Eligard Side Effects
Generic Name: leuprolide,leuprolide acetate
Please note - some side effects for Eligard may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
Side Effects of Eligard - for the Consumer
Eligard Kit
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Eligard Kit:
Seek medical attention right away if any of these SEVERE side effects occur when using Eligard Kit:Dizziness; hot flashes; increased sweating; mild burning, bruising, itching, pain, redness, stinging, or swelling at the injection site; muscle pain; tiredness.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood in the urine; bone pain; burning, numbness, or tingling; fainting; mental or mood changes (eg, depression); seizures; severe dizziness or lightheadedness; symptoms of heart attack (eg, chest, jaw, or left arm pain; numbness of an arm or leg; sudden, severe headache or vomiting); symptoms of high blood sugar (eg, drowsiness; fast breathing; flushing; fruit-like breath odor; increased thirst, hunger, or urination); symptoms of stroke (eg, confusion, one-sided weakness, slurred speech); unusual tiredness or weakness; urination problems (eg, inability to urinate, loss of bladder control, painful urination); vision changes.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
Eligard Suspension
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Eligard Suspension:
Seek medical attention right away if any of these SEVERE side effects occur when using Eligard Suspension:Dizziness; hot flashes; increased sweating; mild burning, bruising, itching, pain, redness, stinging, or swelling at the injection site; muscle pain; tiredness.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood in the urine; bone pain; burning, numbness, or tingling; fainting; mental or mood changes (eg, depression); seizures; severe dizziness or lightheadedness; symptoms of heart attack (eg, chest, jaw, or left arm pain; numbness of an arm or leg; sudden, severe headache or vomiting; vision changes); symptoms of high blood sugar (eg, drowsiness; fast breathing; flushing; fruit-like breath odor; increased thirst, hunger, or urination); symptoms of stroke (eg, confusion, one-sided weakness, slurred speech, vision changes); unusual tiredness or weakness; urination problems (eg, inability to urinate, loss of bladder control, painful urination); vision changes.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
TopEligard Side Effects - for the Professional
Eligard
The safety of all Eligard® formulations was evaluated in clinical trials involving patients with advanced prostate cancer. In addition, the safety of Eligard® 7.5 mg was evaluated in 8 surgically castrated males (Table 7). Eligard®, like other LH-RH analogs, caused a transient increase in serum testosterone concentrations during the first one to two weeks of treatment. Therefore, potential exacerbations of signs and symptoms of the disease during the first weeks of treatment are of concern in patients with vertebral metastases and/or urinary obstruction or hematuria. If these conditions are aggravated, it may lead to neurological problems such as weakness and/or paresthesia of the lower limbs or worsening of urinary symptoms.
During the clinical trials, injection sites were closely monitored. Refer to Table 6 for a summary of reported injection site events.
| 7.5 mg | 22.5 mg | 30 mg | 45 mg | |
|---|---|---|---|---|
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| Study Number | AGL9904 | AGL9909 | AGL0001 | AGL0205 |
| Number of patients | 120 | 117 | 90 | 111 |
| Treatment | 1 injection every month up to 6 months | 1 injection every 3 months up to 6 months | 1 injection every 4 months up to 8 months | 1 injection every 6 months up to 12 months |
| Number of injections | 716 | 230 | 175 | 217 |
| Transient burning/stinging | 248 (34.6%) injections;84% reported as mild | 50 (21.7%) injections; 86% reported as mild | 35 (20%) injections; 100% reported as mild | 35 (16%) injections; 91.4% reported as mild* |
| Pain (generally brief and mild) | 4.3% of injections (18.3% of patients) | 3.5% of injections (6.0% of patients) | 2.3% of injections† (3.3% of patients) | 4.6% of injections‡ |
| Erythema (generally brief and mild) | 2.6% of injections (12.5% of patients) | 0.9% of injections§ (1.7% of patients) | 1.1% of injections (2.2% of patients) | |
| Bruising (Mild) | 2.5% of injections (11.7% of patients) | 1.7% of injections (3.4% of patients) | 2.3% of injections¶ | |
| Pruritis | 1.4% of injections (9.2% of patients) | 0.4% of injections (0.9% of patients) | ||
| Induration | 0.4% of injections (2.5% of patients) | |||
| Ulceration | 0.1% of injections (> 0.8% of patients) | |||
These localized adverse events were non-recurrent over time. No patient discontinued therapy due to an injection site adverse event.
The following possibly or probably related systemic adverse events occurred during clinical trials with Eligard®, and were reported in > 2% of patients (Table 7). Often, causality is difficult to assess in patients with metastatic prostate cancer. Reactions considered not drug-related are excluded.
| 7.5 mg | 7.5 mg | 22.5 mg | 30 mg | 45 mg | ||
|---|---|---|---|---|---|---|
| In the patient populations studied with Eligard® 7.5 mg, a total of 86 hot flashes/sweats adverse events were reported in 70 patients. Of these, 71 events (83%) were mild; 14 (16%) were moderate; 1 (1%) was severe. In the patient population studied with Eligard® 22.5 mg, a total of 84 hot flashes/sweats adverse events were reported in 66 patients. Of these, 73 events (87%) were mild; 11 (13%) were moderate; none were severe. In the patient population studied with Eligard® 30 mg, a total of 75 hot flash adverse events were reported in 66 patients. Of these, 57 events (76%) were mild; 16 (21%) were moderate; 2 (3%) were severe. In the patient population studied with Eligard® 45 mg, a total of 89 hot flash adverse events were reported in 64 patients. Of these, 62 events (70%) were mild; 27 (30%) were moderate; none were severe. |
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| Study Number | AGL9904 | AGL9802 | AGL9909 | AGL0001 | AGL0205 | |
| Number of patients | 120 | 8 | 117 | 90 | 111 | |
| Treatment | 1 injection every month up to 6 months | 1 injection (surgically castrated patients) | 1 injection every 3 months up to 6 months | 1 injection every 4 months up to 8 months | 1 injection every 6 months up to 12 months | |
| Body System | Adverse Event | Number (Percent) | ||||
| Body as a Whole | Malaise and Fatigue | 21 (17.5 %) | 7 (6.0%) | 12 (13.3%) | 13 (11.7%) | |
| Weakness | 4 (3.6%) | |||||
| Nervous System | Dizziness | 4 (3.3%) | 4 (4.4%) | |||
| Vascular | Hot flashes/sweats | 68 (56.7%)* | 2 (25.0%)* | 66 (56.4%)* | 66 (73.3%)* | 64 (57.7%)* |
| Renal/Urinary | Urinary frequency | 3 (2.6%) | 2 (2.2%) | |||
| Nocturia | 2 (2.2%) | |||||
| Gastrointestinal | Nausea | 4 (3.4%) | 2 (2.2%) | |||
| Gastroenteritis/colitis | 3 (2.5%) | |||||
| Skin | Pruritis | 3 (2.6%) | ||||
| Clamminess | 4 (4.4%)* | |||||
| Night sweats | 3 (3.3%)* | 3 (2.7%)* | ||||
| Alopecia | 2 (2.2%) | |||||
| Musculoskeletal | Arthralgia | 4 (3.4%) | ||||
| Myalgia | 2 (2.2%) | 5 (4.5%) | ||||
| Pain in limb | 3 (2.7%) | |||||
| Reproductive | Testicular atrophy | 6 (5.0%) | 4 (4.4%)* | 8 (7.2%)* | ||
| Gynecomastia | 2 (2.2%)* | 4 (3.6%)* | ||||
| Testicular pain | 2 (2.2%) | |||||
| Psychiatric | Decreased libido | 3 (3.3%)* | ||||
In addition, the following possibly or probably related systemic adverse events were reported by < 2% of the patients treated with Eligard® in these clinical studies.
| Body System | Adverse Event |
|---|---|
|
|
| General | Sweating, insomnia, syncope, rigors, weakness, lethargy |
| Gastrointestinal | Flatulence, constipation, dyspepsia |
| Hematologic | Decreased red blood cell count, hematocrit and hemoglobin |
| Metabolic | Weight gain |
| Musculoskeletal | Tremor, backache, joint pain, muscle atrophy, limb pain |
| Nervous | Disturbance of smell and taste, depression, vertigo |
| Psychiatric | Insomnia, depression, loss of libido* |
| Renal/Urinary | Difficulties with urination, pain on urination, scanty urination, bladder spasm, blood in urine, urinary retention, urinary urgency, incontinence, nocturia, nocturia aggravated |
| Reproductive/ Urogenital: |
Testicular soreness/pain, impotence*, decreased libido*, gynecomastia*, breast soreness/tenderness*, testicular atrophy*, erectile dysfunction, penile disorder*, reduced penis size |
| Skin | Alopecia, clamminess, night sweats*, sweating increased* |
| Vascular | Hypertension, hypotension |
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.3 It can be anticipated that long periods of medical castration in men will have effects on bone density.
- 3
- Hatano T et al. Incidence of bone fracture in patients receiving luteinizing hormone-releasing hormone agonists for prostate cancer. BJU International 2000 86: 449–452.
Post-Marketing
Pituitary apoplexyDuring 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.
TopSide Effects by Body System - for Healthcare Professionals
Endocrine
Endocrine side effects of leuprolide have included hot flashes (56% to 91%), gynecomastia (7%), breast changes (7%), breast enlargement (7%), breast tenderness (7% to 14%), decrease in testicular size, diabetes, and impotence. In addition, rare cases of pituitary apoplexy have been reported after the use of gonadotropin-releasing hormone agents.
Endocrine side effects occur in the majority of patients treated with leuprolide and are due to drug-induced hypoestrogenism and hypoandrogenism.
Pituitary apoplexy is a clinical syndrome secondary to infarction of the pituitary gland. In a majority of the cases reported, a pituitary adenoma was diagnosed. A majority of pituitary apoplexy cases occurred within two weeks of the first dose, and some occurred within the first hour. In those cases, pituitary apoplexy presented as sudden headache, vomiting, visual changes, ophthalmoplegia, altered mental status, and sometimes cardiovascular collapse. Immediate medical attention has been required.
Psychiatric
Psychiatric side effects have included depression and emotional lability (up to 45%), insomnia (2% to 7%), anxiety, nervousness, decreased libido (both males and females), increased libido (females), and short-term memory loss.
Nervous system
Nervous system side effects have included headache (7% to 39%), dizziness (5%), blurred vision, lethargy, paresthesias, numbness, peripheral neuropathy, spinal fracture, convulsions, transient ischemic attack, and paralysis. A case of atypical absence seizures induced by leuprolide acetate has also been reported.
Genitourinary
A number of cases of vaginal hemorrhage are reported in the literature. The presence of submucous leiomyomatas may be responsible for these events. These patients typically required emergency surgery and blood transfusions.
Massive ascites developed in one patient 3 weeks after receiving a 3.75 mg leuprolide depot injection for the treatment of leiomyomata uteri. Upon surgical resection, the uterine myomas were noted to be seeping large amounts of serous fluid.
Genitourinary side effects have included vaginal dryness (37%), urinary frequency, hematuria, ovarian hyperstimulation, testicular soreness/pain, breast soreness/tenderness,testicular atrophy, erectile dysfunction, penile disorder, reduced penis size and vaginal hemorrhage.
Cardiovascular
Cardiovascular side effects have included ECG changes (19%), ischemia (19%), peripheral edema (12%), hypertension, hypotension, murmur, phlebitis, venous and arterial thromboembolism, deep vein thrombosis, stroke, sudden cardiac death, arrhythmias, angina, pulmonary edema, pulmonary embolism, and myocardial infarction.
Gastrointestinal
Gastrointestinal side effects have included constipation (7%), anorexia (3% to 6%), nausea and vomiting (5%), weight loss, flatulence, dyspepsia, and weight gain.
Dermatologic
Dermatologic side effects have included skin rash (7%), acne, dry skin, ecchymosis, hair loss (up to 18% of females), pruritus, photosensitivity, clamminess, night sweats, increased sweating, and skin pigmentation.
Musculoskeletal
An initial increase in testosterone levels may occur during the first 2 weeks of therapy with leuprolide. An increase in bone pain, as well as worsening of other signs and symptoms of advanced prostate cancer, may be noted during this time period.
Hypoestrogenism induced by leuprolide may result in small losses in bone density. Prolonged use of leuprolide in females may increase the risk of osteoporosis.
Musculoskeletal side effects have included increased bone pain in patients with advanced prostate cancer, myalgias, arthralgias, muscle atrophy, limb pain, lower bone density scores, and tenosynovitis-like symptoms. A case of polymyositis and a case of noninflammatory myopathy have also been reported.
Hypersensitivity
A case of anaphylaxis after a single intramuscular injection of leuprolide depot is reported in the literature. On two occasions, 24 hours and 6 weeks after injection, the patient required emergency airway management. The patient continued to require regular doses of antihistamines and intermittent epinephrine injections up to 14 weeks after leuprolide administration.
Hypersensitivity reactions have included a rare report of urticaria, shortness of breath, and anaphylaxis with the depot form. Other reports of anaphylactic reactions to synthetic GnRH or GnRH agonist analogs have also been reported in the medical literature.
Hematologic
Hematologic side effects have included anemia, leukopenia, and hemoptysis.
Respiratory
Respiratory side effects have included dyspnea, sinus congestion, cough, pleural rub, and pulmonary fibrosis.
Local
Local side effects have included erythema, ecchymosis, induration, abscess, and irritation at the site of injection.
Oncologic
Oncologic side effects have been reported including case reports of granulomas. Animal studies including an increase in benign pituitary hyperplasia and benign pituitary adenomas, an increase of pancreatic islet cell adenomas in females, and an increase of testicular cell adenomas in males have also been reported.
Other
Other side effects including symptoms consistent with fibromyalgia (e.g., joint and muscle pain, headaches, sleep disorders, gastrointestinal distress, and shortness of breath) have been reported. Hearing disorder, hard nodule in throat, weight gain, and increased uric acid have also been reported.
Hepatic
Hepatic side effects including hepatic dysfunction have been reported.
General
General side effects including sweating, syncope, rigors, weakness, and lethargy have been reported.
Renal
Renal side effects have included difficulties with urination, pain on urination, scanty urination, bladder spasm, blood in urine, urinary retention, urinary urgency, incontinence, nocturia, and aggravated nocturia.
Metabolic
Metabolic side effects have included hyperglycemia.
TopMore Eligard resources
- Eligard Prescribing Information (FDA)
- Eligard Advanced Consumer (Micromedex) - Includes Dosage Information
- Eligard Consumer Overview
- Eligard Kit MedFacts Consumer Leaflet (Wolters Kluwer)
- Leuprolide Prescribing Information (FDA)
- Leuprolide MedFacts Consumer Leaflet (Wolters Kluwer)
- Leuprolide Acetate Monograph (AHFS DI)
- Lupron Consumer Overview
- Lupron Depot Prescribing Information (FDA)
- Lupron Depot MedFacts Consumer Leaflet (Wolters Kluwer)
- Lupron Depot-PED Prescribing Information (FDA)
- Lupron Depot-PED Kit MedFacts Consumer Leaflet (Wolters Kluwer)
- Viadur Prescribing Information (FDA)
- Viadur Implant MedFacts Consumer Leaflet (Wolters Kluwer)
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