Note: This document contains side effect information about lopinavir / ritonavir. Some of the dosage forms listed on this page may not apply to the brand name Kaletra.
Common side effects of Kaletra include: increased serum cholesterol and increased serum triglycerides. Other side effects include: hyperglycemia and increased serum amylase. See below for a comprehensive list of adverse effects.
Applies to lopinavir/ritonavir: oral solution, oral tablet
Along with its needed effects, lopinavir / 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 lopinavir / ritonavir:
Incidence not known
Get emergency help immediately if any of the following symptoms of overdose occur while taking lopinavir / ritonavir:
Symptoms of overdose
Some side effects of lopinavir / 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
Applies to lopinavir / ritonavir: oral capsule, oral liquid, oral tablet
In clinical studies, this drug was used with nucleoside reverse transcriptase inhibitors with or without efavirenz or nevirapine. The most common side effects were diarrhea, nausea, vomiting, hypertriglyceridemia, and hypercholesterolemia. Diarrhea, nausea, and vomiting occurred more often at the start of therapy while hypertriglyceridemia and hypercholesterolemia generally occurred later. Diarrhea was reported more often when this drug was used once a day than when it was used twice a day.
Very common (10% or more): Diarrhea (up to 19.5%), nausea (up to 10.3%)
Common (1% to 10%): Increased amylase, vomiting, abdominal pain (upper and lower), increased lipase, gastroenteritis and colitis, dyspepsia, pancreatitis, gastroesophageal reflux disease, hemorrhoids, flatulence, abdominal distention, constipation
Uncommon (0.1% to 1%): Stomatitis and oral ulcers, duodenitis, gastritis, gastrointestinal hemorrhage (including rectal hemorrhage), dry mouth, gastrointestinal ulcer, fecal incontinence
Frequency not reported: Abnormal feces, dysphagia, abdominal discomfort, enteritis, enterocolitis, eructation, esophagitis, gastric disorder, gastric ulcer, hemorrhagic enterocolitis, mouth ulceration, periodontitis, sialadenitis, stomach discomfort, ulcerative stomatitis
Increased amylase and lipase, greater than 2 times the upper limit of normal (2 x ULN), were reported in up to 8% and up to 5% of patients, respectively.
Pancreatitis, including fatalities, has occurred in patients receiving this drug, 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.
Very common (10% or more): Increased total cholesterol (up to 39%), increased triglycerides (up to 36%)
Common (1% to 10%): Hypercholesterolemia, hypertriglyceridemia, increased glucose, increased uric acid, decreased weight, decreased appetite, decreased inorganic phosphorus, blood glucose disorders (including diabetes mellitus)
Uncommon (0.1% to 1%): Lactic acidosis, increased appetite, anorexia
Frequency not reported: Avitaminosis, hypovitaminosis, dehydration, dyslipidemia, hyperamylasemia, hyperlipasemia, decreased glucose tolerance, lipomatosis, obesity, hyperglycemia, new onset diabetes mellitus, exacerbation of preexisting diabetes mellitus, ketoacidosis, insulin resistance, hyperlactatemia
Postmarketing reports: Redistribution/accumulation of body fat (including central obesity, dorsocervical fat enlargement, peripheral wasting, facial wasting, breast enlargement, "cushingoid appearance")
Increased total cholesterol (greater than 300 mg/dL), triglycerides (greater than 750 mg/dL), glucose (greater than 250 mg/dL), and uric acid (greater than 12 mg/dL) have been reported in up to 39%, up to 36%, up to 5%, and up to 5% of patients, respectively. Decreased inorganic phosphorus (less than 1.5 mg/dL) has been reported in up to 2% of patients.
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.
Very common (10% or more): Increased GGT (up to 29%), increased ALT (up to 11%)
Common (1% to 10%): Increased AST, hepatitis (including increased AST, ALT, GGT), increased total bilirubin
Uncommon (0.1% to 1%): Hepatomegaly, cholangitis, hepatic steatosis, hyperbilirubinemia
Frequency not reported: Fatty liver deposit, cytolytic hepatitis, liver tenderness, hepatic failure, cholecystitis, hepatic dysfunction
Postmarketing reports: Jaundice
Increased GGT (greater than 300 units/L), ALT (greater than 215 units/L), AST (greater than 180 units/L), and total bilirubin (greater than 3.48 mg/dL) have been reported in up to 29%, up to 11%, up to 10%, and 1% of patients, respectively.
Patients with underlying hepatitis B or C or marked elevations in transaminases before initiation of therapy may be at an increased risk for developing further transaminase elevations or liver decompensation. There have been reports of hepatic dysfunction with some cases leading to death. A causal relationship with this drug has not been proven since these cases have generally occurred in patients with advanced HIV who also had underlying chronic hepatitis or cirrhosis and were taking multiple concomitant medications.
Very common (10% or more): Upper respiratory tract infection (up to 13.9%)
Common (1% to 10%): Lower respiratory tract infection
Frequency not reported: Bronchitis, asthma, bronchopneumonia, dyspnea, pulmonary edema, pharyngitis, rhinitis, increased cough, sinusitis, influenza
Common (1% to 10%): Fatigue (including asthenia)
Uncommon (0.1% to 1%): Increased weight
Frequency not reported: Pyrexia, chills, pain, generalized pain, back and abdomen enlargement, chest pain, cyst, edema, peripheral edema, face edema, influenza syndrome, hypertrophy, malaise, drug interaction, increased drug level, infection (bacterial, viral), otitis media, breast enlargement
Increased creatine phosphokinase (greater than 4 x ULN) was reported in up to 5% of patients.
Common (1% to 10%): Musculoskeletal pain (including arthralgia, back pain), increased creatine phosphokinase, myalgia, muscle disorders (such as weakness, spasms)
Uncommon (0.1% to 1%): Rhabdomyolysis, osteonecrosis
Frequency not reported: Arthropathy, arthrosis, muscular weakness, joint disorder, osteoarthritis, extremity pain, myasthenia, myositis, perineal abscess
Common (1% to 10%): Headache (including migraine), neuropathy (including peripheral neuropathy), dizziness
Uncommon (0.1% to 1%): Ageusia, convulsion, vertigo, tremor, cerebrovascular accident/event, tinnitus, dysgeusia, paresthesia
Frequency not reported: Amnesia, ataxia, balance disorder, abnormal coordination, cerebral infarction, dyskinesia, encephalopathy, facial paralysis/palsy, hypertonia, peripheral neuritis, somnolence, hyperacusis, extrapyramidal disorder
Common (1% to 10%): Decreased neutrophils, anemia, decreased hemoglobin, leukopenia, neutropenia, lymphadenopathy
Rare (less than 0.1%): Hemolytic anemia, spontaneous bleeding in hemophiliacs
Frequency not reported: Splenomegaly
Decreased neutrophils (less than 0.75 x 10/L) and hemoglobin (less than 8 g/dL) have been reported in up to 5% and up to 2% of patients, respectively.
Common (1% to 10%): Anxiety, insomnia
Uncommon (0.1% to 1%): Abnormal dreams, decreased libido, depression
Frequency not reported: Affect lability, agitation, apathy, confusional state, disorientation, mood swings, nervousness, abnormal thinking
Common (1% to 10%): Rash (including maculopapular rash), skin infections (including cellulitis, folliculitis, furuncle), acquired lipodystrophy (including facial wasting), dermatitis/rash (including eczema, seborrheic dermatitis), night sweats, pruritus
Uncommon (0.1% to 1%): Alopecia, capillaritis, vasculitis
Frequency not reported: Acne, dry skin, acneiform dermatitis, allergic dermatitis, exfoliative dermatitis, idiopathic capillaritis, generalized rash, nail disorder, seborrhea, benign skin neoplasm, skin discoloration, skin hypertrophy, skin ulcer, skin striae, swelling face, hyperhidrosis, acute generalized exanthematous pustulosis
Postmarketing reports: Toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme
Common (1% to 10%): Decreased calculated CrCl, renal failure
Uncommon (0.1% to 1%): Nephritis
Frequency not reported: Nephrolithiasis, renal disorder
Decreased calculated CrCl (less than 50 mL/min) was reported in up to 3% of patients.
Common (1% to 10%): Hypersensitivity (including urticaria, angioedema)
Frequency not reported: Drug hypersensitivity, severe skin and mucous hypersensitivity reaction with transient multiorgan failure
Common (1% to 10%): Hypertension
Uncommon (0.1% to 1%): Deep vein thrombosis, atherosclerosis (such as myocardial infarction), atrioventricular (AV) block, tricuspid valve incompetence
Frequency not reported: Distended veins, angina pectoris, atrial fibrillation, chest pain, palpitation, orthostatic hypotension, thrombophlebitis, varicose vein, vasculitis, sinus arrest, bradycardia-tachycardia syndrome, vasodilatation
Postmarketing reports: Bradyarrhythmias, first-degree AV block, second-degree AV block, third-degree AV block, QTc interval prolongation, torsades de pointes
Common (1% to 10%): Erectile dysfunction, menstrual disorders (amenorrhea, menorrhagia)
Uncommon (0.1% to 1%): Hematuria
Frequency not reported: Ejaculation disorder, impotence, abnormal urine odor, urine abnormality
Uncommon (0.1% to 1%): Visual impairment
Frequency not reported: Visual disturbance, eye disorder
Uncommon (0.1% to 1%): Immune reconstitution/reactivation syndrome
Frequency not reported: Autoimmune disorders in the setting of immune reconstitution (e.g., Graves' disease, polymyositis, Guillain-Barre syndrome)
Uncommon (0.1% to 1%): Hypogonadism
Frequency not reported: Cushing's syndrome, hypothyroidism, gynecomastia
Frequency not reported: Neoplasm, lipoma
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Kaletra (www.drugs.com/kaletra.html).
March 28, 2020
March 28, 2020
March 28, 2020
March 28, 2020
March 28, 2020
March 28, 2020