ADVERSE REACTIONS
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. (See WARNINGS: Hepatic Effects and PRECAUTIONS: General and Information for Patients.)
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.
Clinical Trials of Systemic Fungal Infections: Adverse Events Occurring with an Incidence of Greater than or Equal to 1% | 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 | |
| RashRash tends to occur more frequently in immunocompromised patients receiving immunosuppressive medications. | 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.
Clinical Trials of Onychomycosis of the Toenail: Adverse Events Leading 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.
Clinical Trials of Onychomycosis of the Fingernail: Adverse Events Leading 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:
Postmarketing Reports of Adverse Drug Reactions | |
|---|
| 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. (See CLINICAL PHARMACOLOGY: Special Populations, CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS: Drug Interactions for more information.)
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REPORTS OF SIDE EFFECTS / ADVERSE REACTIONS RELATED TO SPORANOX
Below is a sample of reports where side effects / adverse reactions may be related to Sporanox. The information is not vetted and should not be cosidered as verified clinical evidence.
Possible Sporanox side effects / adverse reactions in 50 year old male
Reported by a physician from China on 2007-01-09
Patient: 50 year old male
Reactions: Blood Urea Increased, Pharmaceutical Product Complaint, Blood Creatinine Increased
Adverse event resulted in: hospitalization
Suspect drug(s):
Sporanox
Possible Sporanox side effects / adverse reactions in 17 year old male
Reported by a consumer/non-health professional from United States on 2007-02-27
Patient: 17 year old male weighing 64.9 kg (142.7 pounds)
Reactions: Lymphoma
Adverse event resulted in: life threatening event
Suspect drug(s):
Sporanox
Possible Sporanox side effects / adverse reactions in 60 year old female
Reported by a physician from China on 2007-03-07
Patient: 60 year old female
Reactions: Respiratory Failure, Septic Shock, Renal Failure Acute
Adverse event resulted in: death
Suspect drug(s):
Sporanox
Other drugs received by patient: Tazocin; Fluconazole; Tienam
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