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Emtricitabine / rilpivirine / tenofovir Side Effects

In Summary

Commonly reported side effects of emtricitabine/rilpivirine/tenofovir include: depression. Other side effects include: suicidal ideation, attempted suicide, arthralgia, depressed mood, dysphoria, major depressive disorder, and myalgia. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to emtricitabine / rilpivirine / tenofovir: oral tablet

In addition to its needed effects, some unwanted effects may be caused by emtricitabine / rilpivirine / tenofovir. In the event that any of these side effects do occur, they may require medical attention.

Severity: Major

You should check with your doctor immediately if any of these side effects occur when taking emtricitabine / rilpivirine / tenofovir:

More common:
  • Discouragement
  • feeling sad or empty
  • irritability
  • lack of appetite
  • loss of interest or pleasure
  • mental depression
  • thoughts of killing oneself
  • tiredness
  • trouble concentrating
  • trouble sleeping
Less common:
  • Body aches or pain
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • chest pain
  • cough
  • difficulty with breathing
  • ear congestion
  • fever or chills
  • headache
  • loss of voice
  • runny or stuffy nose
  • sneezing
  • sore throat
  • tightness in the chest
  • unsteadiness or awkwardness
  • unusual tiredness or weakness
  • weakness in the arms, hands, legs, or feet
Incidence not known:
  • Abdominal or stomach discomfort
  • agitation
  • bloating
  • bloody or cloudy urine
  • bone pain
  • broken bones, especially the thigh bone
  • changes in behavior
  • confusion
  • constipation
  • dark urine
  • decreased appetite
  • decrease in the amount of urine
  • diarrhea
  • difficulty with swallowing
  • dizziness
  • dry mouth
  • fast heartbeat
  • fast, shallow breathing
  • frequent urination
  • general tiredness and weakness
  • headache
  • hostility
  • increased thirst
  • indigestion
  • irritability
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • lethargy
  • light-colored stools
  • muscle pain or cramps
  • muscle tenderness, wasting, or weakness
  • nausea or vomiting
  • numbness or tingling in the hands, feet, or lips
  • pain in the stomach, side, or abdomen, possibly radiating to the back
  • rapid weight gain
  • seizures
  • skin rash, hives, itching
  • sleepiness
  • swelling of the face, ankles, hands, feet, or lower legs
  • upper right stomach pain
  • vomiting
  • yellow eyes or skin

Severity: Minor

Some of the side effects that can occur with emtricitabine / rilpivirine / tenofovir may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common:
  • Abnormal dreams
Less common:
  • Acid or sour stomach
  • back pain
  • belching
  • difficulty with moving
  • heartburn
  • pain in the joints
  • pain or tenderness around the eyes and cheekbones
  • stomach discomfort or upset
Incidence not known:
  • Lack or loss of strength

For Healthcare Professionals

Applies to emtricitabine / rilpivirine / tenofovir: oral tablet

General

During clinical studies, 550 antiretroviral therapy-naive patients received rilpivirine in combination with emtricitabine-tenofovir disoproxil fumarate (DF). The most common side effects were depression/depressive disorders, nausea, dizziness, abnormal dreams, headache, diarrhea, and insomnia. Treatment was discontinued due to side effects, regardless of severity, in 2% of patients taking rilpivirine in combination with emtricitabine-tenofovir DF. The most common side effects leading to discontinuation were psychiatric disorders. In virologically-suppressed patients switching to emtricitabine / rilpivirine / tenofovir DF, the most common side effects were fatigue, diarrhea, nausea, and insomnia.

The manufacturer product information for emtricitabine, rilpivirine, and tenofovir DF should be consulted.[Ref]

Hepatic

Increased ALT (grade 1: 19%; grade 2: 5%; grade 3: 1%; grade 4: 1%), AST (grade 1: 16%; grade 2: 4%; grade 3: 2%; grade 4: 1%), and total bilirubin (grade 1: 6%; grade 2: 3%; grade 3: 1%) have been reported with emtricitabine-tenofovir DF plus rilpivirine.

Severe acute exacerbations of hepatitis B have been reported in patients coinfected with HBV and HIV-1 after discontinuation of emtricitabine or tenofovir DF and were associated with liver failure and liver decompensation in some emtricitabine-treated patients.

The incidence of hepatic enzyme elevation was higher in patients receiving rilpivirine who were coinfected with hepatitis B or C than in patients without coinfection.

Lactic acidosis and severe hepatomegaly with steatosis (including fatal cases) have been reported with the use of nucleoside analogs.

Hepatic steatosis and hepatitis have also been reported during postmarketing experience with tenofovir DF.[Ref]

Emtricitabine-tenofovir DF plus rilpivirine:
-Very common (10% or more): Increased ALT (up to 19%), increased AST (up to 16%)
-Common (1% to 10%): Increased total bilirubin

Emtricitabine and/or tenofovir DF:
-Frequency not reported: Severe hepatomegaly with steatosis, severe acute exacerbations of hepatitis B

Emtricitabine:
-Common (1% to 10%): Elevated serum AST and/or elevated serum ALT, hyperbilirubinemia
-Frequency not reported: Liver failure, liver decompensation

Rilpivirine:
-Very common (10% or more): Increased transaminases (AST and/or ALT)
-Common (1% to 10%): Cholecystitis, cholelithiasis, increased bilirubin
-Frequency not reported: Hepatic enzyme elevation, hepatotoxicity, drug-induced acute allergic hepatitis

Tenofovir DF:
-Common (1% to 10%): Increased transaminases (AST and/or ALT)
-Rare (less than 0.1%): Hepatic steatosis, hepatitis
-Frequency not reported: Lactic acidosis/severe hepatomegaly with steatosis
-Postmarketing reports: Elevated liver enzymes (primarily AST, ALT, GGT)[Ref]

Metabolic

Emtricitabine-tenofovir DF plus rilpivirine:
-Very common (10% or more): Increased fasted total cholesterol (up to 14%), increased fasted low-density lipoprotein (LDL) cholesterol (up to 13%)
-Common (1% to 10%): Increased fasted triglycerides, hypophosphatemia

Emtricitabine and tenofovir alafenamide:
-Frequency not reported: Increased total cholesterol, increased LDL cholesterol, increased high-density lipoprotein (HDL) cholesterol, increased triglycerides

Emtricitabine and/or tenofovir DF:
-Frequency not reported: Increased alkaline phosphatase, increased or decreased serum glucose, lactic acidosis

Emtricitabine:
-Common (1% to 10%): Hyperglycemia, hypertriglyceridemia

Rilpivirine:
-Very common (10% or more): Increased fasted total cholesterol, increased fasted LDL cholesterol
-Common (1% to 10%): Decreased appetite, increased fasted triglycerides

Tenofovir DF:
-Very common (10% or more): Hypophosphatemia
-Uncommon (0.1% to 1%): Hypokalemia
-Rare (less than 0.1%): Lactic acidosis

Antiretroviral therapy:
-Frequency not reported: Redistribution/accumulation of body fat (including central obesity, dorsocervical fat enlargement, peripheral wasting, facial wasting, breast enlargement, "cushingoid appearance"), increased blood lipid levels, increased glucose levels[Ref]

Increased fasted total cholesterol (grade 1: 14%; grade 2: 6%; grade 3: less than 1%), fasted LDL cholesterol (grade 1: 13%; grade 2: 5%; grade 3: 1%) and fasted triglycerides (grade 2: 1%; grade 3: 1%) have been reported with emtricitabine-tenofovir DF plus rilpivirine.

In clinical trials, the following mean increases were reported in antiretroviral therapy-naive patients after using emtricitabine plus tenofovir alafenamide with elvitegravir plus cobicistat for 48 weeks: total cholesterol increased by 30 mg/dL, LDL cholesterol by 15 mg/dL, HDL cholesterol by 7 mg/dL, and triglycerides by 29 mg/dL.

Increased alkaline phosphatase (greater than 550 units/L) and increased or decreased serum glucose (less than 40 or greater than 250 mg/dL) have been reported with emtricitabine or tenofovir DF.

Lactic acidosis and severe hepatomegaly with steatosis (including fatal cases) have been reported with the use of nucleoside analogs.

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

Lactic acidosis, hypokalemia, and hypophosphatemia have also been reported during postmarketing experience with tenofovir DF.[Ref]

Psychiatric

Depression, insomnia, and abnormal dreams have been reported in at least 10% of therapy-naive patients treated with emtricitabine and tenofovir DF. Anxiety has been reported in at least 5% of therapy-experienced or therapy-naive patients treated with emtricitabine or tenofovir DF.

During Phase 3 trials through 96 weeks, depressive disorders (regardless of causality, severity) were reported in 9% of patients receiving rilpivirine.[Ref]

Emtricitabine / rilpivirine / tenofovir DF:
-Common (1% to 10%): Insomnia

Emtricitabine-tenofovir DF plus rilpivirine:
-Common (1% to 10%): Depression, depressive disorders (reported as depressed mood, depression, dysphoria, major depression, altered mood, negative thoughts, suicide attempt, suicidal ideation), insomnia, abnormal dreams

Emtricitabine and/or tenofovir DF:
-Very common (10% or more): Depression, insomnia, abnormal dreams
-Common (1% to 10%): Anxiety

Emtricitabine:
-Common (1% to 10%): Insomnia, abnormal dreams

Rilpivirine:
-Very common (10% or more): Insomnia
-Common (1% to 10%): Depressive disorders, anxiety, abnormal dreams, depression, sleep disorders, depressed mood[Ref]

Dermatologic

During phase 3 trials, 1% of patients using rilpivirine with emtricitabine and tenofovir DF reported at least grade 2 therapy-related rashes; most rashes were grade 1 or 2 and developed in the first 4 to 6 weeks of therapy.

Rash has been reported in at least 10% of therapy-naive patients treated with emtricitabine and tenofovir DF.

Rash has also been reported during postmarketing experience with tenofovir DF.[Ref]

Emtricitabine / rilpivirine / tenofovir DF:
-Postmarketing reports: Severe skin and hypersensitivity reactions (including drug reaction with eosinophilia and systemic symptoms [DRESS]), severe skin reactions with systemic symptoms (including rashes with fever, blisters, conjunctivitis, angioedema, elevated liver function tests, and/or eosinophilia)

Emtricitabine-tenofovir DF plus rilpivirine:
-Common (1% to 10%): Rash

Emtricitabine and tenofovir DF:
-Very common (10% or more): Rash
-Frequency not reported: Lipodystrophy

Emtricitabine:
-Common (1% to 10%): Vesiculobullous rash, pustular rash, maculopapular rash, rash, pruritus, urticaria, skin discoloration (palmar-plantar hyperpigmentation)
-Postmarketing reports: Angioedema

Rilpivirine:
-Common (1% to 10%): Rash
-Postmarketing reports: Severe skin and hypersensitivity reactions (including DRESS)

Tenofovir DF:
-Very common (10% or more): Rash
-Postmarketing reports: Angioedema[Ref]

Nervous system

Headache and dizziness have been reported in at least 10% of therapy-naive patients treated with emtricitabine and tenofovir DF. Paresthesia and peripheral neuropathy (including peripheral neuritis and neuropathy) have been reported in at least 5% of therapy-experienced or therapy-naive patients treated with emtricitabine or tenofovir DF.[Ref]

Emtricitabine-tenofovir DF plus rilpivirine:
-Common (1% to 10%): Headache, dizziness

Emtricitabine and/or tenofovir DF:
-Very common (10% or more): Headache, dizziness
-Common (1% to 10%): Paresthesia, peripheral neuropathy (including peripheral neuritis, neuropathy)

Emtricitabine:
-Very common (10% or more): Headache
-Common (1% to 10%): Dizziness

Rilpivirine:
-Very common (10% or more): Headache, dizziness
-Common (1% to 10%): Somnolence

Tenofovir DF:
-Very common (10% or more): Dizziness
-Common (1% to 10%): Headache[Ref]

Renal

Emtricitabine-tenofovir DF plus rilpivirine:
-Common (1% to 10%): Increased creatinine

Emtricitabine and tenofovir alafenamide:
-Frequency not reported: Increased serum creatinine, decreased urine protein-to-creatinine ratio (UPCR), worsening renal function

Rilpivirine:
-Common (1% to 10%): Membranous glomerulonephritis, mesangioproliferative glomerulonephritis, nephrolithiasis
-Frequency not reported: Increased serum creatinine, decreased estimated glomerular filtration rate (eGFR)
-Postmarketing reports: Nephrotic syndrome

Tenofovir DF:
-Uncommon (0.1% to 1%): Increased creatinine
-Rare (less than 0.1%): Renal failure (acute and chronic), acute tubular necrosis, proximal renal tubulopathy (including Fanconi syndrome), nephrogenic diabetes insipidus
-Frequency not reported: New onset or worsening renal impairment
-Postmarketing reports: Renal insufficiency, interstitial nephritis (including acute cases)

Tenofovir prodrugs:
-Frequency not reported: Renal impairment (including renal failure, Fanconi syndrome)[Ref]

Increased creatinine (grade 1: 6%; grade 2: 1%; grade 3: less than 1%) has been reported with emtricitabine-tenofovir DF plus rilpivirine.

In 2 trials in antiretroviral therapy-naive HIV-1-infected patients (median eGFR 115 mL/min at baseline) using emtricitabine plus tenofovir alafenamide with elvitegravir plus cobicistat, mean serum creatinine increased by 0.1 mg/dL from baseline to week 48; median UPCR was 44 mg/g at baseline and at week 48. In a trial in virologically-suppressed tenofovir DF-treated patients (mean eGFR 112 mL/min at baseline) who switched to emtricitabine plus tenofovir alafenamide with elvitegravir plus cobicistat, mean serum creatinine was similar to baseline; median UPCR was 61 mg/g at baseline and 46 mg/g at week 48. In a trial in renal dysfunction patients (baseline eGFR 30 to 69 mL/min) using emtricitabine plus tenofovir alafenamide with elvitegravir plus cobicistat, mean serum creatinine was 1.5 mg/dL at baseline and week 24; median UPCR was 161 mg/g at baseline and 93 mg/g at week 24.

During phase 3 trials, an increase in serum creatinine and decrease in eGFR were seen over 96 weeks of therapy with rilpivirine. Most of these changes occurred within the first 4 weeks of therapy, with a mean change of 0.1 mg/dL (range: -0.3 to 0.6 mg/dL) for creatinine and -13.3 mL/min/1.73 m2 (range: -63.7 to 40.1 mL/min/1.73 m2) for eGFR observed after 96 weeks of therapy. In subjects with mild or moderate baseline renal dysfunction, the serum creatinine increase observed was similar to that seen in subjects with normal renal function. These changes were not considered clinically relevant and no subject discontinued therapy due to increases in serum creatinine.

Proximal renal tubulopathy generally resolved or improved after tenofovir DF was stopped; however, decreased CrCl did not completely resolve in some patients after stopping the drug. Rhabdomyolysis, osteomalacia, bone abnormalities (infrequently contributing to fractures), hypokalemia, muscular weakness, myopathy, and hypophosphatemia may occur as a result of proximal renal tubulopathy.

Renal failure, acute renal failure, Fanconi syndrome, proximal renal tubulopathy, increased creatinine, nephrogenic diabetes insipidus, and acute tubular necrosis have also been reported during postmarketing experience with tenofovir DF.[Ref]

Gastrointestinal

Emtricitabine / rilpivirine / tenofovir DF:
-Common (1% to 10%): Diarrhea, nausea

Emtricitabine-tenofovir DF plus rilpivirine:
-Common (1% to 10%): Nausea, increased pancreatic amylase
-Uncommon (0.1% to 1%): Increased lipase

Emtricitabine and tenofovir alafenamide:
-Common (1% to 10%): Nausea

Emtricitabine and/or tenofovir DF:
-Very common (10% or more): Diarrhea, nausea
-Common (1% to 10%): Abdominal pain, dyspepsia, vomiting
-Frequency not reported: Increased pancreatic amylase, increased serum amylase, increased lipase

Emtricitabine:
-Very common (10% or more): Diarrhea, nausea
-Common (1% to 10%): Elevated amylase (including elevated pancreatic amylase), elevated serum lipase, vomiting, abdominal pain, dyspepsia

Rilpivirine:
-Very common (10% or more): Nausea, increased pancreatic amylase
-Common (1% to 10%): Vomiting, diarrhea, abdominal discomfort, abdominal pain, increased lipase, dry mouth

Tenofovir DF:
-Very common (10% or more): Diarrhea, vomiting, nausea
-Common (1% to 10%): Abdominal pain, abdominal distension, flatulence
-Uncommon (0.1% to 1%): Pancreatitis
-Postmarketing reports: Increased amylase[Ref]

In clinical trials, nausea was the most common side effect reported in antiretroviral therapy-naive HIV-1-infected patients using emtricitabine plus tenofovir alafenamide with elvitegravir plus cobicistat.

Diarrhea and nausea have been reported in at least 10% of therapy-naive patients treated with emtricitabine and tenofovir DF. Abdominal pain, dyspepsia, and vomiting have been reported in at least 5% of therapy-experienced or therapy-naive patients treated with emtricitabine or tenofovir DF.

Increased pancreatic amylase (greater than 2 times upper limit of normal [ULN]), serum amylase (greater than 175 units/L), and lipase (greater than 3 times ULN) have been reported with emtricitabine and/or tenofovir DF.

Pancreatitis and abdominal pain have also been reported during postmarketing experience with tenofovir DF.[Ref]

Other

Emtricitabine / rilpivirine / tenofovir DF:
-Common (1% to 10%): Fatigue
-Postmarketing reports: Weight increased

Emtricitabine and/or tenofovir DF:
-Very common (10% or more): Fatigue
-Common (1% to 10%): Fever, pain

Emtricitabine:
-Common (1% to 10%): Pain, asthenia

Rilpivirine:
-Common (1% to 10%): Fatigue
-Postmarketing reports: Weight increased

Tenofovir DF:
-Very common (10% or more): Asthenia
-Frequency not reported: Higher 1,25 vitamin D levels

Antiretroviral therapy:
-Frequency not reported: Increased weight[Ref]

Other side effects have included fatigue in at least 10% of therapy-naive patients treated with emtricitabine and tenofovir DF. Fever and pain have been reported in at least 5% of therapy-experienced or therapy-naive patients treated with emtricitabine or tenofovir DF.

Asthenia has also been reported during postmarketing experience with tenofovir DF.[Ref]

Hypersensitivity

Emtricitabine / rilpivirine / tenofovir DF:
-Postmarketing reports: Severe skin and hypersensitivity reactions (including DRESS)

Emtricitabine:
-Common (1% to 10%): Allergic reaction

Rilpivirine:
-Postmarketing reports: Severe skin and hypersensitivity reactions (including DRESS)

Tenofovir DF:
-Postmarketing reports: Allergic reaction (including angioedema)[Ref]

Immunologic

Emtricitabine, rilpivirine, and/or tenofovir DF:
-Frequency not reported: Immune reconstitution/reactivation syndrome, autoimmune disorders in the setting of immune reconstitution (e.g., Graves' disease, polymyositis, Guillain-Barre syndrome)

Emtricitabine:
-Postmarketing reports: Immune reconstitution syndrome

Rilpivirine:
-Uncommon (0.1% to 1%): Immune reactivation syndrome

Tenofovir DF:
-Postmarketing reports: Immune reconstitution syndrome[Ref]

Musculoskeletal

Emtricitabine and tenofovir alafenamide:
-Very common (10% or more): Decreased bone mineral density (BMD)
-Uncommon (0.1% to 1%): Fractures (excluding fingers and toes)
-Frequency not reported: Increased biochemical markers of bone metabolism, increased BMD

Emtricitabine or tenofovir DF:
-Common (1% to 10%): Arthralgia, back pain, myalgia
-Frequency not reported: Increased creatine kinase

Emtricitabine:
-Very common (10% or more): Elevated creatine kinase

Tenofovir DF:
-Uncommon (0.1% to 1%): Rhabdomyolysis, muscular weakness
-Rare (less than 0.1%): Myopathy
-Frequency not reported: Decreased BMD, increased biochemical markers of bone metabolism, bone abnormalities
-Postmarketing reports: Osteomalacia (manifested as bone pain and which may contribute to fractures)

Combination antiretroviral therapy:
-Frequency not reported: Osteonecrosis[Ref]

In clinical trials, a significant decline in BMD was seen in 15% of therapy-naive HIV-1-infected patients using emtricitabine plus tenofovir alafenamide with elvitegravir plus cobicistat. In virologically-suppressed tenofovir DF-treated patients who switched to emtricitabine plus tenofovir alafenamide with elvitegravir plus cobicistat, mean BMD increased between baseline and week 48; decreased BMD was also reported.

Arthralgia, back pain, and myalgia have been reported in at least 5% of therapy-experienced or therapy-naive patients treated with emtricitabine or tenofovir DF.

Increased creatine kinase (males: greater than 990 units/L; females: greater than 845 units/L) has been reported with emtricitabine or tenofovir DF.

Rhabdomyolysis, osteomalacia, muscular weakness, and myopathy may occur due to proximal renal tubulopathy.

Rhabdomyolysis, muscular weakness, and myopathy have also been reported during postmarketing experience with tenofovir DF.[Ref]

Respiratory

Nasopharyngitis, pneumonia, sinusitis, upper respiratory tract infection, increased cough, and rhinitis have been reported in at least 5% of therapy-experienced or therapy-naive patients treated with emtricitabine or tenofovir DF.[Ref]

Emtricitabine or tenofovir DF:
-Common (1% to 10%): Nasopharyngitis, pneumonia, sinusitis, upper respiratory tract infection, increased cough, rhinitis

Tenofovir DF:
-Postmarketing reports: Dyspnea[Ref]

Hematologic

Decreased neutrophils (less than 750/mm3) have been reported with emtricitabine or tenofovir DF.[Ref]

Emtricitabine or tenofovir DF:
-Frequency not reported: Decreased neutrophils

Emtricitabine:
-Common (1% to 10%): Neutropenia
-Uncommon (0.1% to 1%): Anemia

Rilpivirine:
-Common (1% to 10%): Decreased white blood cell count, decreased hemoglobin, decreased platelet count[Ref]

Genitourinary

Increased glycosuria (3+ or greater) and hematuria (greater than 75 red blood cells/high power field) have been reported with emtricitabine or tenofovir DF.

Proteinuria has also been reported during postmarketing experience with tenofovir DF.[Ref]

Emtricitabine or tenofovir DF:
-Frequency not reported: Increased glycosuria, increased hematuria

Tenofovir DF:
-Uncommon (0.1% to 1%): Proteinuria
-Postmarketing reports: Polyuria[Ref]

Endocrine

Rilpivirine:
-Frequency not reported: Decreased basal cortisol, decreased adrenocorticotropic hormone (ACTH)-stimulated cortisol levels, adrenal insufficiency, abnormal 250 mcg ACTH stimulation test

Tenofovir DF:
-Frequency not reported: Higher serum parathyroid hormone levels[Ref]

In the pooled phase 3 trials, at week 96, there was an overall mean change from baseline in basal cortisol of -19.1 nmol/L (-0.69 mcg/dL) in the rilpivirine group, and of -0.6 nmol/L (-0.02 mcg/dL) in the efavirenz group. At week 96, the mean change from baseline in ACTH-stimulated cortisol levels was lower in the rilpivirine group (+18.4 nmol/L) than in the efavirenz group (+54.1 nmol/L). Mean values for both basal and ACTH-stimulated cortisol values at week 96 were within the normal range.

In the rilpivirine group, 43 of 588 patients with normal 250 mcg ACTH stimulation test at baseline developed abnormal 250 mcg ACTH stimulation test (peak cortisol level less than 18.1 mcg/dL) during the trial versus 18 of 561 patients in the efavirenz group. Abnormal 250 mcg ACTH stimulation test at week 96 was seen in 14 of the 43 rilpivirine patients and 9 of the 18 efavirenz patients. Clinical significance of abnormal 250 mcg ACTH stimulation tests (or the higher rate in the rilpivirine group) has not been established.

Overall, there were no serious side effects, deaths, or treatment discontinuations that could clearly be attributed to adrenal insufficiency.[Ref]

References

1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

2. "Product Information. Complera (emtricitabine / rilpivirine / tenofovir)." Gilead Sciences, Foster City, CA.

3. Cerner Multum, Inc. "Australian Product Information." O 0

4. "Product Information. Odefsey (emtricitabine / rilpivirine / tenofovir)." Gilead Sciences, Foster City, CA.

5. Ahmed Y, Siddiqui W, Enoch CB, Albrecht H, Bookstaver PB "Rare case of rilpivirine-induced severe allergic hepatitis." J Antimicrob Chemother (2012):

6. Panel on Antiretroviral Guidelines for Adults and Adolescents "Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. Department of Health and Human Services. Available from: URL: https://aidsinfo.nih.gov/contentfiles/lvguidelines/adultandadolescentgl.pdf." (4/8/2015):

Not all side effects for emtricitabine / rilpivirine / tenofovir may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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