/dL, ALT 277 U/L, Alk P 375 U/L; bilirubin rose to 7.3 and pruritus persisted; biopsy at 6 months showed decrease in bile ducts; GGT still abnormal 17 months later).

  13. Shiloah E, Horowiz M, Zecler E. [Terbinafine-induced cholestatic liver injury]. Harefuah 1997; 133: 11-2, 80-1. Hebrew. PubMed Citation

  14. Tejada García M, Llvona Hevia AM, Martín Arias L, García-Pando AC. [Terbinafine and cholestatic hepatitis]. Med Clin(Barc) 1997; 109: 356. Spanish. PubMed Citation   (58 year old developed jaundice 40 days after starting terbinafine with bilirubin 13.3 mg/dL, ALT 136 U/L, Alk P 728 U/L, 6 months later, he was anicteric but still had aminotransferase elevations).

  15. Vivas S, Rodríguez M, Palacio MA, Cadenas F, Lomo J, Rodrigo L. [Acute hepatitis associated with terbinafine]. Gastroenterol Hepatol 1997; 20: 456-8. Spanish. PubMed Citation  (59 year old developed abdominal pain and dark urine 32 days after starting terbinafine, presenting 1 week later with bilirubin 13.3→37 mg/dL, ALT 136 U/L and Alk P 728→1258 U/L, with prolonged cholestasis requiring a year for full resolution: seems to be the same case as Tejada Garcia).

  16. Hall M, Monka C, Krupp P, O'Sullivan D. Safety of oral terbinafine: results of a postmarketing surveillance study in 25,884 patients. Arch Dermatol 1997; 133: 1213-9. PubMed Citation  (Results of prospective post-marketing surveillance in 25,884 patients treated with terbinafine average of 13 weeks; adverse events reported in 10.5%; largely gastrointestinal upset [4.9%] and dermatologic [2.3%]; hepatobiliary events in 55 patients [0.2%], 45 with asymptomatic ALT elevations, 5 with non-specific symptoms and 5 with jaundice).

  17. Abdel-Rahman SM, Nahata MC. Oral terbinafine: a new antifungal agent. Ann Pharmacother 1997; 31: 445-56. PubMed Citation  (Extensive review of clinical efficacy of terbinafine for superficial fungal infections; low rate of adverse events ~2% to 7%, asymptomatic ALT elevations in 0.5%, severe hepatitis in 1:120,000).

  18. Fernandes NF, Geller SA, Fong TL. Terbinafine hepatotoxicity: case report and review of the literature. Am J Gastroenterol 1998; 93: 459-60. PubMed Citation  (24 year old developed jaundice and pruritus 3.5 weeks after starting terbinafine with bilirubin 6.6→30.9 mg/dL, ALT 584 U/L, Alk P 222 U/L, biopsy showing bile duct injury and resolution after 3 months).

  19. Gupta AK, del Rosso JQ, Lynde CW, Brown GH, Shear NH. Hepatitis associated with terbinafine therapy: three case reports and a review of the literature. Clin Exp Dermatol 1998; 23: 64-7. PubMed Citation  (Three cases, ages 54, 42 and 74 years, presenting after 3, 4 and 4 weeks with jaundice, bilirubin 8.4, 5.3 and 10.5 mg/dL, ALT 407, 521 and 333 U/L, Alk P 273, 214 and 157 U/L, slow resolution and no or little follow up on two cases).

  20. Agarwal K, Manas DM, Hudson M. Terbinafine and fulminant hepatic failure. N Engl J Med 1999; 340: 1292-3. PubMed Citation  (48 year old developed acute liver failure after 5 days of terbinafine therapy ultimately requiring successful emergency liver transplantation).

  21. García Rodriguez L, Duque A, Castellsague J, Pérez-Gutthann S, Stricker B. A cohort study on the risk of acute liver injury among users of ketoconazole and other antifungal drugs. Br J Clin Pharmacol 1999; 48: 847-52. PubMed Citation  (Population-based study identified 5 cases of acute liver injury during antifungal therapy in 69,830 patients; relative risk for ketoconazole was 228 [~2;1,000 patients], itraconazole 17.7 [~1:10,000] and terbinafine 4.2 [~.2:10,000]).

  22. Chambers WM, Millar A, Jain S, Burroughs AK. Terbinafine-induced hepatic dysfunction. Eur J Gastroenterol Hepatol 2001; 13: 1115-8. PubMed Citation  (41 year old developed jaundice 4 weeks after starting terbinafine which worsened over next 3 to 6 weeks, bilirubin 7.0→33.2 mg/dL, AST 124→63 U/L, Alk P to 568 U/L progressing to prolonged jaundice [5 months], pruritus [10 months] and persistent Alk P elevations).

  23. Conjeevaram G, Vongthavaravat V, Sumner R, Koff RS. Terbinafine-induced hepatitis and pancytopenia. Dig Dis Sci 2001; 46: 1714-6. PubMed Citation  (63 year old with malaise, fever and pancytopenia after 4 weeks of terbinafine therapy which worsened over next 3 weeks, bilirubin 1.7→2.0 mg/dL, ALT 86→1073 U/L, Alk P94→597 U/L, resolution in ~6 weeks).

  24. Iverson SL, Uetrecht JP. Identification of a reactive metabolite of terbinafine: insights into terbinafine-induced hepatotoxicity. Chem Res Toxicol 2001; 14: 175-81. PubMed Citation  (Identified an N-dealkylation product of terbinafine which could bind to hepatobiliary proteins and induce an immune reaction).

  25. Johnstone D, Berger C, Fleckman P. Acute fulminant hepatitis after treatment with rabeprazole and terbinafine. Arch Intern Med 2001; 161: 1677-8. PubMed Citation  (46 year old developed jaundice 4 weeks after starting terbinafine, citalopram and rabepazole with bilirubin 1.2→5.2 mg/dL, ALT >3000 U/L, INR 1.8, mild encephalopathy and renal failure, but eventually recovered).

  26. Andrade RJ, Lucena MI. Acute fulminant hepatitis after treatment with rabeprazole and terbinafine: is rabeprazole the culprit? Arch Intern Med 2002; 162: 360-1. PubMed Citation  (Discuss the case presented by Johnstone et al. suggesting terbinafine was the culprit rather than rabeprazole).

  27. Severe liver damage on terbinafine. Prescrire Int 2002; 11: 16. PubMed Citation  (Mentions that FDA has reported 16 cases of severe liver damage due to terbinafine, including 11 deaths and 2 liver transplants).

  28. Anania FA, Rabin L. Terbinafine hepatotoxicity resulting in chronic biliary ductopenia and portal fibrosis. Am J Med 2002; 112: 741-2. PubMed Citation  (56 year old with jaundice after a short course of terbinafine and developed persistent pruritus and Alk P elevations [550 U/L], liver biopsy 20 months later showing paucity of bile ducts).

  29. Walter RB, Lukaschek J, Renner EL, Müllhaupt B, Bachli EB. Fatal hepatic veno-occlusive disease associated with terbinafine in a liver transplant recipient. J Hepatol 2003; 38: 373-4. PubMed Citation  (35 year old with familial amyloid polyneuropathy and liver transplant developed jaundice 6 weeks after starting terbinafine with ALT 491 U/L, Alk P 1128 U/L and bilirubin 8.9 mg/dL with severe pruritus and ascites and progressive central vein sclerosis and death from gastrointestinal bleeding).

  30. Zapata Garrido AJ, Romo AC, Padilla FB. Terbinafine hepatotoxicity. A case report and review of the literature. Ann Hepatol 2003; 2: 47-51. PubMed Citation  (53 year old developed jaundice and abdominal pain 7 days after starting terbinafine with bilirubin 5.8→23mg/dL, ALT 1272 U/L, Alk P 154 U/L, worsening for 4 weeks and then resolving over the next 4 months).

  31. Ajit C, Suvannasankha A, Zaeri N, Munoz SJ. Terbinafine-associated hepatotoxicity. Am J Med Sci 2003; 325: 292-5. PubMed Citation  (65 year old developed fatigue and jaundice 4 weeks after starting terbinafine with bilirubin 21.0 mg/dL, ALT 179 U/L and Alk P 1040 U/L, slow recovery, biopsy showing bile duct injury; corticosteroids started and improved but not normal after 4 months).

  32. Burstein Z, Vildosola H, Lozano Z, Verona R, Vargas G. Colestasic toxic hepatitis caused by terbinafine: case report. Rev Gastroenterol Peru 2004; 24: 357-62. Spanish. PubMed Citation  (31 year old developed jaundice 40 days after starting terbinafine with bilirubin 3.2 mg/dL, ALT 244 U/L, Alk P 334 U/L, resolving over next 3 months).

  33. Wingfield AB, Fernandez-Obregon AC, Wignall FS, Greer DL. Treatment of tinea imbricate: a randomized clinical trial using griseofulvin, terbinafine, itraconazole and fluconazole. Br J Dermatol 2004; 150: 119-26. PubMed Citation  (Randomized trial of four antifungals for 4 weeks for tinea imbricate in 86 patients in New Guinea; griseofulvin and terbinafine were effective; itraconazole and fluconazole were not; only one patient had ALT elevation [3 fold: terbinafine]).

  34. Nakano N, Hiruma M, Shiraki Y, Chen X, Porgpermdee S, Ikeda S. Combination of pulse therapy with terbinafine tablets and topical terbinafine cream for the treatment of dermatophyte onychomycosis: a pilot study. J Dermatol 2006; 33: 753-8. PubMed Citation  (Trial of pulse therapy with terbinafine in 66 patients [one week every month] found high rate of response and “no abnormal findings in the laboratory tests performed before, during or after pulse therapy”).

  35. Song J, Deresinski S. Hepatotoxicity of antifungal agents. Curr Opin Investig Drugs 2005; 6: 170-7. PubMed Citation  (Extensive review of hepatotoxicity from antifungals; terbinafine reported to cause ALT elevations in 4% of patients; several cases of clinically apparent hepatitis and acute liver failure have been described; typically arising within 4-6 weeks and requiring 3-6 months to resolve; 16 cases of hepatotoxicity reported to FDA, including 11 deaths and 2 liver transplants).

  36. Paredes AH, Lewis JH. Terbinafine-induced acute autoimmune hepatitis in the setting of hepatitis B virus infection. Ann Pharmacother 2007; 41: 880-4. PubMed Citation  (57 year old HBsAg carrier who developed severe acute hepatitis after 12 weeks of terbinafine therapy with ALT 1044 U/L, Alk P 167 U/L, bilirubin 11.0 mg/dL and rise in HBV DNA, suggestive of HBV reactivation rather than terbinafine hepatotoxicity per se).

  37. Kim B, Jang H, Jwa S, Jang B, Kim M, Oh C, Kwon Y, et al. Generalized pustular psoriasis and hepatic dysfunction associated with oral terbinafine therapy. J Korean Med Sci 2007; 22: 167-9. PubMed Citation  (61 year old with psoriasis developed generalized pustular psoriasis 4 days after starting terbinafine with fever, rash, increased white count and neutrophils, ALT 376 U/L, Alk P 564 U/L but no jaundice, responding to corticosteroids within 2 weeks).

  38. Gendre G, Buclin T, Morard I, Fontannaz J, Berney JL. [Terbinafine induced hepatitis with persistent cholestasis]. Rev Med Suisse 2008; 4: 736-9. French. PubMed Citation  (55 year old developed jaundice 6 weeks after starting terbinafine with bilirubin 11.9 mg/dL, ALT 57 U/L and Alk P 590 U/L, jaundice persisting for 3 months and Alk P elevations continuing for more than 6 months; biopsy showing vanishing bile duct syndrome).

  39. Chang CH, Young-Xu Y, Kurth T, Orav JE, Chan AK. The safety of oral antifungal treatments for superficial dermatophytosis and onychomycosis: a meta-analysis. Am J Med 2007; 120: 791-8">PubMed Citation  (The pooled probability of stopping terbinafine because of elevated ALT/AST is 0.31% [95% CI, 0%-0.74%] for 2 to 6 weeks and 0.44% [95% CI, 0.13%-0.76%] for 8 to 48 weeks).

  40. Perveze Z, Johnson MW, Rubin RA, Sellers M, Zayas C, Jones JL, Cross R, et al. Terbinafine-induced hepatic failure requiring liver transplantation. Liver Transpl 2007; 13: 162-4. PubMed Citation  (50 year old developed jaundice during 3 months of terbinafine therapy, then presenting with bilirubin 29→67.7 mg/dL, ALT 149→225 U/L, Alk P 497→584 U/L, progressive hepatic failure leading to liver transplantation, explant showed severe cholestasis and paucity of bile ducts).

  41. Elewski BE, Cáceres HW, DeLeon L, El Shimy S, Hunter JA, Korotkiy N, Rachesky IJ, et al. Terbinafine hydrochloride oral granules versus oral griseofulvin suspension in children with tinea capitis: results of two randomized, investigator-blinded, multicenter, international, controlled trials. J Am Acad Dermatol 2008; 59: 41-54. PubMed Citation  (Pooled analysis of two controlled trials of 6 weeks of terbinafine vs griseofulvin in 1549 children with tinea capitis; no difference in biochemical laboratory results between two groups; low rate of discontinuation because of abnormal liver tests [<1%]).

 

top of page

 


OTHER REFERENCE LINKS
Terbinafine

 

  1. PubMed logoRecent References on Terbinafine

  2. Clinical Trials logoTrials on Terbinafine

top of page