FDA label 30c68860-c802-5dbb-e054-00144ff8d46c

WARNINGS AND PRECAUTIONS Cases of liver failure, some leading to liver transplant or death, have occurred with the use of terbinafine tablets in individuals with and without pre-existing liver disease. In the majority of liver cases reported in association with terbinafine use, the patients had serious underlying systemic conditions. The severity of hepatic events and/or their outcome may be worse in patients with active or chronic liver disease. Treatment with terbinafine tablets should be discontinued if biochemical or clinical evidence of liver injury develops. Terbinafine tablets are not recommended for patients with chronic or active liver disease. Before prescribing terbinafine tablets, pre-existing liver disease should be assessed. Hepatotoxicity may occur in patients with and without pre-existing liver disease. Patients prescribed terbinafine tablets should be warned to report immediately to their physician any symptoms of persistent nausea, anorexia, fatigue, vomiting, right upper abdominal pain or jaundice, dark urine or pale stools. Patients with these symptoms should discontinue taking oral terbinafine, and the patient’s liver function should be immediately evaluated. Taste disturbance, including taste loss, has been reported with the use of terbinafine tablets. It can be severe enough to result in decreased food intake, weight loss, and depressive symptoms. Taste disturbance may resolve within several weeks after discontinuation of treatment, but may be prolonged (greater than one year), or may be permanent. If symptoms of a taste disturbance occur, terbinafine tablets should be discontinued. Smell disturbance, including loss of smell, has been reported with the use of terbinafine tablets. Smell disturbance may resolve after discontinuation of treatment, but may be prolonged (greater than one year), or may be permanent. If symptoms of a smell disturbance occur, terbinafine tablets should be discontinued. Depressive symptoms have occurred during postmarketing use of terbinafine. Prescribers should be alert to depressive symptoms, and patients should be instructed to report depressive symptoms to their physician. Transient decreases in absolute lymphocyte counts (ALC) have been observed in controlled clinical trials. In placebo-controlled trials, 8/465 terbinafine-treated patients (1.7%) and 3/137 placebo-treated patients (2.2%) had decreases in ALC to below 1000/mm3 on two or more occasions. In patients with known or suspected immunodeficiency, physicians should consider monitoring complete blood counts if treatment continues for more than six weeks. Cases of severe neutropenia have been reported. These were reversible upon discontinuation of terbinafine, with or without supportive therapy. If clinical signs and symptoms suggestive of secondary infection occur, a complete blood count should be obtained. If the neutrophil count is <1,000 cells/mm3, terbinafine should be discontinued and supportive management started. There have been postmarketing reports of serious skin reactions (e.g., Stevens-Johnson Syndrome and toxic epidermal necrolysis). If progressive skin rash occurs, treatment with terbinafine tablets should be discontinued. During post-marketing experience, precipitation and exacerbation of cutaneous and systemic lupus erythematosus have been reported in patients taking terbinafine tablets. terbinafine tablets should be discontinued in patients with clinical signs and symptoms suggestive of lupus erythematosus. Measurement of serum transaminases (ALT and AST) is advised for all patients before taking terbinafine tablets.

ADVERSE REACTIONS Because clinical trials are conducted under widely varying conditions, adverse reaction rates in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The most frequently reported adverse events observed in the three US/Canadian placebo-controlled trials are listed in the table below. The adverse events reported encompass gastrointestinal symptoms (including diarrhea, dyspepsia, and abdominal pain), liver test abnormalities, rashes, urticaria, pruritus, and taste disturbances. Changes in the ocular lens and retina have been reported following the use of terbinafine tablets in controlled trials. The clinical significance of these changes is unknown. In general, the adverse events were mild, transient, and did not lead to discontinuation from study participation. The following adverse events have been identified during post-approval use of terbinafine. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Adverse events, based on worldwide experience with terbinafine tablets use, include: idiosyncratic and symptomatic hepatic injury and more rarely, cases of liver failure, some leading to death or liver transplant, serious skin reactions (e.g., Stevens-Johnson Syndrome and toxic epidermal necrolysis), severe neutropenia, thrombocytopenia, agranulocytosis, pancytopenia, anemia, angioedema, and allergic reactions (including anaphylaxis) [see Warnings and Precautions ( 5.1 , 5.5 , and 5.6 ) ]. Psoriasiform eruptions or exacerbation of psoriasis, acute generalized exanthematous pustulosis and precipitation and exacerbation of cutaneous and systemic lupus erythematosus have been reported in patients taking terbinafine [see Warnings and Precautions ( 5.7 ) ]. Cases of taste disturbance, including taste loss, have been reported with the use of terbinafine tablets. It can be severe enough to result in decreased food intake, weight loss, and depressive symptoms [see Warnings and Precautions ( 5.2 ) ]. Depressive symptoms independent of taste disturbance have been reported with use of terbinafine tablets. In some cases, depressive symptoms have been reported to subside with discontinuance of therapy and to recur with reinstitution of therapy [see Warnings and Precautions ( 5.4 ) ]. Cases of smell disturbance, including smell loss, have been reported with the use of terbinafine tablets [see Warnings and Precautions ( 5.3 ) ]. Other adverse reactions which have been reported include malaise, fatigue, vomiting, arthralgia, myalgia, rhabdomyolysis, reduced visual acuity, visual field defect, hair loss, serum sickness-like reaction, vasculitis, pancreatitis, influenza-like illness, pyrexia, increased blood creatine phosphokinase, photosensitivity reactions, tinnitus, hearing impairment and vertigo. Altered prothrombin time (prolongation and reduction) in patients concomitantly treated with warfarin has been reported. MM1