Truvada Side Effects

Please note - some side effects for Truvada may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Truvada - for the Consumer

Truvada

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Truvada:

Abnormal skin sensations; back pain; changes in body fat (eg, increased fat in the upper back and stomach areas, decreased fat in the face, arms, and legs); cough; diarrhea; dizziness; gas; headache; indigestion; lightening of the skin color on the palms of hands or soles of feet; loss of appetite; nausea; sinus drainage; skin discoloration (small spots or freckles); sleeplessness; strange dreams; sweating; vomiting; weakness; weight loss.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bone pain; chest pain; chills; dark urine; decreased urination or difficulty urinating; dizziness; extreme weakness or tiredness; fast or irregular heartbeat; feeling cold, especially in the arms and legs; fever; increased thirst; increased urination; light-colored bowel movements (stools); lightheadedness; mental or mood changes (eg, depression); not feeling like eating for several days; numbness, burning, pain, or tingling in the hands or feet; shortness of breath; severe or persistent dizziness; sore throat; stomach pain with nausea and vomiting; unusual muscle pain; unusual tiredness; yellowing of the skin or eyes.

Truvada Side Effects - for the Professional

Truvada

Most common adverse reactions (incidence ≥10%) are diarrhea, nausea, fatigue, headache, dizziness, depression, insomnia, abnormal dreams, and rash. (6)

To report SUSPECTED ADVERSE REACTIONS, contact Gilead Sciences, Inc. at 1-800-GILEAD-5 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

Side Effects by Body System

General

Side effects have been reported for emtricitabine and/or tenofovir when taken in combination with other antiretroviral agents.

Gastrointestinal

Gastrointestinal side effects associated with emtricitabine and/or tenofovir have included diarrhea (7%), nausea (8%), and vomiting (1%). Abdominal pain and dyspepsia occurred in at least 5% of patients in clinical trials of emtricitabine or tenofovir with other antiretroviral drugs. Flatulence has also been reported. Pancreatitis and increased amylase have been reported during postmarketing experience with tenofovir.

Hepatic

Hepatic side effects associated with emtricitabine and/or tenofovir have included elevated AST (greater than 180 units/L in males and 170 units/L in females; 3%), ALT (greater than 215 units/L in males and 170 units/L in females; 2%), and bilirubin (greater than 2.5 times ULN; up to 3%). Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside/nucleotide analogs, including tenofovir, in combination with other antiretroviral agents. Hepatic steatosis, hepatitis, and increased liver enzymes (primarily AST, ALT, and gamma glutamyl transferase) have been reported during postmarketing experience with tenofovir. Severe acute exacerbations of hepatitis have been reported in patients with hepatitis B after discontinuation of tenofovir.

Metabolic

Metabolic side effects associated with emtricitabine and/or tenofovir have included hyperglycemia (greater than 250 mg/dL; 1%), increased urine glucose (3+ or greater; up to 3%), fasting triglycerides (greater than 750 mg/dL; 4%), fasting cholesterol (greater than 240 mg/dL; 15%), creatine kinase (greater than 990 units/L in males and 845 units/L in females; 7%), serum amylase (greater than 175 units/L; 7%), alkaline phosphatase (greater than 550 units/L; 1%), pancreatic amylase (greater than 2 times ULN; up to 3%), and serum lipase (greater than 2 times ULN; up to 3%), altered serum glucose (less than 40 mg/dL or greater than 250 mg/dL; up to 3%), weight loss, and lactic acidosis. Hypokalemia and hypophosphatemia have been reported during postmarketing experience with tenofovir.

Musculoskeletal

Musculoskeletal side effects have included myalgia and arthralgia in at least 5% of patients in clinical trials of emtricitabine or tenofovir with other antiretroviral drugs. Decreased bone mineral density and increased biochemical markers of bone metabolism have been reported with tenofovir. Rhabdomyolysis, osteomalacia (manifested as bone pain and which may contribute to fractures), muscular weakness, and myopathy have been reported during postmarketing experience with tenofovir.

Nervous system

Nervous system side effects associated with emtricitabine and/or tenofovir have included dizziness (8%), headache (5%), insomnia (4%), and somnolence (3%). Anxiety, peripheral neuropathy (including neuropathy and peripheral neuritis), and paresthesia occurred in at least 5% of patients in clinical trials of emtricitabine or tenofovir with other antiretroviral drugs.

Other

Other side effects associated with emtricitabine and/or tenofovir have included fatigue (7%). Asthenia, pain, back pain, and fever occurred in at least 5% of patients in clinical trials of emtricitabine or tenofovir with other antiretroviral drugs.

Dermatologic

Dermatologic side effects have included rash event (including rash, maculopapular rash, pruritus, urticaria, vesiculobullous rash, pustular rash, exfoliative rash, generalized rash, macular rash, pruritic rash, vesicular rash, and allergic reaction) in at least 5% of patients in clinical trials of emtricitabine or tenofovir with other antiretroviral drugs. Skin discoloration (palmar-plantar hyperpigmentation) has also been reported with emtricitabine.

Psychiatric

Psychiatric side effects associated with emtricitabine and/or tenofovir have included abnormal dreams (4%) and depression (4%).

Respiratory

Respiratory side effects associated with emtricitabine and/or tenofovir have included sinusitis (4%), upper respiratory tract infections (3%), and nasopharyngitis (3%). Increased cough, pneumonia, and rhinitis occurred in at least 5% of patients in clinical trials of emtricitabine or tenofovir with other antiretroviral drugs. Dyspnea has been reported during postmarketing experience with tenofovir.

Hematologic

Hematologic side effects associated with emtricitabine and/or tenofovir have included decreased neutrophil counts (less than 750/mm3; 3%).

Renal

Renal side effects have included new onset or worsening renal impairment with tenofovir. Renal insufficiency, renal failure, acute renal failure, Fanconi syndrome, proximal tubulopathy, increased creatinine, nephrogenic diabetes insipidus, acute tubular necrosis, and interstitial nephritis (including acute cases) have been reported during postmarketing experience with tenofovir.

Genitourinary

Genitourinary side effects associated with emtricitabine and/or tenofovir have included hematuria (greater than 75 RBC/HPF; 2%) and glycosuria (3 plus or greater; less than 1%). Proteinuria and polyuria have been reported during postmarketing experience with tenofovir.

Hypersensitivity

Hypersensitivity side effects have been reported with both emtricitabine and tenofovir. Allergic reaction has been reported during postmarketing experience with tenofovir.

Endocrine

Endocrine side effects associated with tenofovir have included sweating.

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