Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS Common (greater than 2% of patients treated with terbinafine tablets) reported adverse events include headache, diarrhea, rash, dyspepsia, liver enzyme abnormalities, pruritus, taste disturbance, nausea, abdominal pain, and flatulence.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Amici Pharma, Inc.
at 1-866-760-2646 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience 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 3 U.S./Canadian placebo-controlled trials are listed in the Table
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 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.
Most frequently reported adverse events observed in the 3 U.S./Canadian placebo-controlled trials * Liver enzyme abnormalities greater than or equal to 2 times the upper limit of normal range.
5 WARNINGS AND PRECAUTIONS Liver failure, sometimes leading to liver transplant or death, has occurred with the use of oral terbinafine.
Obtain pretreatment serum transaminases.
Prior to initiating treatment and periodically during therapy, assess liver function tests.
Discontinue terbinafine tablets if liver injury develops.
( 5.1 ) Taste disturbance, including taste loss, has been reported with the use of terbinafine tablets.
Like all medications, Terbinafine Hydrochloride can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: