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Itraconazole Side Effects

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

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 or 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 sex organs
  • 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

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
  • indigestion
  • 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
  • swollen joints
  • 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 to sunlight
  • increased sensitivity of the skin to sunlight
  • loss of bladder control
  • 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

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

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]

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

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]

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]

Hepatic

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]

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]

Cardiovascular

Congestive heart failure has also been reported during postmarketing experience.[Ref]

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]

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

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]

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]

Ocular

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

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

Frequency not reported: Abnormal vision[Ref]

Hematologic

Rare (less than 0.1%): Leukopenia

Frequency not reported: Granulocytopenia

Postmarketing reports: Neutropenia, thrombocytopenia[Ref]

Leukopenia has also been reported during postmarketing experience.[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. Cerner Multum, Inc. "Australian Product Information." O 0

7. Debruyne D, Coquerel A "Pharmacokinetics of antifungal agents in onychomycoses." Clin Pharmacokinet 40 (2001): 441-72

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

9. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

10. Lavrijsen A, Balmus K, Nugteren-Huying W, et al "Hepatic injury associated with itraconazole." Lancet 340 (1992): 251-2

11. 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

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

13. 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

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

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. "Itracanazole, terbinafine possibly linked to liver failure." Am J Health Syst Pharm 58 (2001): 1076

18. Gallardoquesada S, Luelmoaguilar J, Guanyabenscalvet C "Hepatotoxicity associated with itraconazole." Int J Dermatol 34 (1995): 589

19. Gelfand MS, Cleveland KO "Acute congestive heart failure and death secondary to itraconazole therapy." AIDS 26 (2012): 1848-50

20. Ahmad SR, Singer SJ, Leissa BG "Congestive heart failure associated with itraconazole." Lancet 357 (2001): 1766-7

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.

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