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: Exacerbations of Hepatitis B [see Boxed Warning , Warnings and Precautions (5.1 ) ] .
Lactic Acidosis/Severe Hepatomegaly with Steatosis [see Warnings and Precautions (5.2) ] .
New Onset or Worsening Renal Impairment [see Warnings and Precautions (5.4) ] .
Psychiatric Symptoms [see Warnings and Precautions (5.5) ] .
Nervous System Symptoms [see Warnings and Precautions (5.6) ] .
Skin and Systemic Hypersensitivity Reaction [see Warnings and Precautions (5.8) ] .
Hepatotoxicity [see Warnings and Precautions (5.9) ].
Pancreatitis [see Warnings and Precautions (5.10) ] .
Bone Loss and Mineralization Effects [see Warnings and Precautions (5.13) ] .
Immune Reconstitution Syndrome [see Warnings and Precautions (5.14) ] .
5 WARNINGS AND PRECAUTIONS Lactic Acidosis/Severe Hepatomegaly with Steatosis: Discontinue treatment in patients who develop symptoms or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity.
( 5.2 ) New Onset or Worsening Renal Impairment: Can include acute renal failure and Fanconi syndrome.
Avoid administering efavirenz, lamivudine and tenofovir disoproxil fumarate tablets with concurrent or recent use of nephrotoxic drugs.
( 5.4 ) Serious Psychiatric Symptoms: Immediate medical evaluation is recommended for serious psychiatric symptoms such as severe depression or suicidal ideation.
( 5.5 ) Nervous System Symptoms (NSS): NSS are frequent, usually begin 1 to 2 days after initiating therapy and resolve in 2 to 4 weeks.
Like all medications, Efavirenz, Lamivudine 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: