This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Lupron (Leuprolide) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.
Reports by Event Outcome
All Cases (101)
Death (2)
Life Threatening Events (2)
Disability (7)
Reports by Reaction Type
Headache (21),
Fatigue (14),
Hot Flush (12),
Pain (9),
Night Sweats (8),
Abortion Spontaneous (8),
Back Pain (8),
Dyspnoea (8),
Arthralgia (8),
Bone Pain (7),
Pain in Extremity (7),
Abdominal Pain Upper (6)
Below are a few examples of reports where side effects / adverse reactions may be related to Lupron (Leuprolide). For a complete list or a specific selection of reports, please use the links above.
Possible Lupron side effects in
Reported by a physician from United States on 2012-08-21
Patient:
Reactions: Headache, Papilloedema
Drug(s) suspected as cause:
Lupron
Possible Lupron side effects in
Reported by a individual with unspecified qualification from United States on 2012-08-10
Patient:
Reactions: Pain in Extremity, NO Therapeutic Response, Paralysis, Hypoaesthesia, Neoplasm
Adverse event resulted in: hospitalization, disablity
Drug(s) suspected as cause:
Lupron
Possible Lupron side effects in 9 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-09
Patient: 9 year old male
Reactions: Glossodynia, Tongue Discolouration
Drug(s) suspected as cause:
Lupron
Possible Lupron side effects in 51 year old female
Reported by a consumer/non-health professional from United States on 2012-08-03
Patient: 51 year old female, weighing 49.9 kg (109.8 pounds)
Reactions: Night Sweats, Loss of Consciousness, Joint Stiffness, Weight Increased, Hot Flush, Fatigue, Malaise, Musculoskeletal Stiffness, Dizziness, Chest Discomfort, Dyspnoea, Tremor, Syncope, Arthralgia, Heart Rate Increased, Feeling Abnormal, Hypertension, Asthenia, Blood Pressure Fluctuation
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Lupron
Other drugs received by patient: Atenolol; Lisinopril; Hydrochlorothiazide; Ibuprofen
Possible Lupron side effects in 84 year old male
Reported by a health professional (non-physician/pharmacist) from Germany on 2012-07-27
Patient: 84 year old male
Reactions: Coronary Artery Disease, Myocardial Infarction
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Lupron
Possible Lupron side effects in male
Reported by a physician from United States on 2012-07-26
Patient: male, weighing 43.1 kg (94.9 pounds)
Reactions: Syncope, Excoriation, Head Injury, Fall, Abdominal Pain Upper, Decreased Appetite, Hypersomnia
Drug(s) suspected as cause:
Lupron
Other drugs received by patient: Zyrtec
Possible Lupron side effects in male
Reported by a physician from United States on 2012-07-23
Patient: male, weighing 74.4 kg (163.6 pounds)
Reactions: Abdominal Pain, Contusion, Cyst, Oropharyngeal Pain, Chronic Obstructive Pulmonary Disease, Animal Bite, Melanocytic Naevus, Blood Creatinine Increased, Arteriosclerosis, Back Pain, Fistula, Hypotension, Haematuria, Osteopenia, Osteitis, Occult Blood Positive, Seasonal Allergy, Diverticulum, Compression Fracture, Neutropenia, Rectal Haemorrhage, Upper-Airway Cough Syndrome, Fall, Sinus Bradycardia, Abdominal Pain Upper, Hypercholesterolaemia, Hyperparathyroidism, Oedema, Bone Disorder, Depression, Myocardial Infarction, Cerebellar Infarction, Lung Disorder, JAW Disorder, Weight Decreased, Night Sweats, Abdominal Hernia, Goitre, Osteomyelitis, Headache, Nocturia, Erectile Dysfunction, Obstructive Uropathy, Pulmonary Granuloma, Gynaecomastia, Loss of Consciousness, Colonic Polyp, Hypoaesthesia Oral, Dyspepsia, Irritable Bowel Syndrome, Epistaxis, Thyroid Cancer, Pain in Extremity, Anaemia, Gingival Disorder, Benign Prostatic Hyperplasia, Osteomalacia, Retinal Ischaemia, Renal Cyst, Gastric Disorder, Cholelithiasis, Sleep Apnoea Syndrome, Gastroduodenitis, Bedridden, Tooth Abscess, Bone Pain, Pain, JAW Fracture, Constipation, Mania, Nephrolithiasis, Bone Scan Abnormal, Dizziness, Bacterial Infection, Chronic Sinusitis, Urine Output, Cholecystitis, RIB Fracture, Oral Discharge, Swelling Face, Nausea, Bone Lesion, Haemoptysis, Urinary Tract Infection, Drug Hypersensitivity, Atrial Fibrillation, Cystitis, Onychomycosis, Renal Failure Chronic, Cerebrovascular Accident, Blood Parathyroid Hormone Increased, Renal Failure, Osteonecrosis of JAW, Dysuria, Spinal Osteoarthritis, Parathyroid Tumour Benign, Hypertension, Blindness, Deep Vein Thrombosis, Infection
Drug(s) suspected as cause:
Aredia
Dosage: 120 mg, qmo
Indication: Osteoporosis
Start date: 1999-01-01
End date: 2006-05-26
Lupron
Dosage: 7.5 mg,
Indication: Prostate Cancer
Start date: 1997-04-22
Zometa
Dosage: 4 mg, qw3
Indication: Osteoporosis
Start date: 2001-12-20
Other drugs received by patient: Cardura; Fosamax; Zocor; Cymbalta; Aggrenox; Celebrex; Carboplatin; Zoloft; Ditropan / USA /; Lipitor; Clindamycin; Ketoconazole; Lovenox; Antiinflammatory / Antirheumatic NON-Steroids; Flutamide; Amitiza; Percocet; Vitamin B6; Lyrica; Prednisone; Lorazepam; Fentanyl Citrate; Taxotere; Potassium Chloride; Thalidomide; Vitamin D; Leukine; Viagra; Citracal; Aspirin; Vioxx; Neurontin; Revlimid; Zetia; Taxol; Proscar; Decadron; Chemotherapeutics NOS; Hydrocodone; Trelstar LA; Neulasta; Nexium; Digoxin
Possible Lupron side effects in male
Reported by a consumer/non-health professional from United States on 2012-07-20
Patient: male
Reactions: Tricuspid Valve Incompetence, Hot Flush, Oedema Peripheral, Back Pain, Subcutaneous Haematoma, Lymphadenopathy Mediastinal, Left Atrial Dilatation, Neutropenia, Inguinal Hernia, Exposed Bone in JAW, Abdominal Pain Upper, Hypercholesterolaemia, Anhedonia, Aortic Arteriosclerosis, Chest Pain, Hilar Lymphadenopathy, Rotator Cuff Syndrome, Injury, Myocardial Infarction, Hyperhomocysteinaemia, Dyspnoea, Mass, Haemorrhoids, Musculoskeletal Pain, Diastolic Dysfunction, Pulmonary Valve Incompetence, Oral Pain, Arthralgia, Mitral Valve Incompetence, DRY Eye, Disability, Leukopenia, Night Sweats, Gastrointestinal Haemorrhage, Pulmonary Embolism, Headache, Erectile Dysfunction, Hypocalcaemia, Radiculopathy, Pathological Fracture, Muscle Spasms, Blood Alkaline Phosphatase Increased, Actinic Keratosis, Intervertebral Disc Protrusion, Pain in Extremity, Anaemia, Eye Inflammation, Hypoaesthesia, Paraesthesia, Spinal Column Stenosis, Dyslipidaemia, Pain, Bone Pain, Periodontitis, Haemorrhoidal Haemorrhage, Synovial Cyst, Fatigue, Skin Cancer, Nerve Root Lesion, Intervertebral Disc Degeneration, Pain in JAW, Bone Lesion, Varicose Vein, Homocystinaemia, Hyperlipidaemia, Osteoarthritis, Anxiety, Neoplasm Malignant, Osteonecrosis of JAW, Suture Related Complication, Pulmonary Thrombosis, Infection
Drug(s) suspected as cause:
Lupron
Zometa
Dosage: 4 mg, monthly
Indication: Prostate Cancer
Start date: 2006-03-01
End date: 2009-03-01
Zometa
Indication: Osteoporosis
Other drugs received by patient: Trelstar; Prednisone TAB; Metoprolol Succinate; Simvastatin; Pepcid; Lunesta; Amoxicillin; Oxycontin; Neulasta; Foltx; Toradol; Lipitor; Warfarin Sodium; Flexeril; Lopressor; Megestrol Acetate; Taxotere; Aspirin; Peridex; Dolasetron; Radiation Therapy; PEN-VEE K; Darvocet-N 50; Casodex; Aloxi; Diclofenac; Percocet; Chemotherapeutics
Possible Lupron side effects in male
Reported by a consumer/non-health professional from United States on 2012-07-19
Patient: male, weighing 83.5 kg (183.6 pounds)
Reactions: Night Sweats, Fatigue, Neuropathy Peripheral, Prostatic Specific Antigen Increased, Glucose Tolerance Impaired, Hypersomnia
Drug(s) suspected as cause:
Lupron
Indication: Product Used FOR Unknown Indication
Start date: 2012-01-01
Zytiga
Administration route: Oral
Indication: Prostate Cancer Metastatic
Start date: 2012-01-01
Other drugs received by patient: Allopurinol; Vivelle-DOT; Lupron; Losartan Potassium; Prevacid; Prednisone
Possible Lupron side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-13
Patient: male, weighing 81.5 kg (179.3 pounds)
Reactions: Thrombosis, Femur Fracture, Pain in Extremity, Fatigue, Malaise, Connective Tissue Disorder, Neoplasm Malignant, Ureteric Obstruction, Musculoskeletal Disorder, Thrombocytopenia, Renal Failure Acute
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Lupron
Samarium
Dosage: 86.9 mg, unk
Indication: Prostate Cancer
Start date: 2010-12-30
End date: 2010-12-30
Zoledronoc Acid
Dosage: 4 mg, qmo
Indication: Prostate Cancer
Start date: 2011-01-12
End date: 2011-01-12
Zoledronoc Acid
Dosage: 4 mg, unk
Start date: 2012-06-20
End date: 2012-06-20
Other drugs received by patient: Coreg; Aspirin; Coenzyme Q10; Multi-Vitamin; Naproxen; Zocor; Fish OIL; Caltrate 600 + Vitamin D; Levothroid; Vitamin D; Calcium; Lotrel; Glucosamine; Simvastatin; Metamucil-2
Possible Lupron side effects in female
Reported by a physician from United States on 2012-07-12
Patient: female, weighing 83.9 kg (184.6 pounds)
Reactions: Pain, Joint Effusion, Arthritis
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Lupron
Possible Lupron side effects in 64 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-02
Patient: 64 year old male, weighing 72.7 kg (160.0 pounds)
Reactions: Dyspnoea, Muscular Weakness
Adverse event resulted in: hospitalization, disablity
Drug(s) suspected as cause:
Lupron
Possible Lupron side effects in male
Reported by a consumer/non-health professional from United States on 2012-07-02
Patient: male, weighing 83.5 kg (183.6 pounds)
Reactions: Night Sweats, Fatigue, Neuropathy Peripheral, Prostatic Specific Antigen Increased, Glucose Tolerance Impaired, Hypersomnia
Drug(s) suspected as cause:
Lupron
Indication: Product Used FOR Unknown Indication
Start date: 2012-01-01
Zytiga
Administration route: Oral
Indication: Prostate Cancer Metastatic
Start date: 2012-01-01
Other drugs received by patient: Prevacid; Prednisone TAB; Vivelle-DOT; Allopurinol; Lupron; Losartan Potassium
Possible Lupron side effects in male
Reported by a physician from United States on 2012-06-27
Patient: male
Reactions: Tricuspid Valve Incompetence, Hot Flush, Oedema Peripheral, Back Pain, Subcutaneous Haematoma, Lymphadenopathy Mediastinal, Left Atrial Dilatation, Neutropenia, Inguinal Hernia, Exposed Bone in JAW, Abdominal Pain Upper, Hypercholesterolaemia, Anhedonia, Chest Pain, Aortic Arteriosclerosis, Rotator Cuff Syndrome, Hilar Lymphadenopathy, Injury, Myocardial Infarction, Hyperhomocysteinaemia, Dyspnoea, Mass, Musculoskeletal Pain, Haemorrhoids, Diastolic Dysfunction, Pulmonary Valve Incompetence, Oral Pain, Arthralgia, Mitral Valve Incompetence, DRY Eye, Leukopenia, Disability, Night Sweats, Gastrointestinal Haemorrhage, Pulmonary Embolism, Headache, Erectile Dysfunction, Hypocalcaemia, Pathological Fracture, Radiculopathy, Muscle Spasms, Actinic Keratosis, Intervertebral Disc Protrusion, Blood Alkaline Phosphatase Increased, Pain in Extremity, Anaemia, Eye Inflammation, Hypoaesthesia, Paraesthesia, Spinal Column Stenosis, Dyslipidaemia, Pain, Bone Pain, Periodontitis, Haemorrhoidal Haemorrhage, Fatigue, Nerve Root Lesion, Skin Cancer, Intervertebral Disc Degeneration, Pain in JAW, Bone Lesion, Homocystinaemia, Varicose Vein, Hyperlipidaemia, Osteoarthritis, Anxiety, Osteonecrosis of JAW, Neoplasm Malignant, Suture Related Complication, Pulmonary Thrombosis, Infection
Drug(s) suspected as cause:
Lupron
Zometa
Indication: Osteoporosis
Zometa
Dosage: 4 mg, monthly
Indication: Prostate Cancer
Start date: 2006-03-01
End date: 2009-03-01
Other drugs received by patient: Prednisone TAB; Foltx; Megestrol Acetate; Aloxi; Metoprolol Tartrate; Lunesta; Peridex; Lipitor; Radiation Therapy; Taxotere; Simvastatin; Amoxicillin; Casodex; Neulasta; Pepcid; Flexeril; Warfarin Sodium; Toradol; Aspirin; Darvocet-N 50; Diclofenac Sodium; Percocet; Dolasetron; Chemotherapeutics; Trelstar; PEN-VEE K; Lopressor; Oxycontin
Possible Lupron side effects in 31 year old female
Reported by a consumer/non-health professional from United States on 2012-06-19
Patient: 31 year old female
Reactions: Maternal Exposure During Pregnancy, Abortion Spontaneous
Drug(s) suspected as cause:
Lovenox
Start date: 2011-01-01
Lupron
Possible Lupron side effects in 31 year old female
Reported by a consumer/non-health professional from United States on 2012-06-08
Patient: 31 year old female
Reactions: Abortion Spontaneous
Drug(s) suspected as cause:
Lovenox
Indication: Product Used FOR Unknown Indication
Lupron
Indication: Product Used FOR Unknown Indication
Start date: 2011-01-01
Possible Lupron side effects in 31 year old female
Reported by a consumer/non-health professional from United States on 2012-06-08
Patient: 31 year old female
Reactions: Maternal Exposure During Pregnancy, Abortion Spontaneous
Drug(s) suspected as cause:
Lovenox
Indication: Product Used FOR Unknown Indication
Lupron
Indication: Product Used FOR Unknown Indication
Start date: 2011-01-01
Possible Lupron side effects in 31 year old female
Reported by a consumer/non-health professional from United States on 2012-06-08
Patient: 31 year old female
Reactions: Abortion Spontaneous
Drug(s) suspected as cause:
Lovenox
Indication: Product Used FOR Unknown Indication
Lupron
Indication: Product Used FOR Unknown Indication
Start date: 2011-01-01
Possible Lupron side effects in 31 year old female
Reported by a consumer/non-health professional from United States on 2012-06-08
Patient: 31 year old female
Reactions: Abortion Spontaneous
Drug(s) suspected as cause:
Lupron
Possible Lupron side effects in male
Reported by a consumer/non-health professional from United States on 2012-06-04
Patient: male
Reactions: Fatigue, Dizziness, Headache, Somnolence, Decreased Appetite
Drug(s) suspected as cause:
Lupron
Possible Lupron side effects in 33 year old female
Reported by a health professional (non-physician/pharmacist) from China on 2012-06-04
Patient: 33 year old female
Reactions: Dyspnoea, Cyanosis, Hypophagia, Abdominal Distension, Pallor
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Lupron
Indication: Haemorrhagic Ovarian Cyst
Start date: 2012-05-16
Lupron
Indication: Uterine Leiomyoma
Possible Lupron side effects in 77 year old male
Reported by a health professional (non-physician/pharmacist) from Germany on 2012-05-25
Patient: 77 year old male
Reactions: Upper Limb Fracture
Drug(s) suspected as cause:
Leuprolide Acetate
Indication: Prostate Cancer
Start date: 2003-01-09
Leuprolide Acetate
Indication: Prostate Cancer
Start date: 2009-10-14
Lupron
Indication: Prostate Cancer
Start date: 2002-06-06
Possible Lupron side effects in 56 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-24
Patient: 56 year old male
Reactions: Hypoaesthesia
Drug(s) suspected as cause:
Lupron
Possible Lupron side effects in male
Reported by a consumer/non-health professional from United States on 2012-05-22
Patient: male, weighing 43.1 kg (94.9 pounds)
Reactions: Excoriation, Head Injury, Fall, Loss of Consciousness, Decreased Appetite, Abdominal Pain Upper, Hypersomnia
Drug(s) suspected as cause:
Lupron
Other drugs received by patient: Zyrtec
Possible Lupron side effects in male
Reported by a physician from United States on 2012-05-18
Patient: male, weighing 66.7 kg (146.8 pounds)
Reactions: Weight Decreased, Abdominal Pain, Vomiting, Lymphadenopathy, Nausea, Oropharyngeal Pain, Hepatitis, Eosinophilia, Malaise, Decreased Appetite
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Lupron
Other drugs received by patient: NO Drugs Reported
Possible Lupron side effects in male
Reported by a physician from France on 2012-05-15
Patient: male
Reactions: Anaemia
Drug(s) suspected as cause:
Lupron
Other drugs received by patient: Orocal D3; Zestril; Amlodipine Besylate
Possible Lupron side effects in 77 year old male
Reported by a health professional (non-physician/pharmacist) from Germany on 2012-05-14
Patient: 77 year old male
Reactions: Upper Limb Fracture
Drug(s) suspected as cause:
Leuprolide Acetate
Indication: Prostate Cancer
Start date: 2003-01-09
Leuprolide Acetate
Indication: Prostate Cancer
Start date: 2009-10-14
Lupron
Indication: Prostate Cancer
Start date: 2002-06-06
Possible Lupron side effects in 45 year old female
Reported by a consumer/non-health professional from United States on 2012-05-10
Patient: 45 year old female, weighing 59.4 kg (130.7 pounds)
Reactions: Fibromyalgia, Quality of Life Decreased
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Lupron
Dosage: injection 1 time a month im
Indication: Endometriosis
Start date: 2003-11-26
End date: 2004-02-28
Lupron
Dosage: injection 1 time a month im
Indication: Endometriosis
Start date: 2003-10-28
End date: 2004-12-28
Possible Lupron side effects in male
Reported by a health professional (non-physician/pharmacist) from Germany on 2012-05-01
Patient: male
Reactions: Cerebrovascular Accident
Adverse event resulted in: life threatening event, hospitalization, disablity
Drug(s) suspected as cause:
Lupron
Indication: Transitional Cell Carcinoma
Lupron
Indication: Prostate Cancer Metastatic
Start date: 2012-01-09
Possible Lupron side effects in 26 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-04-30
Patient: 26 year old female
Reactions: Abortion Spontaneous
Drug(s) suspected as cause:
Chorionic Gonadotropin
Indication: Ovulation Induction
Lupron
Indication: Ovulation Induction
Pergonal (Menotropin FOR Injection, Usp)
Indication: Ovulation Induction
Recombinant Human Follicle-Stimulating Hormone (R-Hfsh)
Indication: Ovulation Induction
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