Atazanavir (Reyataz): Uses, Side Effects and Dosage

What are atazanavir capsules ?

Atazanavir capsules are a prescription medicine that is used to treat human immunodeficiency virus-1 (HIV-1) infection, in combination with other HIV-1 medicines in adults and children at least 6 years of age and older and weighing at least 15 kg.

HIV-1 is the virus that causes AIDS (Acquired Immunodeficiency Syndrome).

Atazanavir capsules should not be used in children younger than 3 months of age.

Do not take atazanavir capsules if you:

• are allergic to atazanavir or any of the ingredients in atazanavir capsules. See the end of this leaflet for a complete list of ingredients in atazanavir capsules.

• are taking any of the following medicines. Taking atazanavir capsules with these medicines may affect how atazanavir capsules work. Atazanavir capsules may cause serious or life-threatening side effects, or death when used with these medicines:

  • alfuzosin
  • lurasidone (when atazanavir capsules are used with ritonavir)
  • amiodarone (when atazanavir capsules are used with ritonavir)
  • lomitapide
  • apalutamide
  • lovastatin
  • carbamazepine
  • midazolam, when taken by mouth for sedation
  • cisapride
  • nevirapine
  • elbasvir and grazoprevir
  • phenobarbital
  • encorafenib
  • phenytoin

  • ergot medicines including:

    • dihydroergotamine
    • ergonovine
    • ergonovine ergotamine
    • methylergonovine
  • pimozide
  • quinidine (when atazanavir capsules are used with ritonavir)
  • rifampin
  • sildenafil, when used for the treatment of pulmonary arterial hypertension
  • simvastatin
  • glecaprevir and pibrentasvir
  • St. John’s wort
  • indinavir
  • triazolam
  • irinotecan
  • ivosidenib

Before taking atazanavir capsules, tell your healthcare provider about all of your medical conditions, including if you:

• have heart problems
• have liver problems, including hepatitis B or C virus
• have kidney problems
• are receiving dialysis treatment
• have diabetes
• have hemophilia

• are pregnant or plan to become pregnant.

  • Atazanavir capsules must be taken with ritonavir during pregnancy.
  • Hormonal forms of birth control, such as injections, vaginal rings or implants, contraceptive patch, and some birth control pills may not work during treatment with atazanavir capsules. Talk to your healthcare provider about forms of birth control that may be used during treatment with atazanavir capsules.
  • Pregnancy Exposure Registry. There is a pregnancy exposure registry for people who take atazanavir capsules during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry.
  • After your baby is born , tell your healthcare provider if your baby’s skin or the white part of their eyes turns yellow.

• are breastfeeding or plan to breastfeed. Atazanavir can pass into your breast milk.

  • Talk to your healthcare provider about the following risks of breastfeeding during treatment with atazanavir capsules:

    • The HIV-1 virus may pass to your baby if your baby does not have the HIV-1 virus.
    • The HIV-1 virus may become harder to treat if your baby has the HIV-1 virus.
    • Your baby may get side effects from atazanavir capsules.

Tell your healthcare provider about all the medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Some medicines interact with atazanavir capsules. Keep a list of your medicines to show your healthcare provider and pharmacist.

• You can ask your healthcare provider or pharmacist for a list of medicines that interact with atazanavir capsules.
• Do not start taking a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to take atazanavir capsules with other medicines.

How should I take atazanavir capsules?

• Take atazanavir capsules exactly as your healthcare provider tells you to.
• Do not change your dose or stop taking atazanavir capsules unless your healthcare provider tells you to.
• Stay under the care of your healthcare provider during treatment with atazanavir capsules.
• Atazanavir capsules must be used with other HIV-1 medicines.
• Take atazanavir capsules 1 time each day.
• Atazanavir comes as capsules.
• Take atazanavir capsules with food.
• Swallow the capsules whole. Do not open the capsules.
• Your child’s healthcare provider will prescribe the right dose of atazanavir capsules based on your child’s weight.
• If you miss a dose of atazanavir capsules, take it as soon as you remember. Then take the next dose at your regular time. Do not take 2 doses at the same time.
• If you take too much atazanavir, call your healthcare provider or go to the nearest hospital emergency room right away.

When your supply of atazanavir capsules starts to run low , get more from your healthcare provider or pharmacy. It is important not to run out of atazanavir capsules. The amount of HIV-1 in your blood may increase if the medicine is stopped for even a short time. The virus may become resistant to atazanavir capsules and harder to treat.

What are the possible side effects of atazanavir capsules?

Atazanavir capsules can cause serious side effects, including:

• A change in the way your heart beats (heart rhythm change). Tell your healthcare provider right away if you get dizzy or lightheaded. These could be symptoms of a heart problem.

• Skin rash. Skin rash is common with atazanavir capsules but can sometimes be severe. Severe rash may develop with other symptoms which could be serious. If you develop a severe rash or a rash with any of the following symptoms, stop taking atazanavir capsules and call your healthcare provider or go to the nearest hospital emergency room right away:

  • general feeling of discomfort or “flu-like” symptoms
  • blisters
  • fever
  • mouth sores
  • muscle or joint aches
  • swelling of your face
  • red or inflamed eyes, like “pink eye” (conjunctivitis)
  • painful, warm, or red lump under your skin

• Liver problems. If you have liver problems, including hepatitis B or C virus, your liver problems may get worse when you take atazanavir capsules. Your healthcare provider will do blood tests to check your liver before you start atazanavir capsules and during treatment. Tell your healthcare provider right away if you get any of the following symptoms:

  • dark “tea-colored” urine
  • nausea
  • your skin or the white part of your eyes turns yellow
  • itching
  • light colored stools
  • stomach-area pain
• Chronic kidney disease. Atazanavir capsules may affect how well your kidneys work. Your healthcare provider will do blood and urine tests to check your kidneys before you start atazanavir capsules and during treatment. Drink plenty of fluids during treatment with atazanavir capsules.
• Kidney stones have happened in some people who take atazanavir capsules, and sometimes may lead to hospitalization. Tell your healthcare provider right away if you get symptoms of kidney stones which may include pain in your low back or low stomach area, blood in your urine, or pain when you urinate.

• Gallbladder stones have happened in some people who take atazanavir capsules, and sometimes may lead to hospitalization. Tell your healthcare provider right away if you get symptoms of a gallbladder problem which may include:

  • pain in the right or middle upper stomach area
  • nausea and vomiting
  • fever
  • your skin or the white part of your eyes turns yellow
• Yellowing of your skin or the white part of your eyes is common with atazanavir capsules but may be a symptom of a serious problem. These symptoms may be due to increases in bilirubin levels in your blood (bilirubin is made by the liver). Tell your healthcare provider right away if your skin or the white part of your eyes turns yellow.
• New or worsening diabetes and high blood sugar (hyperglycemia) have happened in some people who take protease inhibitor medicines like atazanavir capsules. Some people have had to start taking medicine to treat diabetes or have changes to their dose of their diabetes medicine. Tell your healthcare provider if you notice an increase in thirst or if you start urinating more often while taking atazanavir capsules.
• Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV-1 medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your healthcare provider if you start having new symptoms after starting atazanavir capsules.
• Changes in body fat can happen in people taking HIV-1 medicines. These changes may include increased amount of fat in the upper back and neck (“buffalo hump”), breast, and around the main part of your body (trunk). Loss of fat from the legs, arms, and face may also happen. The exact cause and long-term health effects of these conditions are not known.
• Increased bleeding problems in people with hemophilia have happened when taking protease inhibitors like atazanavir capsules.

The most common side effects of atazanavir capsules include:

• nausea
• dizziness
• headache
• muscle pain
• stomach-area pain
• diarrhea
• vomiting
• depression
• trouble sleeping
• fever
• numbness, tingling, or burning of hands or feet

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of atazanavir capsules. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store atazanavir capsules?

• Store atazanavir capsules at room temperature, between 20° to 25°C (68° to 77°F).
• Keep capsules in a tightly closed container.

Keep atazanavir capsules and all medicines out of the reach of children.

General information about the safe and effective use of atazanavir capsules

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use atazanavir capsules for a condition for which it was not prescribed. Do not give atazanavir capsules to other people, even if they have the same symptoms that you have. It may harm them. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about atazanavir capsules that is written for health professionals.

For more information, call Aurobindo Pharma USA, Inc. at 1-866-850-2876.

What are the ingredients in atazanavir capsules?

Active ingredient: atazanavir sulfate

Inactive ingredients: crospovidone, lactose monohydrate, and magnesium stearate. The capsule shells contain the following inactive ingredients: FD&C blue 2, gelatin, iron oxide black, iron oxide red, iron oxide yellow, and titanium dioxide. The capsules are printed with ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac, and titanium dioxide.

Distributed by:

Aurobindo Pharma USA, Inc.

279 Princeton-Hightstown Road

East Windsor, NJ 08520

Manufactured by:

Aurobindo Pharma Limited

Hyderabad-500 032, India

Brands listed are the trademarks of their respective owners and are not trademarks of Aurobindo Pharma Limited.

This Patient Information has been approved by the U.S. Food and Drug Administration.

Revised: 07/2025