Skip to Content

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, 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]

Gastrointestinal

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]

Metabolic

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]

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
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]

Respiratory

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]

Other

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]

Musculoskeletal

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]

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
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]

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
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]

Renal

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]

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
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]

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]

Ocular

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

Immunologic

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)

Endocrine

Uncommon (0.1% to 1%): Hypogonadism
Frequency not reported: Cushing's syndrome, hypothyroidism, gynecomastia[Ref]

Oncologic

Frequency not reported: Neoplasm, lipoma

References

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. AIDSinfo. NIH. National Institutes of Health "Guidelines for the use of antiretroviral agents in pediatric HIV infection. Available from: URL: http://aidsinfo.nih.gov/contentfiles/lvguidelines/pediatricguidelines.pdf." ([2015 Mar 5]):

6. Cerner Multum, Inc. "Australian Product Information." O 0

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

8. 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):

9. HHS Panel on Antiretroviral Guidelines for Adults and Adolescents. 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/lvguidelines/adultandadolescentgl.pdf." ([2014 May]):

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

11. 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

12. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

13. 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

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

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

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

17. 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

18. "FDA approves new protease inhibitor for HIV infection." Am J Health Syst Pharm 57 (2000): 1942

19. 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

20. 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

21. 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

22. 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

23. 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

24. 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

25. 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

26. 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

27. 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

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

29. 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

30. Henney JE "New drug for HIV infection." JAMA 284 (2000): 2178

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

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

33. 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

34. 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

35. 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

36. 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

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

38. 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

39. 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

40. 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

41. 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):

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

43. 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

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

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

46. 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

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

Hide
(web1)