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Truvada

Last reviewed on RxList: 5/8/2017
Truvada Side Effects Center

Last reviewed on RxList 11/14/2016

Truvada (emtricitabine/tenofovir disoproxil fumarate) is a combination of antiviral drugs used to treat HIV, which causes acquired immunodeficiency syndrome (AIDS). Truvada is not a cure for HIV or AIDS. Common side effects of Truvada include:

  • nausea,
  • vomiting,
  • stomach pain,
  • diarrhea,
  • headache,
  • dizziness,
  • depression,
  • joint pain,
  • trouble sleeping,
  • strange dreams,
  • back pain,
  • itching or skin rash,
  • changes in the color of skin on your palms or soles of your feet, or
  • changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

Tell your doctor if you have serious side effects of Truvada including:

  • mental/mood changes (such as depression, anxiety),
  • loss of appetite,
  • stomach or abdominal pain,
  • pink or bloody urine, or
  • changes in the amount of urine.

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 and supplements you use. During pregnancy, Truvada should be used only when prescribed. It is normal to prescribe HIV medicines such as Truvada for pregnant women with HIV. This can decrease the risk of passing HIV to the baby. Truvada may be part of that treatment. Consult your doctor. It is unknown if Truvada passes into breast milk. Because breast milk can transmit HIV, do not breastfeed.

Our Truvada (emtricitabine/tenofovir disoproxil fumarate) Drug Center provides a comprehensive view of available drug information as well as related drugs, user reviews, supplements, and diseases and conditions articles.

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.

Truvada Consumer Information

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

Mild symptoms of lactic acidosis may worsen over time, and this condition can be fatal. Get emergency medical help if you have: unusual muscle pain, trouble breathing, stomach pain, vomiting, irregular heart rate, dizziness, feeling cold, or feeling very weak or tired.

Call your doctor at once if you have:

  • symptoms of new HIV infection--fever, night sweats, tiredness, muscle or joint pain, sore throat, vomiting, diarrhea, rash, swollen glands in your neck or groin;
  • sudden or unusual bone pain;
  • kidney problems--little or no urination, swelling in your feet or ankles, feeling tired or short of breath; or
  • liver problems--nausea, swelling around your midsection, upper stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Emtricitabine and tenofovir affects your immune system, which may cause certain side effects (even weeks or months after you've taken this medicine). Tell your doctor if you have:

  • signs of a new infection--fever, sweats, swollen glands, cold sores, cough, wheezing, diarrhea, weight loss;
  • trouble speaking or swallowing, problems with balance or eye movement, weakness or prickly feeling; or
  • swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence.

Common side effects may include:

  • headache, dizziness, feeling depressed or tired;
  • trouble sleeping, strange dreams;
  • nausea, stomach pain;
  • weight loss; or
  • rash.

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)

Truvada Professional Information

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 DF, include diarrhea, nausea, fatigue, headache, dizziness, depression, insomnia, abnormal dreams, and rash. See also Table 3 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 antiretroviralnaïve 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-naïve subjects receiving VIREAD and/or EMTRIVA (Table 3).

Table 3 Selected Treatment-Emergent Adverse Reactionsa (Grades 2–4) Reported in ≥5% in Any Treatment Group in Study 934 (0–144 Weeks)

  FTC+TDF+EFVb AZT/3TC+EFV
N=257 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.

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.

Laboratory Abnormalities

Laboratory abnormalities observed in this trial were generally consistent with those seen in other trials of VIREAD and/or EMTRIVA (Table 4).

Table 4 Significant Laboratory Abnormalities Reported in ≥1% of Subjects in Any Treatment Group in Study 934 (0–144 Weeks)

  FTC+TDF+EFVa AZT/3TC+EFV
N=257 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 laboratory abnormalities described above for Study 934, Grades 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

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, consult the EMTRIVA prescribing information.

Tenofovir DF

In pediatric clinical trials (Studies 352 and 321) conducted in 184 HIV-1 infected subjects 2 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.

Eighty-nine pediatric subjects (2 to less than 12 years of age) received VIREAD in Study 352 for a median exposure of 104 weeks. Of these, 4 subjects discontinued from the trial due to adverse reactions consistent with proximal renal tubulopathy. Three of these 4 subjects presented with hypophosphatemia and also had decreases in total body or spine BMD Z score [see WARNINGS AND PRECAUTIONS]. For additional information, consult the VIREAD prescribing information.

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 2,830 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 men or transgender women of Hispanic/Latino (72%), White (18%), Black (9%), and Asian (5%) race. The Partners PrEP trial enrolled both men (61−64% across treatment groups) and women in Kenya and Uganda. Table 5 provides a list of all adverse events that occurred in 2% or more of subjects in any treatment group in the iPrEx and Partners PrEP trials.

Laboratory Abnormalities

Table 6 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 5 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% - -
a. Not reported or reported below 2%.

Table 6 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 × ULN)
27 (2%) 21 (2%) 18 (1%) 12 (<1%)
2−4
(>1.4 × ULN)
5 (<1%) 3 (<1%) 2 (<1%) 1 (<1%)
Phosphorus 1
(2.5 – <LLN mg/dL)
81 (7%) 110 (9%) NR a NR a
2−4
(<2.0 mg/dL)
123 (10%) 101 (8%) 140 (9%) 136 (9%)
AST 1
(1.25 – <2.5 × ULN)
175 (14%) 175 (14%) 20 (1%) 25 (2%)
2−4
(>2.6 × ULN)
57 (5%) 61 (5%) 10 (<1%) 4 (<1%)
ALT 1
(1.25 – <2.5 × ULN)
178 (14%) 194 (16%) 21 (1%) 13 (<1%)
2−4
(>2.6 × 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 versus 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 performed 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)

Related Resources for Truvada

Read the Truvada User Reviews »

© Truvada Patient Information is supplied by Cerner Multum, Inc. and Truvada Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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