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Eligard (Leuprolide) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Eligard (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 (37)
Death (1)
Disability (1)

Reports by Reaction Type

Prostatic Specific Antigen Increased (6)Pulmonary Embolism (5)Pain (4)Fatigue (4)Asthenia (4)Haemorrhage (3)Disease Progression (3)Diabetes Mellitus (2)Infection (2)Hot Flush (2)Phimosis (2)Spinal Compression Fracture (2)

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

Possible Eligard side effects in male

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

Patient: male

Reactions: Prostatic Specific Antigen Increased, Fatigue, Neoplasm Malignant, Bone Pain, DRY Mouth, Neoplasm Progression, Asthenia, Terminal State

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Eligard
    Dosage: unk ukn, unk

Zometa
    Dosage: 4 mg/5 ml 1x per 28 days
    Start date: 2012-04-18

Zometa
    Dosage: 4 mg/5 ml 1x per 28 days
    Start date: 2012-07-13

Zometa
    Dosage: 4 mg/5 ml 1x per 28 days
    Start date: 2011-09-13

Zometa
    Dosage: 4 mg/5 ml 1x per 28 days
    Start date: 2012-05-16

Zometa
    Dosage: 4 mg/5 ml 1x per 28 days
    Start date: 2011-07-19

Zometa
    Dosage: 4 mg/5 ml 1x per 28 days
    Start date: 2011-08-16

Zometa
    Dosage: 4 mg/5 ml 1x per 28 days
    Indication: Prostate Cancer
    Start date: 2011-04-22

Zometa
    Dosage: 4 mg/5 ml 1x per 28 days
    Start date: 2012-06-15

Zometa
    Dosage: 4 mg/5 ml 1x per 28 days
    Start date: 2011-10-10

Other drugs received by patient: Bicalutamide; Diclofenac Sodium; Diazepam; Pantoprazole; Naproxen



Possible Eligard side effects in male

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

Patient: male, weighing 105.0 kg (231.0 pounds)

Reactions: Diabetes Mellitus, Abscess Oral, Pain, Disease Progression

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Eligard



Possible Eligard side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-14

Patient:

Reactions: Haemorrhage

Drug(s) suspected as cause:
Eligard



Possible Eligard side effects in male

Reported by a health professional (non-physician/pharmacist) from Netherlands on 2012-08-13

Patient: male

Reactions: Prostatic Specific Antigen Increased, Fatigue, DRY Mouth, Bone Pain, Asthenia, Terminal State

Drug(s) suspected as cause:
Eligard
    Dosage: unk ukn, unk

Zometa
    Dosage: 4 mg/5 ml 1x per 28 days
    Indication: Prostate Cancer
    Start date: 2011-04-22

Zometa
    Dosage: 4 mg/5 ml 1x per 28 days
    Start date: 2012-07-13

Zometa
    Dosage: 4 mg/5 ml 1x per 28 days
    Start date: 2011-09-13

Zometa
    Dosage: 4 mg/5 ml 1x per 28 days
    Start date: 2011-07-19

Zometa
    Dosage: 4 mg/5 ml 1x per 28 days
    Start date: 2011-08-16

Zometa
    Dosage: 4 mg/5 ml 1x per 28 days
    Start date: 2012-04-18

Zometa
    Dosage: 4 mg/5 ml 1x per 28 days
    Start date: 2012-05-16

Zometa
    Dosage: 4 mg/5 ml 1x per 28 days
    Start date: 2011-10-10

Zometa
    Dosage: 4 mg/5 ml 1x per 28 days
    Start date: 2012-06-15

Other drugs received by patient: Diazepam; Bicalutamide; Pantoprazole; Diclofenac; Naproxen



Possible Eligard side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-03

Patient: male, weighing 70.8 kg (155.8 pounds)

Reactions: Hypersensitivity, Pruritus, Skin Burning Sensation

Drug(s) suspected as cause:
Eligard
    Indication: Prostate Cancer

Niaspan
    Administration route: Oral
    Indication: LOW Density Lipoprotein Increased

Other drugs received by patient: Gentavin; Vitamin D; Coumadin; Calcium; Simvastatin



Possible Eligard side effects in male

Reported by a consumer/non-health professional from Germany on 2012-07-20

Patient: male, weighing 105.0 kg (231.0 pounds)

Reactions: Diabetes Mellitus, Abscess Oral, Pain, Disease Progression

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Eligard



Possible Eligard side effects in 74 year old male

Reported by a physician from Czech Republic on 2012-07-06

Patient: 74 year old male, weighing 110.0 kg (242.0 pounds)

Reactions: Pulmonary Embolism

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Casodex
    Administration route: Oral
    Indication: Prostate Cancer
    Start date: 2010-05-27
    End date: 2010-06-27

Eligard
    Indication: Prostate Cancer
    Start date: 2010-05-27
    End date: 2010-05-27

Eligard
    Start date: 2011-07-19
    End date: 2011-07-19

Other drugs received by patient: Antihypertensives



Possible Eligard side effects in 72 year old male

Reported by a physician from United States on 2012-06-22

Patient: 72 year old male

Reactions: Spinal Compression Fracture

Drug(s) suspected as cause:
Eligard



Possible Eligard side effects in 72 year old male

Reported by a physician from United States on 2012-06-18

Patient: 72 year old male

Reactions: Spinal Compression Fracture

Drug(s) suspected as cause:
Eligard



Possible Eligard side effects in male

Reported by a consumer/non-health professional from Germany on 2012-06-11

Patient: male, weighing 75.0 kg (165.0 pounds)

Reactions: Catheter Placement, Haemorrhage, Anastomotic Complication, Pain, Symphysiolysis, Abscess, Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Eligard
    Start date: 2011-07-19

Eligard
    Start date: 2011-10-11

Eligard
    Start date: 2011-04-12

Other drugs received by patient: Carvedilol; Torsemide; Enalapril Maleate; Therapeutic Radiopharmaceuticals; Digimerck; Marcumar; Hydrochlorothiazide



Possible Eligard side effects in 74 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-21

Patient: 74 year old male, weighing 99.8 kg (219.5 pounds)

Reactions: Product Quality Issue, Prostatic Specific Antigen Increased, Blood Testosterone Increased

Drug(s) suspected as cause:
Eligard
    Start date: 2011-12-02
    End date: 2011-12-02

Eligard
    Indication: Prostate Cancer
    Start date: 2012-01-02
    End date: 2012-01-02

Other drugs received by patient: Casodex; Omeprazole; Quinapril



Possible Eligard side effects in 66 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-11

Patient: 66 year old male

Reactions: Lymphadenopathy, Fatigue, Prostatic Specific Antigen Increased, Osteoporosis, Dysuria, Malignant Pleural Effusion, Normochromic Normocytic Anaemia

Adverse event resulted in: death

Drug(s) suspected as cause:
Bicalutamide

Eligard

Eligard
    Indication: Prostate Cancer

Other drugs received by patient: Zoledronic; Docetaxel; Calcitriol; Carboplatin



Possible Eligard side effects in 66 year old male

Reported by a physician from Canada on 2012-04-26

Patient: 66 year old male

Reactions: Fatigue, Pneumonia, Pyrexia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Docetaxel
    Start date: 2012-04-03

Eligard
    Start date: 2011-12-12

Therapeutic Radiopharmaceuticals
    Start date: 2012-04-03



Possible Eligard side effects in 85 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-04-25

Patient: 85 year old male

Reactions: Prostatic Specific Antigen Increased

Drug(s) suspected as cause:
Eligard
    Indication: Prostate Cancer
    Start date: 2011-10-19
    End date: 2011-10-19

Eligard
    Start date: 2012-04-04
    End date: 2012-04-04



Possible Eligard side effects in 77 year old male

Reported by a consumer/non-health professional from United States on 2012-04-23

Patient: 77 year old male, weighing 117.9 kg (259.4 pounds)

Reactions: Monoplegia, Abasia, Hypoaesthesia, Asthenia

Drug(s) suspected as cause:
Eligard

Other drugs received by patient: Nifedipine; Ascorbic Acid; Gabapentin



Possible Eligard side effects in 77 year old male

Reported by a consumer/non-health professional from United States on 2012-04-19

Patient: 77 year old male, weighing 117.9 kg (259.4 pounds)

Reactions: Monoplegia, Hypoaesthesia, Asthenia

Drug(s) suspected as cause:
Eligard

Other drugs received by patient: Nifedipine; Gabapentin; Ascorbic Acid



Possible Eligard side effects in 71 year old male

Reported by a consumer/non-health professional from United States on 2012-04-10

Patient: 71 year old male, weighing 99.3 kg (218.5 pounds)

Reactions: Disease Progression, Myalgia, Dyspnoea Exertional, Hot Flush, AIR Embolism, Lethargy, Decreased Appetite, Influenza Like Illness

Drug(s) suspected as cause:
Casodex
    Indication: Hormone Therapy
    End date: 2011-12-01

Eligard

Provenge
    Indication: Prostate Cancer
    Start date: 2011-12-08
    End date: 2011-12-08

Provenge
    Start date: 2011-12-30
    End date: 2011-12-30

Provenge
    Start date: 2011-12-15
    End date: 2011-12-15

Other drugs received by patient: Amlodipine; Bicalutamide; Janumet; Atorvastatin; Benicar; Flonase; Calcium Carbonate; Loratadine; Atenolol; Aspirin; Xgeva; Cholecalciferol; Citalopram Hydrobromide



Possible Eligard side effects in 80 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-03-21

Patient: 80 year old male, weighing 88.9 kg (195.6 pounds)

Reactions: Phimosis

Drug(s) suspected as cause:
Eligard

Other drugs received by patient: Atorvastatin; Multivitamin; Vitamin B-12; Vitamin B6; Prilosec



Possible Eligard side effects in male

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-03-14

Patient: male, weighing 75.0 kg (165.0 pounds)

Reactions: Haemorrhage, Catheter Placement, Pain, Anastomotic Complication, Symphysiolysis, Abscess, Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Eligard
    Start date: 2011-04-12

Eligard
    Start date: 2011-07-19

Eligard
    Start date: 2011-10-11

Other drugs received by patient: Torsemide; Hydrochlorothiazide; Enalapril Maleate; Digitoxin TAB; Marcumar; Carvedilol



Possible Eligard side effects in 77 year old male

Reported by a pharmacist from United States on 2012-02-21

Patient: 77 year old male

Reactions: Injection Site Reaction, Soft Tissue Necrosis

Drug(s) suspected as cause:
Eligard



Possible Eligard side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-02-17

Patient: male

Reactions: Phimosis

Drug(s) suspected as cause:
Eligard



Possible Eligard side effects in 85 year old male

Reported by a pharmacist from United States on 2012-02-17

Patient: 85 year old male

Reactions: Necrosis, Injection Site Reaction

Drug(s) suspected as cause:
Eligard



Possible Eligard side effects in 74 year old male

Reported by a physician from Czech Republic on 2012-02-01

Patient: 74 year old male, weighing 110.0 kg (242.0 pounds)

Reactions: Pulmonary Embolism

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Casodex
    Administration route: Oral
    Indication: Prostate Cancer
    Start date: 2010-05-27
    End date: 2010-06-27

Eligard
    Indication: Prostate Cancer
    Start date: 2010-05-27
    End date: 2010-05-27

Eligard
    Start date: 2011-07-19
    End date: 2011-07-19

Other drugs received by patient: Antihypertensives



Possible Eligard side effects in

Reported by a pharmacist from United States on 2012-01-26

Patient:

Reactions: Necrosis

Drug(s) suspected as cause:
Eligard



Possible Eligard side effects in 36 year old female

Reported by a pharmacist from United States on 2011-12-30

Patient: 36 year old female

Reactions: Confusional State, Tachyphrenia, Elevated Mood, Logorrhoea, Mania, Off Label Use, Insomnia, Disturbance in Attention, Memory Impairment

Drug(s) suspected as cause:
Eligard



Possible Eligard side effects in 74 year old male

Reported by a physician from Czech Republic on 2011-12-20

Patient: 74 year old male, weighing 110.0 kg (242.0 pounds)

Reactions: Pulmonary Embolism

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Casodex
    Administration route: Oral
    Indication: Prostate Cancer
    Start date: 2010-05-27
    End date: 2010-06-27

Eligard
    Indication: Prostate Cancer
    Start date: 2010-05-27
    End date: 2010-05-27

Eligard
    Start date: 2011-07-19
    End date: 2011-07-19

Other drugs received by patient: Antihypertensives



Possible Eligard side effects in 80 year old male

Reported by a pharmacist from United States on 2011-12-19

Patient: 80 year old male

Reactions: Injection Site Necrosis, Injection Site Ulcer, Skin Necrosis

Drug(s) suspected as cause:
Eligard



Possible Eligard side effects in 76 year old male

Reported by a physician from Slovakia (Slovak Republic) on 2011-12-16

Patient: 76 year old male, weighing 90.0 kg (198.0 pounds)

Reactions: Brachial Plexopathy

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Azilect
    Indication: Parkinson's Disease
    Start date: 2011-05-24

Carbidopa and Levodopa
    Start date: 2010-10-01
    End date: 2010-10-07

Carbidopa and Levodopa
    Start date: 2010-09-17
    End date: 2010-09-23

Carbidopa and Levodopa
    Indication: Parkinson's Disease
    Start date: 2011-05-24

Carbidopa and Levodopa
    Start date: 2010-09-24
    End date: 2010-09-30

Carbidopa and Levodopa
    Start date: 2010-10-08
    End date: 2011-05-23

Eligard
    Dosage: 22.5 mg solution
    Indication: Prostate Cancer

Neupro
    Start date: 2011-05-24
    End date: 2011-05-30

Neupro
    Start date: 2011-05-31
    End date: 2011-06-06

Neupro
    Indication: Parkinson's Disease
    Start date: 2011-06-14

Neupro
    Start date: 2011-06-07
    End date: 2011-06-13

Other drugs received by patient: Lyrica



Possible Eligard side effects in 76 year old male

Reported by a physician from Slovakia (Slovak Republic) on 2011-12-09

Patient: 76 year old male, weighing 90.0 kg (198.0 pounds)

Reactions: Brachial Plexopathy

Drug(s) suspected as cause:
Azilect
    Indication: Parkinson's Disease
    Start date: 2011-05-24

Carbidopa and Levodopa
    Start date: 2010-10-01
    End date: 2010-10-07

Carbidopa and Levodopa
    Start date: 2010-09-24
    End date: 2010-09-30

Carbidopa and Levodopa
    Start date: 2010-10-08
    End date: 2011-05-23

Carbidopa and Levodopa
    Start date: 2010-09-17
    End date: 2010-09-23

Carbidopa and Levodopa
    Indication: Parkinson's Disease
    Start date: 2011-05-24

Eligard
    Dosage: 22.5 mg solution
    Indication: Prostate Cancer

Neupro
    Start date: 2011-06-07
    End date: 2011-06-13

Neupro
    Indication: Parkinson's Disease
    Start date: 2011-06-14

Neupro
    Start date: 2011-05-31
    End date: 2011-06-06

Neupro
    Start date: 2011-05-24
    End date: 2011-05-30

Other drugs received by patient: Lyrica



Possible Eligard side effects in 68 year old male

Reported by a physician from United States on 2011-11-29

Patient: 68 year old male, weighing 102.4 kg (225.3 pounds)

Reactions: Angina Pectoris

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Casodex
    Dosage: 50 mg orally daily for 4 weeks
    Administration route: Oral
    Indication: Prostate Cancer
    Start date: 2011-04-06
    End date: 2011-04-07

Docetaxel
    Dosage: 75 mg/m2 intravenously (iv) once per 3 weeks for 10 cycles
    Indication: Prostate Cancer
    Start date: 2011-04-06
    End date: 2011-04-06

Eligard
    Dosage: 22.5 mg subcutaneously (sc) every 3 months for 18 months
    Indication: Prostate Cancer
    Start date: 2011-04-06
    End date: 2011-04-06

Other drugs received by patient: Calcium Channel Blockers; Prochlorperazine; Pioglitazone; Allopurinol; ALL Other Therapeutic Products; Cholesterol and Triglyceride Reducers; ALL Other Therapeutic Products; ALL Other Therapeutic Products; Zetia; Analgesics; ALL Other Therapeutic Products; Atenolol; Diltiazem HCL; Aspirin; Crestor; Imdur; Dexamethasone; ALL Other Therapeutic Products; Antiemetics and Antinauseants

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