Skip to main content

Evotaz Side Effects

Generic name: atazanavir / cobicistat

Medically reviewed by Drugs.com. Last updated on Nov 29, 2024.

Note: This document provides detailed information about Evotaz Side Effects associated with atazanavir / cobicistat. Some dosage forms listed on this page may not apply specifically to the brand name Evotaz.

Applies to atazanavir / cobicistat: oral tablet, tablet oral.

Serious side effects of Evotaz

Along with its needed effects, atazanavir / 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 atazanavir / cobicistat:

More common side effects

  • chills
  • clay-colored stools
  • dark urine
  • dizziness
  • fever
  • headache
  • itching, skin rash
  • loss of appetite
  • nausea
  • stomach pain
  • unpleasant breath odor
  • unusual tiredness or weakness
  • vomiting of blood
  • yellow eyes or skin

Incidence not known

  • black, tarry stools
  • blistering, peeling, or loosening of the skin
  • blood in the urine
  • chest pain
  • decreased appetite
  • diarrhea
  • gaseous stomach pain
  • joint or muscle pain
  • pain in the groin or genitals
  • painful or difficult urination
  • recurrent fever
  • red skin lesions, often with a purple center
  • red, irritated eyes
  • sharp back pain just below the ribs
  • sore throat
  • sores, ulcers, or white spots in the mouth or on the lips
  • stomach fullness or tenderness
  • swelling of the feet or lower legs
  • swollen glands
  • unusual bleeding or bruising

For healthcare professionals

Applies to atazanavir / cobicistat: oral tablet.

General adverse events

In a clinical trial (based on week 144 data), safety of this drug was evaluated in HIV-1-infected, antiretroviral therapy-naive patients using the individual components with other antiretrovirals. In this trial, patients received atazanavir and cobicistat with emtricitabine-tenofovir disoproxil fumarate (DF) (cobicistat-boosted group) or atazanavir and ritonavir with emtricitabine-tenofovir DF (ritonavir-boosted group). In the cobicistat-boosted group, the most commonly reported side effects were associated with elevated bilirubin levels; the most common side effects (grades 2 to 4) were jaundice and rash. Study treatment was discontinued due to side effects in 11% of patients in both the cobicistat- and the ritonavir-boosted groups. Most of the side effects included from clinical trials were of at least moderate intensity (grade 2 or higher).

The manufacturer product information for atazanavir and cobicistat should be consulted for additional safety information.[Ref]

Hepatic

Atazanavir:

In 1 study through 144 weeks of therapy, hyperbilirubinemia was reported in 97.7% and 97.4% of patients in the cobicistat-boosted and ritonavir-boosted groups, respectively; however, more patients in the cobicistat-boosted group had increases in total bilirubin greater than 2 times the upper limit of normal (2 x ULN) than patients in the ritonavir-boosted group (88% versus 80.9%). Study drug was discontinued due to bilirubin-related side effects in 4.9% and 4% of patients in the cobicistat-boosted and ritonavir-boosted groups, respectively. Increased ALT or AST greater than 3 x ULN was reported in 12.8% and 9% of patients in the cobicistat-boosted and ritonavir-boosted groups, respectively.

Increases in total bilirubin greater than 2.5 x ULN was reported in 73% and 66% of patients in the cobicistat-boosted and ritonavir-boosted groups, respectively. Increased ALT (greater than 5 x ULN), AST (greater than 5 x ULN), and GGT (greater than 5 x ULN) were reported in 6%, 4%, and 4% of patients in the cobicistat-boosted group, respectively, and 3%, 3%, and 2% of patients in the ritonavir-boosted group, respectively.

Jaundice (grades 2 to 4) was reported in 6% and 3% of patients in the cobicistat-boosted and ritonavir-boosted groups, respectively.

Most patients taking atazanavir experienced asymptomatic elevations in indirect (unconjugated) bilirubin related to inhibition of UGT. This hyperbilirubinemia was reversible upon discontinuation of atazanavir.[Ref]

Gastrointestinal

Atazanavir:

Nausea and diarrhea were reported in 2% and 2% of patients in the cobicistat-boosted group, respectively, and 2% and 1% of patients in the ritonavir-boosted group, respectively.

Increased serum amylase (greater than 2 x ULN) was reported in 4% and 2% of patients in the cobicistat-boosted and ritonavir-boosted groups, respectively.

If serum amylase was greater than 1.5 x ULN, lipase was also measured. Increased lipase (grades 3 to 4) was reported in 7% and 3% of patients in the cobicistat-boosted and ritonavir-boosted groups, respectively.[Ref]

Ocular

Ocular icterus (grades 2 to 4) was reported in 4% and 2% of patients in the cobicistat-boosted and ritonavir-boosted groups, respectively.[Ref]

Dermatologic

Atazanavir:

Rash events (grades 2 to 4) were reported in 5% and 4% of patients in the cobicistat-boosted and ritonavir-boosted groups, respectively.[Ref]

Musculoskeletal

Atazanavir:

Increased creatine kinase (at least 10 x ULN) was reported in 8% and 9% of patients in the cobicistat-boosted and ritonavir-boosted groups, respectively.[Ref]

Renal

Atazanavir:

Cobicistat:

In 1 study, serum creatinine increases and estimated CrCl decreases occurred early during therapy in the cobicistat-boosted group, after which they stabilized. After 144 weeks of therapy, eGFR (by Cockcroft-Gault method) change averaged -15.1 mL/min in the cobicistat-boosted group and -8 mL/min in the ritonavir-boosted group.

Renal impairment (including acute renal failure and Fanconi syndrome) has been reported when cobicistat was used in a regimen containing tenofovir DF.

In clinical trials over 144 weeks (n=692), 10 (2.9%) patients using atazanavir, cobicistat, and tenofovir DF discontinued therapy due to a renal side effect; 7 patients had laboratory findings consistent with proximal renal tubulopathy. One patient had baseline renal dysfunction (e.g., estimated CrCl less than 70 mL/min). Laboratory findings in these 7 patients improved but did not completely resolve in all patients when therapy was stopped. No patients required renal replacement therapy.

Postmarketing reports of chronic kidney disease in HIV-infected patients using atazanavir (with or without ritonavir) included biopsy-proven cases of granulomatous interstitial nephritis associated with deposition of atazanavir crystals in renal parenchyma.[Ref]

Genitourinary

Atazanavir:

Increased urine RBC (greater than 75 RBC/high power field) and urine glucose (at least 1000 mg/dL) were reported in 6% and 3% of patients in the cobicistat-boosted group, respectively, and 3% and 3% of patients in the ritonavir-boosted group, respectively.[Ref]

Metabolic

Atazanavir:

Combination antiretroviral therapy:

Antiretroviral therapy:

Increased serum glucose (at least 250 mg/dL) was reported in 2% and 2% of patients in the cobicistat-boosted and ritonavir-boosted groups, respectively.[Ref]

Nervous system

Headache (grades 2 to 4) was reported in 2% and 1% of patients in the cobicistat-boosted and ritonavir-boosted groups, respectively.[Ref]

Other

Atazanavir:

Antiretroviral therapy:

Psychiatric

Hematologic

Atazanavir:

Protease inhibitor therapy:

Decreased neutrophils (less than 750/mm3) were reported in 3% and 2% of patients in the cobicistat-boosted and ritonavir-boosted groups, respectively.[Ref]

Cardiovascular

Atazanavir:

Hypersensitivity

Respiratory

Endocrine

Immunologic

Atazanavir:

Combination antiretroviral therapy:

References

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

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

3. (2015) "Product Information. Evotaz (atazanavir-cobicistat)." Bristol-Myers Squibb

4. (2003) "Product Information. Reyataz (atazanavir)." Bristol-Myers Squibb

Further information

Evotaz side effects can vary depending on the individual. 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.