Norvir

Last updated on RxList: 10/29/2020
Norvir Side Effects Center

What Is Norvir?

Norvir (ritonavir) is an antiviral medication in a group of HIV medicines called protease inhibitors used to treat HIV, which causes acquired immunodeficiency syndrome (AIDS). Norvir is not a cure for HIV or AIDS.

What Are Side Effects of Norvir?

Common side effects of Norvir include:

  • diarrhea,
  • nausea,
  • vomiting,
  • heartburn,
  • stomach pain,
  • loss of appetite,
  • headache,
  • dizziness,
  • tiredness,
  • weakness,
  • changes in taste,
  • tingling/numbness of hands/feet/mouth area,
  • mood changes, or
  • changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

Tell your doctor if you have any serious side effects of Norvir including:

  • unexplained weight loss,
  • persistent muscle aches or weakness,
  • joint pain,
  • severe tiredness,
  • vision changes,
  • severe or 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), or
  • signs of a nerve problem known as Guillain-Barré Syndrome (such as difficulty breathing/swallowing/moving your eyes, drooping face, paralysis, or slurred speech).

Dosage for Norvir

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 m² twice daily by mouth and should not exceed 600 mg twice daily.

What Drugs, Substances, or Supplements Interact with Norvir?

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.

Norvir During Pregnancy and Breastfeeding

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 breastfeed.

Additional Information

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.

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Norvir Consumer Information

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Get emergency medical help if you have signs of an allergic reaction (hives, skin sores, difficult breathing, fast or pounding heartbeats, sweating, mouth sores, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Call your doctor at once if you have:

  • irregular heartbeats, or a light-headed feeling (like you might pass out);
  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
  • signs of a kidney stone--pain in your side or lower back, blood in your urine, painful or difficult urination;
  • high blood sugar--increased thirst, increased urination, hunger, dry mouth, fruity breath odor; or
  • signs of liver or pancreas problems--loss of appetite, upper stomach pain (that may spread to your back), nausea, vomiting, dark urine, jaundice (yellowing of the skin or eyes).

Ritonavir affects your immune system, which may cause certain side effects (even weeks or months after you've taken this medicine). Tell your doctor if you have:

  • signs of a new infection--fever, night sweats, swollen glands, cold sores, cough, wheezing, diarrhea, weight loss;
  • trouble speaking or swallowing, problems with balance or eye movement, weakness or prickly feeling; or
  • swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence.

Common side effects may include:

  • nausea, vomiting, stomach pain, diarrhea;
  • numbness or tingling in your hands or feet or around your mouth;
  • feeling weak or tired;
  • rash; 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)

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SIDE EFFECTS

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

  • Drug Interactions [see WARNINGS AND PRECAUTIONS]
  • Hepatotoxicity [see WARNINGS AND PRECAUTIONS]
  • Pancreatitis [see WARNINGS AND PRECAUTIONS]
  • Allergic Reactions/Hypersensitivity [see WARNINGS AND PRECAUTIONS]

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

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.

Adverse Reactions In Adults

The safety of NORVIR alone and in combination with other antiretroviral agents was studied in 1,755 adult patients. Table 2 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 2: 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 Reactionsn%
Eye disorders
Blurred vision1136.4
Gastrointestinal disorders
Abdominal Pain (upper and lower)*46426.4
Diarrhea including severe with electrolyte imbalance*1,19267.9
Dyspepsia20111.5
Flatulence1428.1
Gastrointestinal hemorrhage*412.3
Gastroesophageal reflux disease (GERD)191.1
Nausea1,00757.4
Vomiting*55931.9
General disorders and administration site conditions
Fatigue including asthenia*81146.2
Hepatobiliary disorders
Blood bilirubin increased (including jaundice)*251.4
Hepatitis (including increased AST, ALT, GGT)*1538.7
Immune system disorders
Hypersensitivity including urticaria and face edema*1148.2
Metabolism and nutrition disorders
Edema and peripheral edema*1106.3
Gout*241.4
Hypercholesterolemia*523.0
Hypertriglyceridemia*1589.0
Lipodystrophy acquired*512.9
Musculoskeletal and connective tissue disorders
Arthralgia and back pain*32618.6
Myopathy/creatine phosphokinase increased*663.8
Myalgia1568.9
Nervous system disorders
Dizziness*27415.6
Dysgeusia*28516.2
Paresthesia (including oral paresthesia)*88950.7
Peripheral neuropathy17810.1
Syncope*583.3
Psychiatric disorders
Confusion*523.0
Disturbance in attention442.5
Renal and urinary disorders
Increased urination*744.2
Respiratory, thoracic and mediastinal disorders
Coughing*38021.7
Oropharyngeal Pain*27915.9
Skin and subcutaneous tissue disorders
Acne*673.8
Pruritus*21412.2
Rash (includes erythematous and maculopapular)*47527.1
Vascular disorders
Flushing, feeling hot*23213.2
Hypertension*583.3
Hypotension including orthostatic hypotension*301.7
Peripheral coldness*211.2
* Represents a medical concept including several similar MedDRA PTs

Laboratory Abnormalities In Adults

Table 3 shows the percentage of adult patients who developed marked laboratory abnormalities.

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

VariableLimitStudy 245 Naive PatientsStudy 247 Advanced PatientsStudy 462 PI-Naive Patients
NORVIR plus ZDVNORVIRZDVNORVIRPlaceboNORVIR plus Saquinavir
ChemistryHigh
Cholesterol> 240 mg/dL30.744.89.336.58.065.2
CPK>1000IU/L9.612.111.09.16.39.9
GGT> 300 IU/L1.85.21.719.611.39.2
SGOT (AST)> 180 IU/L5.39.52.56.47.07.8
SGPT (ALT)> 215 IU/L5.37.83.48.54.49.2
Triglycerides> 800 mg/dL9.617.23.433.69.423.4
Triglycerides> 1500 mg/dL1.82.6-12.60.411.3
Triglycerides Fasting> 1500 mg/dL1.51.3-9.90.3-
Uric Acid> 12 mg/dL---3.80.21.4
HematologyLow
Hematocrit< 30%2.6-0.817.322.00.7
Hemoglobin< 8.0 g/dL0.9--3.83.9-
Neutrophils< 0.5 x 109/L---6.08.3-
RBC< 3.0 x 1012/L1.8-5.918.624.4-
WBC< 2.5 x 109/L-0.96.836.959.43.5
-Indicates no events reported.

Adverse Reactions In Pediatric Patients

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 In Pediatric Patients

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)

© Norvir Patient Information is supplied by Cerner Multum, Inc. and Norvir Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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