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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.

In Summary

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.

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.

Major Side Effects

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
  • slow or irregular heartbeat
  • sore throat
  • sores, ulcers, or white spots in the mouth or on the lips
  • unusual tiredness

Minor Side Effects

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


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]


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[Ref]

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.[Ref]


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")[Ref]

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.[Ref]


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[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]


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[Ref]


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[Ref]


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

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]

Nervous system

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[Ref]


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]


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[Ref]


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[Ref]


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

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


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


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[Ref]


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]


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


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[Ref]


Frequency not reported: Neoplasm, lipoma


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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.

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