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 liquid filled, oral solution, oral tablet
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:Less common
- feeling faint, dizzy, or lightheaded
- feeling of warmth or heat
- flushing or redness of the skin, especially on the face and neck
- dry or itchy skin
- fruity mouth odor
- increased hunger
- increased thirst
- increased urination
- weight loss
- darkened urine
- decreased urination
- difficulty with breathing
- dry mouth
- fast heartbeat
- hives or welts
- increase in heart rate
- 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
- tightness in the chest
- unusual tiredness or weakness
- wrinkled skin
- yellow eyes or skin
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:More common
- Acid or sour stomach
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- change in sense of taste
- general feeling of discomfort or illness
- lack or loss of strength
- sleepiness or unusual drowsiness
- trouble sleeping
- unable to sleep
- Body aches or pain
- difficulty with moving
- dryness or soreness of the throat
- excess air or gas in the stomach or intestines
- feeling sad or empty
- full feeling
- increased urge to urinate during the night
- lack of appetite
- loss of interest or pleasure
- mood or mental changes
- muscle pain or stiffness
- pain in the joints or in unspecified location
- passing gas
- runny nose
- tender, swollen glands in the neck
- throat irritation
- trouble concentrating
- trouble with swallowing
- voice changes
- waking to urinate at night
- Gaining weight around your neck, upper back, breast, face, or waist
For Healthcare Professionals
Applies to ritonavir: oral capsule, oral solution, oral tablet
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 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.
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 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 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 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 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 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 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 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 side effects of at least moderate intensity have included adrenal cortex insufficiency (less than 2%).
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 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 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 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 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 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 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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