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Cobicistat Side Effects

For the Consumer

Applies to cobicistat: oral tablet

Along with its needed effects, cobicistat 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:

Less Common

  • Bloody urine
  • chills
  • clay-colored stools
  • dark urine
  • decreased frequency or amount of urine
  • dizziness
  • fast heartbeat
  • fever
  • headache
  • hives or welts, itching, rash
  • hoarseness
  • increased thirst
  • irritation
  • joint pain, stiffness, or swelling
  • loss of appetite
  • lower back or side pain
  • nausea
  • pain in the groin or genitals
  • redness of the skin
  • sharp back pain just below the ribs
  • stomach pain
  • swelling of the eyelids, face, lips, hands, lower legs, or feet
  • tightness in the chest
  • troubled breathing or swallowing
  • unpleasant breath odor
  • unusual tiredness or weakness
  • vomiting
  • vomiting of blood
  • weight gain
  • yellow eyes or skin

Less Common

  • Muscle pain, stiffness, cramps, or spasms

Some side effects of cobicistat 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:

Less Common

  • Diarrhea
  • discouragement
  • feeling sad or empty
  • irritable
  • loss of interest or pleasure
  • trouble concentrating
  • trouble sleeping
  • upper abdominal or stomach pain

For Healthcare Professionals

Applies to cobicistat: oral tablet

General

In a clinical trial, safety of this drug was evaluated in therapy-naive patients using cobicistat-boosted atazanavir with emtricitabine-tenofovir. The most commonly reported side effects were associated with elevated bilirubin levels including jaundice, ocular icterus, and nausea. Study drug was discontinued due to side effects in 7% of patients in the cobicistat-boosted group; 4.9% discontinued due to bilirubin-related side effects.[Ref]

Hepatic

In 1 clinical trial, hyperbilirubinemia (greater than 1 times the upper limit of normal [1 x ULN]) was reported in 97.7% of patients in the cobicistat-boosted atazanavir group and 97.4% in the ritonavir-boosted atazanavir group. Increases in total bilirubin greater than 2 x ULN was reported in 85.7% of patients in the cobicistat-boosted group and 77.7% in the ritonavir-boosted group. Increases in total bilirubin greater than 2.5 x ULN was reported in 65% of patients in the cobicistat-boosted group and 56% in the ritonavir-boosted group. Increased ALT or AST (greater than 3 x ULN) was reported in 12% of patients in the cobicistat-boosted group and 8.7% in the ritonavir-boosted group. Increased ALT (greater than 5 x ULN), AST (greater than 5 x ULN), and GGT (greater than 5 x ULN) were reported in 3%, 3%, and 2% of patients in the cobicistat-boosted group, respectively.[Ref]

Very common (10% or more): Hyperbilirubinemia, increased total bilirubin, jaundice (up to 13%), increased ALT or AST

Common (1% to 10%): Increased ALT, increased AST, increased GGT[Ref]

Ocular

Very common (10% or more): Ocular icterus (up to 15%)[Ref]

Gastrointestinal

Increased serum amylase (greater than 2 x ULN) was reported in up to 4% of patients in the cobicistat-boosted group.

If serum amylase was greater than 1.5 x ULN, lipase was also measured. Increased lipase (grades 3 to 4) was reported in up to 9% of patients in the cobicistat-boosted group.[Ref]

Very common (10% or more): Nausea (up to 12%)

Common (1% to 10%): Vomiting, diarrhea, dyspepsia, abdominal pain, abdominal distension, flatulence, dry mouth, increased lipase, increased serum amylase

Frequency not reported: Upper abdominal pain[Ref]

Musculoskeletal

Common (1% to 10%): Increased creatine kinase

Uncommon (0.1% to 1%): Myalgia

Frequency not reported: Rhabdomyolysis[Ref]

Increased creatine kinase (at least 10 x ULN) was reported in up to 6% of patients in the cobicistat-boosted group.[Ref]

Genitourinary

Increased urine RBC (greater than 75 RBC/high power field) and urine glucose (at least 1000 mg/dL) have been reported in up to 4% and 3% of patients in the cobicistat-boosted group, respectively.[Ref]

Common (1% to 10%): Hematuria (increased urine RBC), glycosuria (increased urine glucose)

Uncommon (0.1% to 1%): Proteinuria[Ref]

Renal

Nephrolithiasis has been reported with atazanavir. In clinical trials, nephrolithiasis was reported in 2% of patients in the cobicistat-boosted group and no patients in the ritonavir-boosted group. Onset of nephrolithiasis was about 24 weeks.

Renal impairment (including acute renal failure and Fanconi syndrome) has been reported when this drug was used in regimen containing tenofovir.[Ref]

Common (1% to 10%): Nephrolithiasis

Frequency not reported: Decreased estimated CrCl, increased serum creatinine, tubular secretion of creatinine inhibited (actual renal glomerular function not affected), renal impairment (including acute renal failure, Fanconi syndrome), nephropathy, Fanconi syndrome acquired[Ref]

Nervous system

Common (1% to 10%): Headache, dizziness, somnolence, dysgeusia[Ref]

Metabolic

Common (1% to 10%): Hyperglycemia, increased appetite

Frequency not reported: Increased fasted total cholesterol, increased fasted high-density lipoprotein cholesterol, increased fasted low-density lipoprotein cholesterol, increased fasted triglycerides[Ref]

Other

Common (1% to 10%): Fatigue

Uncommon (0.1% to 1%): Pyrexia, asthenia[Ref]

Psychiatric

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

Uncommon (0.1% to 1%): Depression, sleep disorder[Ref]

Dermatologic

Common (1% to 10%): Rash (rash events included allergic dermatitis, drug hypersensitivity, generalized pruritus, eosinophilic pustular folliculitis, rash, generalized rash, macular rash, maculopapular rash, morbilliform rash, papular rash, urticaria)

Uncommon (0.1% to 1%): Pruritus[Ref]

References

1. EMEA. European Medicines Agency "EPARs. European Union Public Assessment Reports. Available from: URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/includes/medicines/medicines_landingpage.jsp&mid."

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

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

4. "Product Information. Tybost (cobicistat)." Gilead Sciences, Foster City, CA.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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