"The U.S. Food and Drug Administration today approved Xofigo (radium Ra 223 dichloride) to treat men with symptomatic late-stage (metastatic) castration-resistant prostate cancer that has spread to bones but not to other organs. It is intended for"...
Lupron Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Lupron Injection (leuprolide acetate) is used in men to treat symptoms of prostate cancer, and in women to treat symptoms of endometriosis (overgrowth of uterine lining outside of the uterus) or uterine fibroids. It is also used to treat precocious (early-onset) puberty in both male and female children. It is a synthetic gonadotropin-releasing hormone. Common side effects include mild burning/pain/bruising at the injection site, hot flashes (flushing), increased sweating, night sweats, tiredness, headache, upset stomach, breast changes, acne, joint/muscle aches, trouble sleeping, reduced sexual interest, vaginal discomfort/dryness, vaginal bleeding, swelling of the ankles/feet, increased urination at night, or dizziness.
Dosage of Lupron Injection depends on the condition being treated, and the patient's age and sex. There may be other drugs that can interact with Lupron Injection. Tell your doctor about all prescription and over-the-counter medications and supplements you use. Lupron Injection must not be used during pregnancy. It may harm a fetus. Non-hormonal birth control methods (e.g., condoms, diaphragm with spermicide) are recommended during treatment. It is not known if this medication passes into breast milk. Because the effects of this drug on a nursing infant are unknown, breast-feeding is not recommended.
Our Lupron Injection (leuprolide acetate) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Lupron in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have a serious side effect such as:
- bone pain, loss of movement in any part of your body;
- swelling, rapid weight gain;
- pain, burning, stinging, bruising, or redness where the medication was injected;
- feeling like you might pass out;
- sudden chest pain or discomfort, wheezing, dry cough or hack;
- painful or difficult urination;
- urinating more often than usual;
- high blood sugar (increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss);
- sudden numbness or weakness (especially on one side of the body), problems with speech or balance;
- sudden headache with vision problems, vomiting, confusion, slow heart rate, weak pulse, fainting, or slow breathing; or
- chest pain spreading to the arm or shoulder, nausea, sweating, general ill feeling.
Rare but serious side effects may include:
- pain or unusual sensations in your back;
- numbness, weakness, or tingly feeling in your legs or feet;
- muscle weakness or loss of use;
- loss of bowel or bladder control; or
- nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
Less serious side effects may include:
- acne, increased growth of facial hair;
- breakthrough bleeding in a female child during the first 2 months of leuprolide treatment;
- dizziness, weakness, tired feeling;
- hot flashes, night sweats, chills, clammy skin;
- nausea, diarrhea, constipation, stomach pain;
- skin redness, itching, or scaling;
- joint or muscle pain;
- vaginal itching or discharge;
- breast swelling or tenderness;
- testicle pain;
- impotence, loss of interest in sex;
- depression, sleep problems (insomnia), memory problems; or
- redness, burning, stinging, or pain where the shot was given.
Read the entire detailed patient monograph for Lupron (Leuprolide Acetate Injection) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Lupron Overview - Patient Information: Side Effects
Infrequently in men, shrinking of the testicles, breast tenderness/swelling, and reduced sexual interest/ability may also occur as a result of lowered testosterone levels. Talk to your doctor if these effects occur.
In girls, when this medication is used regularly, it is expected that the menstrual period will stop (or decrease to light bleeding/spotting during the first 2 months). Tell your doctor promptly if regular periods continue after 2 months of treatment with leuprolide.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
During the first few weeks of treatment, your hormone levels will actually increase before they decrease. This is a normal response by your body to this drug. This may result in a temporary increase in your symptoms for a few weeks.
In men, an increase in testosterone levels at the beginning of treatment may sometimes result in new or worsening symptoms for a few weeks. If you have prostate cancer that has spread to the spine or caused urinary blockage, you may require closer monitoring by your doctor, especially when you first start treatment. Tell your doctor immediately if you experience any of the following serious side effects: bone pain, numbness/tingling/weakness of the arms/legs, blood in the urine, painful/difficult urination, unusual weakness, inability to move.
Tell your doctor right away if you have any serious side effects, including: mental/mood changes (e.g., depression, thoughts of suicide, mood swings, aggression in children), new/worsening bone pain (in adults), easily broken bones (in adults), increased thirst/urination.
Get medical help right away if you have any very serious side effects, including: chest/jaw/left arm pain, irregular heartbeat, weakness on one side of the body, slurred speech, seizures.
Rarely, a very serious problem with your pituitary gland (pituitary apoplexy) may occur, usually in the first hour to 2 weeks after your first injection. Get medical help right away if any of these very serious side effects occur: sudden severe headache, sudden severe mental/mood changes (e.g., severe confusion, difficulty concentrating), vision changes, severe vomiting, fainting.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Lupron (Leuprolide Acetate Injection)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Lupron FDA Prescribing Information: Side Effects
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). In a few cases a temporary worsening of existing hematuria and urinary tract obstruction occurred during the first week. Temporary weakness and paresthesia of the lower limbs have been reported in a few cases.
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.
In a comparative trial of LUPRON INJECTION (leuprolide acetate) versus DES, in 5% or more of the patients receiving either drug, the following adverse reactions were reported to have a possible or probable relationship to drug as ascribed by the treating physician. Often, causality is difficult to assess in patients with metastatic prostate cancer. Reactions considered not drug related are excluded.
|Number of Reports|
|Congestive heart failure||1||5|
|High blood pressure||8||5|
|*Decreased testicular size||7||11|
|*Gynecomastia/breast tenderness or pain||7||63|
|Hemic and Lymphatic System|
|Central/Peripheral Nervous System|
|Urinary tract infection||3||7|
|* Physiologic effect of decreased testosterone.|
In this same study, the following adverse reactions were reported in less than 5% of the patients on LUPRON.
Cardiovascular System-Angina, Cardiac arrhythmias, Myocardial infarction, Pulmonary emboli; Gastrointestinal System-Diarrhea, Dysphagia, Gastrointestinal bleeding, Gastrointestinal disturbance, Peptic ulcer, Rectal polyps; Endocrine System-Libido decrease, Thyroid enlargement; Musculoskeletal System-Joint pain; Central/Peripheral Nervous System-Anxiety, Blurred vision, Lethargy, Memory disorder, Mood swings, Nervousness, Numbness, Paresthesia, Peripheral neuropathy, Syncope/blackouts, Taste disorders; Respiratory System-Cough, Pleural rub, Pneumonia, Pulmonary fibrosis; Integumentary System- Carcinoma of skin/ear, Dry skin, Ecchymosis, Hair loss, Itching, Local skin reactions, Pigmentation, Skin lesions; Urogenital System-Bladder spasms, Dysuria, Incontinence, Testicular pain, Urinary obstruction; Miscellaneous-Depression, Diabetes, Fatigue, Fever/chills, Hypoglycemia, Increased BUN, Increased calcium, Increased creatinine, Infection/inflammation, Ophthalmologic disorders, Swelling (temporal bone).
In an additional clinical trial and from long-term observation of both studies, the following additional adverse events (excluding those considered not drug related) were reported for patients receiving LUPRON.
Cardiovascular System-Bradycardia, Carotid bruit, Extrasystole, Palpitations, Perivascular cuffing (eyes), Ruptured aortic aneurysm, Stroke, Tachycardia, Transient ischemic attack; Gastrointestinal System-Flatus, Dryness of mouth and throat, Hepatitis, Hepatomegaly, Occult blood (rectal exam), Rectal fistula/erythema; Endocrine System-Libido increase, Thyroid nodule; Musculoskeletal System-Ankylosing spondylosis, Arthritis, Blurred disc margins, Bone fracture, Muscle stiffness, Muscle tenderness, Pelvic fibrosis, Spasms/cramps; Central/Peripheral Nervous System-Auditory hallucinations/tinnitus, Decreased hearing, Decreased reflexes, Euphoria, Hyperreflexia, Loss of smell, Motor deficiency; Respiratory System-Chest tightness, Decreased breathing sounds, Hemoptysis, Pleuritic chest pain, Pulmonary infiltrate, Rales/rhonchi, Rhinitis, Strep throat, Wheezing/bronchitis; Integumentary System-Boil (pubic), Bruises, Hives, Keratosis, Mole, Shingles, Spiders; Urogenital System- Blisters on penis, Inguinal hernia, Penile swelling, Post void residual, Prostatic pain, Pyuria; Miscellaneous-Abdominal distention, Facial swelling/edema, Feet burning, Flu, Eyelid growth, Hypoproteinemia, Accidental injury, Knee effusion, Mass, Pallid, Sallow, Weakness.
During postmarketing surveillance which includes other dosage forms and other patient populations, the following adverse events were reported.
Cardiovascular System - Hypotension, Myocardial infarction; Endocrine System -Diabetes; Gastrointestinal System - Hepatic dysfunction; Hemic and Lymphatic System - Decreased WBC; Integumentary System - Hair growth; Central/Peripheral Nervous System - Convulsion, Spinal fracture/paralysis, Hearing disorder; Miscellaneous - Hard nodule in throat, Weight gain, Increased uric acid; Musculoskeletal System - Tenosynovitis-like symptoms; Respiratory System - Respiratory disorders.
Changes in Bone Density
Decreased bone density has been reported in the medical literature in men who have had orchiectomy or who have been treated with an LH-RH agonist analog. In a clinical trial, 25 men with prostate cancer, 12 of whom had been treated previously with leuprolide acetate for at least six months, underwent bone density studies as a result of pain. The leuprolide-treated group had lower bone density scores than the nontreated control group. It can be anticipated that long periods of medical castration in men will have effects on bone density.
During post-marketing surveillance, rare cases of pituitary apoplexy (a clinical syndrome secondary to infarction of the pituitary gland) have been reported after the administration of gonadotropin-releasing hormone agonists. In a majority of these cases, a pituitary adenoma was diagnosed, with a majority of pituitary apoplexy cases occurring within 2 weeks of the first dose, and some within the first hour. In these cases, pituitary apoplexy has presented as sudden headache, vomiting, visual changes, ophthalmoplegia, altered mental status, and sometimes cardiovascular collapse. Immediate medical attention has been required.
See other LUPRON DEPOT and LUPRON INJECTION package inserts for other events reported in the same and different patient populations.
Read the entire FDA prescribing information for Lupron (Leuprolide Acetate Injection) »
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