Lopinavir/Ritonavir Side Effects

Please note - some side effects for Lopinavir/Ritonavir 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 Lopinavir/Ritonavir - for the Consumer

Lopinavir/Ritonavir

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 Lopinavir/Ritonavir:

Diarrhea; headache; nausea; stomach pain or upset; tiredness; vomiting; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; dark urine; fainting; fast, slow, or irregular heartbeat; fever, chills, or sore throat; loss of appetite; loss of consciousness; pale stools; red, swollen, blistered, or peeling skin; severe or persistent dizziness or lightheadedness; severe or persistent nausea, vomiting, or stomach pain; symptoms of high blood sugar (eg, confusion; flushed face; fruit-like breath odor; increased thirst, hunger, or urination; unusual drowsiness); unusual bleeding or bruising; yellowing of the skin or eyes.

Lopinavir/Ritonavir Capsules

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 Lopinavir/Ritonavir Capsules:

Abnormal stools; chills; depression; diarrhea; fever; gas; headache; indigestion; loss of appetite; muscle pain; nausea; pain; prickling or tingling sensation on the skin; shift in body fat to stomach and upper body; sleeplessness; stomach pain; tiredness; vomiting; weakness; weight loss.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood in stool; dark urine; drowsiness; fatigue; flushed face; increased blood sugar; increased thirst or urination; persistent fever; severe stomach pain with nausea and vomiting; unusual bleeding or bruising; unusual hunger; vision changes; yellowing of the skin or eyes.

Lopinavir/Ritonavir 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 Lopinavir/Ritonavir Solution:

Diarrhea; headache; nausea; stomach pain or upset; tiredness; vomiting; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; dark urine; fainting; fast, slow, or irregular heartbeat; fever, chills, or sore throat; loss of appetite; loss of consciousness; pale stools; red, swollen, blistered. or peeling skin; severe or persistent dizziness or lightheadedness; severe or persistent nausea, vomiting, or stomach pain; symptoms of high blood sugar (eg, confusion; flushed face; fruit-like breath odor; increased thirst, hunger, or urination; unusual drowsiness); unusual bleeding or bruising; yellowing of the skin or eyes.

Side Effects by Body System

General

Diarrhea, usually of mild to moderate severity, is the most common side effect associated with lopinavir-ritonavir. During 48 weeks of one study, diarrhea (any severity) occurred in 60% of patients receiving lopinavir-ritonavir tablets once a day compared to 57% receiving the tablets twice a day. In the same trial, treatment was discontinued in 4.8% of patients receiving lopinavir-ritonavir tablets once a day as compared to 3% receiving twice daily dosing due to any adverse effects. During another clinical trial, discontinuations due to side effects were observed in 3.4% of patients receiving lopinavir-ritonavir versus 3.7% receiving comparator.

Cardiovascular

Cardiovascular side effects associated with lopinavir-ritonavir in combination with other antiretroviral agents have included hypertension (3%), distended veins (3%), and atrial fibrillation, atrioventricular (AV) block, myocardial infarction, cerebral infarct, deep vein thrombosis, chest pain, hypertension, palpitation, postural hypotension, thrombophlebitis, varicose vein, and vasculitis in less than 2% of adult patients. Sinus arrest and bradycardia-tachycardia syndrome have also been reported. Bradyarrhythmias, first-degree AV block, second-degree AV block, third-degree AV block, QTc interval prolongation, and torsades de pointes have been reported during postmarketing experience.

Dermatologic

Dermatologic side effects associated with lopinavir-ritonavir in combination with other antiretroviral agents have included rash (up to 5%) and acne, alopecia, dry skin, eczema, acneiform dermatitis, allergic dermatitis, exfoliative dermatitis, cellulitis, folliculitis, furunculosis, lipomatosis, idiopathic capillaritis, maculopapular rash, generalized rash, nail disorder, seborrhea, pruritus, benign skin neoplasm, skin discoloration, skin hypertrophy, skin ulcer, skin striae, swelling face, and hyperhidrosis in less than 2% of patients. Stevens-Johnson syndrome, erythema multiforme, and acute generalized exanthematous pustulosis have also been reported.

Endocrine

Endocrine side effects associated with lopinavir-ritonavir in combination with other antiretroviral agents have included Cushing's syndrome, diabetes mellitus, and hypothyroidism in less than 2% of patients. Ketoacidosis has been reported.

Episodes of hyperglycemia, new onset diabetes mellitus, and exacerbation of preexisting diabetes mellitus have been reported during postmarketing studies in HIV-infected patients receiving protease inhibitors. In some cases, diabetic ketoacidosis has occurred. No causal relationship has been established. Careful monitoring of blood glucose levels should be done and either initiation or dose adjustments of insulin or oral hypoglycemic agents may be needed.

Gastrointestinal

Gastrointestinal side effects associated with lopinavir-ritonavir in combination with other antiretroviral agents have included diarrhea (7% to 28%), nausea (5% to 16%), vomiting (2% to 6%), abdominal pain (1% to 11%), abnormal stools (up to 6%), dyspepsia (up to 6%), dysphagia (up to 2%), flatulence (1% to 4%), and anorexia (up to 2%). Cholangitis, cholecystitis, abdominal distention, upper abdominal pain, constipation, dry mouth, enterocolitis, eructation, esophagitis, fecal incontinence, gastric disorder, gastritis, gastroesophageal reflux disease, hemorrhoids, gastroenteritis, hemorrhagic enterocolitis, increased and decreased appetite, pancreatitis, periodontitis, sialadenitis, stomatitis, stomach discomfort, and ulcerative stomatitis have been reported in less than 2% of patients.

Pancreatitis, including fatalities, has occurred in patients receiving lopinavir-ritonavir therapy, including those who developed hypertriglyceridemia. Although a causal relationship has not been established, marked triglyceride elevation is a risk factor for the development of pancreatitis. Patients who experience signs or symptoms of pancreatitis should be evaluated and lopinavir-ritonavir should be stopped if a diagnosis of pancreatitis is made.

Genitourinary

Genitourinary side effects associated with lopinavir-ritonavir in combination with other antiretroviral agents have included hypogonadism (2%) and ejaculation disorder, breast enlargement, gynecomastia, impotence, and urine abnormality in less than 2% of patients.

Hematologic

Hematologic side effects associated with lopinavir-ritonavir in combination with other antiretroviral agents have included decreased neutrophil counts (1% to 5%) and anemia, leukopenia, splenomegaly, and lymphadenopathy in less than 2% of patients. Hemolytic anemia and spontaneous bleeding in hemophiliacs have been reported rarely.

Hepatic

Hepatic side effects associated with lopinavir-ritonavir in combination with other antiretroviral agents have included elevated AST (1% to 10%), ALT (1% to 11%), and GGT (up to 29%) levels, and jaundice, fatty liver deposit, cytolytic hepatitis, hepatitis, hepatomegaly, and liver tenderness (less than 2% each). Hepatic failure has also been reported.

Metabolic

Metabolic side effects associated with lopinavir-ritonavir in combination with other antiretroviral agents have included elevations in amylase (3% to 8%), bilirubin (1% to 3%), blood glucose (up to 5%), total cholesterol (3% to 39%), triglycerides (3% to 36%), uric acid (up to 5%), and lipase (3% to 5%), decreased phosphorus levels (up to 2%), and weight loss (up to 3%). Avitaminosis, hypovitaminosis, dehydration, decreased glucose tolerance, lactic acidosis, obesity, and weight gain have been reported in less than 2% of patients.

Musculoskeletal

Musculoskeletal side effects have included myalgia (up to 2%) and arthralgia, back pain, arthrosis, bone necrosis, joint disorder, osteoarthritis, extremity pain, and myasthenia in less than 2% of patients receiving lopinavir-ritonavir with other antiretroviral agents.

Nervous system

Nervous system side effects associated with lopinavir-ritonavir in combination with other antiretroviral agents have included headache (2% to 7%), depression (up to 2%), insomnia (up to 3%), decreased libido (up to 2%), and paresthesia (1% to 2%). Amnesia, ataxia, convulsion, dizziness, dyskinesia, encephalopathy, facial paralysis, hypertonia, migraine, neuropathy, peripheral neuropathy, peripheral neuritis, somnolence, hyperacusis, tinnitus, tremor, extrapyramidal syndrome, ageusia, dysgeusia, and vertigo have been reported in less than 2%.

Ocular

Ocular side effects have included visual disturbance and eye disorder in less than 2% of patients receiving lopinavir-ritonavir with other antiretroviral agents.

Other

Other side effects associated with lopinavir-ritonavir in combination with other antiretroviral agents have included asthenia (up to 9%), pyrexia (2%), chills (up to 2%), and generalized pain, back pain, back and abdomen enlargement, chest pain, cyst, edema, peripheral edema, fatigue, face edema, flu syndrome, hypertrophy, malaise, lymphadenopathy, drug interaction, and increased drug level in less than 2% of patients. Elevated creatine kinase has also been reported.

Other

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 receiving antiretroviral therapy. The mechanism and long-term consequences of these events are currently unknown and a causal relationship has not been established.

Oncologic

Oncologic side effects have included neoplasm and lipoma in less than 2% of patients when lopinavir-ritonavir was administered with other antiretroviral agents.

Renal

Renal side effects have included decreased calculated creatinine clearance (2%) and kidney calculus, nephritis, and renal disorder in less than 2% of patients when lopinavir-ritonavir was administered with other antiretroviral agents.

Respiratory

Respiratory side effects have included bronchitis (up to 2%) and asthma, dyspnea, lung edema, rhinitis, increased cough, and sinusitis in less than 2% of patients receiving lopinavir-ritonavir with other antiretroviral agents.

Hypersensitivity

Hypersensitivity side effects have included drug hypersensitivity and hypersensitivity in less than 2% of patients receiving lopinavir-ritonavir in combination with other antiretroviral agents. At least one case of a severe skin and mucous hypersensitivity reaction with transient multiorgan failure has been reported.

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