What the label lists and what reports show
Ledipasvir and sofosbuvir side effects
Ledipasvir and sofosbuvir's FDA label: “The most common adverse reactions (incidence greater than or equal to 10%, all grades) observed with treatment with HARVONI were fatigue, headache, and asthenia.” FAERS holds 19,115 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is fatigue (4,131 reports).
- No generic listed
- Boxed warning
Check it at the source: the ledipasvir and sofosbuvir FDA label on DailyMed (effective December 26, 2024, Gilead Sciences, Inc); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of HARVONI?HARVONI can cause serious side effects, including: Hepatitis B virus reactivation. See " What is the most important information I should know about HARVONI? " Slow heart rate (bradycardia). HARVONI treatment may result in slowing of the heart rate along with other symptoms when taken with amiodarone (Cordarone ® , Nexterone ® , Pacerone ® ), a medicine used to treat certain heart problems. In some cases bradycardia has led to death or the need for a heart pacemaker when amiodarone is taken with HARVONI. Get medical help right away if you take amiodarone with HARVONI and get any of the following symptoms: fainting or near-fainting dizziness or lightheadedness not feeling well weakness extreme tiredness shortness of breath chest pains confusion memory problems The most common side effects of HARVONI include: tiredness headache weakness These are not all the possible side effects of HARVONI. […]
Source: FDA drug label, Gilead Sciences, Inc, effective December 26, 2024 (SPL set f4ec77e4-bae8-4db0-b3d5-bde09c5fa075), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse reactions (incidence greater than or equal to 10%, all grades) observed with treatment with HARVONI were fatigue, headache, and asthenia.
Table 5 Adverse Reactions with ≥5% Greater Frequency Reported in Treatment-Experienced Subjects with Cirrhosis Receiving HARVONI for 24 Weeks or HARVONI + Ribavirin for 12 Weeks Compared to Placebo for 12 weeks
| Reaction | HARVONI 24 weeks (N=78) | HARVONI + RBV 12 weeks (N=76) | Placebo 12 weeks (N=77) |
|---|---|---|---|
| Asthenia | 31% | 36% | 23% |
| Headache | 29% | 13% | 16% |
| Fatigue | 18% | 4% | 1% |
| Cough | 5% | 11% | 1% |
| Myalgia | 9% | 4% | 0 |
| Dyspnea | 3% | 9% | 1% |
| Irritability | 8% | 7% | 1% |
| Dizziness | 5% | 1% | 0 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following serious adverse reactions are described below and elsewhere in labeling: Serious Symptomatic Bradycardia When Coadministered with Amiodarone [see Warnings and Precautions (5.2) ]. The most common adverse reactions (incidence greater than or equal to 10%, all grades) observed with treatment with HARVONI were fatigue, headache, and asthenia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Gilead Sciences, Inc. at 1-800-GILEAD-5 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. If HARVONI is administered with ribavirin to adults, refer to the prescribing information for ribavirin for a description of ribavirin-associated adverse reactions. Clinical Trials in Adult Subjects The safety assessment of HARVONI was based on pooled data from three randomized, open-label Phase 3 clinical trials (ION-3, ION-1, and ION-2) of subjects with genotype 1 HCV with compensated liver disease (with and without cirrhosis) including 215, 539, and 326 subjects who received HARVONI once daily by mouth for 8, 12, and 24 weeks, respectively [see Clinical Studies (14) ]. …
Source: FDA drug label, Gilead Sciences, Inc, effective December 26, 2024 (SPL set f4ec77e4-bae8-4db0-b3d5-bde09c5fa075), via openFDA; the full label on DailyMed
What do FAERS reports show?
19,115 reports list ledipasvir and sofosbuvir among the medicines taken, each a report of something that happened, not proof the medicine caused it; 779 are coded as a death and 2,708 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2016 (5,147, against a median of 221 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens. Of the 20 reactions below, 9 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Ledipasvir and sofosbuvir: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions