FDA approvals and recalls

Hepatitis: FDA Approvals, Recalls, 510(k) Clearances and Side Effect Reports

What the US Food and Drug Administration has cleared, approved and recalled on this topic, and the side effects people report.

Each number has its full source under its own list below.

New drug approvals

1 new medicines approved (since 1 Jan 2023). Medicines with a new active ingredient that the FDA approved, whose label lists a use on this topic.

At the source

  • Hepcludex (bulevirtide)

    Approved for: HEPCLUDEX is indicated for the treatment of chronic hepatitis delta virus (HDV) infection in adults without cirrhosis or with compensated cirrhosis. This indication is approved un…

    BLA761468

Source: openFDA, Novel drug approvals (new molecular entities and new biologics), since 1 Jan 2023. Retrieved 12 Nov 2026.

Drug recalls

5 recalls (since 1 Jan 2023). Recalls of medicines for this topic, newest first.

At the source

Source: openFDA, Drug recall enforcement reports, since 1 Jan 2023. Retrieved 12 Nov 2026.

Device recalls

7 recalls (since 1 Jan 2023). Recalls of medical devices for this topic, newest first.

At the source

Source: openFDA, Medical device recalls, since 1 Jan 2023. Retrieved 12 Nov 2026.

Side effects people report

7,771 side effect reports (reports received since 1 Jan 2023). The reactions named most often in reports about medicines used for this topic.

At the source
  1. 1Fatigue348 reports
  2. 2Hepatitis c278 reports
  3. 3Nausea255 reports
  4. 4Headache236 reports
  5. 5Diarrhoea200 reports
  6. 6Pneumonia164 reports
  7. 7Vomiting158 reports
  8. 8Asthenia155 reports
  9. 9Pyrexia152 reports
  10. 10Acute kidney injury145 reports

Anyone can send a report. A report does not prove that the medicine caused the reaction, and the counts do not show how often it happens.

Source: openFDA, FDA Adverse Event Reporting System (FAERS), reports by reaction, reports received since 1 Jan 2023. Retrieved 12 Nov 2026.

Benchmarks on hepatitis

Countries side by side on public measures for this topic.

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Market reports on hepatitis

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Pharmaceuticals

Antiviral Drugs

Worldwide · 2024–2034

View report Public Health

Hepatitis B Birth Dose Vaccination Public Health Report

Worldwide · 2024–2034

View report Public Health

Hepatitis B Public Health Report

Worldwide · 2024–2034

View report Pharmaceuticals

Hepatitis B Treatment

Worldwide · 2024–2034

View report Public Health

Hepatitis C Public Health Report

Worldwide · 2024–2034

View report Medical Devices

Hepatitis Diagnostics

Worldwide · 2024–2034

View report

FDA approvals and recalls on related topics

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Acuitas market sizes and forecasts are only in our full reports. How we use public data.