Quick answers
- What is Brincidofovir used for?
- The FDA-approved label (Tembexa, Emergent BioDefense Operations Lansing LLC, July 23, 2025) says: “TEMBEXA is an orthopoxvirus nucleotide analog DNA polymerase inhibitor and is indicated for the treatment of human smallpox disease in adult and pediatric patients, including neonates. Limitations of Use: • TEMBEXA is not indicated for the treatment of diseases other than human smallpox disease. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Brincidofovir have a boxed warning?
- Yes. The FDA label for Tembexa has a boxed warning (“WARNING: INCREASED RISK FOR MORTALITY WHEN USED FOR LONGER DURATION”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Brincidofovir?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Brincidofovir been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Brincidofovir?
- 1 company lists prescription products of Brincidofovir in the FDA NDC Directory, including Emergent BioDefense Operations Lansing LLC.
What Brincidofovir is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
TEMBEXA is an orthopoxvirus nucleotide analog DNA polymerase inhibitor and is indicated for the treatment of human smallpox disease in adult and pediatric patients, including neonates. Limitations of Use: • TEMBEXA is not indicated for the treatment of diseases other than human smallpox disease. …
— FDA label: Tembexa, Emergent BioDefense Operations Lansing LLC, effective July 23, 2025. Read the full label on DailyMed →
The FDA has 2 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Its heading: WARNING: INCREASED RISK FOR MORTALITY WHEN USED FOR LONGER DURATION
. Read it on the full label →
2 of 2 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Suspension · Tablet, film coated |
|---|---|
| Route | Oral |
| Prescription products | 2 in the FDA NDC Directory |
| Brand names | Tembexa |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Tembexa, Emergent BioDefense Operations Lansing LLC, effective July 23, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →