Ledipasvir / Sofosbuvir

Common brands: Harvoni, Ribavirin, Lasix, Acid Reducer, 24 Hr Omeprazole

Top reporter: Gilead Sciences, Inc

Hepatitis C Virus NS5A Inhibitor [EPC]Hepatitis C Virus Nucleotide Analog NS5B Polymerase Inhibitor [EPC]Nucleoside Analog Antiviral [EPC]Loop Diuretic [EPC]Nonsteroidal Anti-inflammatory Drug [EPC]
19,106
Total Reports
1,145
Serious Reports
776
Death Reports
30
Reported Reactions
Death Report Ratio: Moderate (4.06%)

Patient Demographics

Male
10,647
Female
7,925

Reported Adverse Reactions (30)

Side effects reported in FDA adverse event reports for Ledipasvir / Sofosbuvir.

# Reaction Reports % of Total
1 FATIGUE 4,130
20.7%
2 HEADACHE 3,706
18.6%
3 NAUSEA 1,242
6.2%
4 DRUG INEFFECTIVE 1,137
5.7%
5 DIARRHOEA 913
4.6%
6 HEPATITIS C 884
4.4%
7 INSOMNIA 835
4.2%
8 VOMITING 442
2.2%
9 DIZZINESS 439
2.2%
10 DRUG DOSE OMISSION 436
2.2%
11 HEPATOCELLULAR CARCINOMA 401
2.0%
12 TREATMENT FAILURE 374
1.9%
13 RASH 361
1.8%
14 ASTHENIA 337
1.7%
15 ARTHRALGIA 330
1.7%
16 CONSTIPATION 325
1.6%
17 PAIN 312
1.6%
18 ANXIETY 305
1.5%
19 PRURITUS 297
1.5%
20 DYSPNOEA 279
1.4%
21 ANAEMIA 277
1.4%
22 DEPRESSION 276
1.4%
23 DRUG INTERACTION 269
1.4%
24 DECREASED APPETITE 257
1.3%
25 DYSPEPSIA 257
1.3%
26 ABDOMINAL DISCOMFORT 242
1.2%
27 MYALGIA 230
1.2%
28 PYREXIA 211
1.1%
29 ABDOMINAL PAIN UPPER 206
1.0%
30 ASCITES 203
1.0%

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.