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) ] .
• Skin and Hypersensitivity Reactions [see Warnings and Precautions (5.2) ] .
• Hepatotoxicity [see Warnings and Precautions (5.3) ] .
• Depressive Disorders [see Warnings and Precautions (5.4) ] .
• New Onset or Worsening Renal Impairment [see Warnings and Precautions (5.5) ] .
• Bone Loss and Mineralization Defects [see Warnings and Precautions (5.6) ] .
• Lactic Acidosis/Severe Hepatomegaly with Steatosis [see Warnings and Precautions (5.8) ] .
• Immune Reconstitution Syndrome [see Warnings and Precautions (5.9) ] .
• Most common adverse reactions to rilpivirine (incidence greater than or equal to 2%, Grades 2–4) are depressive disorders, insomnia, and headache.
( 6.1 ) • Most common adverse reactions to emtricitabine and tenofovir disoproxil fumarate (incidence greater than or equal to 10%) are diarrhea, nausea, fatigue, headache, dizziness, depression, insomnia, abnormal dreams, and rash.
5 WARNINGS AND PRECAUTIONS • Skin and Hypersensitivity Reactions: Severe skin and hypersensitivity reactions have been reported during postmarketing experience, including cases of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS).
Immediately discontinue treatment if hypersensitivity or rash with systemic symptoms or elevations in hepatic serum biochemistries develops and closely monitor clinical status, including hepatic serum biochemistries.
( 5.2 ) • Hepatotoxicity: Hepatic adverse events have been reported in patients receiving a rilpivirine-containing regimen.
Monitor liver-associated tests before and during treatment with emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets in patients with underlying hepatic disease or marked elevations in liver-associated tests.
Also consider monitoring liver-associated tests in patients without risk factors.
Like all medications, Emtricitabine, Rilpivirine, 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: