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Itraconazole Side Effects

Medically reviewed by Drugs.com. Last updated on Aug 18, 2023.

Applies to itraconazole: oral capsule, oral solution.

Warning

Oral route (Capsule)

Congestive Heart Failure, Cardiac Effects and Drug InteractionsSporanox®Itraconazole capsules should not be administered for the treatment of onychomycosis in patients with evidence of ventricular dysfunction such as congestive heart failure (CHF) or a history of CHF. If signs or symptoms of congestive heart failure occur during administration of itraconazole capsules, discontinue administration. When itraconazole was administered intravenously to dogs and healthy human volunteers, negative inotropic effects were seen.Drug Interactions: Coadministration of the following drugs are contraindicated with itraconazole oral capsules: Methadone, disopyramide, dofetilide, dronedarone, quinidine, isavuconazole, ergot alkaloids (such as dihydroergotamine, ergometrine (ergonovine), ergotamine, methylergometrine (methylergonovine)), irinotecan, lurasidone, oral midazolam, pimozide, triazolam, felodipine, nisoldipine, ivabradine, ranolazine, eplerenone, cisapride, naloxegol, lomitapide, lovastatin, simvastatin, avanafil, ticagrelor, finerenone, voclosporin. In addition, coadministration with colchicine, fesoterodine and solifenacin is contraindicated in subjects with varying degrees of renal or hepatic impairment, and coadministration with eliglustat is contraindicated in subjects that are poor or intermediate metabolizers of CYP2D6 and in subjects taking strong or moderate CYP2D6 inhibitors. Coadministration with venetoclax is contraindicated in patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) during the dose initiation and ramp-up phase of venetoclax. Coadministration with itraconazole can cause elevated plasma concentrations of these drugs and may increase or prolong both the pharmacologic effects and/or adverse reactions to these drugs. For example, increased plasma concentrations of some of these drugs can lead to QT prolongation and ventricular tachyarrhythmias including occurrences of torsades de pointes, a potentially fatal arrhythmia.

Oral route (Capsule)

Warning: Congestive Heart Failure and Drug InteractionsTolsura(TM)Congestive Heart Failure:Itraconazole can cause or exacerbate congestive heart failure (CHF). When itraconazole was administered intravenously to healthy human volunteers and dogs, negative inotropic effects were seen. If signs or symptoms of congestive heart failure occur or worsen during administration of itraconazole, reassess the benefit and risk of continuing treatment.Drug Interactions:Coadministration of certain drugs that are metabolized by human CYP3A4 enzymes are contraindicated with itraconazole because plasma concentrations of such drugs are increased, which may also increase or prolong both the pharmacologic effects and/or adverse reactions to these drugs.Coadministration with colchicine, fesoterodine, and solifenacin is contraindicated in subjects with varying degrees of renal or hepatic impairment, and coadministration with eliglustat is contraindicated in subjects that are poor or intermediate metabolizers of CYP2D6 and in subjects taking strong or moderate CYP2D6 inhibitors.Increased plasma concentrations of some of these drugs can lead to QT prolongation and/or ventricular tachyarrhythmias, including occurrences of torsades de pointes, a potentially fatal arrhythmia.

Oral route (Solution)

Congestive Heart Failure, Cardiac Effects and Drug Interactions: If signs or symptoms of congestive heart failure occur during administration of itraconazole oral solution, continued itraconazole use should be reassessed. When itraconazole was administered intravenously to dogs and healthy human volunteers, negative inotropic effects were seen.Drug Interactions: Coadministration of the following drugs are contraindicated with itraconazole oral solution: Methadone, disopyramide, dofetilide, dronedarone, quinidine, isavuconazole, ergot alkaloids (such as dihydroergotamine, ergometrine (ergonovine), ergotamine, methylergometrine (methylergonovine)), irinotecan, lurasidone, oral midazolam, pimozide, triazolam, felodipine, nisoldipine, ivabradine, ranolazine, eplerenone, cisapride, naloxegol, lomitapide, lovastatin, simvastatin, avanafil, ticagrelor, finerenone, voclosporin. In addition, coadministration with colchicine, fesoterodine and solifenacin is contraindicated in subjects with varying degrees of renal or hepatic impairment, and coadministration with eliglustat is contraindicated in subjects that are poor or intermediate metabolizers of CYP2D6 and in subjects taking strong or moderate CYP2D6 inhibitors. Coadministration with venetoclax is contraindicated in patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) during the dose initiation and ramp-up phase of venetoclax. Coadministration with itraconazole can cause elevated plasma concentrations of these drugs and may increase or prolong both the pharmacologic effects and/or adverse reactions to these drugs. For example, increased plasma concentrations of some of these drugs can lead to QT prolongation and ventricular tachyarrhythmias including occurrences of torsades de pointes, a potentially fatal arrhythmia.

Oral route (Tablet)

Do not use itraconazole to treat onychomycosis in patients with ventricular dysfunction (eg, congestive heart failure). If signs or symptoms of congestive heart failure occur, continued use should be reassessed. Itraconazole is contraindicated in patients concomitantly taking cisapride, pimozide, quinidine, dofetilide, levacetylmethadol (levomethadyl), felodipine, oral midazolam, nisoldipine, triazolam, lovastatin, simvastatin, ergot alkaloids such as dihydroergotamine, ergometrine (ergonovine), ergotamine and methylergometrine (methylergonovine), or methadone. Concomitant administration can cause the plasma levels of the concomitant drug to increase. Serious cardiovascular events have been reported in patients taking cisapride, pimozide, levacetylmethadol (levomethadyl), methadone, or quinidine concomitantly with itraconazole or other CYP3A4 inhibitors.

Serious side effects of Itraconazole

Along with its needed effects, itraconazole 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 itraconazole:

More common

Less common

Rare

Incidence not known

Other side effects of Itraconazole

Some side effects of itraconazole 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

Rare

For Healthcare Professionals

Applies to itraconazole: compounding powder, intravenous kit, oral capsule, oral solution, oral tablet.

General

In clinical trials, side effects were reported in about 7% of patients receiving short-term therapy and about 15% of patients receiving prolonged (about 1 month) continuous therapy. The side effects reported most often with the 100-mg capsule formulation were headache, abdominal pain, and nausea; the side effects reported most often with the oral solution were dizziness, headache, dysgeusia, dyspnea, cough, abdominal pain, diarrhea, vomiting, nausea, dyspepsia, rash, and pyrexia. The most serious side effects reported with this drug were serious allergic reactions, cardiac failure/congestive heart failure/pulmonary edema, pancreatitis, serious hepatotoxicity (including some cases of fatal acute liver failure), and serious skin reactions.[Ref]

Gastrointestinal

Very common (10% or more): Nausea (up to 11%), diarrhea (up to 11%)

Common (1% to 10%): Vomiting, abdominal pain/discomfort, dyspepsia, flatulence, gingivitis, constipation, ulcerative stomatitis, gastritis, gastroenteritis

Rare (0.01% to 0.1%): Pancreatitis

Frequency not reported: Dysphagia, hemorrhoids, gastrointestinal disorder[Ref]

Pancreatitis, abdominal pain, vomiting, dyspepsia, nausea, diarrhea, and constipation have also been reported during postmarketing experience.[Ref]

Metabolic

Very common (10% or more): Hypertriglyceridemia (up to 11%)

Common (1% to 10%): Hypokalemia, hypomagnesemia, hypophosphatemia, increased appetite

Uncommon (0.1% to 1%): Fluid overload, hypocalcemia, anorexia, hyperglycemia

Frequency not reported: Dehydration, decreased weight, hyperkalemia[Ref]

Hypertriglyceridemia and hypokalemia have also been reported during postmarketing experience.[Ref]

Nervous system

Common (1% to 10%): Headache, dizziness, hypoacusis, tremor, dysgeusia

Uncommon (0.1% to 1%): Vertigo, somnolence, hypoesthesia, transient/permanent hearing loss, peripheral neuropathy, paresthesia, tinnitus[Ref]

Peripheral neuropathy, paresthesia, hypoesthesia, headache, dizziness, tinnitus, transient/permanent hearing loss, dysgeusia, and tremor have also been reported during postmarketing experience.[Ref]

Respiratory

Common (1% to 10%): Rhinitis, upper respiratory tract infection, sinusitis, cough, pneumonia, increased sputum, dyspnea, pharyngitis, pulmonary infiltration

Uncommon (0.1% to 1%): Pulmonary edema, pharyngolaryngeal pain

Frequency not reported: Dysphonia[Ref]

Pulmonary edema and dyspnea have also been reported during postmarketing experience.[Ref]

Other

Edema and pyrexia have also been reported during postmarketing experience.[Ref]

Common (1% to 10%): Pyrexia, injury, edema, chest pain, fatigue, malaise, pain, asthenia, increased blood alkaline phosphatase, increased blood lactate dehydrogenase, Pneumocystis carinii infection, herpes zoster

Frequency not reported: Unspecified infection, rigors, back pain, hot flushes, implantation complication, face edema, chills, generalized edema, mucosal inflammation

Postmarketing reports: Peripheral edema[Ref]

Dermatologic

Common (1% to 10%): Rash, pruritus, hyperhidrosis, unspecified skin disorder, erythematous rash

Uncommon (0.1% to 1%): Urticaria

Rare (0.01% to 0.1%): Toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, exfoliative dermatitis, leukocytoclastic vasculitis, erythema multiforme, photosensitivity, alopecia[Ref]

Toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, erythema multiforme, exfoliative dermatitis, leukocytoclastic vasculitis, alopecia, photosensitivity, rash, pruritus, and urticaria have also been reported during postmarketing experience.[Ref]

Hepatic

Mild, transient elevations in liver function tests have occurred in up to 7% of patients receiving continuous therapy.

Serious hepatotoxicity (including some cases of fatal acute liver failure), hepatitis, and reversible increases in hepatic enzymes have also been reported during postmarketing experience.[Ref]

Common (1% to 10%): Increased hepatic enzymes (including reversible increases), bilirubinemia, abnormal liver function, increased ALT, jaundice, increased AST, increased GGT, hepatitis, hyperbilirubinemia

Uncommon (0.1% to 1%): Hepatic failure

Rare (0.01% to 0.1%): Serious hepatotoxicity (including some cases of fatal acute liver failure)

Frequency not reported: Cholestasis, cholestatic jaundice[Ref]

Cardiovascular

Common (1% to 10%): Hypertension, vein disorder, abnormal electrocardiogram

Uncommon (0.1% to 1%): Hypotension, orthostatic hypotension, vasculitis, sinus bradycardia, tachycardia, cardiac failure

Frequency not reported: Premature ventricular contractions, left ventricular failure

Postmarketing reports: Congestive heart failure[Ref]

Renal

Common (1% to 10%): Increased serum creatinine

Uncommon (0.1% to 1%): Abnormal renal function, increased blood urea

Frequency not reported: Renal impairment[Ref]

Psychiatric

Common (1% to 10%): Depression, anxiety, abnormal dreaming

Frequency not reported: Insomnia, decreased libido, visual hallucinations, confusional state[Ref]

An elderly patient experienced visual hallucinations, confusion, and weakness after receiving this drug. The symptoms reappeared following accidental doses of this drug 7 and 10 days later.[Ref]

Musculoskeletal

Common (1% to 10%): Myalgia, bursitis, back pain

Uncommon (0.1% to 1%): Arthralgia

Rare (0.01% to 0.1%): Increased blood creatine phosphokinase[Ref]

Increased blood creatine phosphokinase, myalgia, and arthralgia have also been reported during postmarketing experience.[Ref]

Genitourinary

Pollakiuria, menstrual disorders, and erectile dysfunction have also been reported during postmarketing experience.[Ref]

Common (1% to 10%): Cystitis, urinary tract infection

Uncommon (0.1% to 1%): Impotence, menstrual disorders, abnormal urine analysis, pollakiuria, erectile dysfunction

Frequency not reported: Albuminuria, hematuria, gynecomastia, male breast pain, bacteriuria

Postmarketing reports: Urinary incontinence[Ref]

Hypersensitivity

Anaphylactic reactions, allergic reactions, serum sickness, and angioneurotic edema have also been reported during postmarketing experience.[Ref]

Uncommon (0.1% to 1%): Hypersensitivity

Rare (0.01% to 0.1%): Allergic reactions (e.g., pruritus, rash, urticaria, angioedema), serum sickness, angioneurotic edema, anaphylactic reaction

Frequency not reported: Anaphylactic shock

Postmarketing reports: Anaphylaxis, anaphylactoid reaction[Ref]

Hematologic

Leukopenia and thrombocytopenia have also been reported during postmarketing experience.[Ref]

Uncommon (0.1% to 1%): Leukopenia, thrombocytopenia

Frequency not reported: Granulocytopenia

Postmarketing reports: Neutropenia[Ref]

Ocular

Uncommon (0.1% to 1%): Visual disturbances (including blurred vision, diplopia)

Frequency not reported: Abnormal vision[Ref]

Visual disturbances (including blurred vision, diplopia) have also been reported during postmarketing experience.[Ref]

Endocrine

Frequency not reported: Adrenal insufficiency[Ref]

Local

IV:

-Frequency not reported: Injection site inflammation[Ref]

Frequently asked questions

References

1. Tucker R, Denning D, Arathoon E, et al. Itraconazole therapy for nonmeningeal coccidioidomysosis: clinical and laboratory observations. J Am Acad Dermatol. 1990;23:593-601.

2. Kim JA, Ahn KJ, Kim JM, Youn JI. Efficacy and tolerability of itraconazole in patients with fingernail onychomycosis: a 6-week pilot study. Curr Ther Res Clin Exp. 1995;56:1066-75.

3. Haria M, Bryson HM, Goa KL. Itraconazole: a review of its pharmacological properties and therapeutic use in the management of superficial fungal infections. Drugs. 1996;52:253.

4. Tucker R, Haq Y, Denning D, Stevens D. Adverse events associated with itraconazole in 189 patients on chronic therapy. J Antimicrob Chemother. 1990;26:561-6.

5. Lavrijsen A, Balmus K, Nugteren-Huying W, et al. Hepatic injury associated with itraconazole. Lancet. 1992;340:251-2.

6. Piepponen T, Blomquist K, Brandt H, et al. Efficacy and safety of itraconazole in the long-term treatment of onychomycosis. J Antimicrob Chemother. 1992;29:195-205.

7. Product Information. Sporanox (itraconazole). Janssen Pharmaceuticals. 2022.

8. Debruyne D, Coquerel A. Pharmacokinetics of antifungal agents in onychomycoses. Clin Pharmacokinet. 2001;40:441-72.

9. Gupta AK, Ryder JE. The use of oral antifungal agents to treat onychomycosis. Dermatol Clin. 2003;21:469-79, vi.

10. Cerner Multum, Inc. UK Summary of Product Characteristics.

11. Cerner Multum, Inc. Australian Product Information.

12. Chen J, Song X, Yang P, Wang J. Appearance of anaphylactic shock after long-term intravenous itraconazole treatment. Ann Pharmacother. 2009;43:537-41.

13. Thompson GR 3rd, Cadena J, Patterson TF. Overview of antifungal agents. Clin Chest Med. 2009;30:203-15, v.

14. Product Information. Tolsura (itraconazole). Mayne Pharma Inc. 2021.

15. Product Information. Sporanox (itraconazole). Janssen Pharmaceuticals. 2002.

16. Cleveland KO, Campbell JW. Hallucinations associated with itraconazole therapy. Clin Infect Dis. 1995;21:456.

17. Gallardoquesada S, Luelmoaguilar J, Guanyabenscalvet C. Hepatotoxicity associated with itraconazole. Int J Dermatol. 1995;34:589.

18. Itracanazole, terbinafine possibly linked to liver failure. Am J Health Syst Pharm. 2001;58:1076.

19. Ahmad SR, Singer SJ, Leissa BG. Congestive heart failure associated with itraconazole. Lancet. 2001;357:1766-7.

20. Gelfand MS, Cleveland KO. Acute congestive heart failure and death secondary to itraconazole therapy. AIDS. 2012;26:1848-50.

21. Product Information. Sporanox (itraconazole). Ortho Biotech Inc. 2022.

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.