What the label lists and what reports show
Leuprolide side effects
Leuprolide's FDA label lists its adverse reactions in its own words. FAERS holds 78,546 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is hot flush (9,599 reports).
- Generic listed
Check it at the source: the leuprolide FDA label on DailyMed (effective May 28, 2026, Amneal Pharmaceuticals LLC); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What is the most important information I should know about LUPRON DEPOT-PED?During the first 2 to 4 weeks of treatment, LUPRON DEPOT-PED can cause an increase in some hormones. During this time you may notice more signs of puberty in your child, including vaginal bleeding. Call your doctor if these signs continue after the second month of treatment with LUPRON DEPOT-PED. Some people taking gonadotropin releasing hormone (GnRH) agonists like LUPRON DEPOT-PED 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 LUPRON DEPOT-PED. Some people taking GnRH agonists like LUPRON DEPOT-PED 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 LUPRON DEPOT-PED . Severe cutaneous (skin) adverse reactions may happen during treatment with GnRH agonists like LUPRON DEPOT-PED . […]
Source: FDA drug label (Lupron Depot-PED), AbbVie Inc., effective November 14, 2025 (SPL set e99f47d2-da10-3127-ecb3-e5d942ae6e81), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsClinical Trials In the majority of patients testosterone levels increased above baseline during the first week, declining thereafter to baseline levels or below by the end of the second week of treatment. This transient increase was occasionally associated with a temporary worsening of signs and symptoms, usually manifested by an increase in bone pain (see WARNINGS section). Cases of temporary worsening of existing hematuria and urinary tract obstruction have occurred during the first week. Temporary weakness and paresthesia of the lower limbs have been reported. Potential exacerbations of signs and symptoms during the first few weeks of treatment is a concern in patients with vertebral metastases and/or urinary obstruction which, if aggravated, may lead to neurological problems or increase the obstruction. …
Table 3. Adverse Reactions Occurring in ≥2 % in Pediatric Patients with CPP Receiving…
This table is printed in the Lupron Depot-PED label published by AbbVie Inc. of November 14, 2025; the label quoted above does not print one.
| Reaction | % 11.25 mg every 3 Months N=42 | % 30 mg every 3 Months N=42 | % Overall N = 84 |
|---|---|---|---|
| Injection site pain | 19 | 21 | 20 |
| Weight increased | 7 | 7 | 7 |
| Headache | 2 | 7 | 5 |
| Mood altered | 5 | 5 | 5 |
| Injection site swelling | 2 | 2 | 2 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
Source: FDA drug label, Amneal Pharmaceuticals LLC, effective May 28, 2026 (SPL set 4838c674-044e-46b2-81e7-c691b99d8fa5), via openFDA; the full label on DailyMed
What do FAERS reports show?
78,546 reports list leuprolide among the medicines taken, each a report of something that happened, not proof the medicine caused it; 12,172 are coded as a death and 12,255 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. Of the 19 reactions below, 10 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Leuprolide: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions