Ritonavir Side Effects

Some side effects of ritonavir may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

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

Get emergency medical help if you have any of these signs of an allergic reaction while taking ritonavir: 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;

• 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;

• rapid heart rate, increased sweating, tremors in your hands, anxiety, feeling irritable, sleep problems (insomnia);

• diarrhea, unexplained weight loss, menstrual changes, impotence, loss of interest in sex;

• swelling in your neck or throat (enlarged thyroid);

• muscle weakness, tired feeling, trouble speaking or swallowing, joint or muscle pain, feeling short of breath;

• weakness or prickly feeling in your fingers or toes;

• problems with walking, breathing, speech, swallowing, or eye movement;

• severe lower back pain, loss of bladder or bowel control;

• severe pain in your upper stomach spreading to your back, vomiting, fast heart rate;

• nausea, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

• severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Less serious side effects of ritonavir may include:

• mild nausea, vomiting;

• 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.

For Healthcare Professionals

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

General

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

Gastrointestinal

Gastrointestinal side effects of moderate or severe intensity have included nausea (up to 46.6%), diarrhea (up to 25%), vomiting (up to 23.3%), taste perversion (up to 17.2%), anorexia (up to 8.6%), dyspepsia (up to 5.9%), flatulence (up to 3.5%), constipation (up to 3.4%), local throat irritation (up to 2.8%), and fecal incontinence (up to 2.8%). Abnormal stools, bloody diarrhea, cheilitis, colitis, dry mouth, dysphagia, eructation, esophagitis, esophageal ulcer, gastritis, gastroenteritis, gastrointestinal disorder, gastrointestinal hemorrhage, gingivitis, ileus, melena, oral ulcers, pancreatitis, pseudomembranous colitis, rectal disorder, rectal hemorrhage, sialadenitis, stomatitis, tenesmus, tongue edema, and ulcerative colitis have been reported in less than 2% of patients; these side effects were of at least moderate intensity.

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 of moderate or severe intensity have included weight loss (up to 2.4%). Increased cholesterol (greater than 240 mg/dL; up to 65.2%), triglycerides (greater than 800 mg/dL: up to 33.6%; greater than 1500 mg/dL: up to 12.6%), creatine phosphokinase (greater than 1000 international units/L; up to 12.1%), fasting triglycerides (greater than 1500 mg/dL: up to 9.9%), and uric acid (greater than 12 mg/dL; up to 3.8%) have been reported. 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, enzymatic abnormality, gout, increased BUN, hypercholesteremia, and xanthomatosis have been reported in less than 2% of patients; these side effects were of at least moderate intensity. Redistribution/accumulation of body fat, including central obesity, dorsocervical fat enlargement, peripheral wasting, facial wasting, breast enlargement, and "cushingoid appearance" have been observed in patients taking antiretroviral agents; however, a causal relationship has not been established. Dehydration (usually associated with gastrointestinal symptoms, and sometimes resulting in hypotension, syncope, or renal insufficiency) has been reported during postmarketing experience. New onset diabetes mellitus, exacerbation of preexisting diabetes mellitus, and hyperglycemia have been reported during postmarketing experience in HIV-infected patients receiving protease inhibitors; in some cases, diabetic ketoacidosis occurred.

Hematologic

Hematologic side effects of at least moderate intensity have included acute myeloblastic leukemia, anemia, ecchymosis, leukopenia, lymphadenopathy, lymphocytosis, myeloproliferative disorder, and thrombocytopenia in less than 2% of patients. Decreased white blood cells (less than 2.5 x 10(9)/L; up to 36.9%), red blood cells (less than 3 x 10(12)/L; up to 18.6%), hematocrit (less than 30%; up to 17.3%), neutrophils (0.5 x 10(9)/L or less; up to 6%), and hemoglobin (less than 8 g/dL; up to 3.8%) have been reported. Increased bleeding (including spontaneous skin hematomas and hemarthrosis) has been reported in patients with hemophilia type A or B treated with protease inhibitors.

Other

Other side effects of moderate or severe intensity have included asthenia (up to 28.4%), abdominal pain (up to 8.3%), malaise (up to 5.2%), fever (up to 5%), and pain (unspecified; up to 4.3%). Enlarged abdomen, accidental injury, back pain, cachexia, chest pain, chills, edema, facial edema, peripheral edema, facial pain, influenza syndrome, altered hormone level, hypothermia, neck pain, neck rigidity, pelvic pain, substernal chest pain, ear pain, increased cerumen, parosmia, thirst, and taste loss have been reported in less than 2% of patients; these side effects were of at least moderate intensity.

Nervous system

Nervous system side effects of moderate or severe intensity have included dizziness (up to 8.5%), headache (up to 7.8%), circumoral paresthesia (up to 6.7%), peripheral paresthesia (up to 6%), paresthesia (up to 5.2%), insomnia (up to 3.4%), somnolence (up to 2.6%), abnormal thinking (up to 2.6%), confusion (up to 2.1%), and syncope (up to 2.1%). Abnormal gait, agitation, amnesia, aphasia, ataxia, coma, convulsion, dementia, diplopia, grand mal convulsion, hallucinations, hearing impairment, hyperesthesia, hyperkinesia, hypesthesia, incoordination, migraine, neuralgia, neuropathy, paralysis, peripheral neuropathic pain, peripheral neuropathy, peripheral sensory neuropathy, sleep disorder, speech disorder, stupor, subdural hematoma, tinnitus, tremor, urinary retention, vertigo, and vestibular disorder have been reported in less than 2% of patients; these side effects were of at least moderate intensity. Syncope and seizure have been reported during postmarketing experience.

Hepatic

Hepatic side effects of at least moderate intensity have included cholestatic jaundice, hepatic coma, hepatitis, hepatomegaly, hepatosplenomegaly, and liver damage in less than 2% of patients. Increased gamma glutamyltransferase (greater than 300 international units/L; up to 19.6%), AST (greater than 180 international units/L; up to 9.5%), and ALT (greater than 215 international units/L; up to 9.2%), and exacerbation of chronic liver disease have been reported. 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. Hepatic dysfunction (including some fatalities) has been reported during postmarketing experience, generally in patients taking multiple concurrent medications and/or with advanced AIDS.

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.

Psychiatric

Psychiatric side effects of moderate or severe intensity have included depression (up to 7.1%) and anxiety (up to 2.1%). Abnormal dreams, depersonalization, emotional lability, euphoria, decreased libido, manic reaction, nervousness, and personality disorder have been reported in less than 2% of patients; these side effects were of at least moderate intensity.

Cardiovascular

Cardiovascular side effects of moderate or severe intensity have included vasodilation (up to 3.5%). Cardiovascular disorder, cerebral ischemia, cerebral venous thrombosis, hypertension, hypotension, myocardial infarct, palpitation, peripheral vascular disorder, phlebitis, postural hypotension, tachycardia, and vasospasm have been reported in less than 2% of patients; these side effects were of at least moderate intensity. Orthostatic hypotension, 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 of moderate or severe intensity have included rash (up to 3.5%) and sweating (up to 3.4%). Acne, contact dermatitis, dry skin, eczema, erythema multiforme, exfoliative dermatitis, folliculitis, fungal dermatitis, furunculosis, maculopapular rash, molluscum contagiosum, onychomycosis, photosensitivity reaction, pruritus, psoriasis, pustular rash, seborrhea, skin discoloration, skin disorder, skin hypertrophy, skin melanoma, urticaria, and vesiculobullous rash have been reported in less than 2% of patients; these side effects were of at least moderate intensity. Alopecia has been reported in patients receiving indinavir or atazanavir plus ritonavir. Toxic epidermal necrolysis has been reported during postmarketing experience.

Endocrine

Endocrine side effects of at least moderate intensity have included adrenal cortex insufficiency (less than 2%).

Genitourinary

Genitourinary side effects of moderate or severe intensity have included nocturia (up to 2.8%). Breast pain, cystitis, dysuria, glycosuria, hematuria, impotence, menorrhagia, penis disorder, polyuria, urethritis, urinary frequency, urinary tract infection, and vaginitis have been reported in less than 2% of patients; these side effects were of at least moderate intensity.

Hypersensitivity

Hypersensitivity side effects of at least moderate intensity have included allergic reaction (less than 2%). Allergic reactions (including urticaria, mild skin eruptions, bronchospasm, and angioedema), anaphylaxis, toxic epidermal necrolysis, and Stevens-Johnson syndrome have been reported.

Musculoskeletal

Musculoskeletal side effects of moderate or severe intensity have included myalgia (up to 2.4%) and arthralgia (up to 2.1%). Arthritis, arthrosis, bone disorder, bone pain, extraocular palsy, joint disorder, leg cramps, muscle cramps, muscle weakness, myositis, and twitching have been reported in less than 2% of patients; these side effects were of at least moderate intensity.

Renal

Renal side effects of at least moderate intensity have included acute renal failure, renal calculus, renal failure, abnormal kidney function, and kidney pain in less than 2% of patients. Increased serum creatinine has been reported. Renal insufficiency has been reported during postmarketing experience.

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 of moderate or severe intensity have included pharyngitis (up to 2.6%). Asthma, bronchitis, increased cough, dyspnea, epistaxis, hiccup, hypoventilation, interstitial pneumonia, larynx edema, lung disorder, rhinitis, and sinusitis have been reported in less than 2% of patients; these side effects were of at least moderate intensity.

Ocular

Ocular side effects of at least moderate intensity have included abnormal electrooculogram, abnormal electroretinogram, abnormal vision, amblyopia/blurred vision, blepharitis, conjunctivitis, eye disorder, eye pain, iritis, photophobia, uveitis, visual field defect, and vitreous disorder in less than 2% of patients.

Immunologic

Immunologic side effects have included immune reconstitution syndrome. Autoimmune disorders (e.g., Graves' disease, polymyositis, and Guillain-Barre syndrome) have been reported in the setting of immune reconstitution.

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