Prescription medicine
Nafarelin Brand names: Synarel
Nafarelin (Synarel) is a prescription medicine with an FDA approval on record since 1990. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the nafarelin FDA label on DailyMed (effective March 5, 2026, Pfizer Laboratories Div Pfizer Inc); the NDA 19886 record on Drugs@FDA; every nafarelin label on DailyMed.
Highlights of the record
FDA label of March 5, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageFOR 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.
Forms and strengths
- 2 mg/ml
Spray (metered).
On the market
- Earliest approval on file
- February 13, 1990 Synarel, Pfizer; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 272 through July 30, 2026
What is nafarelin used for?
From the label: indications and usageFOR 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. The diagnosis of central precocious puberty (CPP) is suspected when premature development of secondary sexual characteristics occurs at or before the age of 8 years in girls and 9 years in boys, and is accompanied by significant advancement of bone age and/or a poor adult height prediction. The diagnosis should be confirmed by pubertal gonadal sex steroid levels and a pubertal LH response to stimulation by native GnRH. […]
FDA pharmacologic class: Gonadotropin Releasing Hormone Receptor Agonist.
Source: FDA drug label (Synarel), Pfizer Laboratories Div Pfizer Inc, effective March 5, 2026 (SPL set d0aa57cb-d2f4-46d7-af43-7c8b06aa81a6), via openFDA; the full label on DailyMed
What does the patient leaflet for nafarelin say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about SYNAREL?Some people taking GnRH agonists like SYNAREL have had new or worsened mental (psychiatric) problems. Mental (psychiatric) problems may include emotional symptoms such as: • crying • irritability • restlessness (impatience) • anger • acting aggressive Call your child's doctor right away if your child has any new or worsening mental symptoms or problems while taking SYNAREL • Some people taking GnRH agonists like SYNAREL have had seizures. The risk of seizures may be higher in people who: • have a history of seizures. • have a history of epilepsy. • have a history of brain or brain vessel (cerebrovascular) problems or tumors. • are taking a medicine that has been connected to seizures such as taking bupropion or selective serotonin reuptake inhibitors (SSRIs). Seizures have also happened in people who have not had any of these problems. Call your child's doctor right away if your child has a seizure while taking SYNAREL . Severe cutaneous (skin) adverse reactions may happen during treatment with GnRH agonists like SYNAREL. Stop using SYNAREL and call your child’s doctor right away if your child has any of the following signs or symptoms during treatment with SYNAREL: • skin rash or acne • dry skin • itching • blisters on your skin • redness or swelling of your face, hands, or soles of your feet • blisters or sores in your mouth • peeling of your skin • fever • muscle or joint aches • swollen glands
From the patient leaflet: What should your child avoid while taking SYNAREL?Your child should avoid sneezing while taking SYNAREL or right after using it, if possible. This could reduce the amount of medicine your child's body absorbs. • If your child needs to use a nasal decongestant spray while being treated with SYNAREL, they should not use the decongestant spray for at least 2 hours after taking the dose of SYNAREL.
Source: FDA drug label (Synarel), Pfizer Laboratories Div Pfizer Inc, effective March 5, 2026 (SPL set d0aa57cb-d2f4-46d7-af43-7c8b06aa81a6), via openFDA; the full label on DailyMed
Is there a generic for nafarelin (Synarel)?
No generic nafarelin is approved (Drugs@FDA, October 8, 2026).
- 1990 earliest approval on file
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the nafarelin label say about other medicines?
The nafarelin label names 1 other medicine in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Bupropion | warnings | These have included patients with a history of seizures, epilepsy, cerebrovascular disorders, central nervous system anomalies or tumors, and patients on concomitant medications that have been associated with convulsions such as bupropion and SSRIs. |
Source: FDA drug label (Synarel), Pfizer Laboratories Div Pfizer Inc, effective March 5, 2026 (SPL set d0aa57cb-d2f4-46d7-af43-7c8b06aa81a6), via openFDA; the full label on DailyMed
What do FAERS reports show for nafarelin?
The FDA Adverse Event Reporting System holds 272 reports that list nafarelin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 9 are coded as a death and 97 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other gonadotropin releasing hormone receptor agonists
- the pharmacologic class, with prices and generics
- Nafarelin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other