Ritonavir (Norvir): Uses, Side Effects and Dosage

What is the most important information I should know about ritonavir tablets?

• Ritonavir tablets can interact with other medicines and cause serious side effects. It is important to know the medicines that should not be taken with ritonavir tablets. See the section “Who should not take ritonavir tablets?”

What are ritonavir tablets?

• Ritonavir tablets are prescription medicines that are used with other antiviral medicines to treat people with human immunodeficiency virus (HIV-1) infection.

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

Who should not take ritonavir tablets?

Do not take ritonavir tablets if you or your child:

• are allergic to ritonavir or any of the ingredients in ritonavir tablets. See the end of this leaflet for a complete list of ingredients in ritonavir tablets.
• If you take any of the following medicines:

• alfuzosin

• suzetrigine
• apalutamide

• ranolazine
• dronedarone
• colchicine, if you have kidney or liver problems.
• lurasidone
• pimozide
• amiodarone
• ergot-containing medicines including:

• dihydroergotamine mesylate
• ergotamine tartrate
• methylergonovine maleate

• cisapride
• flecainide
• lovastatin
• simvastatin
• lomitapide
• sildenafil (REVATIO^®) only when used for treating the lung problem, pulmonary arterial hypertension (PAH)
• triazolam
• midazolam when taken by mouth
• propafenone
• quinidine
• St. John’s Wort (Hypericum perforatum) or a product that contains St. John’s wort
• ovoriconazole if your ritonavir tablets dose is 400 mg every 12 hours or greater

Serious problems can happen if you or your child takes any of these medicines with ritonavir tablets. This is not a complete list of medicines. Tell your healthcare provider about all of the medicines you or your child take.

Before taking ritonavir tablets, tell your healthcare provider about all of your medical conditions, including if you or your child:

• have liver problems, including Hepatitis B or Hepatitis C
• have heart problems
• have high blood sugar (diabetes)
• have bleeding problems or hemophilia

• are pregnant or plan to become pregnant.

• Ritonavir tablets may reduce how well hormonal birth control works. Females who may become pregnant should use another effective form of birth control or an additional barrier method of birth control during treatment with ritonavir tablets.
• Pregnancy Registry: There is a pregnancy registry for women who take antiviral medicines during pregnancy. The purpose of the 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.

• are breastfeeding or plan to breastfeed. Do not breastfeed if you take ritonavir tablets .

Talk to your healthcare provider about the following risks to your baby from breastfeeding during treatment with ritonavir tablets.

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

Talk to your healthcare provider about the best way to feed your baby.

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 ritonavir tablets. Keep a list of your medicines to show our healthcare provider and pharmacist.

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

How should I take ritonavir tablets?

• Take ritonavir tablets exactly as your healthcare provider tells you to take it.
• You should stay under a healthcare provider's care during treatment with ritonavir tablets. Do not change your dose of ritonavir tablets or stop your treatment without talking with your healthcare provider first.
• If your child is taking ritonavir, your child’s healthcare provider will decide the right dose based on your child's height and weight. Tell your healthcare provider if your child’s weight changes. If your child does not tolerate ritonavir oral powder, ask your child’s healthcare provider for advice.
• Swallow ritonavir tablets whole. Do not chew, break, or crush tablets before swallowing. If you cannot swallow ritonavir tablets whole, tell your healthcare provider. You may need a different medicine.
• Take ritonavir tablets with meals.
• Do not run out of ritonavir tablets. Get your ritonavir tablets prescription refilled from your healthcare provider or pharmacy before you run out.
• If you miss a dose of ritonavir tablets, take it as soon as possible and then take your next scheduled dose at its regular time. If it is almost time for your next dose, wait and take the next dose at the regular time. Do not double the next dose.
• If you take too much ritonavir tablets, call your local poison control center or go to the nearest hospital emergency room right away.

What are the possible side effects of ritonavir tablets?

Ritonavir tablets can cause serious side effects including:

• See “What is the most important information I should know about ritonavir tablets?”
• Liver problems. Some people taking ritonavir tablets in combination with other antiviral medicines have developed liver problems which may be life-threatening. Your healthcare provider should do regular blood tests during your combination treatment with ritonavir tablets. If you have chronic hepatitis B or C infection, your healthcare provider should check your blood tests more often because you have an increased chance of developing liver problems. Tell your healthcare provider right away if you get any of the following signs and symptoms of liver problems:

• loss of appetite
• pain or tenderness on your right side below your ribs
• yellowing of your skin or whites of your eyes

• itchy skin

  • Inflammation of your pancreas (pancreatitis). Ritonavir tablets can cause serious pancreas problems, which may lead to death. Tell your healthcare provider right away if you have signs or symptoms of pancreatitis such as:

• nausea
• stomach (abdomen) pain

• vomiting

  • Allergic reactions. Sometimes these allergic reactions can become severe and require treatment in a hospital. Call your healthcare provider right away if you develop a rash. Stop taking ritonavir tablets and get medical help right away if you have any of the following symptoms of a severe allergic reaction:

• trouble breathing
• wheezing
• dizziness or fainting
• throat tightness or hoarseness
• fast heartbeat or pounding in your chest (tachycardia)
• sweating
• swelling of your face, lips or tongue
• muscle or joint pain
• blisters or skin lesions

• mouth sores or ulcers

  Changes in your heart rhythm and the electrical activity of your heart. These changes may be seen on an EKG (electrocardiogram). Your risk for these problems may be higher if you have a history of abnormal heart rhythm or certain types of heart problems. Tell your healthcare provider right away if you get any of these symptoms:

• dizziness
• lightheadedness
• fainting

• sensation of abnormal heartbeats

  • Increase in cholesterol and triglyceride levels. Treatment with ritonavir tablets may increase your blood levels of cholesterol and triglycerides. Your healthcare provider should do blood tests before you start your treatment with ritonavir tablets and regularly to check for an increase in your cholesterol and triglycerides levels.
  • Diabetes and high blood sugar (hyperglycemia). Some people who take protease inhibitors including ritonavir tablets can get high blood sugar, develop diabetes, or your diabetes can get worse. Tell your healthcare provider if you notice an increase in thirst or urinate often during treatment with ritonavir tablets.
  • 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. Call your healthcare provider right away if you start having new symptoms after starting your HIV-1 medicine.
  • Change in body fat can happen in some people who are taking HIV-1 medicines. These changes may include an increased amount of fat in the upper back and neck (“buffalo hump”), breast, and around the middle 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 for hemophiliacs. Some people with hemophilia have increased bleeding with protease inhibitors including ritonavir tablets.
  • Kidney stones

The most common side effects of ritonavir include:

• diarrhea
• nausea
• vomiting
• upper and lower stomach (abdominal) pain
• tingling feeling or numbness in hands or feet or around the lips
• rash
• feeling weak or tired

These are not all of the possible side effects of ritonavir tablets. 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 ritonavir tablets?

• Store below 30°C (86°F). You may store ritonavir tablets up to 50°C (122°F) for seven days.
• Store ritonavir tablets in the original container given to you by the pharmacist.
• Exposure to high humidity outside the original container for longer than 2 weeks is not recommended.

Throw away ritonavir tablets that are expired or no longer needed.

Keep ritonavir tablets and all medicines out of the reach of children.

General information about the safe and effective use of ritonavir tablets

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

What are the ingredients in ritonavir tablets?

Active ingredient: ritonavir, USP

Inactive ingredients:

Ritonavir tablet: anhydrous dibasic calcium phosphate, colloidal silicon dioxide, copovidone, and sodium stearyl fumarate. The film coating contains: hypromellose, polyethylene glycol, and titanium dioxide.

Distributed by:

Amneal Pharmaceuticals LLC

Bridgewater, NJ 08807

Rev. 08-2026-06

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