leuprolide
Generic leuprolide is a GnRH agonist that's FDA-approved for treating advanced prostate cancer. It's available as an injection under the skin that's given daily. Fertility specialists also often prescribe under-the-skin injections of generic leuprolide "off-label" to help people become pregnant. Some potential side effects of leuprolide include hot flashes and injection site pain.
What is Leuprolide?
What is Leuprolide used for?
Advanced prostate cancer
How Leuprolide works
Leuprolide is a gonadotropin-releasing hormone (GnRH) agonist. It's a lab-made hormone that's similar to the GnRH your body naturally makes.
For prostate cancer, leuprolide lowers testosterone levels over time. This helps slow down the growth of the prostate gland and cancer cells.
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What are the side effects of Leuprolide?
Common Side Effects
- Hot flashes or sweats (55%)
- Changes on electrocardiogram (ECG or EKG; 19%)
- General pain (13%)
- Swelling in the arms or legs (12%)
- Weakness (10%)
Other Side Effects
- Constipation
- Headache
- Dizziness
- Difficulty sleeping
- High blood pressure
- Problems getting or maintaining an erection
- Breast pain
Serious Side Effects
- Heart problems: racing heart, fluttering in your chest, abnormal heartbeats, heart attack
- Stroke: weakness on one side of the body, drooping face, bad headache, trouble walking or speaking
- Convulsion (seizure): tight muscles, uncontrollable movements, painful cramping
Source: DailyMed
The following side effects have also been reported
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
For adults
Less common
Fast or irregular heartbeat
For males only (adults)
More common
Arm, back, or jaw pain
bloody or cloudy urine
blurred vision
chest pain or discomfort
difficult, burning, or painful urination
difficulty with moving
dizziness
frequent urge to urinate
headache
increased urge to urinate during the night
muscle pain or stiffness
nervousness
pain in the joints
pale skin
pounding in the ears
slow or fast heartbeat
sweating
unusual bleeding or bruising
unusual tiredness or weakness
waking to urinate at night
Rare
Pain in the groin or legs (especially in the calves)
Incidence not known
Altered mental status
cold, clammy, pale skin
confusion
double vision
irregular heartbeat
visual changes
vomiting
For females only (adults)
For children
More common
Body aches or pain
chills
cough producing mucus
difficulty in breathing
ear congestion
headache
loss of voice
muscle aches
noisy breathing
pain or redness at the injection site
runny or stuffy nose
tightness in the chest
unusual tiredness or weakness
Less common
Irritability
mood or mental changes
Rare
Burning, itching, or swelling at the injection site
Incidence not known
Seizures
For females only (children)—expected in first few weeks
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
For adults
More common
Sudden sweating and feeling of warmth (hot flashes)
For females only (adults)
For males only (adults)
More common
Back pain
chills
general feeling of discomfort or illness
loss of appetite
pain or discomfort at the injection site
redness of the face, neck, arms, and occasionally, upper chest
shivering
unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
Less common
Decreased size of the testicles
inability to have or keep an erection
For children
More common
feeling of warmth
redness of the face, neck, arms and occasionally, upper chest
stomach pain
vomiting
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Pros and cons of Leuprolide
Pros
Possible to inject the medication at home with proper training
No known interactions with other medications
Cons
Injections can be uncomfortable and hard for some people to do
Can cause flushing and hot flashes
Not a cure for prostate cancer; only helps slow cancer growth
Pharmacist tips for Leuprolide
You might have a flare-up in your prostate cancer symptoms during the first few weeks of treatment with leuprolide. This happens because your testosterone levels first rise before they go down. Tell your care team if flare-up symptoms, like bone pain, blood in your urine, trouble urinating, or weakness, don't go away after a month.
Don't stop taking leuprolide without consulting your prescriber, even if you start to feel better. This medication only works if you continue taking it as prescribed.
You might have some mild irritation, such as burning, itching, or swelling, where you injected leuprolide. These reactions should go away on their own. Let your care team know if the injections are too uncomfortable or if the irritation doesn't go away.
Your prescriber will regularly order lab work to make sure leuprolide is working and to check for side effects. Mark your appointments on your calendar and make sure to get your lab work done on time.
Leuprolide lowers your testosterone levels, which can affect your ability to have an erection. Talk to your prescriber if this concerns you.
It's possible for leuprolide to affect the ability in males to have children. Discuss this possibility with your prescriber before you start leuprolide treatment.
How to inject leuprolide:
If you're injecting leuprolide at home, a healthcare professional will teach you how to give yourself the injections safely. Read the Instructions for Use and call your care team if you have any questions.
Wash your hands and clean the injection site with an alcohol swab.
Draw up your dose of leuprolide into a new syringe as instructed.
Pinch your skin with your fingers and inject leuprolide under the skin, at a 90-degree angle. Push down on the plunger to inject leuprolide, and then remove the needle at the same angle you inserted it.
Throw away used syringes and needles in a sharps container right after injecting. This helps prevent needle-stick injuries.
Make sure to rotate injection sites each time you inject leuprolide. This lets your skin heal after each injection and prevents skin damage.
Frequently asked questions about Leuprolide
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What are the risks and warnings for Leuprolide?
Leuprolide can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Initial worsening of symptoms
When you first start leuprolide, your testosterone levels go up before they start to go down. This can make your prostate cancer symptoms worse. Your testosterone levels should drop and your symptoms should get better after a few weeks. Let your healthcare team know if you experience any bone pain, bladder pain, or blood in your urine that doesn't go away in about a month.
Higher blood sugar levels and risk for diabetes
Some people who took leuprolide have reported a rise in their blood sugar. Having high blood sugar levels raises the risk for new or worsening diabetes. During treatment, your prescriber will regularly check your blood sugar levels and A1C (average blood sugar levels over the past few months). You might need additional medications to manage your blood sugar if it's too high.
Risk for heart problems or stroke
Risk factors: History of heart rhythm problems or heart failure | Electrolyte imbalances | Taking certain heart rhythm medications, mental health medications, or antibiotics
Although the risk is low, some people who take medications like leuprolide might be at risk of having heart problems, such as heart attack or sudden death due to heart problems. There's also a possible low risk for stroke. In addition, medications similar to leuprolide can cause irregular heart rhythms.
Your prescriber will check your risk for heart problems and stroke before you start leuprolide. Let your prescriber know if you have any conditions causing irregular heart rhythms, heart failure, or electrolyte problems. Also share a list of your current medications for them to check for drug interactions that can raise your risk for abnormal heart rhythm. Your prescriber will discuss with you about the risks and benefits of taking leuprolide.
Get emergency help right away if you experience chest or arm pain, shortness of breath, a cold sweat, weakness on one side of the body, drooping face, bad headache, or trouble walking or speaking. These can be signs of a heart attack or stroke. Also be sure to tell your healthcare team if your heart is beating irregularly.
Possible spinal cord and urinary tract problems
Risk factors: History of spine problems | History of urinary tract problems
There have been a few cases of spinal cord compression, or pressure on the spinal cord, in people who take leuprolide. This can possibly lead to paralysis (not being able to move). Also, some people have had a blockage in their urinary tract during treatment. This can lead to kidney damage or urinary problems. These problems might happen during the first few weeks of treatment. Talk to your prescriber about your medical history or your concerns about the medication before you start treatment with leuprolide.
Leuprolide dosage forms
Typical dosing for Leuprolide
Generic leuprolide 1 mg/0.2 mL injection: The typical dose is 1 mg (or 0.2 mL) injected under the skin once daily.
Interactions between Leuprolide and other drugs
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Bepridil
- Cisapride
- Dronedarone
- Mesoridazine
- Pimozide
- Piperaquine
- Saquinavir
- Sparfloxacin
- Terfenadine
- Thioridazine
- Ziprasidone
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Amiodarone
- Amisulpride
- Aripiprazole Lauroxil
- Buprenorphine
- Buserelin
- Ceritinib
- Citalopram
- Clofazimine
- Degarelix
- Deslorelin
- Deutetrabenazine
- Donepezil
- Encorafenib
- Entrectinib
- Formoterol
- Fostemsavir
- Glasdegib
- Gonadorelin
- Goserelin
- Histrelin
- Hydroxychloroquine
- Hydroxyzine
- Inotuzumab Ozogamicin
- Ivosidenib
- Lefamulin
- Lenvatinib
- Lofexidine
- Macimorelin
- Methotrimeprazine
- Mirtazapine
- Moricizine
- Nafarelin
- Osilodrostat
- Osimertinib
- Oxaliplatin
- Ozanimod
- Papaverine
- Pimavanserin
- Pitolisant
- Ponesimod
- Ribociclib
- Selpercatinib
- Sertraline
- Siponimod
- Sotalol
- Sulpiride
- Sunitinib
- Triclabendazole
- Triptorelin
- Vemurafenib
- Voclosporin
- Zotepine
- Zuclopenthixol
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References
Best studies we foundAlyasin, A., et al. (2016). GnRH agonist trigger versus hCG trigger in GnRH antagonist in IVF/ICSI cycles: A review article. International Journal of Reproductive Biomedicine.
Meitheal Pharmaceuticals Inc. (2024). Leuprolide acetate kit [package insert]. DailyMed.
National Cancer Institute. (n.d.). Gonadotropin-releasing hormone.
National Cancer Institute. (2021). Hormone therapy for prostate cancer.
NorthStar RxLLC. (2024). Leuprolide acetate- leuprolide acetate [package insert]. DailyMed.
Society for Assisted Reproductive Technology. (n.d.). ART medications.
Society for Assisted Reproductive Technology. (n.d.). Injection techniques and medications.
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