Prescription medicine
Histrelin Brand names: Supprelin
Histrelin (Supprelin) is a prescription medicine with an FDA approval on record since 1991. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the histrelin FDA label on DailyMed (effective September 25, 2025, Endo USA, Inc.); the NDA 19836 record on Drugs@FDA; every histrelin label on DailyMed.
Highlights of the record
FDA label of September 25, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageSUPPRELIN LA (histrelin acetate) subcutaneous implant is indicated for the treatment of children with central precocious puberty (CPP).
Forms and strengths
- 50 mg
Implant.
On the market
- Earliest approval on file
- December 24, 1991 Supprelin, Shire; Drugs@FDA’s file, where older or withdrawn approvals can be missing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
- Last listed patent
- June 16, 2026 Supprelin LA injection; not a generic launch date
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
- 875 through July 30, 2026
What is histrelin used for?
From the label: indications and usageSUPPRELIN LA (histrelin acetate) subcutaneous implant is indicated for the treatment of children with central precocious puberty (CPP). Children with CPP (neurogenic or idiopathic) have an early onset of secondary sexual characteristics (earlier than 8 years of age in females and 9 years of age in males). They also show a significantly advanced bone age that can result in diminished adult height attainment. […]
FDA pharmacologic class: Gonadotropin Releasing Hormone Receptor Agonist.
Source: FDA drug label (SUPPRELIN LA), Endo USA, Inc., effective September 25, 2025 (SPL set d8fb000e-3cc9-4803-b71d-2cc597661977), via openFDA; the full label on DailyMed
What does the patient leaflet for histrelin 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 SUPPRELIN LA?In the first week of treatment, SUPPRELIN LA can cause an increase in some hormones. During this time you may notice more signs of puberty in your child, including light vaginal bleeding and breast enlargement in girls. Within 4 weeks of treatment, you should see signs in your child that puberty is stopping. Some people who had SUPPRELIN LA placed in their arm have had the implant come through the skin (extrusion). Call your child’s doctor right away if the SUPPRELIN LA implant comes through the skin. Some people taking GnRH agonists like SUPPRELIN LA have had new or worsening 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 SUPPRELIN LA . Some people taking GnRH agonists like SUPPRELIN LA 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 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 SUPPRELIN LA . Severe cutaneous (skin) adverse reactions can happen during treatment with GnRH agonists like SUPPRELIN LA. […]
Source: FDA drug label (SUPPRELIN LA), Endo USA, Inc., effective September 25, 2025 (SPL set d8fb000e-3cc9-4803-b71d-2cc597661977), via openFDA; the full label on DailyMed
Is there a generic for histrelin (Supprelin)?
No generic histrelin is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 1 patent for Supprelin LA injection, the last expiring on June 16, 2026. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1991 earliest approval on file
- 2026 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the histrelin label say about other medicines?
The histrelin label names 3 other medicines 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 and precautions | Reports with GnRH agonists 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. |
| Estradiol | warnings and precautions | WARNINGS AND PRECAUTIONS Initial Agnostic Action: Initial transient increases of estradiol and/or testosterone may cause a temporary worsening of symptoms ( 5.1 ). |
| Testosterone | warnings and precautions | WARNINGS AND PRECAUTIONS Initial Agnostic Action: Initial transient increases of estradiol and/or testosterone may cause a temporary worsening of symptoms ( 5.1 ). |
Source: FDA drug label (SUPPRELIN LA), Endo USA, Inc., effective September 25, 2025 (SPL set d8fb000e-3cc9-4803-b71d-2cc597661977), via openFDA; the full label on DailyMed
What do FAERS reports show for histrelin?
The FDA Adverse Event Reporting System holds 875 reports that list histrelin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 28 are coded as a death and 48 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.
Reports received each year
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
- Histrelin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other