This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Venofer (Iron Sucrose) 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 (96)
Death (2)
Life Threatening Events (13)
Disability (2)
Reports by Reaction Type
Paraesthesia (13),
Dizziness (11),
Dyspnoea (9),
Maternal Exposure During Pregnancy (9),
Oedema Peripheral (8),
Abdominal Pain (7),
Nausea (7),
Hypotension (7),
Malaise (6),
Blood Glucose Increased (6),
Cytolytic Hepatitis (6),
Diarrhoea (6)
Below are a few examples of reports where side effects / adverse reactions may be related to Venofer (Iron Sucrose). For a complete list or a specific selection of reports, please use the links above.
Possible Venofer side effects in 28 year old female
Reported by a physician from Switzerland on 2012-08-07
Patient: 28 year old female
Reactions: Maternal Exposure During Pregnancy, Headache, Paraesthesia, Loss of Consciousness, Dysgeusia, Malaise, Presyncope, Infusion Site Oedema
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Venofer
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 64 year old female
Reported by a pharmacist from United States on 2012-08-07
Patient: 64 year old female, weighing 54.4 kg (119.7 pounds)
Reactions: Anaphylactoid Reaction
Drug(s) suspected as cause:
Venofer
Possible Venofer side effects in 19 year old female
Reported by a physician from Switzerland on 2012-07-27
Patient: 19 year old female
Reactions: Malaise, Oedema Peripheral, Musculoskeletal Chest Pain, Skin Reaction, Paraesthesia
Drug(s) suspected as cause:
Venofer
Possible Venofer side effects in 29 year old female
Reported by a health professional (non-physician/pharmacist) from Switzerland on 2012-07-24
Patient: 29 year old female, weighing 66.0 kg (145.2 pounds)
Reactions: Blood Alkaline Phosphatase Increased, Incorrect Drug Dosage Form Administered, Urticaria, Accidental Overdose, Paraesthesia, Loss of Consciousness, Syncope, Malaise, Skin Discolouration, Diarrhoea, Medication Error, Aspartate Aminotransferase Increased
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Venofer
Possible Venofer side effects in 53 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-17
Patient: 53 year old female
Reactions: Abdominal Pain, LIP Swelling, Chromaturia, Iron Overload, Off Label Use, Spleen Disorder, Diarrhoea, Hepatic Siderosis
Drug(s) suspected as cause:
Venofer
Possible Venofer side effects in 50 year old male
Reported by a pharmacist from Canada on 2012-07-06
Patient: 50 year old male
Reactions: Device Occlusion
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Venofer
Other drugs received by patient: Tylenol; Zofran; Gravol TAB; Diovan; Norvasc; Maxeran
Possible Venofer side effects in female
Reported by a consumer/non-health professional from United States on 2012-07-03
Patient: female
Reactions: Pancreatitis
Drug(s) suspected as cause:
Venofer
Other drugs received by patient: Procrit
Possible Venofer side effects in 26 year old female
Reported by a health professional (non-physician/pharmacist) from Switzerland on 2012-07-02
Patient: 26 year old female
Reactions: Blood Alkaline Phosphatase Increased, Urticaria, Accidental Overdose, Paraesthesia, Loss of Consciousness, Malaise, Medication Error, Skin Discolouration, Diarrhoea, Aspartate Aminotransferase Increased
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Venofer
Possible Venofer side effects in 58 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-21
Patient: 58 year old female
Reactions: Rash Generalised, Blood Urea Increased, Acute Generalised Exanthematous Pustulosis, Skin Exfoliation, Blood Creatinine Increased, Rash Papulosquamous
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Venofer
Other drugs received by patient: Atenolol; Sodium Bicarbonate; Hydrocodone Bitartrate + Acetaminophen
Possible Venofer side effects in 15 year old female
Reported by a physician from United States on 2012-06-21
Patient: 15 year old female, weighing 57.0 kg (125.4 pounds)
Reactions: Pulse Abnormal, Off Label Use, Anxiety, Swelling Face, Hypotension, Pain
Drug(s) suspected as cause:
Venofer
Possible Venofer side effects in 26 year old female
Reported by a health professional (non-physician/pharmacist) from Switzerland on 2012-06-21
Patient: 26 year old female
Reactions: Abdominal Pain, Dysgeusia, Fatigue, Pruritus, Headache
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Venofer
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 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 female
Reported by a health professional (non-physician/pharmacist) from Switzerland on 2012-06-11
Patient: female
Reactions: Ventricular Tachycardia
Drug(s) suspected as cause:
Venofer
Possible Venofer side effects in 79 year old female
Reported by a pharmacist from United States on 2012-06-11
Patient: 79 year old female, weighing 80.0 kg (176.0 pounds)
Reactions: Headache, Infusion Related Reaction
Drug(s) suspected as cause:
Venofer
Possible Venofer side effects in 38 year old female
Reported by a consumer/non-health professional from United States on 2012-06-11
Patient: 38 year old female, weighing 57.6 kg (126.7 pounds)
Reactions: Heart Rate Decreased, Dizziness, Cold Sweat, Blood Pressure Decreased, Loss of Consciousness
Drug(s) suspected as cause:
Venofer
Possible Venofer side effects in 64 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-07
Patient: 64 year old female, weighing 54.4 kg (119.7 pounds)
Reactions: Dyspnoea, Wheezing, Respiratory Distress, Paraesthesia, Anxiety, Hyperventilation, Dizziness, Cough
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Venofer
Dosage: 500 mg/25 ml once iv drip
Indication: Iron Deficiency
Venofer
Dosage: 25 mg/1.25 ml once iv at once
Indication: Iron Deficiency Anaemia
Possible Venofer side effects in 40 year old female
Reported by a health professional (non-physician/pharmacist) from France on 2012-06-07
Patient: 40 year old female
Reactions: Phlebitis, Procedural Pain, Maternal Exposure During Pregnancy, Lung Infection, Post Procedural Swelling, Caesarean Section, Premature Delivery, Jugular Vein Thrombosis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Venofer
Indication: Anaemia
Start date: 2011-12-27
Venofer
Dosage: 2 doses intravenous
Indication: Anaemia
Start date: 2011-12-31
Possible Venofer side effects in 68 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-30
Patient: 68 year old female
Reactions: Chest Discomfort, Nausea, Hyperhidrosis, Burning Sensation, Hot Flush, Dizziness, Asthenia, Blood Glucose Increased, Infusion Related Reaction
Drug(s) suspected as cause:
Venofer
Dosage: 200 mg iv push
Indication: Iron Deficiency Anaemia
Start date: 2012-05-07
End date: 2012-05-07
Venofer
Dosage: intravenous bolus
Other drugs received by patient: Lisinopril; Xanax; Metoprolol Tartrate; Norvasc; Plavix; Omeprazole; Vicodin
Possible Venofer side effects in 72 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-21
Patient: 72 year old male, weighing 86.2 kg (189.6 pounds)
Reactions: Blood Urea Increased, Hyperkalaemia, Restlessness, Blood Creatine Increased, Hyperhidrosis, Chronic Obstructive Pulmonary Disease, Tremor, Anxiety, Type II Hypersensitivity, Heart Rate Decreased, Chest Pain, Proteinuria, Electrocardiogram T Wave Abnormal, Depressed Level of Consciousness, Blood Pressure Decreased, Blood Glucose Increased
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Venofer
Other drugs received by patient: Simvastatin; Folic Acid; Aspirin; Ferrous Sulfate TAB; Cholecalciferol (Vitamin D3); Trazodone HCL; Amiodarone HCL; Levothyroxine Sodium; Paxil; Metoprolol
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:
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
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
Possible Venofer side effects in 83 year old female
Reported by a physician from Switzerland on 2012-05-14
Patient: 83 year old female
Reactions: Cellulitis, Extravasation, Thrombophlebitis Superficial
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Venofer
Possible Venofer side effects in female
Reported by a health professional (non-physician/pharmacist) from Switzerland on 2012-05-14
Patient: female
Reactions: Dyspnoea, Chest Pain, Rash Macular
Drug(s) suspected as cause:
Venofer
Possible Venofer side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-10
Patient: female, weighing 57.0 kg (125.4 pounds)
Reactions: Dysgeusia, Abdominal Pain, Nausea, Vision Blurred, Dizziness
Drug(s) suspected as cause:
Venofer
Possible Venofer side effects in 33 year old female
Reported by a pharmacist from United States on 2012-05-07
Patient: 33 year old female, weighing 68.9 kg (151.7 pounds)
Reactions: Burning Sensation, Dyspnoea
Drug(s) suspected as cause:
Venofer
Possible Venofer side effects in female
Reported by a pharmacist from United States on 2012-05-03
Patient: female
Reactions: Back Pain, Blood Pressure Increased, Pain in Extremity, Joint Swelling, Oedema Peripheral, Paraesthesia
Drug(s) suspected as cause:
Venofer
Dosage: |dosagetext: 500 mg/250 ml ns over 3.5 hrs||freq: once||route: intravenous (not otherwise specified)
Start date: 2012-04-23
End date: 2012-04-23
NS
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 72 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-04-26
Patient: 72 year old male, weighing 86.2 kg (189.6 pounds)
Reactions: Hypersensitivity, Chronic Obstructive Pulmonary Disease, Hyperhidrosis, Blood Calcium Decreased, RED Blood Cell Count Decreased, Chest Pain, Electrocardiogram T Wave Abnormal, Blood Glucose Increased, Blood Urea Increased, Dyspnoea, Restlessness, Blood Creatine Increased, Tremor, Anxiety, Heart Rate Decreased, Blood Pressure Decreased, Infusion Related Reaction
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Venofer
Other drugs received by patient: Levothyroxine, 100 MCG Daily Oral UNK / UNK; Simvastatin, 80 MG Daily Oral UNK / UNK; Amiodarone, 100 MG Daily Oral UNK / UNK; Trazadone, 100 MG Twice Daily Oral UNK / UNK; Aspirin, 81 MG Daily Oral UNK / UNK; Paxil, 20 MG Daily Oral UNK / UNK; Metoprolol, 25 MG Daily Oral UNK / UNK; Folic Acid, 1 MG Daily Oral UNK / UNK
Possible Venofer side effects in 27 year old female
Reported by a health professional (non-physician/pharmacist) from Switzerland on 2012-04-25
Patient: 27 year old female
Reactions: Venous Thrombosis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Venofer
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