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 The following adverse reactions are discussed in other sections of the labeling: Severe Acute Exacerbations of Hepatitis B in Patients Coinfected with HIV-1 and HBV [see Warnings and Precautions (5.1) ] .
Rash [see Warnings and Precautions (5.2) ].
Hepatotoxicity [see Warnings and Precautions (5.3) ].
Psychiatric Symptoms [see Warnings and Precautions (5.5) ].
Nervous System Symptoms [see Warnings and Precautions (5.6) ].
New Onset or Worsening Renal Impairment [see Warnings and Precautions (5.7) ].
Embryo-Fetal Toxicity [see Warnings and Precautions (5.8) ].
Bone Loss and Mineralization Defects [see Warnings and Precautions (5.9) ].
Convulsions [see Warnings and Precautions (5.10) ].
Lactic Acidosis/Severe Hepatomegaly with Steatosis [see Warnings and Precautions (5.11) ].
5 WARNINGS AND PRECAUTIONS Rash: Discontinue if severe rash develops.
( 5.2 , 6.1 ) Hepatotoxicity: Monitor liver function tests before and during treatment in patients with underlying hepatic disease, including hepatitis B or C coinfection, marked transaminase elevations, or who are taking medications associated with liver toxicity.
Among reported cases of hepatic failure, a few occurred in patients with no pre-existing hepatic disease.
( 5.3 , 6.2 , 8.7 ) Risk of adverse reactions or loss of virologic response due to drug interactions: Consult full prescribing information prior to and during treatment for important potential drug interactions.
Consider alternatives to efavirenz, emtricitabine and tenofovir disoproxil fumarate in patients taking other medications with a known risk of Torsade de Pointes or in patients at higher risk of Torsade de Pointes.
Like all medications, Efavirenz, Emtricitabine And Tenofovir Disoproxil Fumarate 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: