Darunavir

Common brands: Prezista, Norvir, Darunavir 600 And 800 Mg, Ritonavir Film Coated, Ritonavir

Top reporter: Janssen Products Lp

Protease Inhibitor [EPC]Cytochrome P450 3A Inhibitor [EPC]Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]
14,955
Total Reports
4,418
Serious Reports
1,491
Death Reports
30
Reported Reactions
Death Report Ratio: High (9.97%)

Patient Demographics

Male
7,683
Female
4,324

Reported Adverse Reactions (30)

Side effects reported in FDA adverse event reports for Darunavir.

# Reaction Reports % of Total
1 FOETAL EXPOSURE DURING PREGNANCY 1,150
7.4%
2 DRUG INTERACTION 983
6.3%
3 PAIN 890
5.7%
4 EMOTIONAL DISTRESS 813
5.2%
5 ANXIETY 812
5.2%
6 ANHEDONIA 705
4.5%
7 CHRONIC KIDNEY DISEASE 571
3.7%
8 EXPOSURE DURING PREGNANCY 566
3.6%
9 MATERNAL EXPOSURE DURING PREGNANCY 536
3.4%
10 DIARRHOEA 499
3.2%
11 DEATH 498
3.2%
12 RENAL FAILURE 498
3.2%
13 ACUTE KIDNEY INJURY 489
3.1%
14 VIROLOGIC FAILURE 476
3.1%
15 OSTEOPOROSIS 437
2.8%
16 DRUG INEFFECTIVE 433
2.8%
17 DEPRESSION 432
2.8%
18 DRUG RESISTANCE 418
2.7%
19 RENAL IMPAIRMENT 408
2.6%
20 NAUSEA 406
2.6%
21 OFF LABEL USE 406
2.6%
22 FATIGUE 403
2.6%
23 ANAEMIA 367
2.4%
24 ABORTION SPONTANEOUS 364
2.3%
25 RASH 361
2.3%
26 DEVICE ISSUE 345
2.2%
27 PREMATURE BABY 338
2.2%
28 PYREXIA 334
2.1%
29 BONE DENSITY DECREASED 323
2.1%
30 TREATMENT NONCOMPLIANCE 318
2.0%

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.