Norvir Side Effects

Generic Name: ritonavir

Please note - some side effects for Norvir may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Norvir - for the Consumer

Norvir

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Norvir:

Abnormal skin sensations around the mouth, fingers, and toes; changes in body fat; diarrhea; headache; nausea; stomach pain; taste changes; vomiting; weakness; weight loss.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); dark urine; fainting; fever, chills, or sore throat; flushed face; gradual onset of drowsiness; increased blood sugar (excessive hunger, thirst, urination); inflammation of the pancreas (nausea; severe stomach pain; vomiting); irregular heartbeat; loss of appetite; loss of consciousness; pale stools; severe or persistent dizziness or lightheadedness; thirst; unusual bruising or bleeding; unusual tiredness or weakness; yellowing of the skin or eyes.

Norvir Solution

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Norvir Solution:

Abnormal skin sensations around the mouth, fingers, and toes; changes in body fat; diarrhea; headache; nausea; stomach pain; taste changes; vomiting; weakness; weight loss.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); dark urine; fainting; fever, chills, or sore throat; flushed face; gradual onset of drowsiness; increased blood sugar (excessive hunger, thirst, urination); inflammation of the pancreas (nausea; severe stomach pain; vomiting); irregular heartbeat; loss of appetite; loss of consciousness; pale stools; severe or persistent dizziness or lightheadedness; thirst; unusual bruising or bleeding; unusual tiredness or weakness; yellowing of the skin or eyes.

Norvir Side Effects - for the Professional

Norvir

Adults

The safety of Norvir alone and in combination with nucleoside reverse transcriptase inhibitors was studied in 1270 adult patients. Table 7 lists treatment-emergent adverse events (at least possibly related and of at least moderate intensity) that occurred in 2% or greater of adult patients receiving Norvir alone or in combination with nucleoside reverse transcriptase inhibitors in Study 245 or Study 247 and in combination with saquinavir in study 462. In that study, 141 protease inhibitor-naive, HIV-infected patients with mean baseline CD4 of 300 cells/µL were randomized to one of four regimens of Norvir + saquinavir, including Norvir 400 mg twice-daily + saquinavir 400 mg twice-daily. Overall the most frequently reported clinical adverse events, other than asthenia, among adult patients receiving Norvir were gastrointestinal and neurological disturbances including nausea, diarrhea, vomiting, anorexia, abdominal pain, taste perversion, and circumoral and peripheral paresthesias. Similar adverse event profiles were reported in adult patients receiving ritonavir in other trials.

Adverse events occurring in less than 2% of adult patients receiving Norvir in all phase II/phase III studies and considered at least possibly related or of unknown relationship to treatment and of at least moderate intensity are listed below by body system.

Abdomen enlarged, accidental injury, allergic reaction, back pain, cachexia, chest pain, chills, facial edema, facial pain, flu syndrome, hormone level altered, hypothermia, kidney pain, neck pain, neck rigidity, pelvic pain, photosensitivity reaction, and substernal chest pain.

Cardiovascular disorder, cerebral ischemia, cerebral venous thrombosis, hypertension, hypotension, migraine, myocardial infarct, palpitation, peripheral vascular disorder, phlebitis, postural hypotension, tachycardia and vasospasm.

Abnormal stools, bloody diarrhea, cheilitis, cholestatic jaundice, colitis, dry mouth, dysphagia, eructation, esophageal ulcer, esophagitis, gastritis, gastroenteritis, gastrointestinal disorder, gastrointestinal hemorrhage, gingivitis, hepatic coma, hepatitis, hepatomegaly, hepatosplenomegaly, ileus, liver damage, melena, mouth ulcer, pancreatitis, pseudomembranous colitis, rectal disorder, rectal hemorrhage, sialadenitis, stomatitis, tenesmus, thirst, tongue edema, and ulcerative colitis.

Adrenal cortex insufficiency and diabetes mellitus.

Acute myeloblastic leukemia, anemia, ecchymosis, leukopenia, lymphadenopathy, lymphocytosis, myeloproliferative disorder, and thrombocytopenia.

Albuminuria, alcohol intolerance, avitaminosis, BUN increased, dehydration, edema, enzymatic abnormality, glycosuria, gout, hypercholesteremia, peripheral edema, and xanthomatosis.

Arthritis, arthrosis, bone disorder, bone pain, extraocular palsy, joint disorder, leg cramps, muscle cramps, muscle weakness, myositis, and twitching.

Abnormal dreams, abnormal gait, agitation, amnesia, aphasia, ataxia, coma, convulsion, dementia, depersonalization, diplopia, emotional lability, euphoria, grand mal convulsion, hallucinations, hyperesthesia, hyperkinesia, hypesthesia, incoordination, libido decreased, manic reaction, nervousness, neuralgia, neuropathy, paralysis, peripheral neuropathic pain, peripheral neuropathy, peripheral sensory neuropathy, personality disorder, sleep disorder, speech disorder, stupor, subdural hematoma, tremor, urinary retention, vertigo, and vestibular disorder.

Asthma, bronchitis, dyspnea, epistaxis, hiccup, hypoventilation, increased cough, interstitial pneumonia, larynx edema, lung disorder, rhinitis, and sinusitis.

Acne, contact dermatitis, dry skin, eczema, erythema multiforme, exfoliative dermatitis, folliculitis, fungal dermatitis, furunculosis, maculopapular rash, molluscum contagiosum, onychomycosis, pruritus, psoriasis, pustular rash, seborrhea, skin discoloration, skin disorder, skin hypertrophy, skin melanoma, urticaria, and vesiculobullous rash.

Abnormal electro-oculogram, abnormal electroretinogram, abnormal vision, amblyopia/blurred vision, blepharitis, conjunctivitis, ear pain, eye disorder, eye pain, hearing impairment, increased cerumen, iritis, parosmia, photophobia, taste loss, tinnitus, uveitis, visual field defect, and vitreous disorder.

Acute kidney failure, breast pain, cystitis, dysuria, hematuria, impotence, kidney calculus, kidney failure, kidney function abnormal, kidney pain, menorrhagia, penis disorder, polyuria, urethritis, urinary frequency, urinary tract infection, and vaginitis.

The following adverse events 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.

Redistribution/accumulation of body fat has been reported.

Cardiovascular System

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.

Hemic and Lymphatic System

There have been reports of increased bleeding in patients with hemophilia A or B.

Nervous System

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

Table 8 shows the percentage of adult patients who developed marked laboratory abnormalities.

Pediatrics

Norvir has been studied in 265 pediatric patients> 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 ≥ 2% of pediatric patients enrolled in Norvir clinical trials.

The following Grade 3-4 laboratory abnormalities occurred in > 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%).

Side Effects by Body System

General

The most frequently occurring side effects associated with ritonavir in combination with other antiretrovirals have included asthenia, and gastrointestinal and neurological disturbances (nausea, diarrhea, vomiting, anorexia, abdominal pain, taste perversion, and circumoral and peripheral paresthesias).

Adverse events in pediatric patients were similar to those in adults.

Gastrointestinal

Gastrointestinal side effects have included nausea (26%), diarrhea (18%), vomiting (15%), taste perversion (10%), anorexia (6%), dyspepsia (5%), throat irritation (3%), and flatulence (1%). These side effects may diminish or disappear after the first 2 to 4 weeks of therapy. However, the frequency with which they occur increases substantially when combined with other antiretroviral agents. Other side effects have included abnormal stools, bloody diarrhea, cheilitis, colitis, constipation, dry mouth, dysphagia, eructation, esophagitis, esophageal ulcer, fecal incontinence, gastritis, gastroenteritis, GI disorder, GI hemorrhage, gingivitis, ileus, melena, oral ulcers, pancreatitis, pseudomembranous colitis, rectal disorder, rectal hemorrhage, sialadenitis, stomatitis, tenesmus, tongue edema, and ulcerative colitis.

Nervous system

Nervous system side effects have included paresthesia (6%), headache (6%), dizziness (3%), insomnia (3%), and somnolence (3%). Additionally, ritonavir may cause abnormal dreams, abnormal gait, abnormal thinking, agitation, amnesia, anxiety, aphasia, ataxia, circumoral and peripheral paresthesia, coma, confusion, convulsion, dementia, decreased libido, depersonalization, depression, diplopia, emotional lability, euphoria, grand mal convulsion, hallucinations, hyperesthesia, hyperkinesia, hypesthesia, incoordination, manic reaction, nervousness, neuralgia, neuropathy, paralysis, peripheral sensory neuropathy, personality disorder, seizure, sleep disorder, speech disorder, stupor, subdural hematoma, tinnitus, tremor, urinary retention, vertigo, and vestibular disorder.

Metabolic

Triglyceride and cholesterol testing should be performed prior to initiation of ritonavir therapy and at periodic intervals during therapy. Lipid disorders should be managed appropriately. Providers should be aware of the serious drug interactions that exist between antihyperlipidemic drugs and ritonavir.

Metabolic side effects have included creatine phosphokinase elevations (greater than 1000 IU/L) in up to 12% of patients, increased cholesterol (greater than 240 mg/dL) in up to 44.8% of patients, and increased triglycerides in up to 34% of patients. Increases of 30% to 40% from baseline have been reported for cholesterol levels and 200% to 300% for triglycerides. Albuminuria, alcohol intolerance, avitaminosis, dehydration, diabetes mellitus, ketoacidosis, edema, enzymatic abnormality, glycosuria, gout, increased BUN, peripheral edema, increased uric acid, weight loss, and xanthomatosis have also been reported. Hyperglycemia has been reported with all the currently approved HIV-1 protease inhibitors.

Cardiovascular

Cardiovascular side effects have included vasodilation, syncope, cerebral ischemia, cerebral venous thrombosis, hypertension, hypotension, migraine, myocardial infarct, palpitation, peripheral vascular disorder, phlebitis, postural hypotension, tachycardia, and vasospasm. First -degree AV block, second-degree AV block, third-degree AV block, and right bundle branch block have been reported during postmarketing experience.

Dermatologic

Dermatologic side effects have rarely included acne, contact dermatitis, dry skin, eczema, erythema multiforme, exfoliative dermatitis, folliculitis, fungal dermatitis, furunculosis, maculopapular rash, molluscum contagiosum, onychomycosis, photosensitivity, pruritus, psoriasis, pustular rash, rash, seborrhea, skin discoloration, skin disorder, skin hypertrophy, skin melanoma, sweating, urticaria, and vesiculobullous rash. Alopecia has been reported in patients receiving indinavir or atazanavir plus ritonavir.

Endocrine

Endocrine side effects have included adrenal cortex insufficiency.

Genitourinary

Genitourinary side effects have included breast pain, cystitis, dysuria, hematuria, impotence, menorrhagia, nocturia, penis disorder, polyuria, urethritis, urinary frequency, urinary tract infection, and vaginitis.

Hematologic

Hematologic side effects have included acute myeloblastic leukemia, anemia, ecchymosis, leukopenia, lymphadenopathy, lymphocytosis, myeloproliferative disorder, thrombocytopenia, and decreases in hematocrit, hemoglobin, and neutrophils. Increased bleeding has been reported in patients with hemophilia A or B.

Hepatic

Hepatic side effects have included increased GGT (greater than 300 IU/L), increased AST (greater than 180 IU/L), increased ALT (greater than 215 IU/L), hepatitis, and liver damage. Hepatic transaminase elevations exceeding 5 times the upper limit of normal, clinical hepatitis, and jaundice have occurred in patients receiving ritonavir alone or in combination with other antiretroviral drugs. Cholestatic jaundice, hepatic coma, hepatomegaly, hepatosplenomegaly, and exacerbation of chronic liver disease have also been reported.

Due to the increased risk and because ritonavir is primarily metabolized by the liver, the manufacturer recommends using ritonavir with caution in patients with preexisting liver disease, liver enzyme abnormalities, or hepatitis. Increased AST/ALT monitoring should be considered in these patients, especially during the first three months of ritonavir therapy.

Hypersensitivity

Hypersensitivity side effects have included allergic reactions, urticaria, mild skin eruptions, bronchospasm, angioedema, anaphylaxis, and Stevens-Johnson syndrome.

Musculoskeletal

Musculoskeletal side effects have included arthralgia, arthritis, arthrosis, bone disorder, bone pain, extraocular palsy, joint disorder, leg cramps, muscle cramps, muscle weakness, myalgia, myositis, and twitching.

Ocular

Ocular side effects have included abnormal electrooculogram, abnormal electroretinogram, abnormal vision, amblyopia, blepharitis, blurred vision, conjunctivitis, eye disorder, eye pain, iritis, photophobia, uveitis, visual field defect, and vitreous disorder.

Renal

Renal side effects have included acute renal failure, reversible renal failure, increased serum creatinine, abnormal kidney function, kidney pain, and kidney stone formation.

Renal insufficiency has been reported in three patients with AIDS receiving ritonavir. All cases occurred within 10 to 15 days after initiation of ritonavir and all were reversible upon discontinuation.

Respiratory

Respiratory side effects have included pharyngitis (3%), asthma, bronchitis, cough, dyspnea, epistaxis, hiccup, hypoventilation, interstitial pneumonia, larynx edema, lung disorder, rhinitis, and sinusitis.

Other

Redistribution/accumulation of body fat, including central obesity, dorsocervical fat enlargement, peripheral wasting, breast enlargement, and "cushingoid appearance" have been observed in patients receiving protease inhibitors. The mechanism and long-term consequences of these events are currently unknown and a causal relationship has not been established.

Other

Other adverse reactions have included abdominal pain, asthenia, enlarge abdomen, accidental injury, back pain, cachexia, chest pain, chills, dehydration (usually associated with gastrointestinal disturbances), fever, facial edema, facial pain, flu syndrome, headache, hypothermia, malaise, neck pain, neck rigidity, pelvic pain, ear pain, hearing impairment, increased cerumen, parosmia, taste loss, and tinnitus.

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