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Ledipasvir Side Effects

The most commonly reported side effects of ledipasvir include fatigue, headache, and nausea, based on 19,692 FDA adverse event reports from 2013 to 2025. 5.9% of reports found the drug to be ineffective.

Ledipasvir side effects

Percentages show how often each reaction appears relative to total reports for ledipasvir.

1
Fatigue22.2%4,364
2
Headache20.0%3,937
3
Nausea7.3%1,444
4
Drug Ineffective5.9%1,158
5
Diarrhoea5.8%1,147
6
Insomnia5.5%1,074
7
Hepatitis C4.6%901
8
Dizziness3.4%667
9
Vomiting3.2%621
10
Arthralgia2.8%553
11
Asthenia2.8%544
12
Pruritus2.7%540
13
Dyspnoea2.5%500
14
Decreased Appetite2.3%460
15
Hepatocellular Carcinoma2.2%437

These are voluntary reports and do not establish that ledipasvir caused these reactions.

Report severity

40.6%Serious8,000 reports
14.0%Hospitalizations2,754 reports
5.5%Fatal1,091 reports

Seriousness is determined by the reporter, not by OpenClaim.

Ledipasvir drug interactions

Other drugs that appear in adverse event reports alongside ledipasvir. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Sofosbuvir96.2%18,942
2
Ribavirin9.0%1,781
3
Etanercept1.5%298
4
Adalimumab1.5%291
5
Acetaminophen1.5%290
6
Pregabalin1.4%284
7
Verapamil-hydrochloride1.4%282
8
Atorvastatin-calcium1.4%280
9
Hydrochlorothiazide1.4%280
10
Telmisartan1.4%280
11
Sertraline-hydrochloride1.4%280
12
Venlafaxine1.4%279
13
Norfloxacin1.4%278
14
Fluvastatin-sodium1.4%278
15
Docetaxel1.4%278

Taken alongside

1
Sofosbuvir3.0%590
2
Furosemide2.7%526
3
Omeprazole2.3%461
4
Amlodipine2.2%436
5
Aspirin2.2%424
6
Spironolactone2.0%400
7
Lisinopril2.0%395
8
Ribavirin1.8%345
9
Acetaminophen1.7%341
10
Insulin1.7%339
11
Gabapentin1.6%313
12
Ergocalciferol1.4%280
13
Albuterol1.4%268
14
Lactulose1.3%263
15
Metformin1.3%258

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports ledipasvir side effects

40.5% of ledipasvir adverse event reports involve female patients and 54.7% involve male patients. The largest age group is adult at 75%. These figures reflect who reports side effects, not underlying risk.

Sex

Female40.5%
Male54.7%
Unknown4.8%

Age group

< 20.1%
2–110.4%
12–170.1%
18–6475.2%
65+24.2%

What is ledipasvir used for

Conditions and purposes for which patients were taking ledipasvir when the adverse event was reported.

Abdominal PainAbnormal BehaviourAcute Hepatitis BAcute Hepatitis CAlanine Aminotransferase IncreasedAlopeciaAlpha 1 Foetoprotein AbnormalAltered State Of ConsciousnessAnaemiaAntiretroviral TherapyAntiviral ProphylaxisAntiviral TreatmentAnxietyAnxiety DisorderArteriosclerosis

Showing 15 of 208 indications

Ledipasvir brand names and reporting trend

Ledipasvir is sold under the brand name Harvoni.

Brand names

Harvoni737

Quarterly reports (20132025)

20132016202020242025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking ledipasvir with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.