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Sporanox Side Effects

Generic Name: itraconazole

Note: This page contains side effects data for the generic drug itraconazole. It is possible that some of the dosage forms included below may not apply to the brand name Sporanox.

It is possible that some side effects of Sporanox may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to itraconazole: oral capsule, oral solution, oral tablet

As well as its needed effects, itraconazole (the active ingredient contained in Sporanox) may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking itraconazole, check with your doctor immediately:

More common
  • Convulsions
  • decreased urine
  • dry mouth
  • fever
  • increased thirst
  • irregular heartbeat
  • loss of appetite
  • mood changes
  • muscle pain or cramps
  • nausea or vomiting
  • numbness or tingling in the hands, feet, or lips
  • shortness of breath
  • unusual tiredness or weakness
Less common
  • Abdominal or stomach cramps or pain
  • blurred vision
  • chest pain
  • chills
  • clay-colored stools
  • cloudy urine
  • cold sweats
  • confusion
  • cough
  • dark urine
  • decrease in urine output or decrease in urine-concentrating ability
  • diarrhea
  • difficult or labored breathing
  • dizziness
  • dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
  • drowsiness
  • feeling unusually cold
  • headache
  • itching
  • 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
  • rash
  • shivering
  • slow, fast, or pounding heartbeat or pulse
  • sneezing
  • sore throat
  • 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
  • Abdominal or stomach tenderness
  • 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 fatigue
  • 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
  • swollen lymph glands
  • tingling of the hands or feet
  • 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 itraconazole side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

Less common
  • Decreased interest in sexual intercourse
  • difficulty having a bowel movement (stool)
  • 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
  • tiredness
  • trouble concentrating
  • trouble sleeping
Rare
  • Acid or sour stomach
  • 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
  • stomach fullness, discomfort, or upset

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.

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

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

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

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

Other

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

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

Hepatic

Common (1% to 10%): Increased hepatic enzymes, 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

Mild, transient elevations in liver function tests have occurred in 1% to 7% of patients receiving continuous therapy.

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

Renal

Common (1% to 10%): Increased serum creatinine
Uncommon (0.1% to 1%): Abnormal renal function, increased blood urea
Frequency not reported: Renal impairment

Psychiatric

Common (1% to 10%): Depression, anxiety, abnormal dreaming
Frequency not reported: Insomnia, decreased libido, visual hallucinations, confusional state

An elderly patient experienced visual hallucinations, confusion, and weakness after receiving itraconazole. The symptoms reappeared following accidental itraconazole doses 7 and 10 days later.

Genitourinary

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

Musculoskeletal

Common (1% to 10%): Myalgia, bursitis, back pain
Rare (less than 0.1%): Increased blood creatine phosphokinase
Postmarketing reports: Arthralgia

Local

IV:
Common (1% to 10%): Application site reaction
Frequency not reported: Injection site inflammation

Hypersensitivity

At least 1 case of anaphylactic shock after long-term IV therapy has been reported.

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

Ocular

Uncommon (0.1% to 1%): Visual disturbances (including blurred vision, diplopia)
Frequency not reported: Abnormal vision

Hematologic

Rare (less than 0.1%): Leukopenia
Frequency not reported: Granulocytopenia
Postmarketing reports: Neutropenia, thrombocytopenia

Endocrine

Frequency not reported: Adrenal insufficiency

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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