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.

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.

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.

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 pain
  • bloody urine
  • bone fractures
  • bone pain
  • change in urination
  • convulsions
  • cough
  • decreased appetite
  • difficulty swallowing
  • dizziness
  • dry mouth
  • fast or irregular heartbeat
  • 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 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

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 were nausea, diarrhea, and headache in therapy-naive patients and nausea and fatigue in virologically-suppressed patients.[Ref]

Genitourinary

Proteinuria (all grades) and hematuria (greater than 75 RBC/high power field) have been reported in up to 52% and 4% of patients, respectively.

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

Very common (10% or more): Proteinuria (up to 52%)
Common (1% to 10%): Hematuria

Emtricitabine or tenofovir:
-Frequency not reported: Glycosuria

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

Gastrointestinal

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:
-Common (1% to 10%): Dyspepsia, vomiting, elevated amylase (including elevated pancreatic amylase), elevated serum lipase, abdominal distension
-Uncommon (0.1% to 1%): Pancreatitis

Tenofovir:
-Postmarketing reports: Pancreatitis, increased amylase, abdominal pain[Ref]

Elevated amylase (greater than 2 times the upper limit of normal [2 x ULN]) was reported in 3% of patients.

If serum amylase was greater than 1.5 x ULN, lipase was also measured. Elevated lipase (grades 3 to 4) has been reported in 17% of patients.

Dyspepsia and vomiting have been reported in at least 5% of patients receiving emtricitabine or tenofovir 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 emtricitabine or tenofovir with other antiretrovirals.[Ref]

Nervous system

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

Emtricitabine or tenofovir:
-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 with other antiretroviral drugs in other clinical trials.[Ref]

Metabolic

Common (1% to 10%): Decreased appetite
Uncommon (0.1% to 1%): Elevated fasting cholesterol, elevated fasting triglycerides

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

Tenofovir:
-Postmarketing reports: Lactic acidosis, hypokalemia, hypophosphatemia

Combination antiretroviral therapy:
-Frequency not reported: Metabolic abnormalities (e.g., hypertriglyceridemia, hypercholesterolemia, insulin resistance, hyperglycemia, hyperlactatemia), redistribution/accumulation of body fat (including central obesity, dorsocervical fat enlargement, peripheral wasting, facial wasting, breast enlargement, "cushingoid appearance")[Ref]

Elevated fasting cholesterol (greater than 300 mg/dL) and elevated fasting triglycerides (greater than 750 mg/dL) have been reported in up to 1% of patients.

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

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.

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 with other antiretroviral drugs in other clinical trials.[Ref]

Musculoskeletal

Common (1% to 10%): Elevated creatine kinase, bone fractures, back pain
Frequency not reported: Decreased bone mineral density

Emtricitabine or tenofovir:
-Very common (10% or more): Elevated creatine kinase
-Common (1% to 10%): Arthralgia, myalgia
-Uncommon (0.1% to 1%): Rhabdomyolysis, muscular weakness
-Rare (less than 0.1%): Osteomalacia (manifested as bone pain and infrequently contributing to fractures), myopathy

Tenofovir:
-Frequency not reported: Decreased bone mineral density, increased biochemical markers of bone metabolism
-Postmarketing reports: Rhabdomyolysis, osteomalacia (manifested as bone pain and which may contribute to fractures), muscular weakness, myopathy

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

Elevated creatine kinase (at least 10 x ULN) has been reported in 8% of patients.

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 emtricitabine or tenofovir with other antiretrovirals.

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

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

Other

Common (1% to 10%): Fatigue

Emtricitabine or tenofovir:
-Very common (10% or more): Asthenia
-Common (1% to 10%): Abdominal pain, fever, pain, back pain

Tenofovir:
-Frequency not reported: Higher 1,25 vitamin D levels
-Postmarketing reports: Asthenia[Ref]

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

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

Psychiatric

Suicidal ideation and suicide attempt were reported in patients with history of depression or psychiatric illness.

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

Common (1% to 10%): Abnormal dreams, insomnia, depression
Uncommon (0.1% to 1%): Suicidal ideation, suicide attempt

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

Renal

Elevated serum creatinine (all grades) has been reported in 10% of patients.

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

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

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)

Emtricitabine or tenofovir:
-Rare (less than 0.1%): Acute tubular necrosis, nephritis (including acute interstitial nephritis), nephrogenic diabetes insipidus

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

Tenofovir:
-Postmarketing reports: Renal insufficiency, acute renal failure, renal failure, Fanconi syndrome, proximal renal tubulopathy, increased creatinine, nephrogenic diabetes insipidus, acute tubular necrosis, 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 emtricitabine or tenofovir with other antiretrovirals.[Ref]

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 or tenofovir:
-Common (1% to 10%): Vesiculobullous rash, pustular rash, maculopapular rash, pruritus, urticaria, skin discoloration (increased pigmentation)
-Uncommon (0.1% to 1%): Angioedema

Emtricitabine:
-Frequency not reported: Skin discoloration (palmar-plantar hyperpigmentation)

Tenofovir:
-Postmarketing reports: Rash[Ref]

Hepatic

Elevated AST (greater than 5 x ULN) and ALT (greater than 3 x ULN) have been reported in 3% and 2% of patients, respectively.

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

Severe acute exacerbations of hepatitis B have been reported in patients coinfected with HBV and HIV-1 after discontinuation of emtricitabine or tenofovir 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 with other antiretroviral drugs in other clinical trials.

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

Common (1% to 10%): Elevated AST, elevated ALT

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

Emtricitabine or tenofovir:
-Common (1% to 10%): Increased transaminases, hyperbilirubinemia
-Rare (less than 0.1%): Hepatic steatosis, hepatitis
-Frequency not reported: Severe acute exacerbations of hepatitis B, elevated ALT, elevated bilirubin

Tenofovir:
-Frequency not reported: Lactic acidosis/severe hepatomegaly with steatosis
-Postmarketing reports: Hepatic steatosis, hepatitis, increased liver enzymes (primarily AST, ALT, GGT)[Ref]

Respiratory

Common (1% to 10%): Upper respiratory tract infection, bronchitis

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

Tenofovir:
-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 with other antiretroviral drugs in other clinical trials.[Ref]

Ocular

Uncommon (0.1% to 1%): Ocular icterus[Ref]

Immunologic

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:
-Postmarketing reports: Immune reconstitution syndrome[Ref]

Hematologic

Emtricitabine or tenofovir:
-Common (1% to 10%): Neutropenia
-Uncommon (0.1% to 1%): Anemia
-Frequency not reported: Decreased neutrophils[Ref]

Neutropenia and anemia were reported in clinical trials or during postmarketing experience for emtricitabine or tenofovir with other antiretrovirals.

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

Hypersensitivity

Allergic reaction was reported in clinical trials or during postmarketing experience for emtricitabine or tenofovir with other antiretrovirals.[Ref]

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

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

Endocrine

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

References

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

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

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

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

5. 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

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