Kaletra Side Effects

Generic name: lopinavir / ritonavir

Medically reviewed by Drugs.com. Last updated on May 28, 2024.

Note: This document provides detailed information about Kaletra Side Effects associated with lopinavir / ritonavir. Some dosage forms listed on this page may not apply specifically to the brand name Kaletra.

Applies to lopinavir / ritonavir: oral solution, oral tablet.

Serious side effects of Kaletra

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:

Less common side effects

• bloating
• blurred vision
• chills
• constipation
• darkened urine
• dry mouth
• fast heartbeat
• fever
• flushed, dry skin
• fruit-like breath odor
• increased hunger
• increased thirst
• increased urination
• indigestion
• loss of appetite
• loss of consciousness
• nausea
• pains in the stomach, side, or abdomen, possibly moving to the back
• sweating
• troubled breathing
• unexplained weight loss
• vomiting
• yellow eyes or skin

Incidence not known

• blistering, peeling, or loosening of the skin
• chest pain or discomfort
• cough
• diarrhea
• itching
• joint or muscle pain
• lightheadedness, dizziness, or fainting
• red skin lesions, often with a purple center
• red, irritated eyes
• slow or irregular heartbeat
• sore throat
• sores, ulcers, or white spots in the mouth or on the lips
• unusual tiredness or weakness

Get emergency help immediately if any of the following symptoms of overdose occur while taking lopinavir / ritonavir:

Symptoms of overdose

• agitation
• confusion
• cool, sweaty skin
• decreased appetite
• decreased awareness or responsiveness
• decreased urine output
• depression
• fast, irregular, or pounding heartbeat
• fast, shallow breathing
• general feeling of discomfort
• headache
• hostility
• irritability
• muscle pain or cramping
• muscle twitching
• pounding, slow heartbeat
• rapid weight gain
• seizures
• severe sleepiness
• stomach discomfort
• swelling of the face, ankles, or hands
• swelling of the feet or lower legs
• unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

Other side effects of Kaletra

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:

Less common side effects

• abnormal stools
• belching
• heartburn
• lack or loss of strength
• pain
• skin rash
• trouble with sleeping

Incidence not known

• redistribution of body fat

For healthcare professionals

Applies to lopinavir / ritonavir: oral capsule, oral liquid, oral tablet.

General adverse events

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.^[Ref]

Other

• Very common (10% or more): Increased total cholesterol (up to 39%), increased triglycerides (up to 36%)
• Common (1% to 10%): Fatigue, asthenia, pain, decreased weight, pyrexia, chills, decreased inorganic phosphorus
• Uncommon (0.1% to 1%): Increased weight
• Frequency not reported: Generalized pain, back and abdomen enlargement, chest pain, cyst, edema, peripheral edema, face edema, influenza syndrome, hypertrophy, malaise, drug interaction, increased drug level, bacterial infection, viral infection, otitis media, breast enlargement

Antiretroviral therapy:

• Frequency not reported: Increased weight, increased blood lipid levels^[Ref]

Increased total cholesterol (greater than 300 mg/dL) and triglycerides (greater than 750 mg/dL) have been reported in up to 39% and up to 36% of patients, respectively. Decreased inorganic phosphorus (less than 1.5 mg/dL) has been reported in up to 2% of patients.^[Ref]

Hepatic

• 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, jaundice
• Frequency not reported: Fatty liver deposit, cytolytic hepatitis, liver tenderness, hepatic failure, cholecystitis, hepatic dysfunction
• Postmarketing reports: Jaundice, hepatitis^[Ref]

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.^[Ref]

Gastrointestinal

• Very common (10% or more): Diarrhea (up to 28%), nausea (up to 16%)
• Common (1% to 10%): Increased amylase, vomiting, abdominal pain, upper abdominal pain, lower abdominal pain, increased lipase, gastroenteritis and colitis, dyspepsia, pancreatitis, gastroesophageal reflux disease, hemorrhoids, flatulence, abdominal distention, abnormal feces, constipation, dysphagia
• 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: Abdominal discomfort, enteritis, enterocolitis, eructation, esophagitis, gastric disorder, gastric ulcer, hemorrhagic enterocolitis, mouth ulceration, periodontitis, sialadenitis, stomach discomfort, ulcerative stomatitis^[Ref]

Increased amylase (greater than 2 times the upper limit of normal [2 x ULN]) and lipase (greater than 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.^[Ref]

Respiratory

• Very common (10% or more): Upper respiratory tract infection (up to 13.9%)
• Common (1% to 10%): Lower respiratory tract infection, bronchitis
• Frequency not reported: Asthma, bronchopneumonia, dyspnea, pulmonary edema, pharyngitis, rhinitis, increased cough, sinusitis, influenza^[Ref]

Metabolic

• Common (1% to 10%): Hypercholesterolemia, hypertriglyceridemia, increased glucose, increased uric acid, decreased appetite, blood glucose disorders (including diabetes mellitus), anorexia
• Uncommon (0.1% to 1%): Lactic acidosis, increased appetite
• 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")

Combination antiretroviral therapy:

• Frequency not reported: Redistribution of body fat (fat loss or fat gain)

Antiretroviral therapy:

• Frequency not reported: Redistribution/accumulation of body fat, increased glucose levels^[Ref]

Increased glucose (greater than 250 mg/dL) and uric acid (greater than 12 mg/dL) have each been reported in up to 5% 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.^[Ref]

Musculoskeletal

• 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^[Ref]

Increased creatine phosphokinase (greater than 4 x ULN) was reported in up to 5% of patients.^[Ref]

Nervous system

• Common (1% to 10%): Headache (including migraine), neuropathy (including peripheral neuropathy), dizziness, paresthesia
• Uncommon (0.1% to 1%): Ageusia, convulsion, vertigo, tremor, cerebrovascular accident/event, tinnitus, dysgeusia
• Frequency not reported: Amnesia, ataxia, balance disorder, abnormal coordination, cerebral infarction, dyskinesia, encephalopathy, facial paralysis/palsy, hypertonia, peripheral neuritis, somnolence, hyperacusis, extrapyramidal disorder^[Ref]

Hematologic

• 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^[Ref]

Decreased neutrophils (less than 0.75 x 10[9]/L) and hemoglobin (less than 8 g/dL) have been reported in up to 5% and up to 2% of patients, respectively.^[Ref]

Psychiatric

• Common (1% to 10%): Anxiety, insomnia, decreased libido, depression
• Uncommon (0.1% to 1%): Abnormal dreams
• Frequency not reported: Affect lability, agitation, apathy, confusional state, disorientation, mood swings, nervousness, abnormal thinking^[Ref]

Dermatologic

• 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
• Rare (0.01% to 0.1%): Stevens-Johnson syndrome, erythema multiforme
• 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, furunculosis
• Postmarketing reports: Toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme^[Ref]

Renal

• Common (1% to 10%): Decreased calculated CrCl, renal failure
• Uncommon (0.1% to 1%): Nephritis
• Frequency not reported: Nephrolithiasis, renal disorder
• Postmarketing reports: Nephrolithiasis^[Ref]

Decreased calculated CrCl (less than 50 mL/min) was reported in up to 3% of patients.^[Ref]

Hypersensitivity

• Common (1% to 10%): Hypersensitivity (including urticaria, angioedema)
• Frequency not reported: Drug hypersensitivity, severe skin and mucous hypersensitivity reaction with transient multiorgan failure^[Ref]

Cardiovascular

• Common (1% to 10%): Hypertension, vasodilatation
• 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
• Postmarketing reports: Bradyarrhythmias, first-degree AV block, second-degree AV block, third-degree AV block, QTc interval prolongation, torsades de pointes^[Ref]

Genitourinary

• 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^[Ref]

Endocrine

• Common (1% to 10%): Hypogonadism
• Frequency not reported: Cushing's syndrome, hypothyroidism, gynecomastia^[Ref]

Ocular

• Uncommon (0.1% to 1%): Visual impairment
• Frequency not reported: Visual disturbance, eye disorder^[Ref]

Immunologic

• Uncommon (0.1% to 1%): Immune reconstitution syndrome/immune reconstitution inflammatory syndrome
• Frequency not reported: Autoimmune disorders in the setting of immune reconstitution (e.g., Graves' disease, polymyositis, Guillain-Barre syndrome, autoimmune hepatitis)

Oncologic

• Frequency not reported: Neoplasm, lipoma

Further information

Kaletra side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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