Skip to main content

Crixivan Side Effects

Generic name: indinavir

Medically reviewed by Drugs.com. Last updated on Mar 4, 2023.

Note: This document contains side effect information about indinavir. Some dosage forms listed on this page may not apply to the brand name Crixivan.

Applies to indinavir: oral capsule.

Serious side effects of Crixivan

Along with its needed effects, indinavir (the active ingredient contained in Crixivan) 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 indinavir:

More common

Less common

Rare

Other side effects of Crixivan

Some side effects of indinavir 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:

More common

Less common

For Healthcare Professionals

Applies to indinavir: oral capsule, oral tablet.

Gastrointestinal

Increased serum amylase (greater than 200% the upper limit of normal [200% ULN]) has been reported in up to 2.1% of patients.[Ref]

Very common (10% or more): Nausea (up to 35.3%), diarrhea (up to 24.6%), vomiting (up to 17.8%), abdominal pain (up to 16.6%), dyspepsia

Common (1% to 10%): Acid regurgitation, increased serum amylase, flatulence, dry mouth

Frequency not reported: Aphthous stomatitis, cheilitis, constipation, eructation, gastritis, gingivitis, glossodynia, gingival hemorrhage, infectious gastroenteritis, taste disorder, dry lips

Postmarketing reports: Pancreatitis, abdominal distention, oral paresthesia[Ref]

Nervous system

Very common (10% or more): Headache (up to 25.2%), taste perversion (up to 19.1%), dizziness (up to 10.7%)

Common (1% to 10%): Somnolence, hypoesthesia, paresthesia

Frequency not reported: Dysesthesia, fasciculation, neuralgia, peripheral neuropathy, tremor, vertigo, epidural lipomatosis, sensory loss, syncope, peripheral paresthesia

Postmarketing reports: Cerebrovascular disorder[Ref]

Other

Very common (10% or more): Asthenia/fatigue (up to 24.3%)

Common (1% to 10%): Fever, malaise

Frequency not reported: Edema/swelling, weight gain, chest pain, chills, influenza-like illness, fungal infection, pain, flushing, angiolipomatosis

Postmarketing reports: Increased serum triglycerides, increased serum cholesterol[Ref]

Dermatologic

Very common (10% or more): Rash (up to 19.1%), dry skin (up to 16.2%)

Common (1% to 10%): Pruritus

Frequency not reported: Body odor, contact dermatitis, dermatitis, folliculitis, herpes simplex, herpes zoster, night sweats, seborrhea, skin disorder, skin infection, sweating, leukocytoclastic vasculitis

Postmarketing reports: Rash (including Stevens-Johnson syndrome, erythema multiforme), hypersensitivity vasculitis, hyperpigmentation, ingrown toenails, paronychia, urticaria, alopecia[Ref]

Hepatic

Very common (10% or more): Asymptomatic hyperbilirubinemia (primarily as elevated indirect bilirubin; about 14%), increased total serum bilirubin (up to 11.9%), increased ALT, increased AST

Common (1% to 10%): Jaundice

Frequency not reported: Cholecystitis, cholestasis, hepatic cytolysis, liver cirrhosis

Postmarketing reports: Hepatitis, hepatic failure, liver function abnormalities[Ref]

Asymptomatic hyperbilirubinemia (total bilirubin at least 2.5 mg/dL [43 mcmol/L]) has been reported in about 14% of patients, primarily as elevated indirect bilirubin; this was associated with elevated ALT, AST, or alkaline phosphatase in less than 1% of patients. Most patients continued therapy without dose reduction and bilirubin values gradually declined towards baseline. Hyperbilirubinemia was reported more often at doses greater than 2.4 g/day compared to doses up to 2.4 g/day.

Increased total serum bilirubin (greater than 250% ULN), ALT (greater than 500% ULN), and AST (greater than 500% ULN) have been reported in up to 11.9%, up to 4.9%, and up to 3.7% of patients, respectively.[Ref]

Renal

Very common (10% or more): Nephrolithiasis/urolithiasis (including flank pain with or without hematuria [including microscopic hematuria]; about 12.4%)

Common (1% to 10%): Flank pain, hydronephrosis, stent placement required

Uncommon (0.1% to 1%): Increased creatinine

Frequency not reported: Papillary necrosis

Postmarketing reports: Nephrolithiasis/urolithiasis (sometimes resulted in renal insufficiency, acute renal failure, pyelonephritis with or without bacteremia), interstitial nephritis (occasionally with indinavir (the active ingredient contained in Crixivan) crystal deposits), renal insufficiency, renal failure[Ref]

The cumulative frequency of nephrolithiasis events increased with duration of drug exposure; however, risk over time remained relatively constant. Of patients who developed nephrolithiasis/urolithiasis in clinical trials, 7 of 246 developed hydronephrosis and 11 of 246 underwent stent placement; after the acute episode, 12 of 246 patients discontinued therapy. In general, nephrolithiasis (including flank pain with or without hematuria [including microscopic hematuria]) was not associated with renal dysfunction and resolved with hydration and temporary interruption of therapy (e.g., 1 to 3 days). Nephrolithiasis/urolithiasis was reported more often at doses greater than 2.4 g/day compared to doses up to 2.4 g/day.

Increased creatinine (greater than 300% ULN) has been reported in up to 0.2% of patients.

During postmarketing experience, interstitial nephritis did not resolve after some patients stopped this drug.[Ref]

Genitourinary

Drug-induced neuropathy has resulted in erectile dysfunction.[Ref]

Very common (10% or more): Hematuria, proteinuria, crystalluria

Common (1% to 10%): Dysuria

Frequency not reported: Nocturia, premenstrual syndrome, pyuria, renal colic, urinary frequency, urinary tract infection, urine abnormality, urine sediment abnormality, erectile dysfunction

Postmarketing reports: Leukocyturia[Ref]

Hematologic

Decreased neutrophils (less than 750/mm3), hemoglobin (less than 7 g/dL), and platelet count (less than 50,000/mm3) have been reported in up to 5.1%, up to 2.4%, and up to 0.9% of patients, respectively.[Ref]

Very common (10% or more): Increased mean cell volume, decreased neutrophils

Common (1% to 10%): Decreased hemoglobin, anemia

Uncommon (0.1% to 1%): Decreased platelet count

Frequency not reported: Increased platelets, lymphadenopathy, spleen disorder, hemolytic anemia

Postmarketing reports: Increased spontaneous bleeding in hemophiliacs, thrombocytopenia, anemia including acute hemolytic anemia[Ref]

Metabolic

Increased glucose (greater than 250 mg/dL) has been reported in up to 1.6% of patients.[Ref]

Common (1% to 10%): Anorexia, increased appetite, increased glucose

Frequency not reported: Insulin resistance

Postmarketing reports: Redistribution/accumulation of body fat (including central obesity, dorsocervical fat enlargement, peripheral wasting, facial wasting, breast enlargement, "cushingoid appearance"), new-onset diabetes mellitus, hyperglycemia, exacerbation of preexisting diabetes mellitus, hypertriglyceridemia, hypercholesterolemia[Ref]

Psychiatric

Common (1% to 10%): Insomnia

Frequency not reported: Agitation, bruxism, dream abnormality, anxiety, anxiety disorder, decreased mental acuity, excitement, nervousness, neurotic disorder, sleep disorder, neurosis

Postmarketing reports: Depression[Ref]

Musculoskeletal

Drug deposition in synovial fluid may have resulted in monoarthritis in a patient. Intraarticular drug levels of 1.36 mcg/mL were measured in the patient's knee joint.[Ref]

Common (1% to 10%): Back pain, myalgia

Frequency not reported: Leg pain, acute monoarthritis, enthesopathies, adhesive capsulitis, muscle cramps, muscle weakness, stiffness, musculoskeletal pain, shoulder pain

Postmarketing reports: Arthralgia, periarthritis, myositis, rhabdomyolysis, increased creatine phosphokinase, osteonecrosis[Ref]

Respiratory

Common (1% to 10%): Cough, dyspnea/difficulty breathing/shortness of breath, upper respiratory infections, pharyngitis

Frequency not reported: Halitosis, pharyngeal hyperemia, pneumonia, rales/rhonchi, respiratory failure, sinus disorder, sinusitis, respiratory distress[Ref]

Hypersensitivity

Frequency not reported: Food allergy

Postmarketing reports: Anaphylactoid reactions, urticaria, vasculitis[Ref]

Cardiovascular

Frequency not reported: Hypertension, palpitation

Postmarketing reports: Cardiovascular disorders (including myocardial infarction, angina pectoris)[Ref]

Immunologic

Frequency not reported: Immune reconstitution syndrome, autoimmune disorders in the setting of immune reconstitution (e.g., Graves' disease, polymyositis, Guillain-Barre syndrome)

Ocular

Frequency not reported: Accommodation disorder, blurred vision, eye pain, eye swelling, orbital edema[Ref]

Endocrine

Frequency not reported: Galactorrhea, hyperprolactinemia[Ref]

References

1. Product Information. Crixivan (indinavir). Merck & Co., Inc. 2001;PROD.

2. Ghosn J, Lamotte C, Ait-Mohand H, et al. Efficacy of a twice-daily antiretroviral regimen containing 100 mg ritonavir/400 mg indinavir in HIV-infected patients. AIDS. 2003;17:209-14.

3. Isaac A, Taylor S, Cane P, et al. Lopinavir/ritonavir combined with twice-daily 400 mg indinavir: pharmacokinetics and pharmacodynamics in blood, CSF and semen. J Antimicrob Chemother. 2004;54:498-502.

4. Anderson PL. Pharmacologic perspectives for once-daily antiretroviral therapy. Ann Pharmacother. 2004;38:1969-70.

5. Rhame FS, Rawlins SL, Petruschke RA, et al. Pharmacokinetics of indinavir and ritonavir administered at 667 and 100 milligrams, respectively, every 12 hours compared with indinavir administered at 800 milligrams every 8 hours in human immunodeficiency virus-infected patients. Antimicrob Agents Chemother. 2004;48:4200-8.

6. Piacenti FJ. An update and review of antiretroviral therapy. Pharmacotherapy. 2006;26:1111-33.

7. Wasmuth JC, Lambertz I, Voigt E, et al. Maintenance of indinavir by dose adjustment in HIV-1-infected patients with indinavir-related toxicity. Eur J Clin Pharmacol. 2007;63:901-8.

8. Warnke D, Barreto J, Temesgen Z. Antiretroviral drugs. J Clin Pharmacol. 2007;47:1570-9.

9. Cersosimo MG, Lasala B, Folgar S, Micheli F. Epidural Lipomatosis Secondary to Indinavir in an HIV-Positive Patient. Clin Neuropharmacol. 2002;25:51-4.

10. Glesby MJ, Aberg JA, Kendall MA, et al. Pharmacokinetic interactions between indinavir plus ritonavir and calcium channel blockers. Clin Pharmacol Ther. 2005;78:143-153.

11. Herry I, Bernard L, de Truchis P, Perronne C. Hypertrophy of the breasts in a patient treated with indinavir. Clin Infect Dis. 1997;25:937-8.

12. Lui A, Karter D, Turett G. Another case of breast hypertrophy in a patient treated with indinavir. Clin Infect Dis. 1998;26:1482.

13. Struble K, Piscitelli SC. Syndromes of abnormal fat redistribution and metabolic complications in HIV-infected patients. Am J Health Syst Pharm. 1999;56:2343-8.

14. Qaqish RB, Fisher E, Rublein J, Wohl DA. HIV-associated lipodystrophy syndrome. Pharmacotherapy. 2000;20:13-22.

15. Pujol RM, Domingo P, XavierMatiasGuiu, Francia E, Sanbeat MA, Alomar A, Vazquez G. HIV-1 protease inhibitor-associated partial lipodystrophy: Clinicopathologic review of 14 cases. J Am Acad Dermatol. 2000;42:193-8.

16. Rodwell GEJ, Maurer TA, Barger TG. Fat redistribution in HIV disease. J Am Acad Dermatol. 2000;42:727-30.

17. Carr A. HIV protease inhibitor-related lipodystrophy syndrome. Clin Infect Dis. 2000;30:s135-42.

18. Martinez E, Mocroft A, GarciaViejo MA, PerezCuevas JB, Blanco JL, Mallolas J, Bianchi L, Conget I, Blanch J, Phillips A, Gatell. Risk of lipodystrophy in HIV-1-infected patients treated with protease inhibitors: a prospective cohort study. Lancet. 2001;357:592-8.

19. Manfredi R, Calza L, Chiodo F. Gynecomastia associated with highly antiretroviral therapy. Ann Pharmacother. 2001;35:438-9.

20. Lichtenstein KA, Ward DJ, Moorman AC, et al. Clinical assessment of HIV-associated lipodystrophy in an ambulatory population. AIDS. 2001;15:1389-98.

21. d'Arminio Monforte A, Testa L, Gianotto M, Gori A, Franzetti F, Sollima S, Bini T, Moroni M. Indinavir-related alopecia. AIDS. 1998;12:328.

22. Bouscarat F, Bouchard C, Bouhour D. Paronychia and pyogenic granuloma of the great toes in patients treated with indinavir. N Engl J Med. 1998;338:1776-7.

23. Gajewski LK, Grimone AJ, Melbourne KM, Vanscoy GJ. Characterization of rash with indinavir in a national patient cohort. Ann Pharmacother. 1999;33:17-21.

24. Kang-Birken SL, Prichard JG. Paronychia of the great toes associated with protease inhibitors. Am J Health Syst Pharm. 1999;56:1674-5.

25. Fung HB, Pecini RA, Brown ST, Gropper CA. Indinavir-associated maculopapular eruption. Pharmacotherapy. 1999;19:1328-30.

26. Rachline A, Lariven S, Descamps V, Grossin M, Bouvet E. Leucocytoclastic vasculitis and indinavir. Br J Dermatol. 2000;143:1112-3.

27. Colson AE, Sax PE, Keller MJ, Turk BK, Pettus PT, Platt R, Choo PW. Paronychia in association with indinavir treatment. Clin Infect Dis. 2001;32:140-3.

28. Drugs for HIV infection. Med Lett Drugs Ther. 2001;43:103-8.

29. Domingo P, Barcelo M. Efavirenz-induced leukocytoclastic vasculitis. Arch Intern Med. 2002;162:355-6.

30. Ginarte M, Losada E, Prieto A, Lorenzo-Zuniga V, Toribio J. Generalized hair loss induced by indinavir plus ritonavir therapy. AIDS. 2002;16:1695-6.

31. Terheggen F, Frissen J, Weigel H, Schouten I, Brinkman K. Nail, hair and skin hyperpigmentation associated with indinavir therapy. AIDS. 2004;18:1612.

32. Lee D, Benson CA, Lewis CE, Grunfeld C, Scherzer R. Prevalence and factors associated with dry skin in HIV infection: the FRAM study. AIDS. 2007;21:2051-2057.

33. Drugs for HIV infection. Treat Guidel Med Lett. 2009;7:11-22.

34. Puro V, Soldani F, De Carli G, Lazarevic Z, Mattioli F, Ippolito G. Drug-induced aminotransferase alterations during antiretroviral HIV post-exposure prophylaxis. AIDS. 2003;17:1988-90.

35. Henry K, Kitch D, Dube M, et al. C-Reactive protein levels over time and cardiovascular risk in HIV-infected individuals suppressed on an indinavir-based regimen: AIDS Clinical Trials Group 5056s. AIDS. 2004;18:2434-2437.

36. Mills E, Wilson K, Clarke M, et al. Milk thistle and indinavir: a randomized controlled pharmacokinetics study and meta-analysis. Eur J Clin Pharmacol. 2005;61:1-7.

37. Rotger M, Taffe P, Bleiber G, et al. Gilbert syndrome and the development of antiretroviral therapy-associated hyperbilirubinemia. J Infect Dis. 2005;192:1381-6.

38. Gagnon RF, Alli AI, Edwardes MD, Watters AK, Tsoukas CM. Low urine pH is associated with reduced indinavir crystalluria in indinavir-treated HIV-infected individuals. Clin Nephrol. 2006;65:13-21.

39. Collin F, Chene G, Retout S, et al. Indinavir Trough Concentration as a Determinant of Early Nephrolithiasis in HIV-1-Infected Adults. Ther Drug Monit. 2007;29:164-170.

40. 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. 2007;21:1073-89.

41. Tozzi V. Pharmacogenetics of antiretrovirals. Antiviral Res. 2010;85:190-200.

42. Tashima KT, Horowitz JD, Rosen S. Indinavir nephropathy. N Engl J Med. 1997;336:138-40.

43. Boubaker K, Sudre P, Bally F, Vogel G, Meuwly JY, Glauser MP, Telenti A. Changes in renal function associated with indinavir. AIDS. 1998;12:f249-54.

44. Sarcletti M, Petter A, Romani N, Lhotta K, Kö, nig P, Maier H, Zangerle R. Pyuria in patients treated with indinavir is associated with renal dysfunction. Clin Nephrol. 2000;54:261-70.

45. Famularo G, Di Toro S, Moretti S, De Simone C. Symptomatic crystalluria associated with indinavir. Ann Pharmacother. 2000;34:1414-8.

46. Salahuddin S, Hsu YS, Buchholz NP, Dieleman JP, Gyssens IC, Kok DJ. Is indinavir crystalluria an indicator for indinavir stone formation?. Aids. 2001;15:1079-80.

47. Dieleman JP, vanderFeltz M, Bangma CH, Stricker BHC, vanderEnde ME. Papillary necrosis associated with the HIV protease inhibitor indinavir. Infection. 2001;29:232-3.

48. Szczech LA. Hypertension and medication-related renal dysfunction in the HIV-infected patient. Semin Nephrol. 2001;21:386-93.

49. Perazella MA. Drug-induced renal failure: update on new medications and unique mechanisms of nephrotoxicity. Am J Med Sci. 2003;325:349-62.

50. Csajka C, Marzolini C, Fattinger K, et al. Population pharmacokinetics of indinavir in patients infected with human immunodeficiency virus. Antimicrob Agents Chemother. 2004;48:3226-32.

51. Grases F, Garcia-Gonzalez R, Redondo E, et al. Effects of escin on indinavir crystallization time in the urine of patients with HIV-I infection: a multicenter, randomized, open-label, controlled, four-period crossover trial. Clin Ther. 2004;26:2045-55.

52. Izzedine H, Launay-Vacher V, Deray G. Antiviral drug-induced nephrotoxicity. Am J Kidney Dis. 2005;45:804-17.

53. Goujard C, Legrand M, Panhard X, et al. High Variability of Indinavir and Nelfinavir Pharmacokinetics in HIV-Infected Patients with a Sustained Virological Response on Highly Active Antiretroviral Therapy. Clin Pharmacokinet. 2005;44:1267-78.

54. Boyd MA, Siangphoe U, Ruxrungtham K, et al. The use of pharmacokinetically guided indinavir dose reductions in the management of indinavir-associated renal toxicity. J Antimicrob Chemother. 2006;57:1161-7.

55. Roling J, Schmid H, Fischereder M, Draenert R, Goebel FD. HIV-Associated Renal Diseases and Highly Active Antiretroviral Therapy-Induced Nephropathy. Clin Infect Dis. 2006;42:1488-95.

56. Nuesch R, Srasuebkul P, Ananworanich J, Ruxrungtham K, Phanuphak P, Duncombe C. Monitoring the toxicity of antiretroviral therapy in resource limited settings: a prospective clinical trial cohort in Thailand. J Antimicrob Chemother. 2006;58:637-44.

57. Pacanowski J, Poirier JM, Petit I, Meynard JL, Girard PM. Atazanavir urinary stones in an HIV-infected patient. AIDS. 2006;20:2131.

58. Salahuddin S, Kok DJ, Buchholz NN. Influence of body temperature on indinavir crystallization under loop of Henle conditions. J Antimicrob Chemother. 2006;59:114-7.

59. Gagnon RF, Alli AI, Watters AK, Tsoukas CM. Indinavir crystalluria. Kidney Int. 2006;70:2047.

60. Unadkat JD, Wara DW, Hughes MD, et al. Pharmacokinetics and safety of indinavir in human immunodeficiency virus-infected pregnant women. Antimicrob Agents Chemother. 2007;51:783-6.

61. Barbour TD, Furlong TJ, Finlayson RJ. Efavirenz-associated podocyte damage. AIDS. 2007;21:257-258.

62. Kopp JB, Miller KD, Mican JA, et al. Crystalluria and urinary tract abnormalities associated with indinavir. Ann Intern Med. 1997;127:119-25.

63. Gentle DL, Stoller ML, Jarrett TW, Ward JF, Geib KS, Wood AF. Protease inhibitor-induced urolithiasis. Urology. 1997;50:508-11.

64. Schrooten W, Colebunders R, Youle M, et al. Sexual dysfunction associated with protease inhibitor containing highly active antiretroviral treatment. AIDS. 2001;15:1019-23.

65. Sollima S, Osio M, Muscia F, et al. Protease inhibitors and erectile dysfunction. AIDS. 2001;15:2331-3.

66. Tozzi V, Narcisco P, Sebastiani G, Frigiotti D, DAmato C. Effects of indinavir treatment on platelet and neutrophil counts in patients with advanced HIV disease. AIDS. 1997;11:1067-8.

67. Maness LJ, Blair DC, Newman N, Coyle TE. Elevation of platelet counts associated with indinavir treatment in human immunodeficiency virus-infected patients. Clin Infect Dis. 1998;26:207-8.

68. MorrisonGriffiths S, Newman M, OMahony C, Pirmohamed M. Adverse drug reaction of the month - Haemolytic anaemia associated with indinavir. Postgrad Med J. 1999;75:313-5.

69. Dube MP. Disorders of glucose metabolism in patients infected with human immunodeficiency virus. Clin Infect Dis. 2000;31:1467-75.

70. Noor MA, Lo JC, Mulligan K, Schwarz JM, Halvorsen RA, Schambelan M, Grunfeld C. Metabolic effects of indinavir in healthy HIV-seronegative men. Aids. 2001;15:f11-8.

71. Fantoni M, Del Borgo C, Autore C. Evaluation and management of metabolic and coagulative disorders in HIV-infected patients receiving highly active antiretroviral therapy. AIDS. 2003;17 Suppl 1:S162-9.

72. Brambilla AM, Novati R, Calori G, et al. Stavudine or indinavir-containing regimens are associated with an increased risk of diabetes mellitus in HIV-infected individuals. AIDS. 2003;17:1993-5.

73. Shankar SS, Dube MP, Gorski JC, Klaunig JE, Steinberg HO. Indinavir impairs endothelial function in healthy HIV-negative men. Am Heart J. 2005;150:933.

74. Bergersen BM. Cardiovascular Risk in Patients with HIV Infection : Impact of Antiretroviral Therapy. Drugs. 2006;66:1971-87.

75. Brooks JI, Gallicano K, Garber G, Angel JB. Acute monoarthritis complicating therapy with indinavir. Aids. 2000;14:2064-5.

76. Grasland A, Ziza JM, Raguin G, Pouchot J, Vinceneux P. Adhesive capsulitis of shoulder and treatment with protease inhibitors in patients with human immunodeficiency virus infection: Report of 8 cases. J Rheumatol. 2000;27:2642-6.

77. Karmochkine M, Raguin G. Severe coronary artery disease in a young HIV-infected man with no cardiovascular risk factor who was treated with indinavir. AIDS. 1998;12:2499.

78. Flynn TE, Bricker LA. Myocardial infarction in HIV-infected men receiving protease inhibitors. Ann Intern Med. 1999;131:548.

79. Cattelan AM, Trevenzoli M, Sasset L, Rinaldi L, Balasso V, Cadrobbi P. Indinavir and systemic hypertension. Aids. 2001;15:805-7.

80. 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. 2009;201:318-30.

81. Hutchinson A, Murphy M, Harries R, Skinner CJ. Galactorrhoea and hyperprolactinaemia associated with protease-inhibitors. Lancet. 2000;356:1003-4.

Further information

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.

Medical Disclaimer