Quick answers
- What is Nafarelin acetate used for?
- The FDA-approved label (Synarel, Pfizer Laboratories Div Pfizer Inc, March 5, 2026) says: “FOR CENTRAL PRECOCIOUS PUBERTY (For Endometriosis, See Reverse Side ) SYNAREL is indicated for treatment of central precocious puberty (CPP) (gonadotropin-dependent precocious puberty) in children of both sexes. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Nafarelin acetate have a boxed warning?
- No. None of the 1 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Nafarelin acetate?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Nafarelin acetate been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Nafarelin acetate?
- 1 company lists prescription products of Nafarelin acetate in the FDA NDC Directory, including Pfizer Laboratories Div Pfizer Inc.
What Nafarelin acetate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
FOR CENTRAL PRECOCIOUS PUBERTY (For Endometriosis, See Reverse Side ) SYNAREL is indicated for treatment of central precocious puberty (CPP) (gonadotropin-dependent precocious puberty) in children of both sexes. …
— FDA label: Synarel, Pfizer Laboratories Div Pfizer Inc, effective March 5, 2026. Read the full label on DailyMed →
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.
The label quoted above has no boxed warning.
Forms and how it is given
| Dosage forms | Spray, metered |
|---|---|
| Route | Nasal |
| Prescription products | 1 in the FDA NDC Directory |
| Brand names | Synarel |
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.
- Pfizer Laboratories Div Pfizer Inc1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA019886 SYNAREL | Pfizer | February 13, 1990 | 27, latest November 24, 2025 2025: Labeling · 2023: Labeling · 2022: Labeling |
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
| RxCUI (RxNorm) | 1797878, 1797880 |
|---|---|
| SPL set ID of the quoted label | d0aa57cb-d2f4-46d7-af43-7c8b06aa81a6 |
| FDA labels (SPL) | 1 |
| FDA applications | NDA019886 |
| Active ingredients (FDA) | NAFARELIN ACETATE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Synarel, Pfizer Laboratories Div Pfizer Inc, effective March 5, 2026; 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 →