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Lopinavir / Ritonavir Side Effects

Medically reviewed by Drugs.com. Last updated on Jul 18, 2024.

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

Serious side effects

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

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

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

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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

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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

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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

Lopinavir/ritonavir 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.

Some side effects may not be reported. You may report them to the FDA.