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Kaletra Side Effects

Generic name: lopinavir / ritonavir

Medically reviewed by Drugs.com. Last updated on Feb 7, 2025.

Note: This document provides detailed information about Kaletra.

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

Precautions

It is very important that your doctor check the progress of you or your child at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Do not use this medicine if you or your child are also using alfuzosin (Uroxatral®), apalutamide (Erleada®), cisapride (Propulsid®), colchicine (Colcrys®), dronedarone (Multaq®), elbasvir/grazoprevir (Zepatier®), ergot medicines (eg, dihydroergotamine, ergotamine, methylergonovine, Cafergot®, Ergomar®, Methergine®, or Migranal®), lomitapide (Juxtapid®), lovastatin (Advicor®, Altoprev®, Mevacor®), lurasidone (Latuda®), oral midazolam (Versed®), pimozide (Orap®), ranolazine (Ranexa®), rifampin (Rifadin®), sildenafil (Revatio®), simvastatin (Simcor®, Vytorin®, Zocor®), or triazolam (Halcion®).

Pancreatitis may occur while you are using this medicine. Check with your doctor right away if you or your child have sudden and severe stomach pain, chills, constipation, nausea, vomiting, fever, or lightheadedness.

Check with your doctor right away if you or your child have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine may increase blood sugar levels. Check with your doctor if you or your child notice a change in the results of your blood or urine sugar tests.

This medicine may cause heart rhythm problems, including PR or QT prolongation. It may change the way your heart beats and cause fainting or serious side effects in some patients. Contact your doctor right away if you or your child have any symptoms of heart rhythm problems, such as fast, pounding, or irregular heartbeats.

This medicine may increase the amount of cholesterol and fats in your blood. If this condition occurs, your doctor may give you some medicines that can lower the amount of cholesterol and fats in the blood. Talk to your doctor if you or your child have concerns.

If you or your child develop a skin rash, hives, or any allergic reaction to this medicine, check with your doctor as soon as possible.

If you are taking the oral liquid, you should limit the amount of alcohol you drink. The Kaletra® oral liquid contains 42% alcohol. Talk to your doctor if you or your child are taking, or plan to take, metronidazole (Flagyl®) or disulfiram (Antabuse®).

Birth control pills that contain estrogen may not work as well while you are using this medicine. To keep from getting pregnant, use an additional form of birth control along with your pills. Other forms of birth control include condoms, a diaphragm, or contraceptive foam or jelly.

Your immune system may get stronger when you start taking HIV medicines. Tell your doctor right away if you notice any changes in your health. Sometimes the immune system will start to fight infections that were hidden in your body, such as pneumonia or tuberculosis, or may result in a flare-up of a hidden autoimmune disorder such as Graves disease, polymyositis, or Guillain-Barré syndrome.

This medicine may cause you to have excess body fat. Tell your doctor if you or your child notice changes in your body shape, such as an increased amount of fat in the upper back and neck, or around the chest and stomach area. You might also lose fat from the legs, arms, and face.

This medicine may increase the risk of bleeding in patients with hemophilia (a bleeding disorder). Talk with your doctor about this risk.

This medicine will not keep you from giving HIV to your partner during sex. Make sure you understand this and practice safe sex, even if your partner also has HIV, by using a latex condom or other barrier method. This medicine will also not keep you from giving HIV to other people if they are exposed to your blood. Do not re-use or share needles with anyone.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription and nonprescription (over-the-counter [OTC]) medicines, and herbal (eg, St. John's wort) or vitamin supplements.

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

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

Antiretroviral therapy:

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

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

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

Metabolic

Combination antiretroviral therapy:

Antiretroviral therapy:

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

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

Nervous system

Hematologic

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

Dermatologic

Renal

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

Hypersensitivity

Cardiovascular

Genitourinary

Endocrine

Ocular

Immunologic

Oncologic

See also:

References

1. (2001) "Product Information. Kaletra (lopinavir-ritonavir)." Abbott Pharmaceutical

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

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

4. Cerner Multum, Inc. "UK Summary of Product Characteristics."

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

6. Leon A, Martinez E, Sarasa M, et al. (2007) "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

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

8. Cerner Multum, Inc. "Australian Product Information."

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

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

11. Cameron DW, Becker S, King MS, et al. (2007) "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, p. 957-63

12. (2009) "Drugs for HIV infection." Treat Guidel Med Lett, 7, p. 11-22

13. Bongiovanni M, Bini T, Tordato F, et al. (2003) "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, p. 171-4

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

31. Worm SW, Sabin C, Weber R, et al. (2009) "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, p. 318-30

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

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.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.