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Lupron Depot (Leuprolide) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Lupron Depot (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 (1464)
Death (145)
Life Threatening Events (8)
Disability (19)

Reports by Reaction Type

Hot Flush (180)Headache (155)Nausea (78)Pain (77)Arthralgia (77)Fatigue (64)Death (62)Prostate Cancer Metastatic (59)Dizziness (58)Insomnia (58)Asthenia (56)Drug Ineffective (49)

Below are a few examples of reports where side effects / adverse reactions may be related to Lupron Depot (Leuprolide). For a complete list or a specific selection of reports, please use the links above.

Possible Lupron Depot side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27

Patient: female

Reactions: Abdominal Pain, Nausea

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lupron Depot



Possible Lupron Depot side effects in male

Reported by a physician from Canada on 2012-08-24

Patient: male, weighing 85.8 kg (188.8 pounds)

Reactions: Malaise, Myocardial Infarction

Adverse event resulted in: death

Drug(s) suspected as cause:
Lupron Depot



Possible Lupron Depot side effects in male

Reported by a physician from Canada on 2012-08-24

Patient: male, weighing 85.8 kg (188.8 pounds)

Reactions: Malaise, Myocardial Infarction

Adverse event resulted in: death

Drug(s) suspected as cause:
Lupron Depot



Possible Lupron Depot side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: female

Reactions: Pneumonia, Pneumothorax

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lupron Depot



Possible Lupron Depot side effects in female

Reported by a physician from United States on 2012-08-24

Patient: female, weighing 63.6 kg (139.8 pounds)

Reactions: Cholelithiasis, Weight Decreased, Anxiety, Nausea, Depression, Decreased Appetite

Drug(s) suspected as cause:
Lupron Depot

Other drugs received by patient: Norethindrone Acetate



Possible Lupron Depot side effects in male

Reported by a physician from United States on 2012-08-24

Patient: male

Reactions: Colon Neoplasm

Drug(s) suspected as cause:
Lupron Depot



Possible Lupron Depot side effects in

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-08-24

Patient:

Reactions: Tinnitus, Deafness

Drug(s) suspected as cause:
Lupron Depot



Possible Lupron Depot side effects in 37 year old female

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: 37 year old female, weighing 62.1 kg (136.7 pounds)

Reactions: Night Sweats, Anxiety, Hot Flush, Disturbance in Attention, Pollakiuria, Memory Impairment, Depression

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Lupron Depot



Possible Lupron Depot side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: female, weighing 38.6 kg (84.9 pounds)

Reactions: Personality Change, Abdominal Operation, Obsessive-Compulsive Disorder, Endometriosis, Anaemia, Partner Stress, Ovarian Cyst, Hysterectomy, Anorexia Nervosa, Abdominal Distension, Mental Disorder, Mood Swings

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lupron Depot



Possible Lupron Depot side effects in male

Reported by a consumer/non-health professional from Canada on 2012-08-24

Patient: male, weighing 72.6 kg (159.8 pounds)

Reactions: Femur Fracture, Osteoporosis, Embolism, Urinary Tract Infection, Fall

Drug(s) suspected as cause:
Lupron Depot



Possible Lupron Depot side effects in male

Reported by a physician from Canada on 2012-08-24

Patient: male, weighing 71.7 kg (157.8 pounds)

Reactions: Night Sweats, Confusional State, Weight Decreased, Lymphadenopathy, Pain, Constipation, Pallor, Groin Pain, Joint Destruction, Weight Bearing Difficulty, Fatigue, Malaise, Liver Function Test Abnormal, Prostate Cancer Metastatic, Decreased Appetite, Back Pain, Pain in Extremity, Muscular Weakness, General Physical Health Deterioration, Euphoric Mood, Diarrhoea, Joint Swelling, Arthralgia, Gait Disturbance, Neuralgia, Mobility Decreased

Adverse event resulted in: death

Drug(s) suspected as cause:
Lupron Depot

Other drugs received by patient: Casodex; Crestor; Micardis



Possible Lupron Depot side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient: male, weighing 61.3 kg (134.8 pounds)

Reactions: Prostatic Specific Antigen Increased, Prostate Cancer Metastatic, Metastases To Bone

Adverse event resulted in: death

Drug(s) suspected as cause:
Lupron Depot

Other drugs received by patient: Marinol; Vicodin; Promethazine; Ondansetron; Unknown Chemotherapy; Gleevec; Bicaltamide; Exgeva



Possible Lupron Depot side effects in female

Reported by a physician from United States on 2012-08-23

Patient: female

Reactions: Vaginal Haemorrhage

Drug(s) suspected as cause:
Lupron Depot

Other drugs received by patient: Egestin



Possible Lupron Depot side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient: female

Reactions: Muscle Strain, Asthma, Oxygen Saturation Decreased, Cough

Drug(s) suspected as cause:
Lupron Depot

Other drugs received by patient: Fluticasone Propionate



Possible Lupron Depot side effects in female

Reported by a physician on 2012-08-23

Patient: female, weighing 40.9 kg (89.9 pounds)

Reactions: Death, Asphyxia

Adverse event resulted in: death

Drug(s) suspected as cause:
Lupron Depot
    Indication: Prophylaxis

Lupron Depot
    Indication: Precocious Puberty
    Start date: 2011-03-28
    End date: 2012-05-25

Lupron Depot
    Indication: Puberty

Other drugs received by patient: Miralax; Benefiber; Keppra; Clonidine HCL; Lamictal; Klonopin; Somatropin Rdna; Depakene; Melatonin; Topamax



Possible Lupron Depot side effects in male

Reported by a consumer/non-health professional from Canada on 2012-08-23

Patient: male, weighing 56.8 kg (124.9 pounds)

Reactions: Death, Prostate Cancer Metastatic, Abasia

Adverse event resulted in: death

Drug(s) suspected as cause:
Lupron Depot



Possible Lupron Depot side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient: female, weighing 81.7 kg (179.8 pounds)

Reactions: Asthma, Dyspnoea, Pharyngeal Oedema, Parosmia, Throat Tightness

Drug(s) suspected as cause:
Lupron Depot
    Indication: Endometriosis
    Start date: 2010-07-01
    End date: 2010-12-01

Unknown Chemical Agents
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Methotrexate; Meloxicam; Plaquenil; Calcium with Vitamin D; Multivitamin; Folic Acid



Possible Lupron Depot side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-22

Patient: female

Reactions: Myalgia, Neuralgia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lupron Depot

Other drugs received by patient: Dicyclomine; Vicodin; Aciphex; Xanax; Tylenol



Possible Lupron Depot side effects in female

Reported by a physician from United States on 2012-08-22

Patient: female

Reactions: Hospitalisation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lupron Depot



Possible Lupron Depot side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-22

Patient: male

Reactions: Visual Impairment, Vision Blurred, Deafness, Headache, DRY Eye

Drug(s) suspected as cause:
Lupron Depot



Possible Lupron Depot side effects in male

Reported by a consumer/non-health professional from Canada on 2012-08-22

Patient: male, weighing 56.8 kg (124.9 pounds)

Reactions: Death, Abasia, Metastases To Bone

Adverse event resulted in: death

Drug(s) suspected as cause:
Lupron Depot



Possible Lupron Depot side effects in male

Reported by a pharmacist from United States on 2012-08-21

Patient: male

Reactions: Injection Site Abscess Sterile

Drug(s) suspected as cause:
Lupron Depot



Possible Lupron Depot side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-20

Patient: male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Lupron Depot



Possible Lupron Depot side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-20

Patient: female

Reactions: Mammoplasty

Drug(s) suspected as cause:
Lupron Depot



Possible Lupron Depot side effects in male

Reported by a physician from Canada on 2012-08-20

Patient: male, weighing 71.7 kg (157.8 pounds)

Reactions: Confusional State, Weight Decreased, Night Sweats, Lymphadenopathy, Pain, Pallor, Constipation, Joint Destruction, Groin Pain, Weight Bearing Difficulty, Fatigue, Malaise, Liver Function Test Abnormal, Prostate Cancer Metastatic, Decreased Appetite, Back Pain, Pain in Extremity, General Physical Health Deterioration, Muscular Weakness, Euphoric Mood, Joint Swelling, Diarrhoea, Arthralgia, Gait Disturbance, Neuralgia, Mobility Decreased

Adverse event resulted in: death

Drug(s) suspected as cause:
Lupron Depot

Other drugs received by patient: Casodex; Micardis; Crestor



Possible Lupron Depot side effects in male

Reported by a health professional (non-physician/pharmacist) from Canada on 2012-08-20

Patient: male, weighing 69.9 kg (153.8 pounds)

Reactions: Gastrointestinal Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lupron Depot



Possible Lupron Depot side effects in 84 year old male

Reported by a physician from Canada on 2012-08-17

Patient: 84 year old male

Reactions: Osteoarthritis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lupron Depot



Possible Lupron Depot side effects in male

Reported by a physician from Canada on 2012-08-17

Patient: male

Reactions: Respiratory Failure, Disease Progression, Metastases To Lung

Adverse event resulted in: death

Drug(s) suspected as cause:
Lupron Depot



Possible Lupron Depot side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-16

Patient: female, weighing 81.7 kg (179.8 pounds)

Reactions: Laparoscopy, Abdominal Pain, Abdominal Distension, Vaginal Haemorrhage

Drug(s) suspected as cause:
Lupron Depot
    Indication: Endometriosis
    Start date: 2012-07-25

Lupron Depot
    Start date: 2006-06-01

Other drugs received by patient: Multi-Vitamin



Possible Lupron Depot side effects in male

Reported by a physician from United States on 2012-08-15

Patient: male

Reactions: Weight Decreased, Hospitalisation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lupron Depot

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