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Stribild Side Effects

Generic Name: cobicistat / elvitegravir / emtricitabine / tenofovir

Note: This page contains side effects data for the generic drug cobicistat / elvitegravir / emtricitabine / tenofovir. It is possible that some of the dosage forms included below may not apply to the brand name Stribild.

For the Consumer

Applies to cobicistat / elvitegravir / emtricitabine / tenofovir: oral tablet

As well as its needed effects, cobicistat / elvitegravir / emtricitabine / tenofovir may cause unwanted side effects that require medical attention.

Major Side Effects

If any of the following side effects occur while taking cobicistat / elvitegravir / emtricitabine / tenofovir, check with your doctor immediately:

More common:
  • Cloudy urine
Incidence not known:
  • Abdominal or stomach discomfort or pain
  • bloody urine
  • bone fractures
  • bone pain
  • change in urination
  • convulsions
  • cough
  • dark-colored urine
  • decreased appetite
  • difficulty with swallowing
  • dizziness
  • dry mouth
  • fast or irregular heartbeat
  • fast, shallow breathing
  • fever
  • general feeling of discomfort
  • increased thirst
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • light-colored stools
  • lower back or side pain
  • mood changes
  • muscle pain, cramps, or stiffness
  • nausea, vomiting or diarrhea
  • numbness or tingling in the hands, feet, or lips
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • skin rash, hives, or itching
  • sleepiness
  • swelling of the face, fingers, or lower legs
  • tightness in the chest
  • trouble breathing
  • unusual tiredness or weakness
  • weight gain
  • yellow eyes and skin

Minor Side Effects

Some cobicistat / elvitegravir / emtricitabine / tenofovir side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

More common:
  • Abnormal dreams
  • headache
Less common:
  • Bloated
  • full feeling
  • passing gas
  • trouble sleeping
  • unusual drowsiness
Incidence not known:
  • Chills
  • constipation
  • indigestion
  • lack or loss of strength
  • pains in the stomach, side, or abdomen, possibly radiating to the back

For Healthcare Professionals

Applies to cobicistat / elvitegravir / emtricitabine / tenofovir: oral tablet

General

In clinical trials, the most common side effects reported with cobicistat / elvitegravir / emtricitabine / tenofovir alafenamide were nausea, diarrhea, and headache. The safety profiles in patients with mild to moderate renal dysfunction and patients coinfected with HIV and hepatitis B virus were similar to safety profiles in patients with normal renal function and patients with HIV-1 monoinfection, respectively.

The most common side effects reported in clinical trials with cobicistat / elvitegravir / emtricitabine / tenofovir disoproxil fumarate (DF) were nausea, diarrhea, upper respiratory tract infection, and depression in therapy-naive patients and nausea and fatigue in virologically-suppressed patients.

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

Genitourinary

Cobicistat / elvitegravir / emtricitabine / tenofovir alafenamide:
-Common (1% to 10%): Hematuria

Cobicistat / elvitegravir / emtricitabine / tenofovir DF:
-Very common (10% or more): Proteinuria (up to 52%)
-Common (1% to 10%): Hematuria

Emtricitabine or tenofovir DF:
-Frequency not reported: Glycosuria

Tenofovir DF:
-Postmarketing reports: Proteinuria, polyuria[Ref]

Hematuria (greater than 75 RBC/high power field) has been reported in up to 3% and up to 4% of patients using cobicistat / elvitegravir / emtricitabine / tenofovir alafenamide and cobicistat / elvitegravir / emtricitabine / tenofovir DF, respectively. Proteinuria (all grades) has been reported in up to 52% of patients using cobicistat / elvitegravir / emtricitabine / tenofovir DF.

Glycosuria (3+ or greater) was reported with emtricitabine or tenofovir DF.[Ref]

Gastrointestinal

Cobicistat / elvitegravir / emtricitabine / tenofovir alafenamide:
-Very common (10% or more): Nausea
-Common (1% to 10%): Diarrhea, vomiting, abdominal pain, flatulence
-Uncommon (0.1% to 1%): Dyspepsia

Cobicistat / elvitegravir / emtricitabine / tenofovir DF:
-Very common (10% or more): Elevated lipase (up to 17%), Nausea (up to 16%), diarrhea (up to 12%), vomiting
-Common (1% to 10%): Flatulence, elevated amylase, abdominal pain, dyspepsia, constipation

Emtricitabine or tenofovir DF:
-Common (1% to 10%): Dyspepsia, vomiting

Tenofovir DF:
-Common (1% to 10%): Elevated amylase (including elevated pancreatic amylase), elevated serum lipase, abdominal distension
-Uncommon (0.1% to 1%): Pancreatitis
-Postmarketing reports: Abdominal pain[Ref]

Elevated amylase (greater than 2 times the upper limit of normal [2 x ULN]) was reported in up to 2% and up to 4% of patients using cobicistat / elvitegravir / emtricitabine / tenofovir alafenamide and cobicistat / elvitegravir / emtricitabine / tenofovir DF, respectively. If serum amylase was greater than 1.5 x ULN in those using cobicistat / elvitegravir / emtricitabine / tenofovir DF, lipase was also measured; elevated lipase (grades 3 to 4) has been reported in 17% of patients using cobicistat / elvitegravir / emtricitabine / tenofovir DF.

Dyspepsia and vomiting have been reported in at least 5% of patients receiving emtricitabine or tenofovir DF with other antiretroviral drugs in other clinical trials.

Elevated amylase (including elevated pancreatic amylase), elevated serum lipase, abdominal distension, and pancreatitis were reported in clinical trials or during postmarketing experience for tenofovir DF with other antiretrovirals.

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

Musculoskeletal

In clinical trials, a significant decline in BMD was seen in 15% of therapy-naive HIV-1-infected patients using cobicistat / elvitegravir / emtricitabine / tenofovir alafenamide; during comparison studies, BMD decreases were greater with cobicistat / elvitegravir / emtricitabine / tenofovir DF. In virologically-suppressed tenofovir DF-treated patients who switched to cobicistat / elvitegravir / emtricitabine / tenofovir alafenamide or who remained on initial regimen, mean BMD increased between baseline and week 48 in those who switched and decreased in those on initial regimen; decreased BMD was also reported in patients who switched to cobicistat / elvitegravir / emtricitabine / tenofovir alafenamide.

Elevated creatine kinase (at least 10 x ULN) has been reported in up to 9% and up to 8% of patients using cobicistat / elvitegravir / emtricitabine / tenofovir alafenamide and cobicistat / elvitegravir / emtricitabine / tenofovir DF, respectively.

Arthralgia, myalgia, and back pain have been reported in at least 5% of patients receiving emtricitabine or tenofovir DF with other antiretroviral drugs in other clinical trials.

Elevated creatine kinase, rhabdomyolysis, muscular weakness, osteomalacia (manifested as bone pain and infrequently contributing to fractures), and myopathy were reported in clinical trials or during postmarketing experience for tenofovir DF with other antiretrovirals.

Rhabdomyolysis, osteomalacia (manifested as bone pain and which may contribute to fractures), muscular weakness, and myopathy have also been reported during postmarketing experience with tenofovir DF.

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

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

Cobicistat / elvitegravir / emtricitabine / tenofovir DF:
-Common (1% to 10%): Elevated creatine kinase, bone fractures, arthralgia
-Frequency not reported: Decreased BMD, back pain

Emtricitabine or tenofovir DF:
-Common (1% to 10%): Arthralgia, myalgia, back pain

Tenofovir DF:
-Very common (10% or more): Elevated creatine kinase
-Uncommon (0.1% to 1%): Rhabdomyolysis, muscular weakness
-Rare (less than 0.1%): Osteomalacia (manifested as bone pain and infrequently contributing to fractures), myopathy
-Frequency not reported: Decreased BMD, increased biochemical markers of bone metabolism

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

Nervous system

Cobicistat / elvitegravir / emtricitabine / tenofovir alafenamide:
-Common (1% to 10%): Headache, dizziness

Cobicistat / elvitegravir / emtricitabine / tenofovir DF:
-Very common (10% or more): Headache, dizziness
-Common (1% to 10%): Somnolence

Emtricitabine or tenofovir DF:
-Common (1% to 10%): Paresthesia, peripheral neuropathy (including peripheral neuritis, neuropathy)[Ref]

Paresthesia and peripheral neuropathy (including peripheral neuritis and neuropathy) have been reported in at least 5% of patients receiving emtricitabine or tenofovir DF with other antiretroviral drugs in other clinical trials.[Ref]

Metabolic

During trials in therapy-naive patients, increases from baseline for the fasting lipid parameters (total cholesterol, direct LDL cholesterol, and HDL cholesterol) were observed with cobicistat / elvitegravir / emtricitabine / tenofovir alafenamide and cobicistat / elvitegravir / emtricitabine / tenofovir DF at 96 weeks of therapy; such increases were greater with cobicistat / elvitegravir / emtricitabine / tenofovir alafenamide.

Elevated fasting LDL cholesterol (greater than 190 mg/dL) and elevated fasting total cholesterol (greater than 300 mg/dL) have been reported in up to 8% and up to 3%, respectively, of patients using cobicistat / elvitegravir / emtricitabine / tenofovir alafenamide and up to 4% and up to 2%, respectively, of patients using cobicistat / elvitegravir / emtricitabine / tenofovir DF.

In clinical trials, the following mean increases in fasting lipid values were reported after 96 weeks of therapy: total cholesterol increased by 31 mg/dL, LDL cholesterol by 18 mg/dL, HDL cholesterol by 7 mg/dL, and triglycerides by 31 mg/dL with cobicistat / elvitegravir / emtricitabine / tenofovir alafenamide and total cholesterol increased by 15 mg/dL, LDL cholesterol by 7 mg/dL, HDL cholesterol by 4 mg/dL, and triglycerides by 13 mg/dL with cobicistat / elvitegravir / emtricitabine / tenofovir DF.

Elevated alkaline phosphatase (greater than 550 units/L), altered serum glucose (less than 40 mg/dL or greater than 250 mg/dL), elevated fasting cholesterol (greater than 240 mg/dL), and elevated fasting triglycerides (greater than 750 mg/dL) have been reported in patients receiving emtricitabine or tenofovir DF with other antiretroviral drugs in other clinical trials.

Hypophosphatemia, hyperglycemia, hypertriglyceridemia, hypokalemia, and lactic acidosis were reported in clinical trials or during postmarketing experience for tenofovir DF with other antiretrovirals.

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

Cobicistat / elvitegravir / emtricitabine / tenofovir alafenamide:
-Common (1% to 10%): Increased fasting low-density lipoprotein (LDL) cholesterol, increased fasting total cholesterol
-Frequency not reported: Increased high-density lipoprotein (HDL) cholesterol, increased triglycerides

Cobicistat / elvitegravir / emtricitabine / tenofovir DF:
-Common (1% to 10%): Decreased appetite, increased fasting LDL cholesterol
-Uncommon (0.1% to 1%): Elevated fasting total cholesterol, elevated fasting triglycerides, increased HDL cholesterol

Emtricitabine or tenofovir DF:
-Frequency not reported: Elevated alkaline phosphatase, altered serum glucose, elevated fasting cholesterol, elevated fasting triglycerides

Tenofovir DF:
-Very common (10% or more): Hypophosphatemia
-Common (1% to 10%): Hyperglycemia, hypertriglyceridemia
-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]

Other

Cobicistat / elvitegravir / emtricitabine / tenofovir alafenamide:
-Common (1% to 10%): Fatigue

Cobicistat / elvitegravir / emtricitabine / tenofovir DF:
-Common (1% to 10%): Fatigue

Emtricitabine or tenofovir DF:
-Common (1% to 10%): Abdominal pain, fever, pain

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]

Abdominal pain, fever, and pain have been reported in at least 5% of patients receiving emtricitabine or tenofovir DF with other antiretroviral drugs in other clinical trials.

Asthenia and pain were reported in clinical trials or during postmarketing experience for tenofovir DF with other antiretrovirals.

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

Psychiatric

Suicidal ideation and suicide attempt were reported with cobicistat / elvitegravir / emtricitabine / tenofovir DF in patients with history of depression or psychiatric illness.

Depression was reported in clinical trials for elvitegravir with other antiretrovirals.

Depression and anxiety have been reported in at least 5% of patients receiving emtricitabine or tenofovir DF with other antiretroviral drugs in other clinical trials.[Ref]

Cobicistat / elvitegravir / emtricitabine / tenofovir alafenamide:
-Common (1% to 10%): Abnormal dreams

Cobicistat / elvitegravir / emtricitabine / tenofovir DF:
-Common (1% to 10%): Abnormal dreams, insomnia, depression
-Uncommon (0.1% to 1%): Suicidal ideation, suicide attempt

Elvitegravir:
-Uncommon (0.1% to 1%): Depression

Emtricitabine or tenofovir DF:
-Common (1% to 10%): Depression, anxiety[Ref]

Renal

In clinical trials of cobicistat / elvitegravir / emtricitabine / tenofovir alafenamide, increases in serum creatinine occurred by the second week of therapy and was stable through 96 weeks. In therapy-naive patients, the change from baseline averaged 0.04 mg/dL (3.5 mcmol/L) after 96 weeks of therapy. Increases from baseline were smaller with cobicistat / elvitegravir / emtricitabine / tenofovir alafenamide than increases with cobicistat / elvitegravir / emtricitabine / tenofovir DF at 96 weeks.

During a trial in HIV-1-infected patients with eGFR 30 to 60 mL/min, renal dysfunction worsened in 2 of 80 patients with eGFR less than 50 mL/min and cobicistat / elvitegravir / emtricitabine / tenofovir alafenamide was discontinued. Transient acute renal failure was reported in 1 patient with eGFR over 50 mL/min.

In 2 trials in therapy-naive HIV-1-infected patients (median eGFR 115 mL/min at baseline), mean serum creatinine increased by 0.1 mg/dL from baseline to week 48 with cobicistat / elvitegravir / emtricitabine / tenofovir alafenamide and cobicistat / elvitegravir / emtricitabine / tenofovir DF; median UPCR was 44 mg/g at baseline and week 48 with cobicistat / elvitegravir / emtricitabine / tenofovir alafenamide and 44 mg/g and 55 mg/g at baseline and week 48, respectively with cobicistat / elvitegravir / emtricitabine / tenofovir DF. In a trial in virologically-suppressed tenofovir DF-treated patients (mean eGFR 112 mL/min at baseline) who switched to cobicistat / elvitegravir / emtricitabine / tenofovir alafenamide or who remained on initial regimen, mean serum creatinine was similar to baseline for both; median UPCR was 61 mg/g at baseline and 46 mg/g at week 48 in those who switched to cobicistat / elvitegravir / emtricitabine / tenofovir alafenamide and 60 mg/g at baseline and 63 mg/g at week 48 in those who remained on initial regimen. In a trial in renal dysfunction patients (baseline eGFR 30 to 69 mL/min) using cobicistat / elvitegravir / emtricitabine / tenofovir alafenamide, 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.

Elevated serum creatinine (all grades) has been reported in 10% of patients using cobicistat / elvitegravir / emtricitabine / tenofovir DF.

In clinical trials, decreases in estimated CrCl occurred early during cobicistat / elvitegravir / emtricitabine / tenofovir DF therapy. The change in eGFR averaged -14 mL/min after 144 weeks of therapy.

In a clinical trial in HIV-1-infected therapy-naive patients with mild to moderate renal dysfunction (eGFR between 50 and 89 mL/min), the change in serum creatinine and eGFR averaged 0.17 mg/dL and -6.9 mL/min, respectively, for cobicistat / elvitegravir / emtricitabine / tenofovir DF.

Acute tubular necrosis, nephritis (including acute interstitial nephritis), and nephrogenic diabetes insipidus were reported in clinical trials or during postmarketing experience for tenofovir DF with other antiretrovirals.

Acute tubular necrosis and nephrogenic diabetes insipidus have also been reported during postmarketing experience with tenofovir DF.

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.[Ref]

Cobicistat / elvitegravir / emtricitabine / tenofovir alafenamide:
-Frequency not reported: Increased serum creatinine, worsening renal dysfunction, transient acute renal failure, decreased urine protein-to-creatinine ratio (UPCR), worsening renal function

Cobicistat / elvitegravir / emtricitabine / tenofovir DF:
-Common (1% to 10%): Elevated serum creatinine
-Uncommon (0.1% to 1%): Renal failure, proximal renal tubulopathy, Fanconi syndrome acquired
-Frequency not reported: New onset or worsening renal impairment (including acute renal failure, Fanconi syndrome), laboratory findings consistent with proximal renal tubular dysfunction, decreased estimated CrCl, decreased estimated glomerular filtration rate (eGFR), increased UPCR

Cobicistat:
-Frequency not reported: Increased serum creatinine, decreased estimated CrCl, tubular secretion of creatinine inhibited (renal glomerular function not affected)

Tenofovir DF:
-Rare (less than 0.1%): Acute tubular necrosis, nephritis (including acute interstitial nephritis), nephrogenic diabetes insipidus
-Postmarketing reports: Renal insufficiency, acute renal failure, renal failure, Fanconi syndrome, proximal renal tubulopathy, increased creatinine, interstitial nephritis (including acute cases)[Ref]

Dermatologic

Vesiculobullous rash, pustular rash, maculopapular rash, pruritus, urticaria, skin discoloration (increased pigmentation), and angioedema were reported in clinical trials or during postmarketing experience for tenofovir DF with other antiretrovirals.[Ref]

Cobicistat / elvitegravir / emtricitabine / tenofovir alafenamide:
-Common (1% to 10%): Rash
-Uncommon (0.1% to 1%): Pruritus

Cobicistat / elvitegravir / emtricitabine / tenofovir DF:
-Common (1% to 10%): Rash (rash event includes dermatitis, drug eruption, eczema, pruritus, generalized pruritus, rash, erythematous rash, generalized rash, macular rash, maculopapular rash, morbilliform rash, papular rash, pruritic rash, urticaria)

Emtricitabine:
-Frequency not reported: Skin discoloration (palmar-plantar hyperpigmentation)
-Postmarketing reports: Angioedema (uncommon)

Tenofovir DF:
-Common (1% to 10%): Vesiculobullous rash, pustular rash, maculopapular rash, pruritus, urticaria, skin discoloration (increased pigmentation)
-Uncommon (0.1% to 1%): Angioedema
-Postmarketing reports: Rash[Ref]

Hepatic

Elevated AST (greater than 5 x ULN) has been reported in 2% and up to 3% of patients using cobicistat / elvitegravir / emtricitabine / tenofovir alafenamide and cobicistat / elvitegravir / emtricitabine / tenofovir DF, respectively. Elevated ALT (greater than 3 x ULN) has been reported in 2% of patients using cobicistat / elvitegravir / emtricitabine / tenofovir DF.

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.

Elevated ALT (greater than 215 units/L in males and 170 units/L in females) and elevated bilirubin (greater than 2.5 x ULN) have been reported in patients receiving emtricitabine or tenofovir DF with other antiretroviral drugs in other clinical trials.

Increased transaminases, hyperbilirubinemia, hepatic steatosis, and hepatitis were reported in clinical trials or during postmarketing experience for tenofovir DF with other antiretrovirals.

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

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

Cobicistat / elvitegravir / emtricitabine / tenofovir alafenamide:
-Common (1% to 10%): Elevated AST

Cobicistat / elvitegravir / emtricitabine / tenofovir DF:
-Common (1% to 10%): Elevated AST, elevated ALT

Emtricitabine:
-Frequency not reported: Liver failure, liver decompensation

Emtricitabine or tenofovir DF:
-Frequency not reported: Severe acute exacerbations of hepatitis B, elevated ALT, elevated bilirubin

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

Respiratory

Cobicistat / elvitegravir / emtricitabine / tenofovir DF:
-Common (1% to 10%): Upper respiratory tract infection, bronchitis

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

Tenofovir DF:
-Postmarketing reports: Dyspnea[Ref]

Nasopharyngitis, pneumonia, sinusitis, upper respiratory tract infection, increased cough, and rhinitis have been reported in at least 5% of patients receiving emtricitabine or tenofovir DF with other antiretroviral drugs in other clinical trials.[Ref]

Ocular

Cobicistat / elvitegravir / emtricitabine / tenofovir DF:
-Uncommon (0.1% to 1%): Ocular icterus[Ref]

Immunologic

Cobicistat / elvitegravir / emtricitabine / 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

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

Hematologic

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

Emtricitabine:
-Uncommon (0.1% to 1%): Anemia

Tenofovir DF:
-Common (1% to 10%): Neutropenia
-Uncommon (0.1% to 1%): Anemia[Ref]

Decreased neutrophils (less than 750/mm3) have been reported in patients receiving emtricitabine or tenofovir DF with other antiretroviral drugs in other clinical trials.

Anemia was reported in clinical trials or during postmarketing experience for emtricitabine with other antiretrovirals.

Neutropenia and anemia were reported in clinical trials or during postmarketing experience for tenofovir DF with other antiretrovirals.[Ref]

Hypersensitivity

Allergic reaction was reported in clinical trials or during postmarketing experience for tenofovir DF with other antiretrovirals.

Allergic reaction (including angioedema) has also been reported during postmarketing experience with tenofovir DF.[Ref]

Tenofovir DF:
-Common (1% to 10%): Allergic reaction[Ref]

Endocrine

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

References

1. "Product Information. Genvoya (cobicistat/elvitegravir/emtricitabine/tenofov)." Gilead Sciences, Foster City, CA.

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

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

4. "Product Information. Stribild (cobicistat/elvitegravir/emtricitabine/tenofov)." Gilead Sciences, Foster City, CA.

5. "A 4-drug combination (stribild) for HIV." Med Lett Drugs Ther 54 (2012): 95-6

6. Olin JL, Spooner LM, Klibanov OM "Elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate single tablet for HIV-1 infection treatment." Ann Pharmacother 46 (2012): 1671-7

It is possible that some side effects of Stribild may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

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