Kaletra Side Effects

Generic Name: lopinavir / ritonavir

Note: This page contains information about the side effects of lopinavir / ritonavir. Some of the dosage forms included on this document may not apply to the brand name Kaletra.

Not all side effects for Kaletra may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to lopinavir / ritonavir: oral capsule liquid filled, oral solution, oral tablet

In addition to its needed effects, some unwanted effects may be caused by lopinavir / ritonavir. In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when taking lopinavir / ritonavir:

Less common
  • 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
  • shortness of breath
  • slow or irregular heartbeat
  • sore throat
  • sores, ulcers, or white spots in the mouth or on the lips
  • unusual tiredness

Some of the side effects that can occur with lopinavir / ritonavir may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

Less common
  • Abnormal stools
  • acid or sour stomach
  • belching
  • headache
  • heartburn
  • lack or loss of strength
  • pain
  • skin rash
  • stomach discomfort, upset, or pain
  • trouble with sleeping
Incidence not known
  • Redistribution of body fat

For Healthcare Professionals

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

General

In clinical studies, lopinavir-ritonavir was used with nucleoside reverse transcriptase inhibitors with or without efavirenz or nevirapine.

Diarrhea was reported more often when lopinavir-ritonavir was used once a day than when it was used twice a day. At least half of patients treated with once-daily lopinavir-ritonavir capsules or tablets, reported diarrhea (any grade). Ongoing diarrhea was reported in 4.2% to 6.3% of patients treated with once-daily lopinavir-ritonavir and in 1.8% to 3.7% of patients treated with twice-daily lopinavir-ritonavir at the time therapy was stopped.

The most commonly reported side effects included 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.

Gastrointestinal

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.

Very common (10% or more): Diarrhea (moderate/severe intensity: 19.5%), nausea (moderate/severe intensity: 10.3%)
Common (1% to 10%): Increased amylase (greater than 2 times upper limit of normal [ULN]; up to 8%), vomiting (moderate/severe intensity: 6.8%), abdominal pain (upper and lower; moderate/severe intensity: 6.1%), increased lipase (greater than 2 times ULN; up to 5%), gastroenteritis and colitis (moderate/severe intensity: 2.5%), dyspepsia (moderate/severe intensity: 2%), pancreatitis (moderate/severe intensity: 1.7%), gastroesophageal reflux disease (moderate/severe intensity: 1.5%), hemorrhoids (moderate/severe intensity: 1.5%), flatulence (moderate/severe intensity: 1.4%), abdominal distention (moderate/severe intensity: 1.3%), constipation (moderate/severe intensity: 1%)
Uncommon (0.1% to 1%): Stomatitis and oral ulcers (moderate/severe intensity: 0.9%), duodenitis and gastritis (moderate/severe intensity: 0.8%), gastrointestinal hemorrhage (including rectal hemorrhage; moderate/severe intensity: 0.5%), dry mouth (moderate/severe intensity: 0.3%), gastrointestinal ulcer (moderate/severe intensity: 0.2%), fecal incontinence (moderate/severe intensity: 0.2%)
Frequency not reported: Abnormal stools, dysphagia, abdominal discomfort, enterocolitis, eructation, esophagitis, gastric disorder, gastric ulcer, hemorrhagic enterocolitis, periodontitis, sialadenitis, stomach discomfort, ulcerative stomatitis

Metabolic

Very common (10% or more): Increased total cholesterol (greater than 300 mg/dL; up to 39%), increased triglycerides (greater than 750 mg/dL; up to 36%)
Common (1% to 10%): Hypercholesterolemia (moderate/severe intensity: 7.4%), hypertriglyceridemia (moderate/severe intensity: 6.2%), increased glucose (greater than 250 mg/dL; up to 5%), increased uric acid (greater than 12 mg/dL; up to 5%), decreased weight (moderate/severe intensity: 2.3%), acquired lipodystrophy (including facial wasting; moderate/severe intensity: 2.2%), decreased appetite (moderate/severe intensity: 2%), decreased inorganic phosphorus (less than 1.5 mg/dL; up to 2%), blood glucose disorders (including diabetes mellitus; moderate/severe intensity: 1.1%)
Uncommon (0.1% to 1%): Increased weight (moderate/severe intensity: 0.8%), lactic acidosis (moderate/severe intensity: 0.4%), increased appetite (moderate/severe intensity: 0.2%)
Frequency not reported: Avitaminosis, anorexia, hypovitaminosis, dehydration, decreased glucose tolerance, obesity, hyperglycemia, new onset diabetes mellitus, exacerbation of preexisting diabetes mellitus, ketoacidosis, redistribution/accumulation of body fat (including central obesity, dorsocervical fat enlargement, peripheral wasting, facial wasting, breast enlargement, "cushingoid appearance")
Postmarketing reports: Redistribution/accumulation of body fat

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.

Hepatic

Lopinavir-ritonavir is primarily metabolized by the liver. Caution should be used when administering this drug to patients with hepatic impairment because lopinavir levels may be increased. 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 lopinavir-ritonavir administration 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): Increased gamma glutamyltransferase (GGT; greater than 300 units/L; up to 29%), increased ALT/SGPT (greater than 215 units/L; up to 11%)
Common (1% to 10%): Increased AST/SGOT (greater than 180 units/L; up to 10%), hepatitis (including increased AST, ALT, GGT; moderate/severe intensity: 3.5%), increased total bilirubin (greater than 3.48 mg/dL; 1%)
Uncommon (0.1% to 1%): Hepatomegaly (moderate/severe intensity: 0.2%), cholangitis (moderate/severe intensity: 0.1%), hepatic steatosis (moderate/severe intensity: 0.1%)
Frequency not reported: Jaundice, fatty liver deposit, cytolytic hepatitis, liver tenderness, hepatic failure, cholecystitis

Respiratory

Very common (10% or more): Upper respiratory tract infection (moderate/severe intensity: 13.9%)
Common (1% to 10%): Lower respiratory tract infection (moderate/severe intensity: 7.7%)
Frequency not reported: Bronchitis, asthma, bronchopneumonia, dyspnea, lung edema, pharyngitis, rhinitis, increased cough, sinusitis

Other

Common (1% to 10%): Fatigue (including asthenia; moderate/severe intensity: 7.6%)
Frequency not reported: Pyrexia, chills, generalized pain, back and abdomen enlargement, chest pain, cyst, edema, peripheral edema, face edema, influenza syndrome, hypertrophy, malaise, drug interaction, increased drug level

Musculoskeletal

Common (1% to 10%): Musculoskeletal pain (including arthralgia, back pain; moderate/severe intensity: 6.4%), increased creatine phosphokinase (greater than 4 times ULN; up to 5%), myalgia (moderate/severe intensity: 1.8%), muscle disorders (such as weakness, spasms; moderate/severe intensity: 1.3%)
Uncommon (0.1% to 1%): Rhabdomyolysis (moderate/severe intensity: 0.7%), osteonecrosis (moderate/severe intensity: 0.1%)
Frequency not reported: Arthropathy, arthrosis, muscular weakness, joint disorder, osteoarthritis, extremity pain, myasthenia

Nervous system

Common (1% to 10%): Headache (including migraine; moderate/severe intensity: 6.3%), neuropathy and peripheral neuropathy (moderate/severe intensity: 2%), dizziness (moderate/severe intensity: 1.7%)
Uncommon (0.1% to 1%): Ageusia (moderate/severe intensity: 0.7%), convulsion (moderate/severe intensity: 0.3%), vertigo (moderate/severe intensity: 0.3%), tremor (moderate/severe intensity: 0.3%), cerebral vascular event (moderate/severe intensity: 0.2%), tinnitus (moderate/severe intensity: 0.2%)
Frequency not reported: Paresthesia, amnesia, ataxia, balance disorder, dyskinesia, encephalopathy, facial paralysis, hypertonia, peripheral neuritis, somnolence, hyperacusis, extrapyramidal syndrome, dysgeusia

Hematologic

Common (1% to 10%): Decreased neutrophils (less than 0.75 x 10(9)/L; up to 5%), anemia (moderate/severe intensity: 2.1%), decreased hemoglobin (less than 80 g/L; up to 2%), leukopenia and neutropenia (moderate/severe intensity: 1.7%), lymphadenopathy (moderate/severe intensity: 1.3%)
Rare (less than 0.1%): Hemolytic anemia, spontaneous bleeding in hemophiliacs
Frequency not reported: Splenomegaly

Psychiatric

Common (1% to 10%): Anxiety (moderate/severe intensity: 3.9%), insomnia (moderate/severe intensity: 3.8%)
Uncommon (0.1% to 1%): Abnormal dreams (moderate/severe intensity: 0.7%), decreased libido (moderate/severe intensity: 0.7%)
Frequency not reported: Depression, affect lability, agitation, apathy, confusional state, disorientation, mood swings, nervousness, abnormal thinking

Dermatologic

Common (1% to 10%): Rash (including maculopapular rash; moderate/severe intensity: 3.8%), skin infections (including cellulitis, folliculitis, furuncle; moderate/severe intensity: 3.3%), dermatitis/rash (including eczema, seborrheic dermatitis; moderate/severe intensity: 1.9%), night sweats (moderate/severe intensity: 1.6%), pruritus (moderate/severe intensity: 1.1%)
Uncommon (0.1% to 1%): Alopecia (moderate/severe intensity: 0.4%), capillaritis and vasculitis (moderate/severe intensity: 0.1%)
Frequency not reported: Acne, dry skin, acneiform dermatitis, allergic dermatitis, exfoliative dermatitis, furunculosis, lipomatosis, 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

Renal

Common (1% to 10%): Decreased calculated CrCl (less than 50 mL/min; up to 3%), renal failure (moderate/severe intensity: 1.2%)
Uncommon (0.1% to 1%): Nephritis (moderate/severe intensity: 0.1%)
Frequency not reported: Kidney calculus, renal disorder

Hypersensitivity

Common (1% to 10%): Hypersensitivity (including urticaria, angioedema; moderate/severe intensity: 2.7%)
Rare (less than 0.1%): Severe skin and mucous hypersensitivity reaction with transient multiorgan failure (at least 1 case)
Frequency not reported: Drug hypersensitivity

Cardiovascular

Common (1% to 10%): Hypertension (moderate/severe intensity: 1.8%)
Uncommon (0.1% to 1%): Deep vein thrombosis (moderate/severe intensity: 0.7%), atherosclerosis such as myocardial infarction (moderate/severe intensity: 0.4%), atrioventricular (AV) block (moderate/severe intensity: 0.1%), tricuspid valve incompetence (moderate/severe intensity: 0.1%)
Frequency not reported: Distended veins, angina pectoris, atrial fibrillation, cerebral infarction, chest pain, palpitation, postural 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

Genitourinary

Common (1% to 10%): Erectile dysfunction (moderate/severe intensity: 1.7% of males), menstrual disorders (amenorrhea, menorrhagia; moderate/severe intensity: 1.7% of females)
Uncommon (0.1% to 1%): Hypogonadism (moderate/severe intensity: 0.8% of males), hematuria (moderate/severe intensity: 0.8%)
Frequency not reported: Ejaculation disorder, breast enlargement, gynecomastia, impotence, abnormal urine odor, urine abnormality

Ocular

Uncommon (0.1% to 1%): Visual impairment (moderate/severe intensity: 0.3%)
Frequency not reported: Visual disturbance, eye disorder

Immunologic

Uncommon (0.1% to 1%): Immune reconstitution syndrome (moderate/severe intensity: 0.1%)
Frequency not reported: Infection (bacterial, viral), influenza, otitis media, perineal abscess, autoimmune disorders in the setting of immune reconstitution (e.g., Graves' disease, polymyositis, Guillain-Barre syndrome)

Endocrine

Frequency not reported: Cushing's syndrome, hypothyroidism

Oncologic

Frequency not reported: Neoplasm, lipoma

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