SOFOSBUVIR

N/A

Manufactured by Gilead Sciences, Inc.

41,429 FDA adverse event reports analyzed

Last updated: 2026-04-14

About SOFOSBUVIR

SOFOSBUVIR is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Gilead Sciences, Inc.. The most commonly reported adverse reactions for SOFOSBUVIR include FATIGUE, DRUG INEFFECTIVE, HEPATITIS C, HEADACHE, NAUSEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for SOFOSBUVIR.

Top Adverse Reactions

FATIGUE2,307 reports
DRUG INEFFECTIVE1,928 reports
HEPATITIS C1,734 reports
HEADACHE1,639 reports
NAUSEA1,386 reports
OFF LABEL USE1,383 reports
ANAEMIA1,185 reports
INSOMNIA1,059 reports
HEPATOCELLULAR CARCINOMA911 reports
TREATMENT FAILURE836 reports
DYSPNOEA783 reports
ASTHENIA778 reports
DIARRHOEA738 reports
DIZZINESS709 reports
PRURITUS705 reports
VOMITING670 reports
ASCITES640 reports
DECREASED APPETITE598 reports
PYREXIA582 reports
RASH578 reports
ARTHRALGIA558 reports
HEPATIC FAILURE547 reports
MALAISE546 reports
DEPRESSION512 reports
MYALGIA484 reports
DRUG INTERACTION473 reports
ABDOMINAL PAIN469 reports
CHILLS466 reports
DEATH411 reports
COUGH404 reports
HAEMOGLOBIN DECREASED402 reports
ACUTE KIDNEY INJURY393 reports
HEPATIC CIRRHOSIS385 reports
PAIN372 reports
HEPATIC ENCEPHALOPATHY364 reports
ABDOMINAL PAIN UPPER353 reports
INFLUENZA LIKE ILLNESS352 reports
ANXIETY346 reports
FALL336 reports
SEPSIS331 reports
HYPERBILIRUBINAEMIA295 reports
DRUG DOSE OMISSION293 reports
HAEMATEMESIS293 reports
SYNCOPE292 reports
WEIGHT DECREASED287 reports
SOMNOLENCE285 reports
PNEUMONIA281 reports
VISION BLURRED273 reports
IRRITABILITY265 reports
TACHYCARDIA253 reports
BLOOD BILIRUBIN INCREASED249 reports
BLOOD PRESSURE INCREASED243 reports
JAUNDICE241 reports
RENAL FAILURE238 reports
ALTERED STATE OF CONSCIOUSNESS236 reports
CARDIO RESPIRATORY ARREST234 reports
RENAL IMPAIRMENT233 reports
COMA231 reports
GENOTYPE DRUG RESISTANCE TEST POSITIVE223 reports
EYE PAIN221 reports
TINNITUS220 reports
BLINDNESS217 reports
HAEMORRHAGIC STROKE215 reports
HEAD DISCOMFORT214 reports
OCULAR DISCOMFORT211 reports
PRESYNCOPE211 reports
GENERALISED OEDEMA209 reports
AMAUROSIS FUGAX205 reports
HAEMATURIA201 reports
CONFUSIONAL STATE195 reports
DIPLOPIA194 reports
THROMBOCYTOPENIA192 reports
URINARY TRACT DISORDER185 reports
OVERDOSE182 reports
CHEST PAIN176 reports
PLATELET COUNT DECREASED174 reports
ALOPECIA173 reports
PHOTOPHOBIA173 reports
BACK PAIN172 reports
PHOTOSENSITIVITY REACTION167 reports
WHITE BLOOD CELL COUNT DECREASED160 reports
CONDITION AGGRAVATED156 reports
CONSTIPATION155 reports
FEELING ABNORMAL154 reports
NEUTROPENIA153 reports
URINARY TRACT INFECTION147 reports
HEPATIC CANCER143 reports
MEMORY IMPAIRMENT141 reports
GASTROINTESTINAL HAEMORRHAGE138 reports
HEPATITIS B REACTIVATION137 reports
LIVER TRANSPLANT133 reports
VIROLOGIC FAILURE131 reports
OEDEMA PERIPHERAL130 reports
PAIN IN EXTREMITY128 reports
PRODUCT USE ISSUE124 reports
ABDOMINAL DISCOMFORT123 reports
VIRAL LOAD INCREASED120 reports
ENCEPHALOPATHY118 reports
MUSCLE SPASMS117 reports
DEHYDRATION116 reports

Report Outcomes

Out of 19,598 classified reports for SOFOSBUVIR:

Serious 72.4%Non-Serious 27.6%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Male10,134 (60.9%)
Female6,447 (38.7%)
Unknown60 (0.4%)

Reports by Age

Age 55582 reports
Age 58581 reports
Age 60578 reports
Age 57534 reports
Age 62534 reports
Age 61533 reports
Age 59507 reports
Age 53486 reports
Age 56483 reports
Age 54479 reports
Age 63447 reports
Age 52417 reports
Age 64399 reports
Age 65378 reports
Age 49364 reports
Age 50348 reports
Age 51315 reports
Age 66302 reports
Age 67284 reports
Age 48242 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with SOFOSBUVIR?

This profile reflects 41,429 FDA FAERS reports that mention SOFOSBUVIR. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for SOFOSBUVIR?

Frequently reported terms in FAERS include FATIGUE, DRUG INEFFECTIVE, HEPATITIS C, HEADACHE, NAUSEA, OFF LABEL USE. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures SOFOSBUVIR?

Labeling and FAERS entries often list Gilead Sciences, Inc. in connection with SOFOSBUVIR. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.