FIRMAGON

Firmagon Adverse Events Reported to the FDA Over Time

How are Firmagon adverse event reports trending over time?

This graph shows volume of adverse events submitted to the FDA by quarter for Firmagon, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Firmagon is flagged as the suspect drug causing the adverse event.

Most Common Firmagon Adverse Events Reported to the FDA

What are the most common Firmagon adverse events reported to the FDA?

Injection Site Pain	116 (5.69%)
Injection Site Erythema	113 (5.55%)
Injection Site Swelling	58 (2.85%)
Hot Flush	45 (2.21%)
Fatigue	37 (1.82%)
Injection Site Reaction	35 (1.72%)
Nausea	33 (1.62%)
Asthenia	32 (1.57%)
Injection Site Induration	32 (1.57%)
Injection Site Nodule	29 (1.42%)
Pain	29 (1.42%)
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Injection Site Warmth	28 (1.37%)
Pyrexia	28 (1.37%)
Prostatic Specific Antigen Increase...	27 (1.33%)
Abdominal Pain	24 (1.18%)
Hyperhidrosis	22 (1.08%)
Chills	21 (1.03%)
Dyspnoea	19 (.93%)
Headache	18 (.88%)
Injection Site Cellulitis	18 (.88%)
Back Pain	17 (.83%)
Injection Site Mass	16 (.79%)
Vomiting	16 (.79%)
Decreased Appetite	15 (.74%)
Erythema	15 (.74%)
Condition Aggravated	14 (.69%)
Injection Site Discomfort	13 (.64%)
Injection Site Rash	13 (.64%)
Dysuria	12 (.59%)
Hypotension	12 (.59%)
Metastases To Bone	12 (.59%)
Myalgia	12 (.59%)
Oedema Peripheral	12 (.59%)
Dizziness	11 (.54%)
Drug Ineffective	11 (.54%)
Dehydration	10 (.49%)
Malaise	10 (.49%)
Musculoskeletal Pain	10 (.49%)
Anaemia	9 (.44%)
Urinary Retention	9 (.44%)
Atrial Fibrillation	8 (.39%)
Bone Pain	8 (.39%)
Diarrhoea	8 (.39%)
Injection Site Inflammation	8 (.39%)
Muscle Spasms	8 (.39%)
No Adverse Event	8 (.39%)
Pelvic Pain	8 (.39%)
Pneumonia	8 (.39%)
Prostate Cancer	8 (.39%)
Rash	8 (.39%)
Somnolence	8 (.39%)
Cardiac Arrest	7 (.34%)
Drug Administered At Inappropriate ...	7 (.34%)
Pain In Extremity	7 (.34%)
Pruritus	7 (.34%)
Renal Failure Acute	7 (.34%)
Urticaria	7 (.34%)
Abasia	6 (.29%)
Abdominal Distension	6 (.29%)
Arthralgia	6 (.29%)
Blood Creatinine Increased	6 (.29%)
Blood Glucose Increased	6 (.29%)
Blood Pressure Decreased	6 (.29%)
Chest Pain	6 (.29%)
Constipation	6 (.29%)
Haematuria	6 (.29%)
Incorrect Route Of Drug Administrat...	6 (.29%)
Injection Site Pruritus	6 (.29%)
Insomnia	6 (.29%)
Metastases To Lung	6 (.29%)
Metastases To Pleura	6 (.29%)
Neutropenia	6 (.29%)
Palpitations	6 (.29%)
Puncture Site Haemorrhage	6 (.29%)
Thrombocytopenia	6 (.29%)
Blood Pressure Increased	5 (.25%)
Deep Vein Thrombosis	5 (.25%)
Diabetes Mellitus	5 (.25%)
Flushing	5 (.25%)
Gait Disturbance	5 (.25%)
Haemoglobin Decreased	5 (.25%)
Heart Rate Decreased	5 (.25%)
Heart Rate Increased	5 (.25%)
Hepatic Necrosis	5 (.25%)
Hydronephrosis	5 (.25%)
Hypoaesthesia	5 (.25%)
Incorrect Dose Administered	5 (.25%)
Influenza Like Illness	5 (.25%)
Injection Site Abscess	5 (.25%)
Injection Site Discolouration	5 (.25%)
Medication Error	5 (.25%)
Vision Blurred	5 (.25%)
Weight Decreased	5 (.25%)
Wrong Technique In Drug Usage Proce...	5 (.25%)
Abdominal Discomfort	4 (.2%)
Activities Of Daily Living Impaired	4 (.2%)
Anaphylactic Shock	4 (.2%)
Anterograde Amnesia	4 (.2%)
Blood Testosterone Increased	4 (.2%)
Burning Sensation	4 (.2%)
Cardiac Failure	4 (.2%)

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This graph shows the top adverse events submitted to the FDA for Firmagon, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Firmagon is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Adverse Event Categories for Firmagon

What are the most common Firmagon adverse events reported to the FDA?

Administration Site Reactions	495 (24.3%)
Gastrointestinal Signs	96 (4.71%)
Neurological	57 (2.8%)
Vascular	56 (2.75%)
Musculoskeletal And Connective Tiss...	50 (2.45%)
Epidermal And Dermal Conditions	47 (2.31%)
Respiratory	40 (1.96%)
Infections - Pathogen Unspecified	37 (1.82%)
Urinary Tract Signs	36 (1.77%)
Medication Errors	35 (1.72%)
Cardiac And Vascular Investigations	32 (1.57%)
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Cardiac Arrhythmias	32 (1.57%)
Immunology And Allergy	31 (1.52%)
Body Temperature Conditions	28 (1.37%)
Metastases	28 (1.37%)
Renal Disorders	26 (1.28%)
Therapeutic And Nontherapeutic Effe...	25 (1.23%)
Muscle	24 (1.18%)
Skin Appendage Conditions	24 (1.18%)
Bacterial Infectious	22 (1.08%)
Appetite And General Nutritional	18 (.88%)
Headaches	18 (.88%)
Gastrointestinal Motility And Defec...	16 (.79%)
Electrolyte And Fluid Balance Condi...	15 (.74%)
Hematology Investigations	15 (.74%)
Central Nervous System Vascular	14 (.69%)
Cardiac Valve	13 (.64%)
Decreased And Nonspecific Blood Pre...	13 (.64%)
Hepatic And Hepatobiliary	13 (.64%)
Physical Examination Topics	13 (.64%)
Reproductive Neoplasms Male Maligna...	13 (.64%)
Reproductive Tract	13 (.64%)
Joint	12 (.59%)
Movement Disorders	12 (.59%)
Myocardial	12 (.59%)
Penile And Scrotal Disorders	12 (.59%)
Allergic Conditions	11 (.54%)
Coronary Artery	11 (.54%)
Metabolic, Nutritional And Blood Ga...	11 (.54%)
Bone Disorders	10 (.49%)
Injuries	10 (.49%)
Renal And Urinary Tract Investigati...	10 (.49%)
Anemias Nonhemolytic And Marrow Dep...	9 (.44%)
Angiedema And Urticaria	9 (.44%)
Glucose Metabolism Disorders	9 (.44%)
Heart Failures	9 (.44%)
Procedural And Device Related Injur...	9 (.44%)
Depressed Mood Disorders	8 (.39%)
Embolism And Thrombosis	8 (.39%)
Lower Respiratory Tract Disorders	8 (.39%)
White Blood Cell	8 (.39%)
Cardiac Disorder Signs	7 (.34%)
Fatal Outcomes	7 (.34%)
Hearing	7 (.34%)
Lifestyle Issues	7 (.34%)
Miscellaneous And Site Unspecified ...	7 (.34%)
Sleep Disorders	7 (.34%)
Bone And Joint Injuries	6 (.29%)
Deliria	6 (.29%)
Endocrine Investigations	6 (.29%)
Platelet	6 (.29%)
Vision	6 (.29%)
Gastrointestinal Hemorrhages	5 (.25%)
Gastrointestinal Stenosis And Obstr...	5 (.25%)
Hepatobiliary	5 (.25%)
Investigations, Imaging And Histopa...	5 (.25%)
Mental Impairment	5 (.25%)
Nephropathies	5 (.25%)
Anterior Eye Structural Change, Dep...	4 (.2%)
Breast	4 (.2%)
Gastrointestinal Neoplasms Malignan...	4 (.2%)
Increased Intracranial Pressure And...	4 (.2%)
Pericardial	4 (.2%)
Vascular Hypertensive	4 (.2%)
Viral Infectious	4 (.2%)
Enzyme	3 (.15%)
Gastrointestinal Inflammatory Condi...	3 (.15%)
Gastrointestinal Ulceration And Per...	3 (.15%)
Male Reproductive Tract Infections ...	3 (.15%)
Neoplasm Related Morbidities	3 (.15%)
Pleural	3 (.15%)
Protein And Chemistry Analyses	3 (.15%)
Seizures	3 (.15%)
Spleen, Lymphatic And Reticulendoth...	3 (.15%)
Testicular And Epididymal	3 (.15%)
Ureteric	3 (.15%)
Abdominal Hernias And Other Abdomin...	2 (.1%)
Acid-base	2 (.1%)
Anxiety Disorders	2 (.1%)
Disturbances In Thinking	2 (.1%)
Eating Disorders	2 (.1%)
Eye	2 (.1%)
Male Genital Tract Therapeutic Proc...	2 (.1%)
Musculoskeletal And Soft Tissue Inv...	2 (.1%)
Ocular Structural Change, Deposit A...	2 (.1%)
Peritoneal And Retroperitoneal Cond...	2 (.1%)
Protein And Amino Acid Metabolism	2 (.1%)
Salivary Gland Conditions	2 (.1%)
Sleep Disturbances	2 (.1%)
Suicidal And Self-injurious Behavio...	2 (.1%)
Therapeutic Procedures And Supporti...	2 (.1%)

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This graph shows the top categories of adverse events submitted to the FDA for Firmagon, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Firmagon is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.