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Truvada

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Truvada

Truvada

Truvada Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Truvada (emtricitabine/tenofovir disoproxil fumarate) is used to treat HIV, which causes acquired immunodeficiency syndrome (AIDS). It is not a cure for HIV or AIDS. It is a combination of antiviral drugs. Common side effects include nausea, vomiting, diarrhea, headache, dizziness, joint pain, trouble sleeping, back pain, or change in the color of skin on your palms or soles of your feet.

The dose of Truvada for adults and pediatric patients 12 years of age and older with body weight 35 kg (77 lb) or more is one tablet (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) once daily taken orally with or without food. Truvada may interact with lithium, methotrexate, pain or arthritis medicines, medicines used to prevent organ transplant rejection, IV antibiotics, antiviral medicines, cancer medicines, herpes medications, medications to treat cytomegalovirus (CMV), or other HIV medicines. Tell your doctor all medications you use. Truvada should be used only when prescribed during pregnancy. It is normal to prescribe HIV medicines for pregnant women with HIV. This can decrease the risk of passing HIV to the baby. This medication may be part of that treatment. Consult your doctor. It is unknown if this medication passes into breast milk. Because breast milk can transmit HIV, do not breastfeed.

Our Truvada (emtricitabine/tenofovir disoproxil fumarate) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Truvada in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

This medication may cause lactic acidosis (a build-up of lactic acid in the body, which can be fatal). Lactic acidosis can start slowly and get worse over time. Get emergency medical help if you have even mild symptoms of lactic acidosis, such as:

  • muscle pain or weakness;
  • numb or cold feeling in your arms and legs;
  • trouble breathing;
  • feeling dizzy, light-headed, tired, or very weak;
  • stomach pain, nausea with vomiting; or
  • fast or uneven heart rate.

Call your doctor at once if you have any of these other serious side effects:

  • signs of liver damage - nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • increased thirst, urinating more or less than usual or not at all;
  • swelling, rapid weight gain, feeling short of breath; or
  • signs of infection such as fever, chills, skin lesions, or cough with yellow or green mucus.

Less serious side effects may include:

  • diarrhea, mild nausea;
  • headache, tired feeling;
  • dizziness, depressed mood;
  • sleep problems (insomnia), strange dreams;
  • mild itching or skin rash;
  • runny or stuffy nose, cough; or
  • changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Truvada (Emtricitabine and Tenofovir Disoproxil Fumarate) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Truvada Overview - Patient Information: Side Effects

SIDE EFFECTS: See also Warning section.

Nausea, vomiting, diarrhea, headache, dizziness, trouble sleeping, back pain, or change in the color of skin on your palms or soles of your feet may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Some people may experience worsening of a previous medical condition (such as an old infection) as their immune systems improve, or develop new conditions because their immune systems have become overactive. This reaction may occur at any time (soon after starting HIV treatment or many months later). Tell your doctor right away if you have any serious side effects, including: unexplained weight loss, persistent muscle aches/weakness, joint pain, numbness/tingling of the hands/feet/arms/legs, severe tiredness, vision changes, severe/persistent headaches, signs of infection (such as fever, chills, trouble breathing, cough, non-healing skin sores), signs of an overactive thyroid (such as irritability, nervousness, heat intolerance, fast/pounding/irregular heartbeat, bulging eyes, unusual growth in the neck/thyroid known as a goiter), signs of a certain nerve problem known as Guillain-Barre Syndrome (such as difficulty breathing/swallowing/moving your eyes, drooping face, paralysis, slurred speech).

Tell your doctor immediately if any of these unlikely but serious side effects occur: mental/mood changes (e.g., depression, anxiety), loss of appetite, stomach/abdominal pain.

Tell your doctor immediately if any of these rare but very serious side effects occur: bone pain, pink/bloody urine, change in the amount of urine.

Changes in body fat may occur while you are taking this product (e.g., increased fat in the upper back and stomach areas, decreased fat in the arms and legs). The cause and long-term effects of these changes are unknown. Discuss the risks and benefits of treatment with your doctor, as well as the possible use of exercise to reduce this side effect.

Tenofovir may increase the risk of bone loss. Discuss the risks and benefits of treatment with your doctor, as well as the possible use of calcium and vitamin D to reduce this side effect. If you are at risk for bone loss, your doctor may monitor your bone mineral density.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Truvada (Emtricitabine and Tenofovir Disoproxil Fumarate)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Truvada FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

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

Adverse Reactions From Clinical Trials Experience In HIV-1 Infected Subjects

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 (Grades 2-4) occurring in greater than or equal to 5% of subjects treated in any treatment group 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 antiretroviralnaive subjects received either VIREAD + EMTRIVA administered in combination with efavirenz (N=257) or zidovudine/lamivudine administered in combination with efavirenz (N=254) for 144 weeks. Subjects had a mean age of 40 years (range 20 to 73 years) and were predominantly male (88%). Overall, 65% were White, 17% were Black, and 13% were Hispanic. 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 Reactionsa (Grades 2-4) Reported in ≥ 5% in Any Treatment Group in Study 934 (0-144 Weeks)

  FTC + TDF + EFVb
N=257
AZT/3TC + EFV
N=254
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 eventc 7% 9%
a Frequencies of adverse reactions are based on all treatment-emergent adverse events, regardless of relationship to study drug.
b From Weeks 96 to 144 of the trial, subjects received TRUVADA with efavirenz in place of VIREAD + EMTRIVA with efavirenz.
c Rash event includes rash, exfoliative rash, rash generalized, rash macular, rash maculo-papular, rash pruritic, and rash vesicular.

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 + EFVa
N=257
AZT/3TC + EFV
N=254
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%
a From Weeks 96 to 144 of the trial, subjects received TRUVADA with efavirenz in place of VIREAD + EMTRIVA with efavirenz.

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, Grades 3-4 laboratory abnormalities of increased bilirubin ( > 2.5 x ULN), increased pancreatic amylase ( > 2.0 x ULN), increased or decreased serum glucose ( < 40 or > 250 mg/dL), and increased serum lipase ( > 2.0 x 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].

Adverse Reactions From Clinical Trial Experience In HIV-1 Uninfected Adult Subjects

No new adverse reactions to TRUVADA were identified from two randomized placebo-controlled clinical trials (iPrEx, Partners PrEP) in which 2830 HIV-1 uninfected adults received TRUVADA once daily for pre-exposure prophylaxis. Subjects were followed for a median of 71 weeks and 87 weeks, respectively. These trials enrolled HIV-negative individuals ranging in age from 18 to 67 years. The iPrEx trial enrolled only males or transgender females of Hispanic/Latino (72%), White (18%), Black (9%) and Asian (5%) race. The Partners PrEP trial enrolled both males (61-64% across treatment groups) and females in Kenya and Uganda. Table 4 provides a list of all adverse events that occurred ≥ 2% of subjects in any treatment group in the iPrEx and Partners PrEP trials.

Laboratory Abnormalities: Table 5 provides a list of laboratory abnormalities observed in both trials. Six subjects in the TDF-containing arms of the Partners PrEP trial discontinued participation in the study due to an increase in blood creatinine compared with no discontinuations in the placebo group. One subject in the TRUVADA arm of the iPrEx trial discontinued from the study due to an increase in blood creatinine and another due to low phosphorous.

In addition to the laboratory abnormalities described above, Grade 1 proteinuria (1+) occurred in 6% of subjects receiving TRUVADA in the iPrEx trial. Grades 2-3 proteinuria (2-4+) and glycosuria (3+) occurred in less than 1% of subjects treated with TRUVADA in the iPrEx trial and Partners PrEP trial.

Table 4 : Selected Adverse Events (All Grades) Reported in ≥ 2% in Any Treatment Group in the iPrEx Trial and Partners PrEP Trial

  iPrEx Trial Partners PrEP Trial
FTC/TDF
(N=1251)
Placebo
(N=1248)
FTC/TDF
(N=1579)
Placebo
(N=1584)
Gastrointestinal Disorders
  Diarrhea 7% 8% 2% 3%
  Abdominal pain 4% 2% -a -
Infections and Infestations
  Pharyngitis 13% 16% - -
  Urethritis 5% 7% - -
  Urinary tract infection 2% 2% 5% 7%
  Syphilis 6% 5% - -
  Secondary syphilis 6% 4% - -
  Anogenital warts 2% 3% - -
Musculoskeletal and Connective Tissue Disorders
  Back pain 5% 5% - -
Nervous System Disorders
  Headache 7% 6% - -
Psychiatric Disorders
  Depression 6% 7% - -
  Anxiety 3% 3% - -
Reproductive System and Breast Disorders
  Genital ulceration 2% 2% 2% 2%
Investigations
  Weight decreased 3% 2% - -
aNot reported or reported below 2%.

Table 5 : Laboratory Abnormalities (Highest Toxicity Grade) Reported for Each Subject in the iPrEx Trial and Partners PrEP Trial

  Gradeb iPrEx Trial Partners PrEP Trial
FTC/TDF
N= 1251
Placebo
N= 1248
FTC/TDF
N=1579
Placebo
N=1584
Creatinine 1(1.1-1.3 X ULN) 27 (2%) 21 (2%) 18 (1%) 12 ( < 1%)
2-4 ( > 1.4 x ULN) 5 ( < 1%) 3 ( < 1%) 2 ( < 1%) 1 ( < 1%)
Phosphorus 1(2.5 - 81 (7%) 110 (9%) NR a NRa
2-4( < 2.0 mg/dL) 123 (10%) 101 (8%) 140 (9%) 136 (9%)
AST 1(1.25- < 2.5 x ULN) 175 (14%) 175 (14%) 20 (1%) 25 (2%)
2-4( > 2.6 x ULN) 57 (5%) 61 (5%) 10 ( < 1%) 4 ( < 1%)
ALT 1(1.25- < 2.5 x ULN) 178 (14%) 194 (16%) 21 (1%) 13 ( < 1%)
2-4( > 2.6 x ULN) 84 (7%) 82 (7%) 4 ( < 1%) 6 ( < 1%)
Hemoglobin 1(8.5 -10 mg/dL) 49 (4%) 62 (5%) 56 (4%) 39 (2%)
2-4( < 9.4 mg/dL) 13 (1%) 19 (2%) 28 (2%) 39 (2%)
Neutrophils 1(1000-1300/mm³) 23 (2%) 25 (2%) 208 (13%) 163 (10%)
2-4( < 750/mm³) 7 ( < 1%) 7 ( < 1%) 73 (5%) 56 (3%)
a Grade 1 phosphorus was not reported for the Partners PrEP trial.
b Grading is per DAIDS criteria.

Changes in Bone Mineral Density

In clinical trials of HIV-1 uninfected individuals, decreases in BMD were observed. In the iPrEx trial, a substudy of 503 subjects found mean changes from baseline in BMD ranging from -0.4% to -1.0% across total hip, spine, femoral neck, and trochanter in the TRUVADA group compared with the placebo group, which returned toward baseline after discontinuation of treatment. Thirteen percent of subjects receiving TRUVADA vs. 6% of subjects receiving placebo lost at least 5% of BMD at the spine during treatment. Bone fractures were reported in 1.7% of the TRUVADA group compared with 1.4% in the placebo group. No correlation between BMD and fractures was noted [See Clinical Studies]. The Partners PrEP trial found similar fracture rates between treatment and placebo groups (0.8% and 0.6%, respectively). No BMD evaluations were conducted during this trial [See Clinical Studies].

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.

Read the entire FDA prescribing information for Truvada (Emtricitabine and Tenofovir Disoproxil Fumarate) »

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Truvada - User Reviews

Truvada User Reviews

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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