Itraconazole Side Effects
Medically reviewed by Drugs.com. Last updated on Aug 12, 2020.
In Summary
Commonly reported side effects of itraconazole include: nausea. Other side effects include: vomiting. See below for a comprehensive list of adverse effects.
For the Consumer
Applies to itraconazole: oral capsule, oral solution, oral tablet
Warning
Oral route (Capsule)
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 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. 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 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. 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 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.
Side effects requiring immediate medical attention
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
- Decreased urine output
- dry mouth
- fever
- increased thirst
- irregular heartbeat
- loss of appetite
- mood changes
- muscle pain or cramps
- nausea
- numbness or tingling in the hands, feet, or lips
- seizures
- trouble breathing
- unusual tiredness or weakness
- vomiting
Less common
- Blurred vision
- chest pain
- chills
- clay-colored stools
- cloudy urine
- cold sweats
- confusion
- cough
- dark urine
- decrease in urine-concentrating ability
- diarrhea
- dizziness
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- drowsiness
- feeling unusually cold
- headache
- itching, skin rash
- light-colored stools
- mental changes
- muscle cramps in the hands, arms, feet, legs, or face
- muscle spasms (tetany) or twitching
- nervousness
- noisy, rattling breathing
- numbness and tingling around the mouth or fingertips
- pounding in the ears
- shivering
- slow, fast, or pounding heartbeat or pulse
- sneezing
- sore throat
- stomach cramps or pain
- sweating
- swelling of the fingers, hands, feet, or lower legs
- tightness in the chest
- trembling
- troubled breathing at rest
- unpleasant breath odor
- vomiting of blood
- weight gain
- yellow eyes or skin
Rare
- Black, tarry stools
- bleeding gums
- blistering, peeling, or loosening of the skin
- bloating or swelling of the face, arms, hands, lower legs, or feet
- blood in the urine or stools
- blue lips and fingernails
- burning, crawling, itching, numbness, painful, prickling, "pins and needles", or tingling feelings
- continuing ringing or buzzing or other unexplained noise in the ears
- coughing that sometimes produces a pink frothy sputum
- cracks in the skin
- decreased appetite
- difficulty with swallowing
- dilated neck veins
- disturbed color perception
- double vision
- extreme tiredness or weakness
- fast or irregular breathing
- feeling of discomfort
- general feeling of tiredness or weakness
- halos around lights
- hearing loss
- hives or welts
- inflammation of the joints
- joint pain
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
- loss of heat from the body
- loss of vision
- lower back or side pain
- night blindness
- overbright appearance of lights
- painful or difficult urination
- pale skin
- pinpoint red spots on the skin
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- rapid weight gain
- red skin lesions, often with a purple center
- red, irritated eyes
- red, swollen skin
- scaly skin
- sores, ulcers, or white spots on the lips or in the mouth
- stomach pain, continuing
- stomach tenderness
- swollen lymph glands
- tunnel vision
- unsteadiness or awkwardness
- unusual bleeding or bruising
- unusual weight gain or loss
- upper right abdominal or stomach pain
- weakness in the arms, hands, legs, or feet
Incidence not known
- Bloating
- constipation
- difficult, fast, noisy breathing
- indigestion
- loss of bladder control
- pains in the stomach, side, or abdomen, possibly radiating to the back
Side effects not requiring immediate medical attention
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
- Decreased interest in sexual intercourse
- difficulty having a bowel movement
- difficulty with moving
- discouragement
- feeling of constant movement of self or surroundings
- feeling sad or empty
- inability to have or keep an erection
- irritability
- loss in sexual ability, desire, drive, or performance
- loss of interest or pleasure
- muscle aching or stiffness
- pain or tenderness around the eyes and cheekbones
- passing of gas
- sensation of spinning
- sleepiness or unusual drowsiness
- soreness of the skin
- stomach fullness or discomfort
- stuffy or runny nose
- trouble concentrating
- trouble sleeping
Rare
- Belching
- change in taste
- hair loss or thinning of the hair
- heartburn
- increased need to urinate
- increased sensitivity of the eyes or skin to sunlight
- loss of taste
- menstrual changes
- passing urine more often
- redness or other discoloration of the skin
- severe sunburn
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% to 9% of patients receiving short-term therapy and about 15% of patients receiving prolonged (about 1 month) continuous therapy.[Ref]
Gastrointestinal
Very common (10% or more): Nausea (up to 11%), diarrhea (up to 11%)
Common (1% to 10%): Vomiting, abdominal pain or discomfort, dyspepsia, flatulence, gingivitis, constipation, ulcerative stomatitis, gastritis, gastroenteritis
Rare (less than 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, increased blood alkaline phosphatase, hypomagnesemia, increased blood lactate dehydrogenase, 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 or permanent hearing loss, peripheral neuropathy
Rare (less than 0.1%): Paresthesia, tinnitus[Ref]
Peripheral neuropathy, paresthesia, hypoesthesia, headache, dizziness, tinnitus, transient or 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, Pneumocystis carinii infection, herpes zoster
Frequency not reported: Unspecified infection, rigors, back pain, hot flushes, implantation complication, face edema, chills, generalized edema
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 (less than 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 1% 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
Rare (less than 0.1%): Serious hepatotoxicity (including some cases of fatal acute liver failure)
Frequency not reported: Cholestasis, cholestatic jaundice, hepatic failure[Ref]
Cardiovascular
Common (1% to 10%): Hypertension, vein disorder, abnormal electrocardiogram
Uncommon (0.1% to 1%): Hypotension, orthostatic hypotension, vasculitis, sinus bradycardia, tachycardia
Rare (less than 0.1%): Congestive heart failure
Frequency not reported: Premature ventricular contractions, cardiac failure, left ventricular failure[Ref]
Congestive heart failure has also been reported during postmarketing experience.[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 itraconazole. The symptoms reappeared following accidental itraconazole doses 7 and 10 days later.[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
Rare (less than 0.1%): Pollakiuria, erectile dysfunction
Frequency not reported: Albuminuria, hematuria, gynecomastia, male breast pain, bacteriuria
Postmarketing reports: Urinary incontinence[Ref]
Musculoskeletal
Common (1% to 10%): Myalgia, bursitis, back pain
Rare (less than 0.1%): Increased blood creatine phosphokinase
Postmarketing reports: Arthralgia[Ref]
Increased blood creatine phosphokinase and myalgia have also been reported during postmarketing experience.[Ref]
Local
IV:
Common (1% to 10%): Application site reaction
Frequency not reported: Injection site inflammation[Ref]
Hypersensitivity
At least 1 case of anaphylactic shock after long-term IV therapy has been reported.
Anaphylactic reactions, allergic reactions, serum sickness, and angioneurotic edema have also been reported during postmarketing experience.[Ref]
Uncommon (0.1% to 1%): Hypersensitivity
Rare (less than 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]
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]
Hematologic
Leukopenia has also been reported during postmarketing experience.[Ref]
Rare (less than 0.1%): Leukopenia
Frequency not reported: Granulocytopenia
Postmarketing reports: Neutropenia, thrombocytopenia[Ref]
Endocrine
Frequency not reported: Adrenal insufficiency[Ref]
References
1. "Product Information. Sporanox injection (itraconazole)" Ortho Biotech Inc, Raritan, NJ.
2. Haria M, Bryson HM, Goa KL "Itraconazole: a review of its pharmacological properties and therapeutic use in the management of superficial fungal infections." Drugs 52 (1996): 253
3. 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 56 (1995): 1066-75
4. Tucker R, Denning D, Arathoon E, et al "Itraconazole therapy for nonmeningeal coccidioidomysosis: clinical and laboratory observations." J Am Acad Dermatol 23 (1990): 593-601
5. "Product Information. Sporanox oral solution (itraconazole)." Janssen Pharmaceutica, Titusville, NJ.
6. Gupta AK, Ryder JE "The use of oral antifungal agents to treat onychomycosis." Dermatol Clin 21 (2003): 469-79, vi
7. Cerner Multum, Inc. "Australian Product Information." O 0
8. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
9. Piepponen T, Blomquist K, Brandt H, et al "Efficacy and safety of itraconazole in the long-term treatment of onychomycosis." J Antimicrob Chemother 29 (1992): 195-205
10. Tucker R, Haq Y, Denning D, Stevens D "Adverse events associated with itraconazole in 189 patients on chronic therapy." J Antimicrob Chemother 26 (1990): 561-6
11. Lavrijsen A, Balmus K, Nugteren-Huying W, et al "Hepatic injury associated with itraconazole." Lancet 340 (1992): 251-2
12. Chen J, Song X, Yang P, Wang J "Appearance of anaphylactic shock after long-term intravenous itraconazole treatment." Ann Pharmacother 43 (2009): 537-41
13. Thompson GR 3rd, Cadena J, Patterson TF "Overview of antifungal agents." Clin Chest Med 30 (2009): 203-15, v
14. Debruyne D, Coquerel A "Pharmacokinetics of antifungal agents in onychomycoses." Clin Pharmacokinet 40 (2001): 441-72
15. Cleveland KO, Campbell JW "Hallucinations associated with itraconazole therapy." Clin Infect Dis 21 (1995): 456
16. "Product Information. Sporanox (itraconazole)." Janssen Pharmaceutica, Titusville, NJ.
17. Gallardoquesada S, Luelmoaguilar J, Guanyabenscalvet C "Hepatotoxicity associated with itraconazole." Int J Dermatol 34 (1995): 589
18. "Itracanazole, terbinafine possibly linked to liver failure." Am J Health Syst Pharm 58 (2001): 1076
19. Ahmad SR, Singer SJ, Leissa BG "Congestive heart failure associated with itraconazole." Lancet 357 (2001): 1766-7
20. Gelfand MS, Cleveland KO "Acute congestive heart failure and death secondary to itraconazole therapy." AIDS 26 (2012): 1848-50
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