Ritonavir Side Effects

It is possible that some side effects of ritonavir may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to ritonavir: oral capsule liquid filled, oral solution, oral tablet

As well as its needed effects, ritonavir may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking ritonavir, check with your doctor immediately:

Less common
  • Fainting
  • feeling faint, dizzy, or lightheaded
  • feeling of warmth or heat
  • flushing or redness of the skin, especially on the face and neck
  • headache
  • sweating
Rare
  • Confusion
  • dehydration
  • dry or itchy skin
  • fruity mouth odor
  • increased hunger
  • increased thirst
  • increased urination
  • nausea
  • vomiting
  • weight loss
Incidence not known
  • Bloating
  • chills
  • constipation
  • convulsions
  • cough
  • darkened urine
  • decreased urination
  • difficulty with breathing
  • dry mouth
  • fast heartbeat
  • fever
  • hives or welts
  • increase in heart rate
  • indigestion
  • itching
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • loss of appetite
  • loss of bladder control
  • muscle spasm or jerking of all extremities
  • noisy breathing
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • rapid breathing
  • redness of the skin
  • shortness of breath
  • skin rash
  • sudden loss of consciousness
  • sunken eyes
  • thirst
  • tightness in the chest
  • unusual tiredness or weakness
  • wheezing
  • wrinkled skin
  • yellow eyes or skin

Some ritonavir side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

More common
  • Acid or sour stomach
  • belching
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • change in sense of taste
  • diarrhea
  • dizziness
  • general feeling of discomfort or illness
  • heartburn
  • lack or loss of strength
  • sleepiness or unusual drowsiness
  • sleeplessness
  • trouble sleeping
  • unable to sleep
  • weakness
Less common
  • Body aches or pain
  • congestion
  • delusions
  • dementia
  • difficulty with moving
  • discouragement
  • dryness or soreness of the throat
  • excess air or gas in the stomach or intestines
  • fear
  • feeling sad or empty
  • full feeling
  • hoarseness
  • increased urge to urinate during the night
  • irritability
  • lack of appetite
  • loss of interest or pleasure
  • mood or mental changes
  • muscle pain or stiffness
  • nervousness
  • pain in the joints or in unspecified location
  • passing gas
  • runny nose
  • tender, swollen glands in the neck
  • throat irritation
  • tiredness
  • trouble concentrating
  • trouble with swallowing
  • voice changes
  • waking to urinate at night
Incidence not known
  • Gaining weight around your neck, upper back, breast, face, or waist

For Healthcare Professionals

Applies to ritonavir: oral capsule, oral solution, oral tablet

General

The most frequently reported side effects associated with ritonavir alone and in combination with other antiretrovirals were gastrointestinal (including nausea, diarrhea, vomiting, upper and lower abdominal pain), neurological disturbances (including paresthesia and oral paresthesia), rash, and fatigue/asthenia.

Gastrointestinal

Very common (10% or more): Diarrhea (including severe with electrolyte imbalance; 67.9%), nausea (57.4%), vomiting (31.9%), abdominal pain (upper and lower; 26.4%), dyspepsia (11.5%)
Common (1% to 10%): Flatulence (8.1%), gastrointestinal hemorrhage (2.3%), gastroesophageal reflux disease (1.1%)
Frequency not reported: Abnormal stools, bloody diarrhea, cheilitis, colitis, constipation, dry mouth, dysphagia, eructation, esophagitis, esophageal ulcer, fecal incontinence, gastritis, gastroenteritis, gastrointestinal disorder, gingivitis, ileus, local throat irritation, melena, oral ulcers, pancreatitis, pseudomembranous colitis, rectal disorder, rectal hemorrhage, sialadenitis, stomatitis, taste perversion, tenesmus, tongue edema, ulcerative colitis

Metabolic

Increases of 30% to 40% from baseline have been reported for cholesterol levels and 200% to 300% for triglycerides. 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.

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.

Very common (10% or more): Increased cholesterol (greater than 240 mg/dL; up to 65.2%), increased triglycerides (greater than 800 mg/dL: up to 33.6%; greater than 1500 mg/dL: up to 12.6%)
Common (1% to 10%): Increased fasting triglycerides (greater than 1500 mg/dL: up to 9.9%), hypertriglyceridemia (9%), increased uric acid (greater than 12 mg/dL; up to 3.8%), hypercholesterolemia (3%), acquired lipodystrophy (2.9%), gout (1.4%)
Frequency not reported: Albuminuria, alcohol intolerance, anorexia, avitaminosis, dehydration, diabetes mellitus, enzymatic abnormality, weight loss, xanthomatosis, redistribution/accumulation of body fat (including central obesity, dorsocervical fat enlargement, peripheral wasting, facial wasting, breast enlargement, "cushingoid appearance")
Postmarketing reports: Dehydration (usually associated with gastrointestinal symptoms, and sometimes resulting in hypotension, syncope, or renal insufficiency), new onset diabetes mellitus, exacerbation of preexisting diabetes mellitus, hyperglycemia, diabetic ketoacidosis

Nervous system

Very common (10% or more): Paresthesia (including oral paresthesia; 50.7%), dysgeusia (16.2%), dizziness (15.6%), peripheral neuropathy (10.1%)
Common (1% to 10%): Syncope (3.3%)
Frequency not reported: Abnormal gait, headache, circumoral paresthesia, peripheral paresthesia, amnesia, aphasia, ataxia, coma, convulsion, dementia, diplopia, grand mal convulsion, hearing impairment, hyperesthesia, hyperkinesia, hypesthesia, incoordination, migraine, neuralgia, neuropathy, paralysis, peripheral neuropathic pain, peripheral sensory neuropathy, sleep disorder, somnolence, speech disorder, stupor, subdural hematoma, tinnitus, tremor, urinary retention, vertigo, vestibular disorder
Postmarketing reports: Syncope, seizure

Cardiac and neurologic events have been reported during postmarketing experience when ritonavir was used with disopyramide, mexiletine, nefazodone, fluoxetine, and beta blockers. Possible drug interaction could not be excluded.

Other

Acute ergot toxicity has been reported when ritonavir was used with ergotamine or dihydroergotamine.

Very common (10% or more): Fatigue (including asthenia; 46.2%), flushing/feeling hot (13.2%)
Common (1% to 10%): Edema and peripheral edema (6.3%), peripheral coldness (1.2%)
Frequency not reported: Enlarged abdomen, accidental injury, cachexia, chest pain, chills, facial edema, facial pain, fever, influenza syndrome, altered hormone level, hypothermia, malaise, neck pain, neck rigidity, pain, pelvic pain, substernal chest pain, ear pain, increased cerumen, parosmia, thirst, taste loss
Postmarketing reports: Acute ergot toxicity (characterized by vasospasm and ischemia of extremities and other tissues [including the CNS])

Hematologic

Increased bleeding (including spontaneous skin hematomas and hemarthrosis) has been reported in patients with hemophilia type A or B treated with protease inhibitors.

Very common (10% or more): Decreased white blood cells (less than 2.5 x 10(9)/L; up to 36.9%), decreased red blood cells (less than 3 x 10(12)/L; up to 18.6%), decreased hematocrit (less than 30%; up to 17.3%)
Common (1% to 10%): Decreased neutrophils (0.5 x 10(9)/L or less; up to 6%), decreased hemoglobin (less than 8 g/dL; up to 3.8%)
Frequency not reported: Acute myeloblastic leukemia, anemia, ecchymosis, leukopenia, lymphadenopathy, lymphocytosis, myeloproliferative disorder, thrombocytopenia, increased bleeding (including spontaneous skin hematomas, hemarthrosis)

Dermatologic

Alopecia has been reported in patients receiving indinavir or atazanavir plus ritonavir.

Very common (10% or more): Rash (includes erythematous and maculopapular; 27.1%), pruritus (12.2%)
Common (1% to 10%): Acne (3.8%)
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, sweating, urticaria, vesiculobullous rash, alopecia
Postmarketing reports: Toxic epidermal necrolysis

Respiratory

Very common (10% or more): Coughing (21.7%), oropharyngeal pain (15.9%)
Frequency not reported: Asthma, bronchitis, increased cough, dyspnea, epistaxis, hiccup, hypoventilation, interstitial pneumonia, larynx edema, lung disorder, pharyngitis, rhinitis, sinusitis

Hepatic

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 3 months of ritonavir therapy.

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 gamma glutamyltransferase (GGT; greater than 300 international units/L; up to 19.6%)
Common (1% to 10%): Increased AST (greater than 180 international units/L; up to 9.5%), increased ALT (greater than 215 international units/L; up to 9.2%), hepatitis (including increased AST, ALT, GGT; 8.7%), increased blood bilirubin (including jaundice; 1.4%)
Frequency not reported: Exacerbation of chronic liver disease, cholestatic jaundice, hepatic coma, hepatomegaly, hepatosplenomegaly, liver damage, hepatic transaminase elevations exceeding 5 times the upper limit of normal, 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 (greater than 1000 international units/L; up to 12.1%)
Common (1% to 10%): Myalgia (8.9%), myopathy/increased creatine phosphokinase (3.8%)
Frequency not reported: Arthritis, arthrosis, bone disorder, bone pain, extraocular palsy, joint disorder, leg cramps, muscle cramps, muscle weakness, myositis, twitching

Hypersensitivity

Common (1% to 10%): Hypersensitivity (including urticaria, face edema; 8.2%)
Frequency not reported: Allergic reactions (including urticaria, mild skin eruptions, bronchospasm, angioedema), anaphylaxis, toxic epidermal necrolysis, Stevens-Johnson syndrome

Ocular

Common (1% to 10%): Blurred vision (6.4%)
Frequency not reported: Abnormal electrooculogram, abnormal electroretinogram, abnormal vision, amblyopia/blurred vision, blepharitis, conjunctivitis, eye disorder, eye pain, iritis, photophobia, uveitis, visual field defect, vitreous disorder

Genitourinary

Common (1% to 10%): Increased urination (4.2%)
Frequency not reported: Breast pain, cystitis, dysuria, glycosuria, hematuria, impotence, menorrhagia, nocturia, penis disorder, polyuria, urethritis, urinary frequency, urinary tract infection, vaginitis

Cardiovascular

Cardiac and neurologic events have been reported during postmarketing experience when ritonavir was used with disopyramide, mexiletine, nefazodone, fluoxetine, and beta blockers. Possible drug interaction could not be excluded.

Common (1% to 10%): Hypertension (3.3%), hypotension (including orthostatic hypotension; 1.7%)
Frequency not reported: Cardiovascular disorder, cerebral ischemia, cerebral venous thrombosis, myocardial infarct, palpitation, peripheral vascular disorder, phlebitis, postural hypotension, tachycardia, vasodilation, vasospasm
Postmarketing reports: Orthostatic hypotension, first-degree atrioventricular (AV) block, second-degree AV block, third-degree AV block, right bundle branch block

Psychiatric

Common (1% to 10%): Confusion (3%), disturbance in attention (2.5%)
Frequency not reported: Abnormal dreams, depression, anxiety, depersonalization, emotional lability, euphoria, insomnia, abnormal thinking, agitation, hallucinations, decreased libido, manic reaction, nervousness, personality disorder

Renal

Renal insufficiency was reported in 3 patients with AIDS receiving ritonavir. All cases occurred within 10 to 15 days after initiation of ritonavir and all were reversible upon discontinuation.

Frequency not reported: Acute renal failure, renal calculus, renal failure, abnormal kidney function, kidney pain, increased serum creatinine, increased BUN
Postmarketing reports: Renal insufficiency

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 ritonavir was used with fluticasone or budesonide.

Frequency not reported: Adrenal cortex insufficiency
Postmarketing reports: Cushing's syndrome, adrenal suppression

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