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Index of reports
> Life Threatening Events (13)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Venofer (Iron Sucrose) life threatening events. The selected reports were submitted to the FDA during the sample period of about a year.
Possible Venofer side effects in 22 year old female
Reported by a consumer/non-health professional from United States on 2012-08-07
Patient: 22 year old female
Reactions: Flushing, Heart Rate Increased, Drug Hypersensitivity, Respiratory Arrest, Toxicity To Various Agents, Convulsion, Oxygen Saturation Decreased
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Venofer
Other drugs received by patient: TPN; Lipids; Phenobarbital TAB
Possible Venofer side effects in 83 year old female
Reported by a pharmacist from United States on 2012-06-14
Patient: 83 year old female, weighing 75.5 kg (166.0 pounds)
Reactions: Blood Pressure Increased, Blood Alkaline Phosphatase Increased, Alanine Aminotransferase Increased, Unresponsive To Stimuli, Musculoskeletal Pain, Somnolence, Paraesthesia, Fatigue, Oedema Peripheral, Bradycardia, Cardiac Arrest, Sinus Tachycardia, Respiration Abnormal, Blood Glucose Increased
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Sodium Chloride
Dosage: 250 ml, one dose,, intravenous drip
Indication: Anaemia
Start date: 2012-04-20
End date: 2012-04-20
Venofer
Dosage: 500 mg (25 ml), 1 dose,, intravenous drip
Indication: Anaemia
Start date: 2012-04-20
End date: 2012-04-20
Other drugs received by patient: Omeprazole; Aspirin; MAG Oxide; Benicar; Fish OIL; Premarin; Tegretol; Osteo-BI-Flex; Clonidine
Possible Venofer side effects in 83 year old female
Reported by a physician from United States on 2012-06-14
Patient: 83 year old female, weighing 75.3 kg (165.7 pounds)
Reactions: Blood Pressure Increased, Unresponsive To Stimuli, Pain, Somnolence, Sinus Bradycardia, Paraesthesia, Fatigue, Cardiac Pacemaker Insertion, Oedema Peripheral, Dizziness, Feeling Abnormal, Sinus Tachycardia, Cardiac Arrest, Blood Glucose Increased
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Sodium Chloride 0.9%
Dosage: 250 ml (one dose) intravenous
Indication: Anaemia
Start date: 2012-04-20
End date: 2012-04-20
Venofer
Dosage: 500 mg (25 ml) 1 dose intravenous
Indication: Iron Deficiency Anaemia
Start date: 2012-04-20
End date: 2012-04-20
Other drugs received by patient: Omeprazole; Benicar .20 MG (2 Tablets Daily); Tegretol .200 MG Twice A DAY; Clonidine .1 MG (1 / 2 TAB Twice A Day); Osteobiflex .2 Tablets A DAY; Fish OIL .20 MG Daily; Premarin .625 MG Daily; Aspirin; Magoxide .400 MG Daily
Possible Venofer side effects in female
Reported by a pharmacist from United States on 2012-05-17
Patient: female, weighing 75.3 kg (165.7 pounds)
Reactions: Peripheral Coldness, Unresponsive To Stimuli, Somnolence, Pallor, Sinus Bradycardia, Fatigue, Oedema Peripheral, Oxygen Saturation Decreased, Blood Pressure Diastolic Decreased, Respiration Abnormal, Blood Glucose Increased, Blood Pressure Systolic Increased, Musculoskeletal Pain, Body Temperature Decreased, Paraesthesia, Cardiac Arrest, Feeling Abnormal, Sinus Tachycardia
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Sodium Chloride 0.9%
Dosage: 250 ml 1 dose iv 4 hours 3 minutes
Indication: Anaemia
Start date: 2012-04-20
End date: 2012-04-20
Venofer
Dosage: 500 mg -25 ml- 1 dose iv 4 hours 3 minutes
Indication: Anaemia
Start date: 2012-04-20
End date: 2012-04-20
Possible Venofer side effects in female
Reported by a physician from France on 2012-04-30
Patient: female, weighing 57.0 kg (125.4 pounds)
Reactions: Aspartate Aminotransferase Increased, Hepatic Failure, Pancreatitis, Lipase Increased
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Valsartan
Dosage: 160 mg, qd
Administration route: Oral
Indication: Hypertension
Start date: 2011-04-18
End date: 2011-07-15
Venofer
Dosage: 200 mg, per week
Start date: 2010-12-10
End date: 2011-04-01
Other drugs received by patient: Zocor; Sevelamer; Cinacalcet Hydrochloride; Lasix; Omeprazole; Eupressyl; Folic Acid
Possible Venofer side effects in 76 year old female
Reported by a consumer/non-health professional from United States on 2012-04-10
Patient: 76 year old female
Reactions: Back Pain, Dyspnoea, Pain in Extremity, Vaginal Haemorrhage, Burning Sensation, Sensation of Foreign Body, Diarrhoea, Cough
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Venofer
Possible Venofer side effects in male
Reported by a individual with unspecified qualification from United States on 2012-03-13
Patient: male
Reactions: Acute Pulmonary Oedema
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Venofer
Possible Venofer side effects in 24 year old female
Reported by a pharmacist from United States on 2011-12-15
Patient: 24 year old female, weighing 76.4 kg (168.1 pounds)
Reactions: LIP Swelling, Vomiting, Gastrointestinal Haemorrhage, Nausea, Crohn's Disease, Dyskinesia, Anaphylactic Reaction, Hypotension, Hypoaesthesia, Convulsion, Flushing, Syncope, Oedema Peripheral, Vasospasm
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Venofer
Other drugs received by patient: Acetaminophen; Mesalamine; Prednisone; Oral Contraceptive; Prednisone
Possible Venofer side effects in 28 year old female
Reported by a pharmacist from Turkey on 2011-12-08
Patient: 28 year old female, weighing 54.0 kg (118.8 pounds)
Reactions: Pulmonary Oedema, Anaphylactic Shock
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Venofer
Possible Venofer side effects in 37 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2011-11-16
Patient: 37 year old female, weighing 63.5 kg (139.7 pounds)
Reactions: Blood Mercury Abnormal, Confusional State, Hypotension, Tachycardia, Mental Status Changes, Encephalopathy, Amnesia, Delirium, Fall, Paraesthesia, Dysgeusia, Impaired Driving Ability, Dizziness, Hypertension, Complex Partial Seizures
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Venofer
Other drugs received by patient: Celexa; Oral Contraceptive; Palmelor (Nortriptyline); Elavil; Klonopin; Vitamin TAB; Armour Thyroid, 90 MCG; Lexapro
Possible Venofer side effects in 58 year old female
Reported by a consumer/non-health professional from United States on 2011-11-10
Patient: 58 year old female, weighing 63.5 kg (139.7 pounds)
Reactions: Abdominal Pain, Dyspnoea, Vomiting, Hypotension, Anaemia, Ascites, Syncope, Diarrhoea, Abdominal Distension, Shock
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Venofer
Possible Venofer side effects in 51 year old male
Reported by a pharmacist from Canada on 2011-11-07
Patient: 51 year old male, weighing 80.0 kg (176.0 pounds)
Reactions: Dyspnoea, Dysphagia, Blood Pressure Systolic Increased, Restlessness, Tachycardia, Drug Hypersensitivity, Swollen Tongue, Pallor, Heart Rate Irregular, Palatal Oedema
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Venofer
Other drugs received by patient: Ativan; Colace (Docusate Sodium); Seroquel; Effient; Novasc (Amlodipine Besylate); Zocor; Metoprolol Tartrate; Nitroglycerin; Aspirin; Flomax; Renagel; Ramipril; Ferrous Fumarate; Eprex; Furosemide; Pantoloc (Pantoprazole); Prolrel (Hydromorphone); Hydromorphone HCL; Replivite; Calcitriol Injection, USP (0132-25)(calcitriol Injection); Clonodine HCL
Possible Venofer side effects in 37 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2011-10-28
Patient: 37 year old female, weighing 63.5 kg (139.7 pounds)
Reactions: Tachycardia, Hypotension, Encephalopathy, Fall, Amnesia, Convulsion, Paraesthesia, Impaired Driving Ability, Dysgeusia, Circulatory Collapse, Complex Partial Seizures, Hypertension
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Venofer
Other drugs received by patient: Elavil; Palmelor (Nortriptyline); Thyroid TAB; Celexa; Vitamin TAB; Klonopin; Lexapro; Oral Contraceptive
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