Ketoconazole

Common brands: Nizoral, Anti Dandruff, 1% Ketoconazole, Anti-Dandruff, Cysndra Ketoconazole 1% Medicated Shampoos

Top reporter: Kramer Laboratories

Azole Antifungal [EPC]Corticosteroid [EPC]Nonsteroidal Anti-inflammatory Drug [EPC]Benzodiazepine [EPC]Proton Pump Inhibitor [EPC]
16,790
Total Reports
7,807
Serious Reports
1,102
Death Reports
30
Reported Reactions
Death Report Ratio: High (6.56%)

Patient Demographics

Male
7,281
Female
7,673

Reported Adverse Reactions (30)

Side effects reported in FDA adverse event reports for Ketoconazole.

# Reaction Reports % of Total
1 DRUG INEFFECTIVE 1,701
9.2%
2 OFF LABEL USE 1,209
6.5%
3 FATIGUE 949
5.1%
4 PRURITUS 936
5.0%
5 NAUSEA 860
4.6%
6 RASH 827
4.4%
7 DIARRHOEA 788
4.2%
8 PAIN 738
4.0%
9 HEADACHE 728
3.9%
10 PSORIASIS 649
3.5%
11 DYSPNOEA 621
3.3%
12 DIZZINESS 603
3.2%
13 PRODUCT USE IN UNAPPROVED INDICATION 565
3.0%
14 ARTHRALGIA 552
3.0%
15 CHRONIC KIDNEY DISEASE 521
2.8%
16 ASTHENIA 480
2.6%
17 CONDITION AGGRAVATED 477
2.6%
18 ANXIETY 474
2.6%
19 VOMITING 464
2.5%
20 ALOPECIA 457
2.5%
21 FALL 441
2.4%
22 DEATH 433
2.3%
23 RENAL FAILURE 426
2.3%
24 DRUG INTERACTION 405
2.2%
25 PNEUMONIA 389
2.1%
26 WEIGHT DECREASED 389
2.1%
27 PRODUCT DOSE OMISSION ISSUE 388
2.1%
28 ACUTE KIDNEY INJURY 387
2.1%
29 ERYTHEMA 376
2.0%
30 MALAISE 353
1.9%

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.