Itraconazole

Common brands: Sporanox, Tolsura, Itraconazole Oral, Prograf, Prednisone

Top reporter: Janssen Pharmaceuticals, Inc.

Azole Antifungal [EPC]Corticosteroid [EPC]Calcineurin Inhibitor Immunosuppressant [EPC]Proton Pump Inhibitor [EPC]Polyene Antifungal [EPC]
11,462
Total Reports
4,778
Serious Reports
2,251
Death Reports
30
Reported Reactions
Death Report Ratio: High (19.64%)

Patient Demographics

Male
5,353
Female
4,597

Reported Adverse Reactions (30)

Side effects reported in FDA adverse event reports for Itraconazole.

# Reaction Reports % of Total
1 DRUG INTERACTION 1,144
10.2%
2 DRUG INEFFECTIVE 1,114
10.0%
3 OFF LABEL USE 620
5.5%
4 PYREXIA 583
5.2%
5 DYSPNOEA 483
4.3%
6 PNEUMONIA 468
4.2%
7 NAUSEA 455
4.1%
8 DIARRHOEA 397
3.6%
9 CONDITION AGGRAVATED 393
3.5%
10 FEBRILE NEUTROPENIA 370
3.3%
11 FATIGUE 335
3.0%
12 RASH 307
2.7%
13 ANAEMIA 302
2.7%
14 NEUTROPENIA 298
2.7%
15 COUGH 291
2.6%
16 VOMITING 288
2.6%
17 SEPSIS 284
2.5%
18 DEATH 271
2.4%
19 HEADACHE 262
2.3%
20 THROMBOCYTOPENIA 258
2.3%
21 MALAISE 253
2.3%
22 HYPERTENSION 243
2.2%
23 PRODUCT USE IN UNAPPROVED INDICATION 236
2.1%
24 PLATELET COUNT DECREASED 234
2.1%
25 ASTHENIA 231
2.1%
26 RENAL IMPAIRMENT 226
2.0%
27 HYPOKALAEMIA 224
2.0%
28 BRONCHOPULMONARY ASPERGILLOSIS 214
1.9%
29 OEDEMA PERIPHERAL 199
1.8%
30 PAIN 199
1.8%

Important Disclaimer

FDA adverse event reports are submitted voluntarily and do not prove causation. A reported reaction does not mean the drug caused it. Drugs with more users naturally have more reports. Always consult your doctor or pharmacist before making medication decisions.