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Lupron

Last reviewed on RxList: 5/30/2017
Lupron Side Effects Center

Last reviewed on RxList 9/16/2016

Lupron Injection (leuprolide acetate) is a synthetic gonadotropin-releasing hormone 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. Lupron Injection is also used to treat precocious (early-onset) puberty in both male and female children. Common side effects of Lupron Injection include:

  • redness/burning/stinging/pain/bruising at the injection site,
  • hot flashes (flushing),
  • increased sweating,
  • night sweats,
  • tiredness,
  • headache,
  • upset stomach,
  • nausea,
  • diarrhea,
  • constipation,
  • stomach pain,
  • breast swelling or tenderness,
  • acne,
  • joint/muscle aches or pain,
  • trouble sleeping (insomnia),
  • reduced sexual interest,
  • vaginal discomfort/dryness/itching/discharge,
  • vaginal bleeding,
  • swelling of the ankles/feet,
  • increased urination at night,
  • dizziness,
  • breakthrough bleeding in a female child during the first 2 months of leuprolide treatment,
  • weakness,
  • chills,
  • clammy skin,
  • skin redness,
  • itching or scaling,
  • testicle pain,
  • impotence,
  • depression,
  • increased growth of facial hair, or
  • memory problems.

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, breastfeeding 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.

Lupron Consumer Information

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.

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.

Read the entire detailed patient monograph for Lupron (Leuprolide Acetate Injection)

Lupron Professional Information

SIDE EFFECTS

Clinical 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). 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.

  LUPRON
(N=98)
DES
(N=101)
Number of Reports
Cardiovascular System
  Congestive heart failure 1 5
  ECG changes/ischemia 19 22
  High blood pressure 8 5
  Murmur 3 8
  Peripheral edema 12 30
  Phlebitis/thrombosis 2 10
Gastrointestinal System
  Anorexia 6 5
  Constipation 7 9
  Nausea/vomiting 5 17
Endocrine System
  *Decreased testicular size 7 11
  *Gynecomastia/breast tenderness or pain 7 63
  *Hot flashes 55 12
  *Impotence 4 12
Hemic and Lymphatic System
  Anemia 5 5
Musculoskeletal System
  Bone pain 5 2
  Myalgia 3 9
Central/Peripheral Nervous System
  Dizziness/lightheadedness 5 7
  General pain 13 13
  Headache 7 4
  Insomnia/sleep disorders 7 5
Respiratory System
  Dyspnea 2 8
  Sinus congestion 5 6
Integumentary System
  Dermatitis 5 8
Urogenital System
  Frequency/urgency 6 8
  Hematuria 6 4
  Urinary tract infection 3 7
Miscellaneous
  Asthenia 10 10
* 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 SystemAngina, Cardiac arrhythmias, Myocardial infarction, Pulmonary emboli; Gastrointestinal System—Diarrhea, Dysphagia, Gastrointestinal bleeding, Gastrointestinal disturbance, Peptic ulcer, Rectal polyps; Endocrine SystemLibido 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 SystemCarcinoma of skin/ear, Dry skin, Ecchymosis, Hair loss, Itching, Local skin reactions, Pigmentation, Skin lesions; Urogenital SystemBladder 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 SystemBradycardia, Carotid bruit, Extrasystole, Palpitations, Perivascular cuffing (eyes), Ruptured aortic aneurysm, Stroke, Tachycardia, Transient ischemic attack; Gastrointestinal SystemFlatus, Dryness of mouth and throat, Hepatitis, Hepatomegaly, Occult blood (rectal exam), Rectal fistula/erythema; Endocrine System—Libido increase, Thyroid nodule; Musculoskeletal SystemAnkylosing 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 SystemBoil (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.

Postmarketing

During postmarketing surveillance which includes other dosage forms and other patient populations, the following adverse events were reported.

Symptoms consistent with an anaphylactoid or asthmatic process have been rarely (incidence rate of about 0.002%) reported. Rash, urticaria, and photosensitivity reactions have also been reported.

Localized reactions including induration and abscess have been reported at the site of injection.

Symptoms consistent with fibromyalgia (e.g., joint and muscle pain, headaches, sleep disorders, gastrointestinal distress, and shortness of breath) have been reported individually and collectively.

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.

Pituitary apoplexy: 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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© Lupron Patient Information is supplied by Cerner Multum, Inc. and Lupron Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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