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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.

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; cough; darkened skin color on the palms of hands or soles of feet; diarrhea; dizziness; gas; headache; indigestion; joint pain; loss of appetite; nausea; sinus drainage; skin discoloration (small spots or freckles); strange dreams; sweating; tiredness; trouble sleeping; vomiting; weakness; weight loss.

Seek medical attention right away if any of these SEVERE side effects occur when using Truvada:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); bone pain; chest pain; fever; mental or mood changes (eg, depression); muscle pain or weakness; numbness, burning, pain, or tingling in the hands or feet; severe or persistent dizziness; severe or persistent nausea or vomiting; shortness of breath; stomach pain; symptoms of kidney problems (eg, increased or decreased urination, increased thirst); symptoms of lactic acidosis (eg, unusual weakness or tiredness; unusual muscle pain; fast or difficult breathing; stomach pain with nausea and vomiting; feeling cold, especially in the arms and legs; dizziness or light-headedness; fast or irregular heartbeat); symptoms of liver problems (eg, yellowing of the skin or eyes; dark urine; pale stools; persistent loss of appetite).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Truvada Side Effects - for the Professional

Truvada

The following adverse reactions are discussed in other sections of the labeling:

Adverse Reactions from Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed 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.

Clinical Trials in Adult Subjects

The most common adverse reactions (incidence greater than or equal to 10%, any severity) occurring in Study 934, an active-controlled clinical trial of efavirenz, emtricitabine, and tenofovir disoproxil fumarate, include diarrhea, nausea, fatigue, headache, dizziness, depression, insomnia, abnormal dreams, and rash. See also Table 2 for the frequency of treatment-emergent adverse reactions (Grade 2–4) occurring in greater than or equal to 5% of subjects treated with efavirenz, emtricitabine, and tenofovir disoproxil fumarate in this trial.

Skin discoloration, manifested by hyperpigmentation on the palms and/or soles was generally mild and asymptomatic. The mechanism and clinical significance are unknown.

Study 934 - Treatment Emergent Adverse Reactions: In Study 934, 511 antiretroviral-naive subjects received either VIREAD + EMTRIVA administered in combination with efavirenz (N=257) or zidovudine/lamivudine administered in combination with efavirenz (N=254). Adverse reactions observed in this trial were generally consistent with those seen in other trials in treatment-experienced or treatment-naive subjects receiving VIREAD and/or EMTRIVA (Table 2).

Table 2 Selected Treatment-Emergent Adverse Reactions* (Grades 2–4) Reported in ≥5% in Any Treatment Group in Study 934 (0–144 Weeks)
FTC + TDF + EFV† AZT/3TC + EFV
N=257 N=254
*
Frequencies of adverse reactions are based on all treatment-emergent adverse events, regardless of relationship to study drug.
†
From Weeks 96 to 144 of the trial, subjects received Truvada with efavirenz in place of VIREAD + EMTRIVA with efavirenz.
‡
Rash event includes rash, exfoliative rash, rash generalized, rash macular, rash maculo-papular, rash pruritic, and rash vesicular.
Gastrointestinal Disorder
  Diarrhea 9% 5%
  Nausea 9% 7%
  Vomiting 2% 5%
General Disorders and Administration Site Condition
  Fatigue 9% 8%
Infections and Infestations
  Sinusitis 8% 4%
  Upper respiratory tract infections 8% 5%
  Nasopharyngitis 5% 3%
Nervous System Disorders
  Headache 6% 5%
  Dizziness 8% 7%
Psychiatric Disorders
  Depression 9% 7%
  Insomnia 5% 7%
Skin and Subcutaneous Tissue Disorders
  Rash event‡ 7% 9%

Laboratory Abnormalities: Laboratory abnormalities observed in this trial were generally consistent with those seen in other trials of VIREAD and/or EMTRIVA (Table 3).

Table 3 Significant Laboratory Abnormalities Reported in ≥1% of Subjects in Any Treatment Group in Study 934 (0–144 Weeks)
FTC + TDF + EFV* AZT/3TC + EFV
N=257 N=254
*
From Weeks 96 to 144 of the trial, subjects received Truvada with efavirenz in place of VIREAD + EMTRIVA with efavirenz.
Any ≥ Grade 3 Laboratory Abnormality 30% 26%
Fasting Cholesterol (>240 mg/dL) 22% 24%
Creatine Kinase
(M: >990 U/L)
(F: >845 U/L)		 9% 7%
Serum Amylase (>175 U/L) 8% 4%
Alkaline Phosphatase (>550 U/L) 1% 0%
AST
(M: >180 U/L)
(F: >170 U/L)		 3% 3%
ALT
(M: >215 U/L)
(F: >170 U/L)		 2% 3%
Hemoglobin (<8.0 mg/dL) 0% 4%
Hyperglycemia (>250 mg/dL) 2% 1%
Hematuria (>75 RBC/HPF) 3% 2%
Glycosuria (≥3+) <1% 1%
Neutrophils (<750/mm3) 3% 5%
Fasting Triglycerides (>750 mg/dL) 4% 2%

In addition to the events described above for Study 934, other adverse reactions that occurred in at least 5% of subjects receiving EMTRIVA or VIREAD with other antiretroviral agents in clinical trials include anxiety, arthralgia, increased cough, dyspepsia, fever, myalgia, pain, abdominal pain, back pain, paresthesia, peripheral neuropathy (including peripheral neuritis and neuropathy), pneumonia, and rhinitis.

In addition to the laboratory abnormalities described above for Study 934, Grade 3/4 laboratory abnormalities of increased bilirubin (>2.5 × ULN), increased pancreatic amylase (>2.0 × ULN), increased or decreased serum glucose (<40 or >250 mg/dL), and increased serum lipase (>2.0 × ULN) occurred in up to 3% of subjects treated with EMTRIVA or VIREAD with other antiretroviral agents in clinical trials.

Clinical Trials in Pediatric Subjects 12 Years of Age and Older

Emtricitabine: In addition to the adverse reactions reported in adults, anemia and hyperpigmentation were observed in 7% and 32%, respectively, of pediatric subjects (3 months to less than 18 years of age) who received treatment with EMTRIVA in the larger of two open-label, uncontrolled pediatric trials (N=116). For additional information, please consult the EMTRIVA prescribing information.

Tenofovir Disoproxil Fumarate: In a pediatric clinical trial conducted in subjects 12 to less than 18 years of age, the adverse reactions observed in pediatric subjects who received treatment with VIREAD were consistent with those observed in clinical trials of VIREAD in adults [See Warnings and Precautions (5.5)].

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of VIREAD. No additional adverse reactions have been identified during postapproval use of EMTRIVA. Because postmarketing reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Immune System Disorders
allergic reaction, including angioedema

Metabolism and Nutrition Disorders
lactic acidosis, hypokalemia, hypophosphatemia

Respiratory, Thoracic, and Mediastinal Disorders
dyspnea

Gastrointestinal Disorders
pancreatitis, increased amylase, abdominal pain

Hepatobiliary Disorders
hepatic steatosis, hepatitis, increased liver enzymes (most commonly AST, ALT gamma GT)

Skin and Subcutaneous Tissue Disorders
rash

Musculoskeletal and Connective Tissue Disorders
rhabdomyolysis, osteomalacia (manifested as bone pain and which may contribute to fractures), muscular weakness, myopathy

Renal and Urinary Disorders
acute renal failure, renal failure, acute tubular necrosis, Fanconi syndrome, proximal renal tubulopathy, interstitial nephritis (including acute cases), nephrogenic diabetes insipidus, renal insufficiency, increased creatinine, proteinuria, polyuria

General Disorders and Administration Site Conditions
asthenia

The following adverse reactions, listed under the body system headings above, may occur as a consequence of proximal renal tubulopathy: rhabdomyolysis, osteomalacia, hypokalemia, muscular weakness, myopathy, hypophosphatemia.

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Side Effects by Body System - for Healthcare Professionals

General

Side effects have been reported for emtricitabine and/or tenofovir when taken in combination with other antiretroviral agents. The most common side effects (any severity; greater than or equal to 10%) reported during a clinical study of efavirenz, emtricitabine, and tenofovir included diarrhea, nausea, fatigue, headache, dizziness, depression, insomnia, abnormal dreams, and rash.

Gastrointestinal

Gastrointestinal side effects (Grades 2 to 4) have included diarrhea (up to 9%), nausea (up to 9%), and vomiting (up to 2%). 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, abdominal pain, and increased amylase have been reported during postmarketing experience with tenofovir.

Hepatic

Hepatic side effects 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

Hypokalemia and hypophosphatemia may occur as a result of proximal renal tubulopathy.

Metabolic side effects have included hyperglycemia (greater than 250 mg/dL; up to 2%), increased urine glucose (3+ or greater; up to 3%), fasting triglycerides (greater than 750 mg/dL; 4%), fasting cholesterol (greater than 240 mg/dL; up to 22%), creatine kinase (greater than 990 units/L in males and 845 units/L in females; up to 9%), serum amylase (greater than 175 units/L; up to 8%), 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%), and weight loss. Redistribution/accumulation of body fat, including central obesity, dorsocervical fat enlargement, peripheral wasting, facial wasting, breast enlargement, and "cushingoid appearance," have been observed in patients taking antiretroviral agents; however, a causal relationship has not been established. Hypokalemia, lactic acidosis, 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.

Rhabdomyolysis, osteomalacia, muscular weakness, and myopathy may occur as a result of proximal renal tubulopathy.

Nervous system

Nervous system side effects (Grades 2 to 4) have included dizziness (8%), headache (up to 6%), and insomnia (up to 5%). Somnolence has been reported. 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 (Grades 2 to 4) have included fatigue (up to 9%). Asthenia, pain, abdominal pain, back pain, and fever occurred in at least 5% of patients in clinical trials of emtricitabine or tenofovir with other antiretroviral drugs. Asthenia has also been reported during postmarketing experience with tenofovir.

Dermatologic

Dermatologic side effects (Grades 2 to 4) have included rash event (including rash, maculopapular rash, exfoliative rash, generalized rash, macular rash, pruritic rash, and vesicular rash; up to 7%). Skin discoloration (palmar-plantar hyperpigmentation) has been reported with emtricitabine. Sweating has been reported with tenofovir. Rash has also been reported during postmarketing experience with tenofovir.

Psychiatric

Psychiatric side effects (Grades 2 to 4) have included depression (up to 9%). Abnormal dreams have been reported during a clinical study of efavirenz, emtricitabine, and tenofovir. Anxiety occurred in at least 5% of patients in clinical trials of emtricitabine or tenofovir with other antiretroviral drugs.

Respiratory

Respiratory side effects (Grades 2 to 4) have included sinusitis (up to 8%), upper respiratory tract infections (up to 8%), and nasopharyngitis (up to 5%). 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 have included decreased neutrophil counts (less than 750/mm3; 3%).

Renal

Rhabdomyolysis, osteomalacia, hypokalemia, muscular weakness, myopathy, and hypophosphatemia may occur as a result of proximal renal tubulopathy.

Renal side effects have included new onset or worsening renal impairment with tenofovir. Renal insufficiency, renal failure, acute renal failure, Fanconi syndrome, proximal renal 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 have included hematuria (greater than 75 RBC/HPF; up to 3%) and glycosuria (3 plus or greater; less than 1%). Proteinuria and polyuria have been reported during postmarketing experience with tenofovir.

Immunologic

Immunologic side effects have included immune reconstitution syndrome.

Hypersensitivity

Hypersensitivity side effects have included allergic reaction (including angioedema) during postmarketing experience with tenofovir.

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