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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