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Commonly reported side effects of ritonavir include: asthenia, diarrhea, hypertriglyceridemia, increased gamma-glutamyl transferase, nausea, vomiting, and unpleasant taste. Other side effects include: abdominal pain, dyspepsia, fever, hyperlipidemia, increased serum alanine aminotransferase, peripheral paresthesia, dysgeusia, and oral paresthesia. See below for a comprehensive list of adverse effects.For the Consumer
Applies to ritonavir: oral capsule liquid filled, oral powder, oral solution, oral tablet
Oral route (Capsule, Liquid Filled; Solution; Tablet)
Coadministration of ritonavir with several classes of drugs including sedative hypnotics, antiarrhythmics, or ergot alkaloid preparations may result in potentially serious or life-threatening adverse events due to possible effects of ritonavir on the hepatic metabolism of certain drugs. Review medications taken by patients prior to prescribing ritonavir or when prescribing other medications to patients already taking ritonavir.
Along with its needed effects, ritonavir may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking ritonavir:
Incidence not known
Some side effects of ritonavir may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Incidence not known
For Healthcare Professionals
Applies to ritonavir: oral capsule, oral powder for reconstitution, oral solution, oral tabletGeneral
The most frequently reported side effects associated with this drug alone and in combination with other antiretrovirals were gastrointestinal (including nausea, diarrhea, vomiting, upper and lower abdominal pain), neurological disturbances (including paresthesia, oral paresthesia), rash, and fatigue/asthenia.
When used as a pharmacokinetic enhancer, side effects were dependent on the coadministered protease inhibitor. The manufacturer product information for the coadministered protease inhibitor should be consulted.Gastrointestinal
Pancreatitis (including some fatalities) has been reported in patients using this drug, including those who developed hypertriglyceridemia.
Limit for high chemistry included amylase greater than 2 times the upper limit of normal (2 x ULN).
Very common (10% or more): Diarrhea (including severe with electrolyte imbalance; up to 67.9%), nausea (up to 57.4%), vomiting (up to 31.9%), upper and lower abdominal pain (up to 26.4%), dyspepsia (up to 11.5%)
Common (1% to 10%): Flatulence, gastrointestinal (GI) hemorrhage, gastroesophageal reflux disease, mouth ulcer, pancreatitis, increased amylase, constipation, circumoral paresthesia, local throat irritation
Frequency not reported: Abnormal stools, bloody diarrhea, cheilitis, colitis, dry mouth, dysphagia, eructation, esophagitis, esophageal ulcer, fecal incontinence, gastritis, gastroenteritis, GI disorder, GI symptoms, gingivitis, ileitis, ileus, melena, oral moniliasis, periodontal abscess, pseudomembranous colitis, rectal disorder, rectal hemorrhage, sialadenitis, stomatitis, tenesmus, tongue edema, ulcerative colitisMetabolic
Very common (10% or more): Increased cholesterol (up to 65.2%), increased triglycerides (up to 33.6%)
Common (1% to 10%): Increased fasting triglycerides, hypertriglyceridemia, increased uric acid, hypercholesterolemia, increased glucose, gout, dehydration, anorexia, increased alkaline phosphatase, decreased potassium, decreased calcium
Uncommon (0.1% to 1%): Diabetes mellitus, increased magnesium, increased LDH, increased chloride, increased potassium, decreased sodium, decreased chloride, decreased magnesium
Rare (0.01% to 0.1%): Hyperglycemia
Frequency not reported: Alcohol intolerance, avitaminosis, enzymatic abnormality, xanthomatosis, redistribution/accumulation of body fat
-Frequency not reported: Redistribution/accumulation of body fat (including central obesity, dorsocervical fat enlargement, peripheral wasting, facial wasting, breast enlargement, "cushingoid appearance"), increased blood lipid levels, increased glucose levels
Protease inhibitor therapy:
-Postmarketing reports: New onset diabetes mellitus, exacerbation of preexisting diabetes mellitus, hyperglycemia, diabetic ketoacidosis
Limits for high chemistry included cholesterol greater than 240 mg/dL, triglycerides greater than 800 mg/dL, triglycerides greater than 1500 mg/dL (greater than 16.9 mmol/L), fasting triglycerides greater than 1500 mg/dL (greater than 16.9 mmol/L), uric acid greater than 12 mg/dL (greater than 0.7 mmol/L), glucose greater than 13.8 mmol/L, alkaline phosphatase greater than 550 units/L, LDH greater than 1170 units/L, chloride greater than 122 mmol/L, and potassium greater than 6 mmol/L. Limits for low chemistry included potassium 3 mmol/L, calcium less than 3.45 mmol/L, chloride less than 84 mmol/L, magnesium less than 1 mmol/L, and sodium less than 123 mmol/L.
Increases of 30% to 40% from baseline have been reported for cholesterol levels and 200% to 300% for triglycerides.
Dehydration (usually associated with GI symptoms, and sometimes resulting in hypotension, syncope, or renal insufficiency) has been reported (including during postmarketing experience); orthostatic hypotension, syncope, and renal insufficiency have also been reported without known dehydration.
Hyperglycemia has also been reported during postmarketing experience in patients with and without known history of diabetes.
New onset diabetes mellitus, exacerbation of preexisting diabetes mellitus, and hyperglycemia have been reported in HIV-infected patients receiving protease inhibitors; in some cases, diabetic ketoacidosis occurred. No causal relationship has been established.Nervous system
Very common (10% or more): Paresthesia (including oral and peripheral paresthesia; up to 50.7%), dysgeusia (16.2%), dizziness (up to 15.6%), taste perversion (up to 15.5%), peripheral neuropathy (10.1%), headache
Common (1% to 10%): Syncope, seizure, somnolence
Frequency not reported: Abnormal gait, amnesia, aphasia, ataxia, coma, convulsion, dementia, grand mal convulsion, hearing impairment, hyperesthesia, hyperkinesia, hypoesthesia, incoordination, migraine, neuralgia, neuropathy, paralysis, peripheral neuropathic pain, peripheral sensory neuropathy, sleep disorder, speech disorder, stupor, subdural hematoma, tinnitus, tremor, vertigo, vestibular disorder, cerebral ischemia, cerebral venous thrombosis, taste loss
Postmarketing reports: Neurologic events
Syncope and seizure have also been reported during postmarketing experience.
Cardiac and neurologic events have been reported during postmarketing experience when this drug was used with disopyramide, mexiletine, nefazodone, fluoxetine, and beta blockers. Possible drug interaction could not be excluded.Other
Very common (10% or more): Fatigue (including asthenia; 46.2%), asthenia (up to 14.2%), flushing/feeling hot (13.2%)
Common (1% to 10%): Edema, peripheral edema, peripheral coldness, fever, weight loss, malaise
Uncommon (0.1% to 1%): Decreased albumin
Frequency not reported: Breast pain, enlarged abdomen, accidental injury, cachexia, chest pain, chills, facial edema, facial pain, influenza syndrome, hypothermia, neck pain, neck rigidity, pain (unspecified), pelvic pain, substernal chest pain, ear pain, increased cerumen, parosmia, thirst
Postmarketing reports: Acute ergot toxicity (characterized by vasospasm, ischemia of extremities and other tissues [including the central nervous system])
-Frequency not reported: Increased weight
Limit for low chemistry included albumin less than 20 g/L.
Acute ergot toxicity has been reported when this drug was used with ergotamine or dihydroergotamine.Hematologic
Limits for low hematology included WBCs less than 2.5 x 10(9)/L, RBCs less than 3 x 10(12)/L, hematocrit less than 30% (less than 0.3), neutrophils up to 0.5 x 10(9)/L, hemoglobin less than 8 g/dL, and platelet count less than 2 x 10(9)/L. Limits for high hematology included eosinophils greater than 1 x 10(9)/L, neutrophils greater than 20 x 10(9)/L, WBCs greater than 25 x 10(9)/L, and prothrombin time greater than 1.5 x ULN.
Increased bleeding (including spontaneous skin hematomas and hemarthrosis) in patients with hemophilia type A or B treated has been associated with protease inhibitors. In many of the reported cases, treatment with protease inhibitors was continued or restarted and some patients required additional factor VIII. A causal relationship between protease inhibitor therapy and these episodes has not been established.
Very common (10% or more): Decreased WBCs (up to 36.9%), decreased RBCs (up to 18.6%), decreased hematocrit (up to 17.3%)
Common (1% to 10%): Decreased neutrophils, decreased hemoglobin, thrombocytopenia, increased eosinophils, increased neutrophils, increased WBCs
Uncommon (0.1% to 1%): Increased prothrombin time, decreased platelet count
Frequency not reported: Acute myeloblastic leukemia, anemia, ecchymosis, leukopenia, lymphadenopathy, lymphocytosis, myeloproliferative disorder
Protease inhibitor therapy:
-Frequency not reported: Increased bleeding (including spontaneous skin hematomas, hemarthrosis) in hemophiliacsDermatologic
Toxic epidermal necrolysis has also been reported during postmarketing experience.
Alopecia has been reported in patients using indinavir or atazanavir plus this drug.
Very common (10% or more): Rash (including erythematous rash, maculopapular rash; up to 27.1%), pruritus (up to 12.2%)
Common (1% to 10%): Acne, acquired lipodystrophy, sweating
Rare (0.01% to 0.1%): Stevens-Johnson syndrome, toxic epidermal necrolysis
Frequency not reported: Contact dermatitis, dry skin, eczema, erythema multiforme, exfoliative dermatitis, folliculitis, fungal dermatitis, furunculosis, maculopapular rash, molluscum contagiosum, onychomycosis, photosensitivity reaction, psoriasis, pustular rash, seborrhea, skin discoloration, skin disorder, skin hypertrophy, skin melanoma, urticaria, vesiculobullous rash, alopeciaRespiratory
Very common (10% or more): Coughing (21.7%), oropharyngeal pain (15.9%), pharyngitis
Frequency not reported: Asthma, bronchitis, increased cough, dyspnea, epistaxis, hiccup, hypoventilation, interstitial pneumonia, larynx edema, lung disorder, rhinitis, sinusitisHepatic
Limits for high chemistry included GGT greater than 300 international units/L, AST greater than 180 international units/L, ALT greater than 215 international units/L, and total bilirubin greater than 61 mcmol/L.
Hepatic dysfunction (including some fatalities) has been reported, generally in patients taking multiple concurrent medications and/or with advanced AIDS.
Very common (10% or more): Increased GGT (up to 19.6%)
Common (1% to 10%): Increased AST, increased ALT, hepatitis (including increased AST, ALT, GGT), increased blood bilirubin (including jaundice), increased total bilirubin
Frequency not reported: Exacerbation of chronic liver disease, cholangitis, cholestatic jaundice, hepatic coma, hepatomegaly, hepatosplenomegaly, liver damage, liver function tests abnormal, hepatic transaminase elevations exceeding 5 x ULN, clinical hepatitis, jaundice
Postmarketing reports: Hepatic dysfunction (including some fatalities)Musculoskeletal
Very common (10% or more): Arthralgia and back pain (18.6%), increased creatine phosphokinase (CPK; up to 12.1%)
Common (1% to 10%): Myalgia, myopathy/increased CPK, myositis, rhabdomyolysis
Frequency not reported: Arthritis, arthrosis, bone disorder, bone pain, extraocular palsy, joint disorder, leg cramps, muscle cramps, muscle weakness, twitching, osteonecrosis
Limit for high chemistry included CPK greater than 1000 international units/L.
Osteonecrosis has been reported, particularly in patients with advanced HIV disease, long-term combination antiretroviral therapy, or other risk factors (including corticosteroid use, alcohol use, severe immunosuppression, higher body mass index).Hypersensitivity
Common (1% to 10%): Hypersensitivity (including urticaria, face edema)
Rare (0.01% to 0.1%): Anaphylaxis
Frequency not reported: Allergic reactions (including urticaria, mild skin eruptions, bronchospasm, angioedema)Ocular
Common (1% to 10%): Blurred vision
Frequency not reported: Abnormal electrooculogram, abnormal electroretinogram, abnormal vision, amblyopia/blurred vision, blepharitis, conjunctivitis, diplopia, eye disorder, eye pain, iritis, photophobia, uveitis, visual field defect, vitreous disorderGenitourinary
Common (1% to 10%): Increased urination, menorrhagia
Frequency not reported: Albuminuria, cystitis, dysuria, glycosuria, hematuria, impotence, nocturia, penis disorder, polyuria, urethritis, urinary frequency, urinary retention, urinary tract infection, vaginitis
Menorrhagia has also been reported during postmarketing experience.Cardiovascular
Common (1% to 10%): Hypertension, hypotension (including orthostatic hypotension), vasodilation
Uncommon (0.1% to 1%): Myocardial infarction
Frequency not reported: PR interval prolonged, cardiovascular disorder, palpitation, peripheral vascular disorder, phlebitis, postural hypotension, tachycardia, vasospasm, hemorrhage
Postmarketing reports: Orthostatic hypotension, first-degree atrioventricular (AV) block, second-degree AV block, third-degree AV block, right bundle branch block, cardiac events
Myocardial infarction has also been reported during postmarketing experience.
Cardiac and neurologic events have been reported during postmarketing experience when this drug was used with disopyramide, mexiletine, nefazodone, fluoxetine, and beta blockers. Possible drug interaction could not be excluded.Psychiatric
Common (1% to 10%): Confusion, disturbance in attention, insomnia, anxiety, abnormal thinking
Frequency not reported: Abnormal dreams, depression, depersonalization, emotional lability, euphoria, agitation, hallucinations, decreased libido, manic reaction, nervousness, personality disorderRenal
Common (1% to 10%): Renal impairment (e.g., oliguria, elevated creatinine)
Uncommon (0.1% to 1%): Acute renal failure, increased creatinine
Frequency not reported: Renal calculus, renal failure, abnormal kidney function, kidney pain, pyelonephritis, increased BUN
Postmarketing reports: Renal insufficiency
Limit for high chemistry included creatinine greater than 0.3 mmol/L.
Renal insufficiency was reported in 3 AIDS patients receiving this drug. All cases occurred within 10 to 15 days after starting this drug and all were reversible upon discontinuation.Immunologic
Frequency not reported: Immune reconstitution syndrome, autoimmune disorders in the setting of immune reconstitution (e.g., Graves' disease, polymyositis, Guillain-Barre syndrome)Endocrine
Cushing's syndrome and adrenal suppression have been reported when this drug was used with fluticasone or budesonide.
Common (1% to 10%): Decreased free and total thyroxin
Frequency not reported: Adrenal cortex insufficiency, hormone level altered
Postmarketing reports: Cushing's syndrome, adrenal suppression
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