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Lupron (Leuprolide) - Side Effect Reports to FDA

 
 



Index of reports > All Cases (101)

Below is the selection of side effect reports (a.k.a. adverse event reports) related to Lupron (Leuprolide) all cases. The selected reports were submitted to the FDA during the sample period of about a year.

 Reports 1 - 30 of 101   Next >>

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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