Sofosbuvir

Common brands: Sovaldi, Ribavirin, Pegasys, Lasix, Aldactone

Top reporter: Gilead Sciences, Inc.

Hepatitis C Virus Nucleotide Analog NS5B Polymerase Inhibitor [EPC]Nucleoside Analog Antiviral [EPC]Interferon alpha [EPC]Proton Pump Inhibitor [EPC]Nonsteroidal Anti-inflammatory Drug [EPC]
19,611
Total Reports
2,221
Serious Reports
1,798
Death Reports
30
Reported Reactions
Death Report Ratio: High (9.17%)

Patient Demographics

Male
10,135
Female
6,450

Reported Adverse Reactions (30)

Side effects reported in FDA adverse event reports for Sofosbuvir.

# Reaction Reports % of Total
1 FATIGUE 2,312
8.9%
2 DRUG INEFFECTIVE 1,930
7.4%
3 HEPATITIS C 1,735
6.6%
4 HEADACHE 1,643
6.3%
5 NAUSEA 1,393
5.3%
6 OFF LABEL USE 1,385
5.3%
7 ANAEMIA 1,188
4.6%
8 INSOMNIA 1,062
4.1%
9 HEPATOCELLULAR CARCINOMA 911
3.5%
10 TREATMENT FAILURE 836
3.2%
11 DYSPNOEA 786
3.0%
12 ASTHENIA 779
3.0%
13 DIARRHOEA 742
2.8%
14 DIZZINESS 712
2.7%
15 PRURITUS 708
2.7%
16 VOMITING 672
2.6%
17 ASCITES 643
2.5%
18 DECREASED APPETITE 600
2.3%
19 PYREXIA 585
2.2%
20 RASH 580
2.2%
21 ARTHRALGIA 561
2.2%
22 MALAISE 548
2.1%
23 HEPATIC FAILURE 547
2.1%
24 DEPRESSION 512
2.0%
25 MYALGIA 487
1.9%
26 DRUG INTERACTION 475
1.8%
27 ABDOMINAL PAIN 473
1.8%
28 CHILLS 469
1.8%
29 DEATH 411
1.6%
30 COUGH 406
1.6%

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.