Sporanox Side Effects
Generic Name: itraconazole
Please note - some side effects for Sporanox may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).
Side Effects of Sporanox - for the Consumer
Sporanox PulsePak
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Sporanox PulsePak:
Seek medical attention right away if any of these SEVERE side effects occur when using Sporanox PulsePak:Diarrhea; dizziness; gas; headache; nausea; stomach pain or upset; stuffy nose.
Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloating; chest pain; confusion; dark urine; diarrhea; depression; fast or irregular heartbeat; fever; loss of appetite; numbness or tingling of the hands or feet; pale stools; red, swollen, blistered, or peeling skin; severe or persistent nausea; shortness of breath; sudden weight gain; swelling of the hands, ankles, or feet; swollen or tender abdomen; unusual tiredness or fatigue; vomiting; yellowing of the skin or eyes.
Sporanox
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Sporanox:
Seek medical attention right away if any of these SEVERE side effects occur when using Sporanox:Diarrhea; gas; headache; nausea; runny nose; stomach pain or upset; vomiting.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloating; chest pain; confusion; dark urine; depression; fast or irregular heartbeat; fever; loss of appetite; numbness or tingling of the hands or feet; pain, redness, or swelling at the injection site; pale stools; red, swollen, blistered, or peeling skin; severe or persistent nausea; severe or persistent vomiting; shortness of breath; sudden weight gain; swelling of the hands, ankles, or feet; swollen or tender stomach; unusual bruising or bleeding; unusual tiredness or fatigue; yellowing of the skin or eyes.
Sporanox Capsules
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Sporanox Capsules:
Seek medical attention right away if any of these SEVERE side effects occur when using Sporanox Capsules:Diarrhea; gas; headache; nausea; runny nose; stomach pain or upset; vomiting.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloating; chest pain; confusion; dark urine; depression; fast or irregular heartbeat; fever; loss of appetite; numbness or tingling of the hands or feet; pale stools; red, swollen, blistered, or peeling skin; severe or persistent nausea; severe or persistent vomiting; shortness of breath; sudden weight gain; swelling of the hands, ankles, or feet; swollen or tender stomach; unusual bruising or bleeding; unusual tiredness or fatigue; yellowing of the skin or eyes.
Sporanox Solution
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Sporanox Solution:
Seek medical attention right away if any of these SEVERE side effects occur when using Sporanox Solution:Diarrhea; dizziness; gas; headache; nausea; runny nose; stomach pain or upset; vomiting.
TopSevere allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloating; chest pain; confusion; dark urine; depression; fast or irregular heartbeat; fever; loss of appetite; numbness or tingling of the hands or feet; pale stools; red, swollen, blistered, or peeling skin; severe or persistent nausea; severe or persistent vomiting; shortness of breath; sudden weight gain; swelling of the hands, ankles, or feet; swollen or tender abdomen; unusual tiredness or fatigue; yellowing of the skin or eyes.
Sporanox Side Effects - for the Professional
Sporanox
Sporanox® has been associated with rare cases of serious hepatotoxicity, including liver failure and death. Some of these cases had neither pre-existing liver disease nor a serious underlying medical condition. If clinical signs or symptoms develop that are consistent with liver disease, treatment should be discontinued and liver function testing performed. The risks and benefits of Sporanox® use should be reassessed.
Adverse Events Reported in Empiric Therapy in Febrile Neutropenic (ETFN) Patients
Adverse events considered at least possibly drug related in a clinical trial of empiric therapy in 384 febrile, neutropenic patients (192 treated with Sporanox® and 192 with amphotericin B) with suspected fungal infections are listed in Table 2 below. Patients received a regimen of Sporanox® Injection followed by Sporanox® Oral Solution. The dose of Sporanox® Injection was 200 mg twice daily for the first two days followed by a single daily dose of 200 mg for the remainder of the intravenous treatment period. The majority of patients received between 7 and 14 days of Sporanox® Injection. The dose of Sporanox® Oral Solution was 200 mg (20 mL) b.i.d. for the remainder of therapy.
| Adverse Event | Sporanox ® (N=192) % |
Amphotericin B (N=192) % |
| Gastrointestinal system disorders | ||
| Nausea | 11 | 15 |
| Diarrhea | 10 | 9 |
| Vomiting | 7 | 10 |
| Abdominal pain | 3 | 3 |
| Metabolic and nutritional disorders | ||
| Hypokalemia | 9 | 28 |
| Serum creatinine increased | 3 | 25 |
| LDH increased | 2 | 0 |
| Alkaline phosphatase increased | 2 | 2 |
| Hypomagnesemia | 2 | 4 |
| Blood urea nitrogen increased | 1 | 6 |
| Fluid overload | 1 | 3 |
| Hypocalcemia | 1 | 2 |
| Liver and biliary system disorders | ||
| Bilirubinemia | 6 | 3 |
| Hepatic function abnormal | 3 | 2 |
| SGPT/ALT increased | 3 | 1 |
| Jaundice | 2 | 1 |
| SGOT/AST increased | 2 | 1 |
| Skin and appendage disorders | ||
| Rash | 5 | 3 |
| Sweating increased | 2 | 1 |
| CNS and peripheral nervous system | ||
| Headache | 2 | 2 |
| Body as a whole | ||
| Edema | 2 | 2 |
| Rigors | 1 | 34 |
| Fever | 0 | 7 |
| Respiratory system disorder | ||
| Dyspnea | 1 | 3 |
| Urinary system disorder | ||
| Renal function abnormal | 1 | 12 |
| Cardiovascular disorders, general | ||
| Hypotension | 1 | 3 |
| Hypertension | 0 | 2 |
| Heart rate and rhythm disorders | ||
| Tachycardia | 1 | 3 |
The following additional adverse events considered at least possibly related occurred in between 1 and 2% of patients who received Sporanox® Injection and Oral Solution: constipation, hypophosphatemia, gamma-GT increased, erythematous rash, pruritus, dizziness, tremor, and pulmonary infiltration.
Adverse Events Reported in Oropharyngeal or Esophageal Candidiasis Trials
U.S. adverse experience data are derived from 350 immunocompromised patients (332 HIV seropositive/AIDS) treated for oropharyngeal or esophageal candidiasis. Table 3 below lists adverse events reported by at least 2% of patients treated with Sporanox® Oral Solution in U.S. clinical trials. Data on patients receiving comparator agents in these trials are included for comparison.
Treated Patients in U.S. Clinical Trials (Total)
Body System/ Adverse Event |
Itraconazole | |||
| Total (n = 350*) % |
All controlled studies (n = 272) % |
Fluconazole (n = 125†) % |
Clotrimazole (n = 81‡) % | |
|
||||
| Gastrointestinal disorders | ||||
| Nausea Diarrhea Vomiting Abdominal pain Constipation |
11 11 7 6 2 |
10 10 6 4 2 |
11 10 8 7 1 |
5 4 1 7 0 |
| Body as a whole | ||||
| Fever Chest pain Pain Fatigue |
7 3 2 2 |
6 3 2 1 |
8 2 4 2 |
5 0 0 0 |
| Respiratory disorders | ||||
| Coughing Dyspnea Pneumonia Sinusitis Sputum increased |
4 2 2 2 2 |
4 3 2 2 3 |
10 5 0 4 3 |
0 1 0 0 1 |
| Skin and appendages disorders | ||||
| Rash Increased sweating Skin disorder unspecified |
4 3 2 |
5 4 2 |
4 6 2 |
6 1 1 |
| Central/peripheral nervous system | ||||
| Headache Dizziness |
4 2 |
4 2 |
6 4 |
6 1 |
| Resistance mechanism disorders | ||||
| Pneumocystis carinii infection | 2 | 2 | 2 | 0 |
| Psychiatric disorders | ||||
| Depression | 2 | 1 | 0 | 1 |
Adverse events reported by less than 2% of patients in U.S. clinical trials with Sporanox® included: adrenal insufficiency, asthenia, back pain, dehydration, dyspepsia, dysphagia, flatulence, gynecomastia, hematuria, hemorrhoids, hot flushes, implantation complication, infection unspecified, injury, insomnia, male breast pain, myalgia, pharyngitis, pruritus, rhinitis, rigors, stomatitis ulcerative, taste perversion, tinnitus, upper respiratory tract infection, vision abnormal, and weight decrease. Edema, hypokalemia and menstrual disorders have been reported in clinical trials with itraconazole capsules.
Post-marketing Experience
Worldwide post-marketing experiences with the use of Sporanox® (all formulations) include very rare reports (<1/10,000) of the adverse events listed below:
| Blood and lymphatic system disorders | |
| Very rare | Leukopenia, neutropenia, thrombocytopenia |
| Immune system disorders | |
| Very rare | Serum sickness; angioneurotic edema; anaphylaxis; anaphylactic, anaphylactoid and allergic reactions |
| Metabolism and nutrition disorders | |
| Very rare | Hypertriglyceridemia, hypokalemia |
| Nervous system disorders | |
| Very rare | Peripheral neuropathy, paresthesia, hypoesthesia, headache, dizziness |
| Eye disorders | |
| Very rare | Visual disturbances, including vision blurred and diplopia |
| Ear and labyrinth disorder | |
| Very rare | Tinnitus, transient or permanent hearing loss |
| Cardiac disorders | |
| Very rare | Congestive heart failure |
| Respiratory, thoracic and mediastinal disorders | |
| Very rare | Pulmonary edema |
| Gastrointestinal disorders | |
| Very rare | Abdominal pain, vomiting, dyspepsia, nausea, diarrhea, constipation, dysgeusia |
| Hepato-biliary disorders | |
| Very rare | Serious hepatotoxicity (including some cases of fatal acute liver failure), hepatitis, reversible increases in hepatic enzymes |
| Skin and subcutaneous tissue disorders | |
| Very rare | Toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, exfoliative dermatitis, leukocytoclastic vasculitis, urticaria, alopecia, photosensitivity, rash, pruritus |
| Musculoskeletal and connective tissue disorders | |
| Very rare | Myalgia, arthralgia |
| Renal and urinary disorders | |
| Very rare | Pollakiuria, urinary incontinence |
| Reproductive system and breast disorders | |
| Very rare | Menstrual disorders, erectile dysfunction |
| General disorders and administration site conditions | |
| Very rare | Peripheral edema |
There is limited information on the use of Sporanox® during pregnancy. Cases of congenital abnormalities including skeletal, genitourinary tract, cardiovascular and ophthalmic malformations as well as chromosomal and multiple malformations have been reported during post-marketing experience. A causal relationship with Sporanox® has not been established.
TopSporanox Capsules
Sporanox® has been associated with rare cases of serious hepatotoxicity, including liver failure and death. Some of these cases had neither pre-existing liver disease nor a serious underlying medical condition. If clinical signs or symptoms develop that are consistent with liver disease, treatment should be discontinued and liver function testing performed. The risks and benefits of Sporanox® use should be reassessed.
Adverse Events in the Treatment of Systemic Fungal Infections
Adverse event data were derived from 602 patients treated for systemic fungal disease in U.S. clinical trials who were immunocompromised or receiving multiple concomitant medications. Treatment was discontinued in 10.5% of patients due to adverse events. The median duration before discontinuation of therapy was 81 days (range: 2 to 776 days). The table lists adverse events reported by at least 1% of patients.
| Body System/Adverse Event | Incidence (%) (N=602) |
|---|---|
|
|
| Gastrointestinal | |
| Nausea | 11 |
| Vomiting | 5 |
| Diarrhea | 3 |
| Abdominal Pain | 2 |
| Anorexia | 1 |
| Body as a Whole | |
| Edema | 4 |
| Fatigue | 3 |
| Fever | 3 |
| Malaise | 1 |
| Skin and Appendages | |
| Rash* | 9 |
| Pruritus | 3 |
| Central/Peripheral Nervous System | |
| Headache | 4 |
| Dizziness | 2 |
| Psychiatric | |
| Libido Decreased | 1 |
| Somnolence | 1 |
| Cardiovascular | |
| Hypertension | 3 |
| Metabolic/Nutritional | |
| Hypokalemia | 2 |
| Urinary System | |
| Albuminuria | 1 |
| Liver and Biliary System | |
| Hepatic Function Abnormal | 3 |
| Reproductive System, Male | |
| Impotence | 1 |
Adverse events infrequently reported in all studies included constipation, gastritis, depression, insomnia, tinnitus, menstrual disorder, adrenal insufficiency, gynecomastia, and male breast pain.
Adverse Events Reported in Toenail Onychomycosis Clinical Trials
Patients in these trials were on a continuous dosing regimen of 200 mg once daily for 12 consecutive weeks.
The following adverse events led to temporary or permanent discontinuation of therapy.
| Adverse Event | Incidence (%) Itraconazole (N=112) |
|---|---|
| Elevated Liver Enzymes (greater than twice the upper limit of normal) | 4 |
| Gastrointestinal Disorders | 4 |
| Rash | 3 |
| Hypertension | 2 |
| Orthostatic Hypotension | 1 |
| Headache | 1 |
| Malaise | 1 |
| Myalgia | 1 |
| Vasculitis | 1 |
| Vertigo | 1 |
The following adverse events occurred with an incidence of greater than or equal to 1% (N=112): headache: 10%; rhinitis: 9%; upper respiratory tract infection: 8%; sinusitis, injury: 7%; diarrhea, dyspepsia, flatulence, abdominal pain, dizziness, rash: 4%; cystitis, urinary tract infection, liver function abnormality, myalgia, nausea: 3%; appetite increased, constipation, gastritis, gastroenteritis, pharyngitis, asthenia, fever, pain, tremor, herpes zoster, abnormal dreaming: 2%.
Adverse Events Reported in Fingernail Onychomycosis Clinical Trials
Patients in these trials were on a pulse regimen consisting of two 1-week treatment periods of 200 mg twice daily, separated by a 3-week period without drug.
The following adverse events led to temporary or permanent discontinuation of therapy.
Adverse Event |
Incidence (%) Itraconazole (N=37) |
|---|---|
| Rash/Pruritus | 3 |
| Hypertriglyceridemia | 3 |
The following adverse events occurred with an incidence of greater than or equal to 1% (N=37): headache: 8%; pruritus, nausea, rhinitis: 5%; rash, bursitis, anxiety, depression, constipation, abdominal pain, dyspepsia, ulcerative stomatitis, gingivitis, hypertriglyceridemia, sinusitis, fatigue, malaise, pain, injury: 3%.
Post-marketing Experience
Worldwide post-marketing experiences with the use of Sporanox® (all formulations) include very rare reports (<1/10,000) of the adverse events listed below:
| Blood and lymphatic system disorders | |
| Very rare | Leukopenia, neutropenia, thrombocytopenia |
| Immune system disorders | |
| Very rare | Serum sickness; angioneurotic edema; anaphylaxis; anaphylactic, anaphylactoid and allergic reactions |
| Metabolism and nutrition disorders | |
| Very rare | Hypertriglyceridemia, hypokalemia |
| Nervous system disorders | |
| Very rare | Peripheral neuropathy, paresthesia, hypoesthesia, headache, dizziness |
| Eye disorders | |
| Very rare | Visual disturbances, including vision blurred and diplopia |
| Ear and labyrinth disorder | |
| Very rare | Tinnitus, transient or permanent hearing loss |
| Cardiac disorders | |
| Very rare | Congestive heart failure |
| Respiratory, thoracic and mediastinal disorders | |
| Very rare | Pulmonary edema |
| Gastrointestinal disorders | |
| Very rare | Abdominal pain, vomiting, dyspepsia, nausea, diarrhea, constipation,dysgeusia |
| Hepato-biliary disorders | |
| Very rare | Serious hepatotoxicity (including some cases of fatal acute liver failure), hepatitis, reversible increases in hepatic enzymes |
| Skin and subcutaneous tissue disorders | |
| Very rare | Toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, exfoliative dermatitis, leukocytoclastic vasculitis, urticaria, alopecia, photosensitivity, rash, pruritus |
| Musculoskeletal and connective tissue disorders | |
| Very rare | Myalgia, arthralgia |
| Renal and urinary disorders | |
| Very rare | Pollakiuria, urinary incontinence |
| Reproductive system and breast disorders | |
| Very rare | Menstrual disorders, erectile dysfunction |
| General disorders and administration site conditions | |
| Very rare | Peripheral edema |
There is limited information on the use of Sporanox® during pregnancy. Cases of congenital abnormalities including skeletal, genitourinary tract, cardiovascular and ophthalmic malformations as well as chromosomal and multiple malformations have been reported during post-marketing experience. A causal relationship with Sporanox® has not been established.
TopSporanox Injection
Sporanox® has been associated with rare cases of serious hepatotoxicity, including liver failure and death. Some of these cases had neither pre-existing liver disease nor a serious underlying medical condition. If clinical signs or symptoms develop that are consistent with liver disease, treatment should be discontinued and liver function testing performed. The risks and benefits of Sporanox® use should be reassessed.
Adverse Events Reported in Trials in Patients with Sporanox® Injection
Adverse events considered at least possibly drug related are shown in Table 2 and are based on the experience of 360 patients treated with Sporanox® Injection in four pharmacokinetic, one uncontrolled and four active controlled studies where the control was amphotericin B or fluconazole. Nearly all patients were neutropenic or were otherwise immunocompromised and were treated empirically for febrile episodes, for documented systemic fungal infections, or in trials to determine pharmacokinetics. The dose of Sporanox® Injection was 200 mg twice daily for the first two days followed by a single daily dose of 200 mg for the remainder of the intravenous treatment period. The majority of patients received between 7 and 14 days of Sporanox® Injection.
| Total | Comparative Studies | |||
|---|---|---|---|---|
| Adverse Event | Sporanox® Injection (N=360) % |
Sporanox® Injection (N=234) % |
Intravenous Fluconazole (N=32) % |
Intravenous Amphotericin B (N=202) % |
| Gastrointestinal system disorders | ||||
| Nausea | 8 | 9 | 0 | 15 |
| Diarrhea | 6 | 6 | 3 | 9 |
| Vomiting | 4 | 6 | 0 | 10 |
| Abdominal pain | 2 | 2 | 0 | 3 |
| Constipation | 0 | 1 | 3 | 0 |
| Metabolic and nutritional disorders | ||||
| Hypokalemia | 5 | 8 | 0 | 29 |
| Alkaline phosphatase increased | 1 | 2 | 3 | 2 |
| Serum creatinine increased | 2 | 2 | 3 | 26 |
| Hypomagnesemia | 1 | 1 | 0 | 5 |
| Blood urea nitrogen increased | 0 | 1 | 0 | 7 |
| Fluid overload | 0 | 0 | 0 | 3 |
| Hypocalcemia | 0 | 0 | 0 | 3 |
| Liver and biliary system disorders | ||||
| Bilirubinemia | 4 | 6 | 9 | 3 |
| SGPT/ALT Increased | 2 | 3 | 3 | 1 |
| Hepatic function abnormal | 1 | 2 | 0 | 2 |
| Jaundice | 1 | 2 | 0 | 0 |
| SGOT/AST increased | 1 | 2 | 0 | 0 |
| Body as a whole – General disorders | ||||
| Pain | 1 | 2 | 0 | 0 |
| Rigors | 0 | 0 | 0 | 34 |
| Fever | 0 | 0 | 0 | 6 |
| Skin and appendages disorders | ||||
| Rash | 3 | 3 | 3 | 3 |
| Sweating increased | 1 | 2 | 0 | 0 |
| Respiratory system disorder | ||||
| Dyspnea | 0 | 0 | 0 | 3 |
| Central and peripheral nervous system disorders | ||||
| Dizziness | 1 | 2 | 0 | 1 |
| Headache | 2 | 2 | 0 | 3 |
| Urinary system disorders | ||||
| Renal function abnormal | 1 | 1 | 0 | 11 |
| Application site disorder | ||||
| Application site reaction | 4 | 0 | 0 | 0 |
| Cardiovascular disorders, general | ||||
| Hypotension | 0 | 0 | 0 | 3 |
| Hypertension | 0 | 0 | 0 | 2 |
| Heart rate and rhythm disorders | ||||
| Tachycardia | 0 | 1 | 0 | 3 |
| Vascular (extracardiac) disorders | ||||
| Vein disorder | 3 | 0 | 0 | 0 |
The following adverse events occurred in less than 2% of patients in clinical trials of Sporanox® Injection: LDH increased, edema, albuminuria, hyperglycemia, and hepatitis.
Post-marketing Experience
Worldwide post-marketing experiences with the use of Sporanox® include adverse events of gastrointestinal origin, such as dyspepsia, nausea, vomiting, diarrhea, abdominal pain and constipation. Other reported adverse events include peripheral edema, congestive heart failure and pulmonary edema, headache, dizziness, peripheral neuropathy, menstrual disorders, reversible increases in hepatic enzymes, hepatitis, liver failure, hypokalemia, hypertriglyceridemia, alopecia, allergic reactions (such as pruritus, rash, urticaria, angioedema, anaphylaxis), Stevens-Johnson syndrome, anaphylactic, anaphylactoid and allergic reactions, photosensitivity and neutropenia. There is limited information on the use of Sporanox® during pregnancy. Cases of congenital abnormalities including skeletal, genitourinary tract, cardiovascular and ophthalmic malformations as well as chromosomal and multiple malformations have been reported during post-marketing experience. A causal relationship with Sporanox® has not been established.
TopSide Effects by Body System
General
In general, pooled data involving 15,000 patients suggest that adverse effects occur in approximately 7% of patients treated with itraconazole for 4 weeks or less, and up to 18% in patients treated for more than one month. Most reported adverse effects are transient and considered mild to moderate in nature.
Cardiovascular
Cardiovascular side effects have included hypertension (up to 3.2%), vein disorder (3%), hypotension (1%), orthostatic hypotension (1%), vasculitis (1%), and tachycardia (up to 1%). Premature ventricular contractions have been reported. Congestive heart failure has been reported during postmarketing experience.
Hepatic
Hepatic side effects have included bilirubinemia (up to 6%), abnormal liver function (up to 3%), increased SGPT/ALT (up to 3%), jaundice (up to 2%), increased SGOT/AST (up to 2%), increased gamma-glutamyltransferase (1% to 2%), and hepatitis (less than 2%). Mild, transient elevations in liver function tests have occurred in 1% to 7% of patients receiving continuous therapy. Rare cases of serious hepatotoxicity (including liver failure and death) and rare cases of reversible hepatitis (4 to 6 weeks after initiating itraconazole therapy) have been reported. Isolated cases of cholestatic jaundice have also been reported.
Gastrointestinal
Gastrointestinal side effects have included nausea (up to 11%), diarrhea (up to 11%), vomiting (7%), abdominal pain (up to 6%), dyspepsia (up to 4%), flatulence (up to 4%), gingivitis (3%), constipation (up to 3%), ulcerative stomatitis (up to 3%), gastritis (2%), increased appetite (2%), gastroenteritis (2%), dysphagia (less than 2%), hemorrhoids (less than 2%), dysgeusia (less than 2%), and anorexia (1%). Cholestasis and pancreatitis have been reported.
Hypersensitivity
Hypersensitivity side effects have included rash and pruritus in up to 5% of treated patients (may be more likely in immunocompromised patients). Anaphylaxis; anaphylactic, anaphylactoid, and allergic reactions; serum sickness; and angioneurotic edema have been reported during postmarketing experience. At least one case of anaphylactic shock following long-term intravenous therapy has been reported.
Metabolic
Metabolic side effects have included hypertriglyceridemia (up to 11%), hypokalemia (up to 9%), increased alkaline phosphatase (up to 2%), hypomagnesemia (up to 2%), increased lactate dehydrogenase (up to 2%), hypophosphatemia (1% to 2%), hyperglycemia (less than 2%), dehydration (less than 2%), decreased weight (less than 2%), fluid overload (1%), and hypocalcemia (1%).
Endocrine
Endocrine side effects have included adrenal insufficiency (less than 2%).
Nervous system
Nervous system side effects have included headache (up to 10%), dizziness (up to 4%), tremor (1% to 2%), insomnia (less than 2%), tinnitus (less than 2%), vertigo (1%), and somnolence (1%). An elderly patient experienced visual hallucinations, confusion, and weakness after receiving itraconazole. The symptoms reappeared following accidental itraconazole doses 7 and 10 days later. Transient or permanent hearing loss, peripheral neuropathy, paresthesia, and hypoesthesia have been reported during postmarketing experience.
Dermatologic
Dermatologic side effects have included rash (up to 9%), pruritus (up to 5%), increased sweating (up to 3%), unspecified skin disorder (2.3%), and erythematous rash (1% to 2%). Toxic epidermal necrolysis, Stevens-Johnson syndrome, exfoliative dermatitis, leukocytoclastic vasculitis, erythema multiforme, photosensitivity, urticaria, and alopecia have been reported during postmarketing experience.
Local
Local side effects associated with the intravenous formulation have included application site reaction (4%).
Renal
Renal side effects have included increased serum creatinine (up to 3%), abnormal renal function (1%), and increased blood urea nitrogen (up to 1%).
Hematologic
Hematologic side effects have included neutropenia, leukopenia, and thrombocytopenia during postmarketing experience.
Psychiatric
Psychiatric side effects have included depression (up to 3%), anxiety (3%), abnormal dreaming (2%), and decreased libido (up to 2%).
Respiratory
Respiratory side effects have included rhinitis (up to 9%), upper respiratory tract infection (up to 8%), sinusitis (up to 7%), coughing (4%), pneumonia (2%), increased sputum (2%), dyspnea (up to 2%), pharyngitis (up to 2%), and pulmonary infiltration (1% to 2%). Pulmonary edema has been reported during postmarketing experience.
Genitourinary
Genitourinary side effects have included cystitis (3%), urinary tract infection (3%), albuminuria (less than 2%), hematuria (less than 2%), gynecomastia (less than 2%), male breast pain (less than 2%), impotence (1%), and menstrual disorders (infrequent). Urinary incontinence and pollakiuria have been reported during postmarketing experience.
Musculoskeletal
Musculoskeletal side effects have included myalgia (up to 3%) and bursitis (3%). Arthralgia has been reported during postmarketing experience.
Other
Other side effects have included fever (up to 7%), injury (up to 7%), edema (up to 4%), chest pain (3%), fatigue (up to 3%), malaise (up to 3%), pain (up to 3%), asthenia (up to 2%), rigors (less than 2%), back pain (less than 2%), hot flushes (less than 2%), and implantation complication (less than 2%). Peripheral edema has been reported during postmarketing experience.
Ocular
Ocular side effects have included abnormal vision (less than 2%). Visual disturbances (including blurred vision and diplopia) have been reported during postmarketing experience.
TopMore resources:
Sporanox - Includes detailed dosage instructions.
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