What the label lists and what reports show
Glecaprevir and pibrentasvir side effects
Glecaprevir and pibrentasvir's FDA label: “In subjects receiving MAVYRET, the most commonly reported adverse reactions (greater than 10%) are headache and fatigue.” FAERS holds 10,923 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 (2,565 reports).
- No generic listed
- Boxed warning
Check it at the source: the glecaprevir and pibrentasvir FDA label on DailyMed (effective June 25, 2025, AbbVie 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 MAVYRET?MAVYRET can cause serious side effects, including: Hepatitis B virus reactivation. See “What is the most important information I should know about MAVYRET?” In people who had or have advanced liver problems before starting treatment with MAVYRET: rare risk of worsening liver problems, liver failure and death. Your healthcare provider will check you for signs and symptoms of worsening liver problems during treatment with MAVYRET. […]
Source: FDA drug label, AbbVie Inc., effective June 25, 2025 (SPL set 7bf99777-0401-9095-8645-16c6e907fcc0), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsIn subjects receiving MAVYRET, the most commonly reported adverse reactions (greater than 10%) are headache and fatigue.
Table 5. Adverse Reactions Reported in ≥5% of Treatment-Naïve Adults without Cirrhosis Receiving MAVYRET for 8 Weeks or 12 Weeks in ENDURANCE-3
| Adverse Reaction | MAVYRET* 8 Weeks (N = 157) % | MAVYRET 12 Weeks (N = 233) % | DCV 1 + SOF 2 12 Weeks (N = 115) % |
|---|---|---|---|
| Headache | 16 | 17 | 15 |
| Fatigue | 11 | 14 | 12 |
| Nausea | 9 | 12 | 12 |
| Diarrhea | 7 | 3 | 3 |
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, continuedIn subjects receiving MAVYRET, the most commonly reported adverse reactions (greater than 10%) are headache and fatigue. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact AbbVie Inc. at 1-800-633-9110 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 clinical trials of MAVYRET cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Overall Adverse Reactions in Subjects with Chronic HCV Infection without Cirrhosis or with Compensated Cirrhosis (Child-Pugh A) The adverse reactions data for MAVYRET in subjects without cirrhosis or with compensated cirrhosis (Child-Pugh A) were derived from nine registrational Phase 2 and 3 trials which evaluated approximately 2,300 adults infected with genotype 1, 2, 3, 4, 5, or 6 HCV who received MAVYRET for 8, 12 or 16 weeks [see Clinical Studies ( 14 ) ]. The overall proportion of subjects who permanently discontinued treatment due to adverse reactions was 0.1% for subjects who received MAVYRET for 8, 12 or 16 weeks. The most common adverse reactions, all grades, observed in greater than or equal to 5% of subjects receiving 8, 12, or 16 weeks of treatment with MAVYRET were headache (13%), fatigue (11%), and nausea (8%). …
Source: FDA drug label, AbbVie Inc., effective June 25, 2025 (SPL set 7bf99777-0401-9095-8645-16c6e907fcc0), via openFDA; the full label on DailyMed
What do FAERS reports show?
10,923 reports list glecaprevir and pibrentasvir among the medicines taken, each a report of something that happened, not proof the medicine caused it; 289 are coded as a death and 1,317 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 2019 (3,713, against a median of 437 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens. Of the 21 reactions below, 7 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?
- Glecaprevir and pibrentasvir: 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