LEDIPASVIR AND SOFOSBUVIR

N/A

Manufactured by Gilead Sciences, Inc

27,933 FDA adverse event reports analyzed

Last updated: 2026-04-14

About LEDIPASVIR AND SOFOSBUVIR

LEDIPASVIR AND 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 LEDIPASVIR AND SOFOSBUVIR include FATIGUE, HEADACHE, NAUSEA, DRUG INEFFECTIVE, DIARRHOEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for LEDIPASVIR AND SOFOSBUVIR.

Top Adverse Reactions

FATIGUE4,130 reports
HEADACHE3,706 reports
NAUSEA1,240 reports
DRUG INEFFECTIVE1,137 reports
DIARRHOEA913 reports
HEPATITIS C883 reports
INSOMNIA835 reports
VOMITING442 reports
DIZZINESS439 reports
DRUG DOSE OMISSION436 reports
HEPATOCELLULAR CARCINOMA400 reports
TREATMENT FAILURE374 reports
RASH359 reports
ASTHENIA337 reports
ARTHRALGIA330 reports
CONSTIPATION325 reports
PAIN311 reports
ANXIETY305 reports
PRURITUS297 reports
DYSPNOEA279 reports
DEPRESSION276 reports
ANAEMIA275 reports
DRUG INTERACTION269 reports
DECREASED APPETITE257 reports
DYSPEPSIA257 reports
ABDOMINAL DISCOMFORT242 reports
MYALGIA230 reports
PYREXIA211 reports
ABDOMINAL PAIN UPPER206 reports
ASCITES203 reports
MALAISE201 reports
DEATH196 reports
HYPERTENSION187 reports
ABDOMINAL PAIN184 reports
PAIN IN EXTREMITY184 reports
COUGH179 reports
ALOPECIA177 reports
WEIGHT DECREASED174 reports
FEELING ABNORMAL170 reports
BACK PAIN169 reports
BLOOD PRESSURE INCREASED168 reports
CONFUSIONAL STATE167 reports
ACUTE KIDNEY INJURY157 reports
NASOPHARYNGITIS156 reports
MEMORY IMPAIRMENT148 reports
IRRITABILITY147 reports
HEPATIC CIRRHOSIS141 reports
WEIGHT INCREASED140 reports
ABDOMINAL DISTENSION138 reports
INFLUENZA LIKE ILLNESS136 reports
PNEUMONIA136 reports
SOMNOLENCE136 reports
MUSCLE SPASMS133 reports
FALL130 reports
CONDITION AGGRAVATED129 reports
RENAL IMPAIRMENT125 reports
CHEST PAIN121 reports
HEPATIC ENCEPHALOPATHY121 reports
PERIPHERAL SWELLING116 reports
GENOTYPE DRUG RESISTANCE TEST POSITIVE112 reports
OFF LABEL USE109 reports
MIGRAINE108 reports
VISION BLURRED106 reports
HEPATITIS C VIRUS TEST POSITIVE105 reports
OEDEMA PERIPHERAL105 reports
DEHYDRATION103 reports
HEPATIC CANCER103 reports
BLOOD CREATININE INCREASED102 reports
GASTROOESOPHAGEAL REFLUX DISEASE102 reports
HEPATIC FAILURE100 reports
OVERDOSE97 reports
RENAL FAILURE97 reports
TINNITUS92 reports
PALPITATIONS88 reports
SYNCOPE88 reports
URINARY TRACT INFECTION88 reports
DRY SKIN87 reports
DYSPHAGIA86 reports
HAEMOGLOBIN DECREASED85 reports
SLEEP DISORDER85 reports
MATERNAL EXPOSURE DURING PREGNANCY84 reports
THROMBOCYTOPENIA84 reports
FLATULENCE83 reports
DRY MOUTH82 reports
SEPSIS81 reports
PRODUCT DOSE OMISSION80 reports
GAIT DISTURBANCE78 reports
PLATELET COUNT DECREASED78 reports
BRADYCARDIA77 reports
VISUAL IMPAIRMENT75 reports
BLOOD BILIRUBIN INCREASED74 reports
HYPOAESTHESIA74 reports
GASTROINTESTINAL HAEMORRHAGE73 reports
THERAPY CESSATION73 reports
CHILLS71 reports
MYOCARDIAL INFARCTION71 reports
SEIZURE71 reports
AMNESIA70 reports
GLOMERULAR FILTRATION RATE DECREASED69 reports
ATRIAL FIBRILLATION67 reports

Report Outcomes

Out of 19,095 classified reports for LEDIPASVIR AND SOFOSBUVIR:

Serious 38.9%Non-Serious 61.1%

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

Male10,645 (57.3%)
Female7,925 (42.7%)
Unknown1 (0.0%)

Reports by Age

Age 59765 reports
Age 60763 reports
Age 62757 reports
Age 61744 reports
Age 63733 reports
Age 58708 reports
Age 57668 reports
Age 64631 reports
Age 56621 reports
Age 65588 reports
Age 55578 reports
Age 66470 reports
Age 54462 reports
Age 53456 reports
Age 52395 reports
Age 67378 reports
Age 68333 reports
Age 51318 reports
Age 50284 reports
Age 49238 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 LEDIPASVIR AND SOFOSBUVIR?

This profile reflects 27,933 FDA FAERS reports that mention LEDIPASVIR AND SOFOSBUVIR. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for LEDIPASVIR AND SOFOSBUVIR?

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

Who manufactures LEDIPASVIR AND SOFOSBUVIR?

Labeling and FAERS entries often list Gilead Sciences, Inc in connection with LEDIPASVIR AND 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.