Drug · FAERS side-effect profile with label screen
Elbasvir and Grazoprevir side effects: what 4,243 FDA adverse event reports show
Drug class
Hepatitis C Virus NS5A Inhibitor, Hepatitis C Virus NS3/4A Protease Inhibitor
FDA label (Established Pharmacologic Class) · compare the class
Brand names
Zepatier
openFDA label
Who reports
4,243 reports · 34% serious · 123 with death outcome · 47% female
openFDA FAERS counts, all years, deduplication not applied
Used for
ZEPATIER ® is indicated for the treatment of chronic hepatitis C virus (HCV) genotype 1 or 4 infection in adult and pediatric patients 12 years of age and older or weighing at least 30 kg. ZEPATIER is indicated for use with ribavirin in certain patient populations .
FDA label, Indications and Usage
What it is
ZEPATIER is a fixed-dose combination tablet containing elbasvir and grazoprevir for oral administration. Elbasvir is an HCV NS5A inhibitor, and grazoprevir is an HCV NS3/4A protease inhibitor.
FDA label, Description section
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 ZEPATIER. HBV react.
FDA label
How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation.
Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)?
That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.
Causality screen of the 40 strongest signals
Labeled — boxed warning 1Labeled adverse reaction 5Labeled (related wording) 2Likely indication confounding 1Reporting / coding artifact 4Lab value / disease marker 2Not in label — unassessed 25
What the badges mean
- Labeled — boxed warning The term (or its clinical synonym) appears in the FDA boxed warning: causality is regulator-recognised and considered serious.
- 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. 71 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Hepatitis c | 137 | 56.0 47.5–66.2ROR 57.9 · χ² 7,273 / p <1e-300 | 55.0 EB05 47.7 · IC025 +5.2 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 100.4 | no trial data cached |
| Pemphigus | 70 | 28.0 22.2–35.3ROR 28.4 · χ² 1,785 / p <1e-300 | 27.6 EB05 22.6 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 47.7 · ♀ 100% (drug 47%) · 100% clinician | no trial data cached |
| Pulmonary fibrosis | 105 | 27.3 22.6–33.0ROR 28.0 · χ² 2,621 / p <1e-300 | 27.0 EB05 23.0 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious PRR 46.9 · ♀ 100% (drug 47%) · 90% clinician | no trial data cached |
| Pericarditis | 73 | 21.7 17.3–27.3ROR 22.1 · χ² 1,418 / p <1e-300 | 21.5 EB05 17.7 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 37.3 · ♀ 100% (drug 47%) · 100% clinician | no trial data cached |
| Liver injury | 73 | 15.0 11.9–18.8ROR 15.2 · χ² 935 / p 1e-205 | 14.8 EB05 12.1 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 26.1 · ♀ 97% (drug 47%) · 100% clinician | no trial data cached |
| Red blood cell sedimentation rate increased | 32 | 14.3 10.1–20.2ROR 14.4 · χ² 382 / p 3e-85 | 13.9 EB05 10.1 · IC025 +3.0 3/3 methods agree | Lab value / disease marker | serious PRR 27.6 · ♀ 100% (drug 47%) | no trial data cached |
| Hypercalcaemia | 32 | 12.9 9.1–18.2ROR 12.9 · χ² 337 / p 1e-75 | 12.4 EB05 9.0 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 23.5 · ♀ 100% (drug 47%) | no trial data cached |
| Type 2 diabetes mellitus | 74 | 10.8 8.7–13.6ROR 11.0 · χ² 651 / p 5e-144 | 10.6 EB05 8.6 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 19.5 · ♀ 98% (drug 47%) · 100% clinician | no trial data cached |
| Ulcer | 33 | 10.3 7.3–14.4ROR 10.3 · χ² 266 / p 4e-60 | 9.6 EB05 7.0 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 21.4 · ♀ 100% (drug 47%) | no trial data cached |
| Basal cell carcinoma | 32 | 10.1 7.2–14.3ROR 10.2 · χ² 254 / p 1e-57 | 9.5 EB05 6.9 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 17.8 · ♀ 100% (drug 47%) | no trial data cached |
| Synovitis | 36 | 9.9 7.1–13.7ROR 10.0 · χ² 278 / p 1e-62 | 9.3 EB05 6.9 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 17.6 · ♀ 100% (drug 47%) | no trial data cached |
| Drug eruption | 35 | 9.8 7.1–13.7ROR 9.9 · χ² 269 / p 1e-60 | 9.2 EB05 6.8 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 18.7 · ♀ 90% (drug 47%) | no trial data cached |
| Psoriatic arthropathy | 75 | 9.2 7.4–11.6ROR 9.4 · χ² 542 / p 3e-120 | 8.9 EB05 7.3 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 19.8 · ♀ 98% (drug 47%) · 100% clinician | no trial data cached |
| Adverse event | 150 | 8.1 6.9–9.4ROR 8.3 · χ² 922 / p 6e-203 | 7.9 EB05 6.9 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | serious PRR 16.1 | no trial data cached |
| Prescribed underdose | 32 | 7.9 5.6–11.2ROR 8.0 · χ² 187 / p 7e-43 | 7.3 EB05 5.3 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 23.2 · ♀ 100% (drug 47%) | no trial data cached |
| Dermatitis | 32 | 7.6 5.4–10.8ROR 7.7 · χ² 178 / p 6e-41 | 7.0 EB05 5.2 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 26.5 · ♀ 100% (drug 47%) | no trial data cached |
| Drug dose omission | 253 | 7.5 6.6–8.4ROR 7.9 · χ² 1,420 / p <1e-300 | 7.4 EB05 6.6 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | serious PRR 9.7 | no trial data cached |
| Hepatic cirrhosis | 27 | 7.1 4.9–10.4ROR 7.2 · χ² 137 / p 7e-32 | 6.5 EB05 4.6 · IC025 +2.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 12.3 | no trial data cached |
| Oedema | 77 | 7.0 5.6–8.8ROR 7.1 · χ² 393 / p 8e-88 | 6.8 EB05 5.6 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 14.3 · ♀ 91% (drug 47%) · 96% clinician | no trial data cached |
| Ligament sprain | 14 | 7.0 4.2–11.8ROR 7.0 · χ² 66 / p 2e-16 | 5.9 EB05 3.7 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Hepatitis (liver inflammation) | 35 | 6.8 4.9–9.4ROR 6.8 · χ² 166 / p 2e-38 | 6.3 EB05 4.7 · IC025 +2.1 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 11.8 · ♀ 97% (drug 47%) | no trial data cached |
| Skin ulcer | 34 | 6.5 4.7–9.1ROR 6.6 · χ² 153 / p 2e-35 | 6.0 EB05 4.5 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 14.3 · ♀ 100% (drug 47%) | no trial data cached |
| Stomatitis (mouth sores) | 79 | 6.4 5.2–8.0ROR 6.5 · χ² 358 / p 3e-80 | 6.2 EB05 5.1 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 15.5 · ♀ 97% (drug 47%) · 99% clinician | no trial data cached |
| Sleep disorder | 87 | 6.2 5.0–7.6ROR 6.3 · χ² 371 / p 6e-83 | 6.0 EB05 5.0 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 15.3 · ♀ 93% (drug 47%) · 91% clinician | no trial data cached |
| Fatigue (tiredness) | 957 | 6.1 5.8–6.4ROR 7.6 · χ² 4,222 / p <1e-300 | 6.1 EB05 5.8 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.7 | no trial data cached |
| Vitamin d deficiency | 12 | 6.1 3.5–10.7ROR 6.1 · χ² 46 / p 6e-12 | 5.0 EB05 3.1 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 12.5 | no trial data cached |
| Headache | 755 | 6.0 5.6–6.4ROR 7.0 · χ² 3,207 / p <1e-300 | 5.9 EB05 5.6 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.4 | no trial data cached |
| Insomnia (trouble sleeping) | 308 | 5.7 5.1–6.4ROR 6.1 · χ² 1,206 / p 1e-264 | 5.7 EB05 5.1 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.5 · ♀ 67% (drug 47%) | no trial data cached |
| Dyspepsia (indigestion) | 106 | 5.3 4.4–6.5ROR 5.5 · χ² 371 / p 5e-83 | 5.2 EB05 4.4 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 12.8 · ♀ 82% (drug 47%) | no trial data cached |
| Injury | 72 | 5.0 4.0–6.3ROR 5.1 · χ² 230 / p 4e-52 | 4.9 EB05 4.0 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 10.5 · ♀ 98% (drug 47%) · 99% clinician | no trial data cached |
| Mobility decreased | 72 | 5.0 4.0–6.3ROR 5.0 · χ² 225 / p 4e-51 | 4.8 EB05 4.0 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 12.5 · ♀ 98% (drug 47%) · 99% clinician | no trial data cached |
| Migraine | 94 | 4.9 4.0–6.0ROR 5.0 · χ² 289 / p 4e-65 | 4.8 EB05 4.0 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 13.2 · ♀ 89% (drug 47%) | no trial data cached |
| Treatment failure | 80 | 4.8 3.9–6.0ROR 4.9 · χ² 239 / p 3e-54 | 4.7 EB05 3.9 · IC025 +1.9 3/3 methods agree | Reporting / coding artifact | serious PRR 12.5 | no trial data cached |
| Joint swelling | 115 | 4.7 3.9–5.7ROR 4.8 · χ² 335 / p 4e-75 | 4.6 EB05 4.0 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 12.8 · ♀ 91% (drug 47%) | no trial data cached |
| C-reactive protein increased | 34 | 4.6 3.3–6.5ROR 4.7 · χ² 93 / p 3e-22 | 4.4 EB05 3.3 · IC025 +1.6 3/3 methods agree | Lab value / disease marker | serious PRR 8.2 · ♀ 93% (drug 47%) | no trial data cached |
| Poor quality sleep | 19 | 4.4 2.8–6.9ROR 4.4 · χ² 46 / p 5e-12 | 4.0 EB05 2.7 · IC025 +1.2 3/3 methods agree | Reporting / coding artifact | serious PRR 0.7 | no trial data cached |
| Aspartate aminotransferase increased | 47 | 4.4 3.3–5.8ROR 4.4 · χ² 119 / p 4e-28 | 4.2 EB05 3.3 · IC025 +1.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.5 · ♀ 88% (drug 47%) | no trial data cached |
| Rash pruritic | 44 | 4.0 3.0–5.4ROR 4.1 · χ² 98 / p 3e-23 | 3.9 EB05 3.0 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 11.8 · ♀ 87% (drug 47%) | no trial data cached |
| Dialysis | 11 | 3.8 2.1–6.9ROR 3.8 · χ² 20 / p 3e-6 | 3.4 EB05 2.0 · IC025 +0.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.6 | no trial data cached |
| Sinusitis | 79 | 3.8 3.1–4.7ROR 3.9 · χ² 161 / p 4e-37 | 3.7 EB05 3.1 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 12.1 · ♀ 96% (drug 47%) · 95% clinician | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).
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) | 957 | 6.1 5.8–6.4ROR 7.6 · χ² 4,222 / p <1e-300 | 6.1 EB05 5.8 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.7 | no trial data cached |
| Headache | 755 | 6.0 5.6–6.4ROR 7.0 · χ² 3,207 / p <1e-300 | 5.9 EB05 5.6 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.4 | no trial data cached |
| Nausea | 553 | 3.5 3.2–3.7ROR 3.8 · χ² 1,005 / p 8e-221 | 3.5 EB05 3.2 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.8 | no trial data cached |
| Insomnia (trouble sleeping) | 308 | 5.7 5.1–6.4ROR 6.1 · χ² 1,206 / p 1e-264 | 5.7 EB05 5.1 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.5 · ♀ 67% (drug 47%) | no trial data cached |
| Drug dose omission | 253 | 7.5 6.6–8.4ROR 7.9 · χ² 1,420 / p <1e-300 | 7.4 EB05 6.6 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | serious PRR 9.7 | no trial data cached |
| Adverse event | 150 | 8.1 6.9–9.4ROR 8.3 · χ² 922 / p 6e-203 | 7.9 EB05 6.9 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | serious PRR 16.1 | no trial data cached |
| Hepatitis c | 137 | 56.0 47.5–66.2ROR 57.9 · χ² 7,273 / p <1e-300 | 55.0 EB05 47.7 · IC025 +5.2 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 100.4 | no trial data cached |
| Joint swelling | 115 | 4.7 3.9–5.7ROR 4.8 · χ² 335 / p 4e-75 | 4.6 EB05 4.0 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 12.8 · ♀ 91% (drug 47%) | no trial data cached |
| Dyspepsia (indigestion) | 106 | 5.3 4.4–6.5ROR 5.5 · χ² 371 / p 5e-83 | 5.2 EB05 4.4 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 12.8 · ♀ 82% (drug 47%) | no trial data cached |
| Weight increased (weight gain) | 105 | 2.3 1.9–2.8ROR 2.4 · χ² 79 / p 3e-19 | 2.3 EB05 2.0 · IC025 +0.9 | Not in label — unassessed | serious PRR 5.4 · ♀ 84% (drug 47%) | no trial data cached |
| Pulmonary fibrosis | 105 | 27.3 22.6–33.0ROR 28.0 · χ² 2,621 / p <1e-300 | 27.0 EB05 23.0 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious PRR 46.9 · ♀ 100% (drug 47%) · 90% clinician | no trial data cached |
| Urticaria (hives) | 97 | 2.9 2.4–3.5ROR 2.9 · χ² 118 / p 8e-28 | 2.9 EB05 2.4 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 8.1 · ♀ 88% (drug 47%) | no trial data cached |
| Migraine | 94 | 4.9 4.0–6.0ROR 5.0 · χ² 289 / p 4e-65 | 4.8 EB05 4.0 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 13.2 · ♀ 89% (drug 47%) | no trial data cached |
| Abdominal discomfort | 93 | 2.8 2.2–3.4ROR 2.8 · χ² 103 / p 2e-24 | 2.7 EB05 2.3 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 1.6 | no trial data cached |
| No adverse event | 90 | 2.5 2.0–3.1ROR 2.5 · χ² 81 / p 1e-19 | 2.5 EB05 2.1 · IC025 +1.0 3/3 methods agree | Reporting / coding artifact | serious PRR 3.1 | 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.
- Pemphigus — n=70, PRR 28.0
- Pulmonary fibrosis — n=105, PRR 27.3
- Pericarditis — n=73, PRR 21.7
- Liver injury — n=73, PRR 15.0
- Hypercalcaemia — n=32, PRR 12.9
- Type 2 diabetes mellitus — n=74, PRR 10.8
- Ulcer — n=33, PRR 10.3
- Basal cell carcinoma — n=32, PRR 10.1
- Synovitis — n=36, PRR 9.9
- Drug eruption — n=35, PRR 9.8
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 Elbasvir and Grazoprevir?
In FDA FAERS, the most frequently co-reported reaction terms for Elbasvir and Grazoprevir are fatigue, headache, nausea, insomnia, hepatitis c, joint swelling. 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 Elbasvir and Grazoprevir 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 ZEPATIER. HBV react.
Do FAERS signals prove that Elbasvir and Grazoprevir 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 164dc02a-9180-426a-b8b5-04ab39d2bbd4, effective 20260313; matched on
openfda.generic_name.exact:"ELBASVIR AND GRAZOPREVIR") - 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, 111 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.