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Firmagon (Degarelix) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Firmagon (Degarelix) 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 (85)
Death (9)
Life Threatening Events (11)

Reports by Reaction Type

Injection Site Pain (14)Fatigue (13)Asthenia (12)Injection Site Erythema (11)Pyrexia (10)Abdominal Pain (8)Headache (8)Dyspnoea (7)Malaise (6)Palpitations (6)Dizziness (6)Back Pain (6)

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

Possible Firmagon side effects in 78 year old male

Reported by a health professional (non-physician/pharmacist) from Portugal on 2012-08-09

Patient: 78 year old male

Reactions: Puncture Site Haemorrhage, Neutropenia, Pyrexia, Thrombocytopenia, Liver Disorder

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Firmagon
    Dosage: (240 mg qd subcutaneous) ; (80 mg 1x/month subcutaneous)
    Indication: Prostate Cancer Metastatic
    Start date: 2012-04-03

Firmagon
    Dosage: (240 mg qd subcutaneous) ; (80 mg 1x/month subcutaneous)
    Indication: Prostate Cancer Metastatic
    Start date: 2012-03-05
    End date: 2012-03-05

Estramustine Phosphate Sodium (Estramustine) 140 MG
    Dosage: (280 mg tid oral)
    Administration route: Oral
    Indication: Prostate Cancer
    Start date: 2012-02-01
    End date: 2012-02-14

Other drugs received by patient: Acetylsalicylic Acid SRT; Bisoprolol Fumarate; Neupogen; Lisinopril; Calcium Carbonate; Bicalutamide; Darbepoetin Alfa; Esomeprazole Sodium; Allopurinol; Calcitriol



Possible Firmagon side effects in 52 year old male

Reported by a individual with unspecified qualification from Canada on 2012-08-08

Patient: 52 year old male

Reactions: Abdominal Pain, Gastrointestinal Neoplasm

Drug(s) suspected as cause:
Firmagon



Possible Firmagon side effects in 72 year old male

Reported by a health professional (non-physician/pharmacist) from Netherlands on 2012-08-03

Patient: 72 year old male

Reactions: Vomiting, Nausea

Drug(s) suspected as cause:
Firmagon

Other drugs received by patient: Morphine



Possible Firmagon side effects in 53 year old male

Reported by a individual with unspecified qualification from Denmark on 2012-08-01

Patient: 53 year old male

Reactions: Musculoskeletal Pain, Musculoskeletal Discomfort, Injection Site Pain, Myalgia, Malaise, Injection Site Erythema, Injection Site Reaction, Influenza Like Illness

Drug(s) suspected as cause:
Firmagon

Other drugs received by patient: Spirocort



Possible Firmagon side effects in 67 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-07-30

Patient: 67 year old male

Reactions: Supraventricular Extrasystoles, Cardiac Arrest

Adverse event resulted in: death, life threatening event

Drug(s) suspected as cause:
Firmagon

Other drugs received by patient: Atorvastatin; Aspirin; Tenormin; Athymil; Theralen; Ramipril; Glucophage



Possible Firmagon side effects in 85 year old male

Reported by a health professional (non-physician/pharmacist) from Canada on 2012-07-24

Patient: 85 year old male

Reactions: Abdominal Pain, Vomiting, Diarrhoea, Gastroenteritis, Faecal Incontinence, Asthenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Firmagon
    Dosage: 240 mg total subcutaneous; 80 mg 1x/month subcutaneous
    Indication: Prostate Cancer
    Start date: 2011-08-03

Firmagon
    Dosage: 240 mg total subcutaneous; 80 mg 1x/month subcutaneous
    Indication: Prostate Cancer
    Start date: 2011-07-05
    End date: 2011-07-05

Other drugs received by patient: Calcium + Vitamin D; Tylenol (Caplet); Atorvastatin; Aspirin; Pantoloc / 01263202 /; Bicalutamide



Possible Firmagon side effects in male

Reported by a health professional (non-physician/pharmacist) from Canada on 2012-07-24

Patient: male

Reactions: Back Pain, Bone Pain, Pelvic Pain

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Firmagon

Other drugs received by patient: Tylenol with Codein / 00116401 /



Possible Firmagon side effects in 81 year old male

Reported by a individual with unspecified qualification from Germany on 2012-07-24

Patient: 81 year old male

Reactions: Drug Eruption, Pruritus

Drug(s) suspected as cause:
Firmagon



Possible Firmagon side effects in 61 year old male

Reported by a health professional (non-physician/pharmacist) from Netherlands on 2012-07-20

Patient: 61 year old male, weighing 93.5 kg (205.7 pounds)

Reactions: Injection Site Erythema, Pain in Extremity, Injection Site Pain, Pyrexia, Injection Site Rash, Injection Site Swelling, Erythema

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Firmagon
    Dosage: 240 mg 1x subcutaneous, 80 mg 1x/month subcutaneous
    Indication: Prostate Cancer
    Start date: 2011-11-11
    End date: 2011-12-12

Firmagon
    Dosage: 240 mg 1x subcutaneous, 80 mg 1x/month subcutaneous
    Indication: Prostate Cancer
    Start date: 2011-10-12
    End date: 2011-10-12



Possible Firmagon side effects in 82 year old male

Reported by a health professional (non-physician/pharmacist) from Canada on 2012-07-17

Patient: 82 year old male, weighing 88.9 kg (195.6 pounds)

Reactions: Dysuria, Device Occlusion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Firmagon

Other drugs received by patient: Insulin; Crestor; Metformin Hydrochloride



Possible Firmagon side effects in 80 year old male

Reported by a health professional (non-physician/pharmacist) from Canada on 2012-07-09

Patient: 80 year old male

Reactions: Gastrointestinal Haemorrhage

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Firmagon

Other drugs received by patient: Tamsulosin HCL; Theo-DUR; Lopressor; Detrol; Norvasc; Lanoxin; Altace; Cloxacillin Sodium; Lipitor; Ezetimibe; Fluticasone Propionate; Pantoprazole; Potassium Chloride; Spiriva; Aspirin; Furosemide; Levothyroxine Sodium; Spironolactone; Coumadin; Calciferol; Iron



Possible Firmagon side effects in 85 year old male

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-07-02

Patient: 85 year old male

Reactions: Eye Disorder, Erythema, Onychomadesis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Firmagon



Possible Firmagon side effects in 71 year old male

Reported by a health professional (non-physician/pharmacist) from Canada on 2012-06-18

Patient: 71 year old male

Reactions: Pneumonia, Dizziness, Headache

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Firmagon



Possible Firmagon side effects in 71 year old male

Reported by a health professional (non-physician/pharmacist) from Canada on 2012-06-18

Patient: 71 year old male

Reactions: Pneumonia, Dizziness, Headache

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Firmagon



Possible Firmagon side effects in 64 year old male

Reported by a consumer/non-health professional from United States on 2012-06-14

Patient: 64 year old male, weighing 99.8 kg (219.6 pounds)

Reactions: Chest Discomfort, Dyspnoea, Sensation of Heaviness, Drug Hypersensitivity, Prostatic Specific Antigen Decreased, Palpitations, Chest Pain, Heart Rate Increased

Drug(s) suspected as cause:
Firmagon
    Dosage: two injection (120 mg each)
    Start date: 2012-01-20

Firmagon
    Dosage: two injections(120 mg each)

Firmagon

Zoladex
    Start date: 2011-01-01

Firmagon
    Dosage: loadign dose
    Indication: Prostate Cancer
    Start date: 2010-12-09

Firmagon
    Dosage: last maintenance dose
    Start date: 2011-06-01

Firmagon

Other drugs received by patient: Lupron



Possible Firmagon side effects in 71 year old male

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-06-12

Patient: 71 year old male

Reactions: Anterograde Amnesia, Nervous System Disorder, Injection Site Pain, Hypoaesthesia, Mobility Decreased

Drug(s) suspected as cause:
Firmagon
    Dosage: (240 mg 1x subcutaneous), (80 mg 1x/month subcutaneous)
    Indication: Prostate Cancer
    Start date: 2011-07-08
    End date: 2011-07-08

Firmagon
    Dosage: (240 mg 1x subcutaneous), (80 mg 1x/month subcutaneous)
    Indication: Prostate Cancer
    Start date: 2011-08-16
    End date: 2011-08-17



Possible Firmagon side effects in 73 year old male

Reported by a health professional (non-physician/pharmacist) from Canada on 2012-06-04

Patient: 73 year old male, weighing 69.0 kg (151.8 pounds)

Reactions: Blood Pressure Increased, Dyspnoea, Aphasia, Hyperhidrosis, Tremor, Fatigue, Malaise, Heart Rate Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Firmagon
    Dosage: (240 mg qd subcutaneous), (80 mg 1x/month subcutaneous)
    Indication: Prostate Cancer
    Start date: 2012-05-18

Firmagon
    Dosage: (240 mg qd subcutaneous), (80 mg 1x/month subcutaneous)
    Indication: Prostate Cancer
    Start date: 2012-04-23
    End date: 2012-04-23

Other drugs received by patient: Albuterol; Perindopril Erbumine; Spiriva; Symbicort



Possible Firmagon side effects in 73 year old male

Reported by a health professional (non-physician/pharmacist) from Canada on 2012-05-29

Patient: 73 year old male, weighing 69.0 kg (151.8 pounds)

Reactions: Speech Disorder, Fatigue, Dyspnoea, Hyperhidrosis, Tremor

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Firmagon

Other drugs received by patient: Symbicort; Albuterol; Perindopril Erbumine



Possible Firmagon side effects in 83 year old male

Reported by a pharmacist from United States on 2012-05-23

Patient: 83 year old male, weighing 93.5 kg (205.7 pounds)

Reactions: Injection Site Erythema, Drug Hypersensitivity, Injection Site Pain, Injection Site Swelling

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Firmagon



Possible Firmagon side effects in 78 year old male

Reported by a health professional (non-physician/pharmacist) from Portugal on 2012-05-23

Patient: 78 year old male

Reactions: Puncture Site Haemorrhage, Hepatic Necrosis, Toxicity To Various Agents, Neutropenia, Pyrexia, Device Related Infection, Thrombocytopenia

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Firmagon
    Dosage: (240 mg qd subcutaneous) , (80 mg 1x/month subcutaneous),
    Indication: Prostate Cancer Metastatic
    Start date: 2012-03-05
    End date: 2012-03-05

Firmagon
    Dosage: (240 mg qd subcutaneous) , (80 mg 1x/month subcutaneous),
    Indication: Prostate Cancer Metastatic
    Start date: 2012-04-03

Firmagon

Estramustine Phosphate Sodium (Estramustine ) 140 MG
    Dosage: (280 mg tid oral)
    Administration route: Oral
    Indication: Prostate Cancer Metastatic
    Start date: 2012-02-01
    End date: 2012-02-14

Other drugs received by patient: Calcium Carbonate; Bicalutamide; Lisinopril; Bisoprolol Fumarate; Esomeprazole Magnesium; Allopurinol; Acetylsalicylic Acid SRT; Neupogen; Calcitriol; Darbepoetin Alfa



Possible Firmagon side effects in 66 year old male

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

Patient: 66 year old male

Reactions: Wrong Technique in Drug Usage Process, Cellulitis, Injection Site Abscess, Abdominal Wall Abscess

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Firmagon
    Dosage: (240 mg 1x subcutaneous) ; (80 mg 1x subcutaneous)
    Indication: Prostate Cancer
    Start date: 2010-01-01

Firmagon
    Dosage: (240 mg 1x subcutaneous) ; (80 mg 1x subcutaneous)
    Indication: Prostate Cancer
    Start date: 2010-10-15
    End date: 2010-10-15



Possible Firmagon side effects in 78 year old male

Reported by a individual with unspecified qualification from Portugal on 2012-05-16

Patient: 78 year old male

Reactions: Puncture Site Haemorrhage, Hepatic Necrosis, Device Related Infection, Neutropenia, Pyrexia, Thrombocytopenia, Metastases To Bone

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Firmagon

Other drugs received by patient: Lisinopril; Bicalutamide; Estramustine Phosphate Sodium; Calcitriol; Darbepoetin Alfa; Bisoprolol Fumarate; Esomeprazole Magnesium; Allopurinol; Calcium Carbonate; Aspirin



Possible Firmagon side effects in 71 year old male

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-05-14

Patient: 71 year old male

Reactions: Anterograde Amnesia, Injection Site Pain, Hypoaesthesia, Muscle Spasms

Drug(s) suspected as cause:
Firmagon
    Dosage: 240 mg 1 x/month, subcutaneous
    Indication: Prostate Cancer
    Start date: 2011-07-08
    End date: 2011-07-08

Firmagon
    Dosage: 240 mg 1 x/month, subcutaneous
    Indication: Prostate Cancer
    Start date: 2011-08-16



Possible Firmagon side effects in 75 year old male

Reported by a individual with unspecified qualification from Canada on 2012-05-08

Patient: 75 year old male

Reactions: Rhabdomyolysis

Drug(s) suspected as cause:
Firmagon

Other drugs received by patient: Hydromorphone HCL; Casodex; Tamsulosin HCL; Abiraterone; Taxotere; Dexamethasone; Crestor; Lactulose; Aspirin; Zometa; Diltiazem; Prednisone TAB; Zantac; Lorazepam; Acetate



Possible Firmagon side effects in 79 year old male

Reported by a health professional (non-physician/pharmacist) from Portugal on 2012-05-03

Patient: 79 year old male

Reactions: Puncture Site Haemorrhage, Pyrexia, Device Related Infection, Neutropenia, Thrombocytopenia

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Firmagon
    Dosage: 240 mg, qd, 80 mg 1xmonth, subcutaneous
    Indication: Prostate Cancer Metastatic
    Start date: 2012-03-05
    End date: 2012-03-05

Firmagon
    Dosage: 240 mg, qd, 80 mg 1xmonth, subcutaneous
    Indication: Prostate Cancer Metastatic
    Start date: 2012-04-03

Other drugs received by patient: Lisinopril; Esomeprazole Magnesium; Allopurinol; Calcium Carbonate; Darbepoetin Alfa; Estramustine Phosphate Sodium; Acetylsalicylic Acid SRT; Bisoprolol Fumarate; Calcitriol; Bicalutamide



Possible Firmagon side effects in 66 year old male

Reported by a health professional (non-physician/pharmacist) from Ireland on 2012-05-03

Patient: 66 year old male

Reactions: Wrong Technique in Drug Usage Process, Injection Site Abscess

Drug(s) suspected as cause:
Firmagon



Possible Firmagon side effects in 79 year old male

Reported by a health professional (non-physician/pharmacist) from Belgium on 2012-05-03

Patient: 79 year old male

Reactions: Malaise, Palpitations, Injection Site Induration, Chills, Injection Site Reaction, Rash, Abscess, Injection Site Swelling

Drug(s) suspected as cause:
Firmagon



Possible Firmagon side effects in 71 year old male

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-05-02

Patient: 71 year old male

Reactions: Monoplegia, Unresponsive To Stimuli, Paralysis, Injection Site Pain, Amnesia, Muscle Spasms

Drug(s) suspected as cause:
Firmagon
    Dosage: (240 mg 1x subcutaneous), (80 mg 1x/month subcutaneous)
    Indication: Prostate Cancer
    Start date: 2011-08-16

Firmagon
    Dosage: (240 mg 1x subcutaneous), (80 mg 1x/month subcutaneous)
    Indication: Prostate Cancer
    Start date: 2011-07-08
    End date: 2011-07-08



Possible Firmagon side effects in 68 year old male

Reported by a individual with unspecified qualification from Canada on 2012-04-25

Patient: 68 year old male

Reactions: Hypophagia, Abasia, Unresponsive To Stimuli

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Firmagon

Other drugs received by patient: Hydromorhphone; Methadone HCL



Possible Firmagon side effects in 67 year old male

Reported by a individual with unspecified qualification from Canada on 2012-04-24

Patient: 67 year old male

Reactions: Aphagia, Haemoglobin Decreased, Dysstasia, Renal Disorder, General Physical Health Deterioration, Asthenia, Decreased Appetite

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Firmagon

Other drugs received by patient: Ascorbic Acid; Multi-Vitamins

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