Prescription medication · GnRH Agonist
leuprolide
Also sold as Lupron. VABRINTY treats advanced prostate cancer in men.
Data updated 2026-05-15
- 1,385
- FDA reportsRarely reported
- $267.68
- Generic price (NADAC)
leuprolide (Lupron) is a prescription GnRH Agonist. VABRINTY treats advanced prostate cancer in men.
VABRINTY is a medicine that treats advanced prostate cancer. It contains leuprolide, which lowers testosterone levels.
Verify with FDA → · CMS NADAC pricing →
Drug Pricing (NADAC)
Generic Price
$267.68/unit
Generic Available
Yes (8 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
VABRINTY treats advanced prostate cancer in men.
Common side effects
Feeling tired or weak, Hot flashes or sweats, Testicles shrinking
Key warnings
VABRINTY can cause a temporary increase in testosterone levels, which may worsen symptoms at first.
The sections below are summarized in plain English from leuprolide's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
VABRINTY contains leuprolide, which is a GnRH agonist. It lowers the amount of testosterone your body makes. This can help to slow the growth of prostate cancer cells.
How to Take It
VABRINTY is given as a shot under the skin by a healthcare provider. You will get a shot every 1, 3, 4, or 6 months, depending on the dose your doctor prescribes. The injection site should be changed each time. The shot is usually given in the upper or mid-abdominal area.
This is a plain-language summary of leuprolide's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
Pregnancy & Breastfeeding
VABRINTY can harm an unborn baby. Females should not take VABRINTY if they are pregnant or may become pregnant. It is not known if VABRINTY passes into breast milk, so talk to your doctor about breastfeeding.
This is a plain-language summary of leuprolide's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.
Missed Dose
If you miss a dose of VABRINTY, contact your doctor right away to reschedule your injection. It is important to get your injections on time.
This is a plain-language summary of leuprolide's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
Storage
Store VABRINTY in the refrigerator between 36°F to 46°F. Before mixing, it can be stored at room temperature (59°F to 86°F) for up to 8 weeks.
Side Effects (from patient reports)
Based on 1,385 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for leuprolide, by number of reports
- Feeling tired
Feeling tired
82 reports
- Feeling sick to your stomach
Feeling sick to your stomach
61 reports
- Pain in your head
Pain in your head
58 reports
- Cancer getting worse
Cancer getting worse
53 reports
- The illness is getting worse
The illness is getting worse
50 reports
- Fever with low white blood cell count
Fever with low white blood cell count
43 reports
- The medicine was not stored correctly
The medicine was not stored correctly
41 reports
- Sudden feeling of heat
Sudden feeling of heat
36 reports
- Low red blood cell count
Low red blood cell count
35 reports
- Throwing up
Throwing up
35 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for leuprolide each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where leuprolide sits
leuprolide has more FDA adverse-event reports than 9% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is leuprolide; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 1,385 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2005–2025.
Total Reports
1,385
Reports Mentioning Death
119
8.6% of reports — not proof of cause
Hospitalization Reports
457
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 2 | FATIGUE | 82 |
| 4 | NAUSEA | 61 |
| 5 | HEADACHE | 58 |
| 6 | MALIGNANT NEOPLASM PROGRESSION | 53 |
| 7 | DISEASE PROGRESSION | 50 |
| 8 | FEBRILE NEUTROPENIA | 43 |
| 9 | PRODUCT STORAGE ERROR | 41 |
| 10 | HOT FLUSH | 36 |
| 12 | ANAEMIA | 35 |
| 13 | VOMITING | 35 |
| 14 | TREATMENT FAILURE | 34 |
| 15 | DIARRHOEA | 33 |
| 16 | DIZZINESS | 33 |
| 17 | ASTHENIA | 32 |
| 18 | PAIN | 31 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
VABRINTY can cause a temporary increase in testosterone levels, which may worsen symptoms at first. This could include bone pain, nerve problems, or trouble urinating. VABRINTY may also increase your risk of high blood sugar, diabetes, heart problems, and seizures. Tell your doctor right away if you have signs of a severe skin reaction.
Common Questions
How often will I get the VABRINTY injection?
Will VABRINTY cure my prostate cancer?
What should I do if I have side effects?
Can VABRINTY affect my fertility?
Will my prostate cancer symptoms get worse when I start VABRINTY?
Does VABRINTY interact with other medications?
Can VABRINTY cause diabetes?
Can VABRINTY cause heart problems?
What if I have a history of seizures?
Is VABRINTY safe for older adults?
What are the common side effects of leuprolide?
What drug class is leuprolide?
Is leuprolide safe during pregnancy?
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What the FDA Data Shows for leuprolide
The FDA label for leuprolide (sold under brand names such as Lupron) classifies it as a prescription-only medication in the GnRH Agonist class. VABRINTY treats advanced prostate cancer in men. Official labeling lists 3 commonly reported side effects, including Feeling tired or weak, Hot flashes or sweats, Testicles shrinking.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 1,385 voluntary reports. Interaction data is drawn directly from FDA-approved prescribing information. NADAC pricing from CMS shows a generic unit cost of $267.68.
Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice, always consult a licensed healthcare provider before starting, stopping, or changing any medication.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.
Last updated: June 1, 2025
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages