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Norvir

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Norvir

Norvir Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Norvir (ritonavir) is used to treat HIV, which causes acquired immunodeficiency syndrome (AIDS). It is not a cure for HIV or AIDS. It is an antiviral medication in a group of HIV medicines called protease inhibitors. Common side effects include diarrhea, nausea, vomiting, heartburn, stomach pain, loss of appetite, headache, dizziness, tiredness, weakness, changes in taste, or tingling/numbness of hands/feet/mouth area.

The recommended adult dosage of Norvir is 600 mg twice daily by mouth. The recommended dose for children greater than 1 month is 350 to 400 mg per mē twice daily by mouth and should not exceed 600 mg twice daily. Norvir may interact with ADHD medications, atovaquone, quinine, dronabinol, St. John's wort, theophylline, steroids, antibiotics, antifungals, antidepressants, heart or blood pressure medications, cholesterol-lowering medicines, medicines to prevent organ transplant rejection, other HIV/AIDS medicines, insulin or oral diabetes medication, medicine to treat a psychiatric disorder, erectile dysfunction medications, pain medications, sedatives, or seizure medications. Tell your doctor all medications you use. During pregnancy, Norvir should be used only when prescribed. It is normal to prescribe HIV medicines for pregnant women with HIV. This has been shown to decrease the risk of giving HIV to the baby. This drug may be part of that treatment. Consult your doctor. It is unknown if this medication passes into breast milk. Because breast milk can transmit HIV, do not breast-feed.

Our Norvir (ritonavir) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Norvir in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking ritonavir and call your doctor at once if you have any of these serious side effects:

  • slow or uneven heart rate, feeling like you might pass out;
  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;
  • increased urination or extreme thirst;
  • easy bruising or bleeding (nosebleed or bleeding gums);
  • signs of a new infection, such as fever or chills, cough, or flu symptoms;
  • severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate; or
  • low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • mild nausea, vomiting, diarrhea, stomach pain;
  • numbness or tingling, especially around your mouth;
  • headache, mood changes; or
  • changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Norvir (Ritonavir Capsules, Oral Solution) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Norvir Overview - Patient Information: Side Effects

SIDE EFFECTS: Diarrhea, nausea, vomiting, heartburn, stomach pain, loss of appetite, headache, dizziness, tiredness, weakness, changes in taste, or tingling/numbness of mouth area may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Some people may experience worsening of a previous medical condition (such as an old infection) as their immune systems improve, or develop new conditions because their immune systems have become overactive. This reaction may occur at any time (soon after starting HIV treatment or many months later). Tell your doctor right away if you have any serious side effects, including: unexplained weight loss, persistent muscle aches/weakness, joint pain, numbness/tingling of the hands/feet/arms/legs, severe tiredness, vision changes, severe/persistent headaches, signs of infection (such as fever, chills, trouble breathing, cough, non-healing skin sores), signs of an overactive thyroid (such as irritability, nervousness, heat intolerance, fast/pounding/irregular heartbeat, bulging eyes, unusual growth in the neck/thyroid known as a goiter), signs of a certain nerve problem known as Guillain-Barre Syndrome (such as difficulty breathing/swallowing/moving your eyes, drooping face, paralysis, slurred speech).

Tell your doctor immediately if any of these unlikely but serious side effects occur: persistent nausea/vomiting, stomach/abdominal pain, dark urine, yellowing eyes/skin, mental/mood changes (such as depression, anxiety), increased urination (especially at night), increased thirst.

Seek immediate medical attention if any of these rare but serious side effects occur: symptoms of a heart attack (such as chest/jaw/left arm pain, shortness of breath, unusual sweating), easy bruising/bleeding, fainting, fast/irregular heartbeat.

Changes in body fat may occur while you are taking this medication (such as increased fat in the upper back and stomach areas, decreased fat in the arms and legs). The cause and long-term effects of these changes are unknown. Discuss the risks and benefits of treatment with your doctor, as well as the possible use of exercise to reduce this side effect.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Norvir (Ritonavir Capsules, Oral Solution)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Norvir FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The following adverse reactions are discussed in greater detail in other sections of the labeling.

When co-administering NORVIR with other protease inhibitors, see the full prescribing information for that protease inhibitor including adverse reactions.

Adult Clinical Trial Experience

Because clinical trials are conducted under widely varying conditions, adverse reactions rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety of NORVIR alone and in combination with other antiretroviral agents was studied in 1,755 adult patients. Table 3 lists treatment-emergent Adverse Reactions (with possible or probable relationship to study drug) occurring in greater than or equal to 1% of adult patients receiving NORVIR in combined Phase II/IV studies.

The most frequently reported adverse drug reactions among patients receiving NORVIR alone or in combination with other antiretroviral drugs were gastrointestinal (including diarrhea, nausea, vomiting, abdominal pain (upper and lower)), neurological disturbances (including paresthesia and oral paresthesia), rash, and fatigue/asthenia.

Table 3: Treatment-Emergent Adverse Reactions (With Possible or Probable Relationship to Study Drug) Occurring in greater than or equal to 1% of Adult Patients Receiving NORVIR in Combined Phase II/IV Studies (N = 1,755)

Adverse Reactions n %
Eye disorders
  Blurred vision 113 6.4
Gastrointestinal disorders
  Abdominal Pain (upper and lower)* 464 26.4
  Diarrhea including severe with electrolyte imbalance* 1,192 67.9
  Dyspepsia 201 11.5
  Flatulence 142 8.1
  Gastrointestinal hemorrhage* 41 2.3
  Gastroesophageal reflux disease (GERD) 19 1.1
  Nausea 1,007 57.4
  Vomiting* 559 31.9
General disorders and administration site conditions
  Fatigue including asthenia* 811 46.2
Hepatobiliary disorders
  Blood bilirubin increased (including jaundice)* 25 1.4
  Hepatitis (including increased AST, ALT, GGT)* 153 8.7
Immune system disorders
  Hypersensivity including urticatria and face edema* 114 8.2
Metabolism and nutrition disorders  
  Edema and peripheral edema* 110 6.3
  Gout* 24 1.4
  Hypercholesterolemia*   52 3
  Hypertriglyceridemia* 158 9
  Lipodystrophy acquired* 51 2.9
Musculoskeletal and connective tissue disorders
  Arthralgia and back pain* 326 18.6
  Myopathy/creatine phosphokinase increased* 66 3.8
  Myalgia 156 8.9
Nervous system disorders
  Dizziness* 274 15.6
  Dysgeusia* 285 16.2
  Paresthesia (including oral paresthesia)* 889 50.7
  Peripheral neuropathy 178 10.1
  Syncope* 58 3.3
Psychiatric disorders
  Confusion* 52 3
  Disturbance in attention 44 2.5
  Renal and urinary disorders
  Increased urination* 74 4.2
Respiratory, thoracic and mediastinal disorders
  Coughing* 380 21.7
  Oropharyngeal Pain* 279 15.9
Skin and subcutaneous tissue disorders
  Acne* 67 3.8
  Pruritus* 214 12.2
  Rash (includes erythematous and maculopapular)* 475 27.1
Vascular disorders
  Flushing, feeling hot* 232 13.2
  Hypertension* 58 3.3
  Hypotension including orthostatic hypotension* 30 1.7
  Peripheral coldness* 21 1.2
* Represents a medical concept including several similar MedDRA PTs

Laboratory Abnormalities

Table 4 shows the percentage of adult patients who developed marked laboratory abnormalities.

Table 4: Percentage of Adult Patients, by Study and Treatment Group, with Chemistry and Hematology Abnormalities Occurring in greater than 3% of Patients Receiving NORVIR

Variable Limit Study 245 Naive Patients Study 247 Advanced Patients Study 462 PI-Naive Patients
NORVIR plus ZDV NORVIR ZDV NORVIR Placebo NORVIR plus Saquinavir
Chemistry High            
Cholesterol > 240 mg/dL 30.7 44.8 9.3 36.5 8 65.2
CPK > 1000 IU/L 9.6 12.1 11 9.1 6.3 9.9
GGT > 300 IU/L 1.8 5.2 1.7 19.6 11.3 9.2
SGOT (AST) > 180 IU/L 5.3 9.5 2.5 6.4 7 7.8
SGPT (ALT) > 215 IU/L 5.3 7.8 3.4 8.5 4.4 9.2
Triglycerides > 800 mg/dL 9.6 17.2 3.4 33.6 9.4 23.4
Triglycerides > 1500 mg/dL 1.8 2.6 - 12.6 0.4 11.3
Triglycerides Fasting > 1500 mg/dL 1.5 1.3 - 9.9 0.3 -
Uric Acid > 12 mg/dL - - - 3.8 0.2 1.4
Hematology Low            
Hematocrit < 30% 2.6 - 0.8 17.3 22 0.7
Hemoglobin < 8.0 g/dL 0.9 - - 3.8 3.9 -
Neutrophils ≤ 0.5 x 109/L - - - 6 8.3 -
RBC < 3.0 x 1012/L 1.8 - 5.9 18.6 24.4 -
WBC < 2.5 x 109/L - 0.9 6.8 36.9 59.4 3.5
-Indicates no events reported.

Pediatric Clinical Trial Experience

NORVIR has been studied in 265 pediatric patients greater than 1 month to 21 years of age. The adverse event profile observed during pediatric clinical trials was similar to that for adult patients.

Vomiting, diarrhea, and skin rash/allergy were the only drug-related clinical adverse events of moderate to severe intensity observed in greater than or equal to 2% of pediatric patients enrolled in NORVIR clinical trials.

Laboratory Abnormalities

The following Grade 3-4 laboratory abnormalities occurred in greater than 3% of pediatric patients who received treatment with NORVIR either alone or in combination with reverse transcriptase inhibitors: neutropenia (9%), hyperamylasemia (7%), thrombocytopenia (5%), anemia (4%), and elevated AST (3%).

Postmarketing Experience

The following adverse events (not previously mentioned in the labeling) have been reported during post-marketing use of NORVIR. Because these reactions are reported voluntarily from a population of unknown size, it is not possible to reliably estimate their frequency or establish a causal relationship to NORVIR exposure.

Body as a Whole

Dehydration, usually associated with gastrointestinal symptoms, and sometimes resulting in hypotension, syncope, or renal insufficiency has been reported. Syncope, orthostatic hypotension, and renal insufficiency have also been reported without known dehydration.

Co-administration of ritonavir with ergotamine or dihydroergotamine has been associated with acute ergot toxicity characterized by vasospasm and ischemia of the extremities and other tissues including the central nervous system.

Cardiovascular System

First-degree AV block, second-degree AV block, third-degree AV block, right bundle branch block have been reported [see WARNINGS AND PRECAUTIONS].

Cardiac and neurologic events have been reported when ritonavir has been co-administered with disopyramide, mexiletine, nefazodone, fluoxetine, and beta blockers. The possibility of drug interaction cannot be excluded.

Endocrine System

Cushing's syndrome and adrenal suppression have been reported when ritonavir has been co-administered with fluticasone propionate or budesonide.

Nervous System

There have been postmarketing reports of seizure. Also, see Cardiovascular System.

Skin and subcutaneous tissue disorders

Toxic epidermal necrolysis (TEN) has been reported.

Read the entire FDA prescribing information for Norvir (Ritonavir Capsules, Oral Solution) »

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Norvir - User Reviews

Norvir User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Norvir sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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