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leuprolide

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Brand names: Lupron

GnRH Agonist Rx

VABRINTY is a medicine that treats advanced prostate cancer. It contains leuprolide, which lowers testosterone levels.

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.

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.

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.

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.

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 597 FDA adverse event reports.

The medicine is not working
106
Feeling tired
82
Using the medicine for something it's not approved for
67
Feeling sick to your stomach
61
Pain in your head
58
Cancer getting worse
53
The illness is getting worse
50
Fever with low white blood cell count
43
The medicine was not stored correctly
41
Sudden feeling of heat
36

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

Death-Related Reports

119

Hospitalization Reports

457

Top Indication

Product Used For Unknown Indication

Gender Distribution

Female 555 (43%)
Male 749 (57%)

Age Distribution

0–17 90
18–44 257
45–64 188
65–74 268
75+ 243

Most Reported Adverse Reactions (FAERS)

# Reaction Reports
1 DRUG INEFFECTIVE 106
2 FATIGUE 82
3 OFF LABEL USE 67
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
11 PRODUCT USE IN UNAPPROVED INDICATION 36
12 ANAEMIA 35
13 VOMITING 35
14 TREATMENT FAILURE 34
15 DIARRHOEA 33

Reactions in Death Reports

DEATH 29
DRUG INEFFECTIVE 18
MALIGNANT NEOPLASM PROGRESSION 16
ACUTE KIDNEY INJURY 10
ANAEMIA 10
METASTASES TO BONE 9
PNEUMONIA 8
PROSTATE CANCER 8
HYPOTENSION 7
DISEASE PROGRESSION 6

Reactions in Hospitalization Reports

FEBRILE NEUTROPENIA 37
DRUG INEFFECTIVE 35
NAUSEA 27
ACUTE KIDNEY INJURY 26
FATIGUE 26
VOMITING 24
OFF LABEL USE 23
ANAEMIA 22
FALL 20
HYPOTENSION 19

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?
You will get an injection every 1, 3, 4, or 6 months, depending on what your doctor prescribes.
Will VABRINTY cure my prostate cancer?
VABRINTY helps to slow down the growth of prostate cancer, but it may not cure it.
What should I do if I have side effects?
Tell your doctor about any side effects you have while taking VABRINTY.
Can VABRINTY affect my fertility?
Yes, VABRINTY may affect fertility in both men and women.
Will my prostate cancer symptoms get worse when I start VABRINTY?
Your symptoms may temporarily worsen during the first few weeks of treatment.
Does VABRINTY interact with other medications?
Tell your doctor about all the medicines you take, including prescription and over-the-counter drugs.
Can VABRINTY cause diabetes?
VABRINTY may increase your risk of developing diabetes or worsen existing diabetes.
Can VABRINTY cause heart problems?
VABRINTY may increase your risk of heart attack, stroke, or sudden death.
What if I have a history of seizures?
Tell your doctor if you have a history of seizures, as VABRINTY may increase the risk of seizures.
Is VABRINTY safe for older adults?
VABRINTY has been studied in older adults, but it is not known if they respond differently than younger adults.
What are the common side effects of leuprolide?
The most commonly reported side effects of leuprolide include Feeling tired or weak, Hot flashes or sweats, Testicles shrinking. Based on 597 FDA adverse event reports. Always consult your healthcare provider about potential side effects.
What drug class is leuprolide?
leuprolide belongs to the GnRH Agonist drug class. It requires a prescription (Rx). VABRINTY treats advanced prostate cancer in men.
Is leuprolide safe during pregnancy?
VABRINTY can harm an unborn baby. Females should not take VABRINTY if they are pregnant or may become pregnant. Always consult your healthcare provider before using any medication during pregnancy or breastfeeding.

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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 597 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

All federal data sources used on this page