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


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.[Ref]


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.[Ref]

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[Ref]


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[Ref]

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.[Ref]


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.[Ref]

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[Ref]


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[Ref]


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[Ref]


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[Ref]

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[Ref]


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[Ref]


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


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[Ref]


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[Ref]


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[Ref]


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[Ref]


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[Ref]


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


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)


Frequency not reported: Cushing's syndrome, hypothyroidism[Ref]


Frequency not reported: Neoplasm, lipoma


1. Cvetkovic R, Goa K "Lopinavir/Ritonavir : A Review of its Use in the Management of HIV Infection." Drugs 63 (2003): 769-802

2. Eron J Jr, Yeni P, Gathe J Jr, et al. "The KLEAN study of fosamprenavir-ritonavir versus lopinavir-ritonavir, each in combination with abacavir-lamivudine, for initial treatment of HIV infection over 48 weeks: a randomised non-inferiority trial." Lancet 368 (2006): 476-82

3. Mangum EM, Graham KK "Lopinavir-Ritonavir: a new protease inhibitor." Pharmacotherapy 21 (2001): 1352-63

4. Hicks C, King MS, Gulick RM, et al. "Long-term safety and durable antiretroviral activity of lopinavir / ritonavir in treatment-naive patients: 4 year follow-up study." AIDS 18 (2004): 775-779

5. Leon A, Martinez E, Sarasa M, et al. "Impact of steady-state lopinavir plasma levels on plasma lipids and body composition after 24 weeks of lopinavir / ritonavir-containing therapy free of thymidine analogues." J Antimicrob Chemother (2007):

6. Panel on Antiretroviral Therapy and Medical Management of HIV-Infected Children. NIH. National Institutes of Health "Guidelines for the use of antiretroviral agents in pediatric HIV infection. Available from: URL: http://aidsinfo.nih.gov/guidelines/html/2/pediatric-treatment-guidelines/0" ([2012 Nov 5]):

7. "Drugs for HIV infection." Med Lett Drugs Ther 43 (2001): 103-8

8. "Product Information. Kaletra (lopinavir-ritonavir)" Abbott Pharmaceutical, Abbott Park, IL.

9. Corbett AH, Lim ML, Kashuba AD "Kaletra (Lopinavir/Ritonavir)." Ann Pharmacother 36 (2002): 1193-1203

10. Eron JJ, Feinberg J, Kessler HA, et al. "Once-Daily versus Twice-Daily Lopinavir/Ritonavir in Antiretroviral-Naive HIV-Positive Patients: A 48-Week Randomized Clinical Trial." J Infect Dis 189 (2004): 265-72

11. Warnke D, Barreto J, Temesgen Z "Antiretroviral drugs." J Clin Pharmacol 47 (2007): 1570-9

12. Borras-Blasco J, Belda A, Rosique-Robles D, Castera E, Abad J, Amoros-Quiles I "Hair loss induced by lopinavir-ritonavir." Pharmacotherapy 27 (2007): 1215-8

13. HHS Panel on Antiretroviral Guidelines for Adults and Adolescents – A Working Group of the Office of AIDS Research Advisory Council (OARAC). NIH. National Institutes of Health "Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. Available from: URL: http://aidsinfo.nih.gov/ContentFiles/AdultandAdolescentGL.pdf." ([2011 Oct 14]):

14. Guest JL, Ruffin C, Tschampa JM, DeSilva KE, Rimland D "Differences in rates of diarrhea in patients with human immunodeficiency virus receiving lopinavir-ritonavir or nelfinavir." Pharmacotherapy 24 (2004): 727-35

15. Oldfield V, Plosker GL "Lopinavir/Ritonavir : A Review of its Use in the Management of HIV Infection." Drugs 66 (2006): 1275-1299

16. Rabaud C, Burty C, Grandidier M, et al. "Tolerability of postexposure prophylaxis with the combination of zidovudine-lamivudine and lopinavir-ritonavir for HIV infection." Clin Infect Dis 40 (2005): 303-5

17. Brennan-Benson P, Pakianathan M, Rice P, et al. "Enfurvitide prevents vertical transmission of multidrug-resistant HIV-1 in pregnancy but does not cross the placenta." AIDS 20 (2006): 297-9

18. Voigt E, Wasmuth JC, Vogel M, et al. "Safety, Efficacy and Development of Resistance under the New Protease Inhibitor Lopinavir/Ritonavir: 48-Week Results." Infection 32 (2004): 82-8

19. Johnson M, Grinsztejn B, Rodriguez C, et al. "Atazanavir plus ritonavir or saquinavir, and lopinavir / ritonavir in patients experiencing multiple virological failures." AIDS 19 (2005): 685-94

20. Borras-Blasco J, Navarro-Ruiz A, Borras C, Castera E "Adverse cutaneous reactions associated with the newest antiretroviral drugs in patients with human immunodeficiency virus infection." J Antimicrob Chemother 62 (2008): 879-88

21. Hammer SM, Saag MS, Schechter M, et al. "Treatment for adult HIV infection: 2006 recommendations of the International AIDS Society-USA panel." JAMA 296 (2006): 827-43

22. Roberts DM, Ray JE, Buckley NA "Mild clinical toxicity and dose-dependent pharmacokinetics following acute lopinavir / ritonavir poisoning in a HIV-positive patient." AIDS 22 (2008): 792-3

23. Cameron DW, Becker S, King MS, et al. "Exploratory study comparing the metabolic toxicities of a lopinavir / ritonavir plus saquinavir dual protease inhibitor regimen versus a lopinavir / ritonavir plus zidovudine/lamivudine nucleoside regimen." J Antimicrob Chemother 59 (2007): 957-63

24. Anderson PL "Pharmacologic perspectives for once-daily antiretroviral therapy." Ann Pharmacother 38 (2004): 1969-70

25. Johnson M, Grinsztejn B, Rodriguez C, et al. "96-week comparison of once-daily atazanavir/ritonavir and twice-daily lopinavir / ritonavir in patients with multiple virologic failures." AIDS 20 (2006): 711-718

26. Martinez E, Domingo P, Galindo MJ, et al. "Risk of metabolic abnormalities in patients infected with HIV receiving antiretroviral therapy that contains lopinavir-ritonavir." Clin Infect Dis 38 (2004): 1017-23

27. Piacenti FJ "An update and review of antiretroviral therapy." Pharmacotherapy 26 (2006): 1111-33

28. Molto J, Santos JR, Negredo E, Miranda C, Videla S, Clotet B "Lopinavir / ritonavir monotherapy as a simplification strategy in routine clinical practice." J Antimicrob Chemother 60 (2007): 436-9

29. "Drugs for HIV infection." Treat Guidel Med Lett 7 (2009): 11-22

30. Doco-Lecompte T, Garrec A, Thomas L, Trechot P, May T, Rabaud C "Lopinavir-ritonavir (Kaletra) and lithiasis: seven cases." AIDS 18 (2004): 705-6

31. Bongiovanni M, Bini T, Tordato F, et al. "Immunovirological outcomes in 70 HIV-1-infected patients who switched to lopinavir / ritonavir after failing at least one protease inhibitor-containing regimen: a retrospective cohort study." J Antimicrob Chemother 51 (2003): 171-4

32. Bergersen BM "Cardiovascular Risk in Patients with HIV Infection : Impact of Antiretroviral Therapy." Drugs 66 (2006): 1971-87

33. Badiou S, De Boever CM, Dupuy AM, Baillat V, Cristol JP, Reynes J "Small dense LDL and atherogenic lipid profile in HIV-positive adults: influence of lopinavir / ritonavir-containing regimen." AIDS 17 (2003): 772-4

34. Fischl MA, Collier AC, Mukherjee AL, et al. "Randomized open-label trial of two simplified, class-sparing regimens following a first suppressive three or four-drug regimen." AIDS 21 (2007): 325-333

35. Soriano V, Puoti M, Sulkowski M, et al. "Care of patients coinfected with HIV and hepatitis C virus: 2007 updated recommendations from the HCV-HIV International Panel." AIDS 21 (2007): 1073-89

36. Manfredi R, Sabbatani S "Serious, multi-organ hypersensitivity to lopinavir alone, involving cutaneous-mucous rash, and myeloid, liver, and kidney function." AIDS 20 (2006): 2399-2400

37. Canta F, Marrone R, Bonora S, et al. "Pharmacokinetics and hepatotoxicity of lopinavir / ritonavir in non-cirrhotic HIV and hepatitis C virus (HCV) co-infected patients." J Antimicrob Chemother (2005):

38. Yazdanpanah Y, Viget N, Cheret A, et al. "Increased bleeding in HIV-positive haemophiliac patients treated with lopinavir-ritonavir." AIDS 17 (2003): 2397-9

39. Ghosn J, Duvivier C, Tubiana R, Katlama C, Caumes E "Acute generalized exanthematous pustulosis induced by HIV postexposure prophylaxis with lopinavir-ritonavir." Clin Infect Dis 41 (2005): 1360-1

40. Yotsumoto M, Kitano K, Saito H "Bradycardia-tachycardia syndrome induced by lopinavir-ritonavir in a patient with AIDS." AIDS 19 (2005): 1547-8

41. Calza L, Manfredi R, Verucchi G "Myocardial infarction risk in HIV-infected patients: epidemiology, pathogenesis, and clinical management." AIDS 24 (2010): 789-802

42. Worm SW, Sabin C, Weber R, et al. "Risk of myocardial infarction in patients with HIV infection exposed to specific individual antiretroviral drugs from the 3 major drug classes: The Data Collection on Adverse Events of Anti-HIV Drugs (D:A:D) Study." J Infect Dis 201 (2009): 318-30

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