Glecaprevir and Pibrentasvir side effects: what 10,923 FDA adverse event reports show
Drug class
Hepatitis C Virus NS3/4A Protease Inhibitor, Hepatitis C Virus NS5A Inhibitor
Brand names
Mavyret
Who reports
10,923 reports · 26% serious · 289 with death outcome · 47% female
Used for
MAVYRET is indicated for the treatment of adult and pediatric patients 3 years and older with acute or chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5 or 6 infection without cirrhosis or with compensated cirrhosis (Child-Pugh A). MAVYRET is indi.
What it is
MAVYRET contains glecaprevir, a HCV NS3/4A PI, and pibrentasvir a HCV NS5A inhibitor. MAVYRET is available as a fixed dose combination tablet or coated pellets in unit-dose packets for oral administration. Glecaprevir/Pibrentasvir Film-Coated Immediate Release Tablets
Boxed warning
RISK OF HEPATITIS B VIRUS REACTIVATION IN PATIENTS COINFECTED WITH HCV AND HBV Test all patients for evidence of current or prior hepatitis B virus (HBV) infection before initiating treatment with MAVYRET. HBV reacti.
Causality screen of the 40 strongest signals
What the badges mean
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 755 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Viral load | 12 | 142.0 79.0–255.2ROR 142.2 · χ² 1,434 / p <1e-300 | 109.6 EB05 66.8 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=2 | no trial data cached |
| Hepatitis c virus test positive | 21 | 70.6 45.7–109.1ROR 70.8 · χ² 1,323 / p 5e-290 | 64.3 EB05 44.4 · IC025 +4.0 3/3 methods agree | Lab value / disease marker | serious n=3 | no trial data cached |
| Hepatitis c rna increased | 11 | 63.3 34.7–115.4ROR 63.4 · χ² 594 / p 2e-131 | 55.7 EB05 33.2 · IC025 +3.1 3/3 methods agree | Likely indication confounding term in indications; also in warnings | – | no trial data cached |
| Chronic hepatitis c | 11 | 55.0 30.2–100.1ROR 55.0 · χ² 515 / p 3e-114 | 49.2 EB05 29.3 · IC025 +3.0 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=4 | no trial data cached |
| Wrong schedule | 21 | 43.4 28.2–66.9ROR 43.5 · χ² 810 / p 2e-178 | 41.0 EB05 28.3 · IC025 +3.7 3/3 methods agree | Reporting / coding artifact | serious n=2 | no trial data cached |
| Viral load increased | 46 | 22.9 17.1–30.6ROR 23.0 · χ² 929 / p 2e-204 | 22.4 EB05 17.5 · IC025 +3.7 3/3 methods agree | Lab value / disease marker | serious n=6 · ♀ 16% (drug 47%) | no trial data cached |
| Heart transplant | 10 | 21.6 11.6–40.3ROR 21.6 · χ² 174 / p 4e-40 | 20.2 EB05 11.0 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious n=8 | no trial data cached |
| Hepatic pain | 34 | 15.4 11.0–21.5ROR 15.4 · χ² 439 / p 8e-98 | 15.0 EB05 11.1 · IC025 +3.1 3/3 methods agree | Labeled (related wording) related wording | serious n=8 | no trial data cached |
| Hepatitis c | 78 | 12.3 9.9–15.4ROR 12.4 · χ² 796 / p 2e-175 | 12.1 EB05 9.9 · IC025 +3.1 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 12.1 | no trial data cached |
| Ocular icterus | 25 | 11.1 7.5–16.5ROR 11.2 · χ² 219 / p 6e-50 | 10.3 EB05 7.1 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious n=10 · ♀ 72% (drug 47%) | no trial data cached |
| Liver transplant | 20 | 10.7 6.9–16.5ROR 10.7 · χ² 164 / p 6e-38 | 9.6 EB05 6.2 · IC025 +2.4 3/3 methods agree | Labeled (related wording) related wording | serious n=20 | no trial data cached |
| Hepatic cirrhosis | 101 | 10.4 8.6–12.7ROR 10.5 · χ² 847 / p 1e-186 | 10.2 EB05 8.6 · IC025 +3.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 21.3 | no trial data cached |
| Renal transplant | 13 | 6.9 4.0–11.9ROR 6.9 · χ² 60 / p 5e-15 | 5.7 EB05 3.5 · IC025 +1.6 3/3 methods agree | Labeled (related wording) related wording | serious n=13 | no trial data cached |
| Headache | 2,206 | 6.8 6.5–7.0ROR 8.2 · χ² 11,168 / p <1e-300 | 6.8 EB05 6.5 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.2 | no trial data cached |
| Chromaturia | 78 | 6.6 5.3–8.3ROR 6.7 · χ² 368 / p 3e-82 | 6.4 EB05 5.3 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 6.0 | no trial data cached |
| Fatigue (tiredness) | 2,565 | 6.4 6.1–6.6ROR 8.0 · χ² 11,978 / p <1e-300 | 6.3 EB05 6.1 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.2 | no trial data cached |
| Blood bilirubin increased | 84 | 6.0 4.8–7.4ROR 6.0 · χ² 342 / p 1e-76 | 5.8 EB05 4.8 · IC025 +2.2 3/3 methods agree | Lab value / disease marker | serious PRR 7.0 · 92% clinician | no trial data cached |
| Therapy cessation | 146 | 5.5 4.7–6.5ROR 5.6 · χ² 533 / p 4e-118 | 5.4 EB05 4.7 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious PRR 5.3 · 96% clinician | no trial data cached |
| Virologic failure | 15 | 5.3 3.2–8.9ROR 5.4 · χ² 49 / p 2e-12 | 4.6 EB05 3.0 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious n=3 | no trial data cached |
| Rehabilitation therapy | 10 | 5.0 2.7–9.3ROR 5.0 · χ² 28 / p 6e-8 | 4.1 EB05 2.4 · IC025 +1.0 3/3 methods agree | Reporting / coding artifact | serious n=8 | no trial data cached |
| Energy increased | 15 | 4.9 2.9–8.1ROR 4.9 · χ² 42 / p 4e-11 | 4.3 EB05 2.8 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious n=3 | no trial data cached |
| Product use complaint | 34 | 4.2 3.0–5.9ROR 4.2 · χ² 80 / p 2e-19 | 4.0 EB05 3.0 · IC025 +1.4 3/3 methods agree | Reporting / coding artifact | serious n=5 | no trial data cached |
| Hepatocellular carcinoma | 15 | 3.8 2.3–6.3ROR 3.8 · χ² 28 / p 6e-8 | 3.4 EB05 2.2 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious PRR 8.5 | no trial data cached |
| Product dose omission | 127 | 3.7 3.1–4.4ROR 3.7 · χ² 246 / p 8e-56 | 3.6 EB05 3.1 · IC025 +1.6 3/3 methods agree | Reporting / coding artifact | serious PRR 0.5 · 94% clinician | no trial data cached |
| Faeces discoloured | 40 | 3.5 2.6–4.8ROR 3.6 · χ² 71 / p 2e-17 | 3.4 EB05 2.6 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 3.9 | no trial data cached |
| Pruritus (itching) | 658 | 3.3 3.1–3.6ROR 3.5 · χ² 1,098 / p 4e-241 | 3.3 EB05 3.1 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.2 | no trial data cached |
| Pruritus generalised | 36 | 3.2 2.3–4.4ROR 3.2 · χ² 51 / p 5e-13 | 3.1 EB05 2.3 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 1.6 · ♀ 71% (drug 47%) | no trial data cached |
| Insurance issue | 23 | 3.0 2.0–4.5ROR 3.0 · χ² 28 / p 6e-8 | 2.8 EB05 2.0 · IC025 +0.8 3/3 methods agree | Not in label — unassessed | serious PRR 1.2 | no trial data cached |
| Increased appetite | 29 | 3.0 2.1–4.3ROR 3.0 · χ² 36 / p 1e-9 | 2.9 EB05 2.1 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Jaundice (yellowing of skin/eyes) | 41 | 2.9 2.2–4.0ROR 2.9 · χ² 50 / p 8e-13 | 2.8 EB05 2.2 · IC025 +1.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.7 | no trial data cached |
| Cholecystectomy | 17 | 2.9 1.8–4.6ROR 2.9 · χ² 19 / p 7e-6 | 2.7 EB05 1.8 · IC025 +0.6 | Not in label — unassessed | serious PRR 6.3 | no trial data cached |
| Nausea | 1,134 | 2.8 2.6–2.9ROR 3.0 · χ² 1,321 / p 2e-289 | 2.8 EB05 2.6 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 1.6 | no trial data cached |
| Sluggishness | 14 | 2.6 1.6–4.5ROR 2.7 · χ² 13 / p 2e-4 | 2.5 EB05 1.6 · IC025 +0.4 | Not in label — unassessed | serious n=3 | no trial data cached |
| Arthropod bite | 10 | 2.6 1.4–4.9ROR 2.6 · χ² 8 / p 0.002 | 2.4 EB05 1.4 · IC025 +0.2 | Not in label — unassessed | serious n=5 | no trial data cached |
| Dialysis | 19 | 2.6 1.6–4.0ROR 2.6 · χ² 17 / p 2e-5 | 2.5 EB05 1.7 · IC025 +0.5 | Labeled adverse reaction exact term | serious PRR 4.5 | no trial data cached |
| Renal pain | 14 | 2.5 1.5–4.3ROR 2.5 · χ² 12 / p 3e-4 | 2.4 EB05 1.5 · IC025 +0.4 | Labeled (related wording) related wording | – | no trial data cached |
| Ascites | 38 | 2.5 1.8–3.4ROR 2.5 · χ² 32 / p 7e-9 | 2.4 EB05 1.9 · IC025 +0.7 | Labeled adverse reaction exact term | serious PRR 4.8 | no trial data cached |
| Thirst | 23 | 2.5 1.6–3.7ROR 2.5 · χ² 19 / p 7e-6 | 2.4 EB05 1.7 · IC025 +0.6 | Not in label — unassessed | serious PRR 1.3 | no trial data cached |
| Pulmonary congestion | 16 | 2.3 1.4–3.8ROR 2.3 · χ² 11 / p 5e-4 | 2.2 EB05 1.5 · IC025 +0.3 | Not in label — unassessed | serious PRR 1.5 | no trial data cached |
| Abdominal discomfort | 198 | 2.3 2.0–2.6ROR 2.3 · χ² 141 / p 7e-33 | 2.3 EB05 2.0 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious PRR 1.6 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Fatigue (tiredness) | 2,565 | 6.4 6.1–6.6ROR 8.0 · χ² 11,978 / p <1e-300 | 6.3 EB05 6.1 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.2 | no trial data cached |
| Headache | 2,206 | 6.8 6.5–7.0ROR 8.2 · χ² 11,168 / p <1e-300 | 6.8 EB05 6.5 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.2 | no trial data cached |
| Nausea | 1,134 | 2.8 2.6–2.9ROR 3.0 · χ² 1,321 / p 2e-289 | 2.8 EB05 2.6 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 1.6 | no trial data cached |
| Pruritus (itching) | 658 | 3.3 3.1–3.6ROR 3.5 · χ² 1,098 / p 4e-241 | 3.3 EB05 3.1 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.2 | no trial data cached |
| Diarrhoea (diarrhea) | 480 | 1.4 1.3–1.6ROR 1.5 · χ² 64 / p 5e-16 | 1.4 EB05 1.3 · IC025 +0.4 | Labeled adverse reaction exact term | serious PRR 1.1 | no trial data cached |
| Vomiting | 315 | 1.3 1.2–1.4ROR 1.3 · χ² 21 / p 3e-6 | 1.3 EB05 1.2 · IC025 +0.2 | Labeled adverse reaction exact term | serious PRR 1.3 | no trial data cached |
| Rash | 313 | 1.4 1.2–1.5ROR 1.4 · χ² 34 / p 3e-9 | 1.4 EB05 1.3 · IC025 +0.3 | Labeled adverse reaction exact term | serious PRR 1.3 | no trial data cached |
| Dizziness | 231 | 0.9 0.8–1.0ROR 0.9 · χ² 3 / p 0.040 | 0.9 EB05 0.8 · IC025 -0.4 PRR-only: not supported by EBGM or IC | Not in label — unassessed | serious PRR 1.0 | no trial data cached |
| Death | 225 | 0.5 0.4–0.6ROR 0.5 · χ² 116 / p 3e-27 | 0.5 EB05 0.5 · IC025 -1.2 PRR-only: not supported by EBGM or IC | Outcome field, not a reaction boxed warning mentions mortality | serious PRR 1.1 | no trial data cached |
| Pain | 211 | 0.7 0.6–0.8ROR 0.7 · χ² 38 / p 3e-10 | 0.7 EB05 0.6 · IC025 -0.8 PRR-only: not supported by EBGM or IC | Labeled adverse reaction exact term | serious PRR 0.8 | no trial data cached |
| Insomnia (trouble sleeping) | 201 | 1.4 1.3–1.7ROR 1.5 · χ² 28 / p 7e-8 | 1.4 EB05 1.3 · IC025 +0.3 | Not in label — unassessed | serious PRR 1.0 | no trial data cached |
| Abdominal discomfort | 198 | 2.3 2.0–2.6ROR 2.3 · χ² 141 / p 7e-33 | 2.3 EB05 2.0 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious PRR 1.6 | no trial data cached |
| Drug ineffective (drug did not work) | 188 | 0.3 0.2–0.3ROR 0.3 · χ² 385 / p 5e-86 | 0.3 EB05 0.2 · IC025 -2.1 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 0.4 | no trial data cached |
| Asthenia (weakness) | 158 | 0.8 0.7–0.9ROR 0.8 · χ² 7 / p 0.004 | 0.8 EB05 0.7 · IC025 -0.6 PRR-only: not supported by EBGM or IC | Labeled adverse reaction exact term | serious PRR 1.3 | no trial data cached |
| Abdominal pain upper | 149 | 1.4 1.2–1.6ROR 1.4 · χ² 16 / p 3e-5 | 1.4 EB05 1.2 · IC025 +0.2 | Labeled adverse reaction exact term | serious PRR 1.3 | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Chromaturia — n=78, PRR 6.6
- Faeces discoloured — n=40, PRR 3.5
- Pruritus generalised — n=36, PRR 3.2
- Insurance issue — n=23, PRR 3.0
- Increased appetite — n=29, PRR 3.0
- Thirst — n=23, PRR 2.5
- Abdominal discomfort — n=198, PRR 2.3
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Glecaprevir and Pibrentasvir?
In FDA FAERS, the most frequently co-reported reaction terms for Glecaprevir and Pibrentasvir are fatigue, headache, nausea, pruritus, diarrhoea, vomiting. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Glecaprevir and Pibrentasvir have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: RISK OF HEPATITIS B VIRUS REACTIVATION IN PATIENTS COINFECTED WITH HCV AND HBV Test all patients for evidence of current or prior hepatitis B virus (HBV) infection before initiating treatment with MAVYRET. HBV reacti.
Do FAERS signals prove that Glecaprevir and Pibrentasvir causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 7bf99777-0401-9095-8645-16c6e907fcc0, effective 20250625; matched on
openfda.generic_name.exact:"GLECAPREVIR AND PIBRENTASVIR") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 795 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.