Harvoni Safety Profile & Adverse Events

Safety Profile Overview

Direct-acting antiviral combination that revolutionized hepatitis C treatment with greater than 95% cure rates. Bradycardia risk with amiodarone.

Generic Name

ledipasvir/sofosbuvir

Brand Names

Harvoni

Therapeutic Class

HCV Direct-Acting Antiviral

Manufacturer

Gilead

What Pharma Signal Tracks for Harvoni

Adverse Events (FAERS) — All FDA Adverse Event Reporting System reports mentioning Harvoni, including serious outcomes, hospitalizations, and deaths.
FDA Recalls — Class I, II, and III recalls, market withdrawals, and safety alerts related to Harvoni products.
Label Changes — Boxed warning additions, new contraindications, dosing modifications, and safety-related labeling supplements.
Risk Score — Composite risk score (0–100) combining adverse event rates, recall history, and label severity with explainable breakdown.
Pharmacovigilance Signals — Proportional Reporting Ratio (PRR) and Reporting Odds Ratio (ROR) analysis detecting disproportionate adverse reactions.
Trend Analysis — Monthly time series with anomaly detection for emerging safety signals.

Data Disclaimer: Pharma Signal aggregates data from the FDA Adverse Event Reporting System (FAERS) and other public regulatory sources. FAERS reports do not establish causation. Report counts may reflect prescription volume rather than relative safety. Always consult healthcare professionals for medical decisions.

Get Harvoni Safety Data via API

One API call returns adverse events, risk scores, recalls, and pharmacovigilance signals for Harvoni.

curl "https://api.pharma-signal.com/drug/safety/harvoni" \
  -H "X-API-Key: your_key"

# Returns risk score, adverse event counts,
# serious/death rates, recalls, and signals

Try the API API Reference

Related Safety Intelligence

Pharma Signal provides comparative analysis across therapeutic classes. Compare Harvoni against other HCV Direct-Acting Antiviral drugs, or explore the full manufacturer portfolio for Gilead.

Head-to-head comparison — Compare up to 5 drugs side by side on all safety metrics.
Therapeutic class benchmarking — See how Harvoni ranks within HCV Direct-Acting Antiviral on serious event rates.
Company portfolio risk — View all drugs from Gilead with aggregate risk exposure.
AI analyst briefs — Get a natural-language safety assessment combining all data sources.