Stribild Side Effects

Generic name: cobicistat / elvitegravir / emtricitabine / tenofovir

Note: This document contains side effect information about cobicistat / elvitegravir / emtricitabine / tenofovir. Some of the dosage forms listed on this page may not apply to the brand name Stribild.

Some side effects of Stribild may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

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

Along with its needed effects, cobicistat / elvitegravir / emtricitabine / tenofovir may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking cobicistat / elvitegravir / emtricitabine / tenofovir:

• Cloudy urine

• 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 side effects of cobicistat / elvitegravir / emtricitabine / tenofovir may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Abnormal dreams
• headache

• Bloated
• full feeling
• passing gas
• trouble sleeping
• unusual drowsiness

• 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

Genitourinary

Cobicistat / elvitegravir / emtricitabine / tenofovir:
Very common (10% or more): Proteinuria (all grades; 39%)

Emtricitabine or tenofovir:
Frequency not reported: Glycosuria (greater than or equal to 3 +)

Tenofovir:
Postmarketing reports: Proteinuria, polyuria

Gastrointestinal

A lipase test was performed in subjects with serum amylase greater than 1.5 times ULN.

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

Cobicistat / elvitegravir / emtricitabine / tenofovir:
Very common (10% or more): Nausea (16%), diarrhea (12%)
Common (1% to 10%): Elevated lipase (Grades 3 to 4; 12%), flatulence (2%), elevated amylase (greater than 2 times ULN; 2%)

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

Tenofovir:
Postmarketing reports: Pancreatitis, increased amylase, abdominal pain

Psychiatric

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

Cobicistat / elvitegravir / emtricitabine / tenofovir:
Common (1% to 10%): Abnormal dreams (9%), insomnia (3%)

Emtricitabine or tenofovir:
Common (1% to 10%): Depression, anxiety

Renal

Cobicistat / elvitegravir / emtricitabine / tenofovir:
Common (1% to 10%): Elevated serum creatinine (all grades; 7%)
Frequency not reported: New onset or worsening renal impairment (including acute renal failure, Fanconi syndrome)

Cobicistat:
Frequency not reported: Increased serum creatinine, decreased estimated creatinine clearance

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)

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

Nervous system

Cobicistat / elvitegravir / emtricitabine / tenofovir:
Common (1% to 10%): Headache (7%), dizziness (3%), somnolence (1%)

Emtricitabine or tenofovir:
Common (1% to 10%): Paresthesia, peripheral neuropathy (including peripheral neuritis, neuropathy)

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.

Musculoskeletal

Cobicistat / elvitegravir / emtricitabine / tenofovir:
Common (1% to 10%): Elevated creatine kinase (greater than or equal to 10 times ULN; 5%)

Emtricitabine or tenofovir:
Common (1% to 10%): Arthralgia, myalgia

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

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.

Other

Cobicistat / elvitegravir / emtricitabine / tenofovir:
Common (1% to 10%): Fatigue (5%)

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

Tenofovir:
Postmarketing reports: Asthenia

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.

Dermatologic

Cobicistat / elvitegravir / emtricitabine / tenofovir:
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, popular rash, pruritic rash, urticaria; 3%)

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

Tenofovir:
Postmarketing reports: Rash

Hepatic

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.

Lactic acidosis and severe hepatomegaly with steatosis (including fatal cases) have been reported with the use of nucleoside analogs, including tenofovir, in combination with other antiretroviral agents.

Cobicistat / elvitegravir / emtricitabine / tenofovir:
Common (1% to 10%): Elevated AST (greater than 5 times ULN; 2%)

Emtricitabine:
Frequency not reported: Liver failure, liver decompensation

Emtricitabine or tenofovir:
Frequency not reported: Severe acute exacerbations of hepatitis B, elevated ALT (greater than 215 units/L in males and 170 units/L in females), elevated bilirubin (greater than 2.5 times ULN)

Tenofovir:
Frequency not reported: Lactic acidosis/severe hepatomegaly with steatosis
Postmarketing reports: Hepatic steatosis, hepatitis, increased liver enzymes (primarily AST, ALT, gamma glutamyltransferase)

Metabolic

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

Cobicistat / elvitegravir / emtricitabine / tenofovir:
Uncommon (0.1% to 1%): Elevated fasting cholesterol (greater than 300 mg/dL; 1% or less), elevated fasting triglycerides (greater than 750 mg/dL; 1% or less)

Emtricitabine or tenofovir:
Frequency not reported: 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), elevated fasting triglycerides (greater than 750 mg/dL)

Tenofovir:
Postmarketing reports: Lactic acidosis, hypokalemia, hypophosphatemia

Ocular

Cobicistat / elvitegravir / emtricitabine / tenofovir:
Uncommon (0.1% to 1%): Ocular icterus (less than 1%)

Immunologic

Cobicistat / elvitegravir / emtricitabine / tenofovir:
Frequency not reported: Immune reconstitution syndrome, autoimmune disorders in the setting of immune reconstitution (e.g., Graves' disease, polymyositis, and Guillain-Barre syndrome)

Respiratory

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.

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

Tenofovir:
Postmarketing reports: Dyspnea

Hematologic

Emtricitabine or tenofovir:
Frequency not reported: Decreased neutrophils (less than 750/mm3)

Hypersensitivity

Tenofovir:
Postmarketing reports: Allergic reaction (including angioedema)

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