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Heparin (Heparin) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Heparin 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 (451)
Death (126)
Life Threatening Events (68)
Disability (19)

Reports by Reaction Type

Heparin-Induced Thrombocytopenia (79)Thrombocytopenia (34)Haemorrhage (29)Dyspnoea (24)Cerebral Haemorrhage (23)Pyrexia (21)Pulmonary Embolism (20)Gastrointestinal Haemorrhage (15)Thrombosis in Device (15)Nausea (15)Haemoglobin Decreased (15)Deep Vein Thrombosis (15)

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

Possible Heparin side effects in 18 year old female

Reported by a physician from Slovenia on 2012-08-23

Patient: 18 year old female

Reactions: Pulmonary Haemorrhage, Gastrointestinal Haemorrhage, Injection Site Haemorrhage, Sepsis, Shock Haemorrhagic, Acute Respiratory Distress Syndrome, Bone Marrow Failure, Staphylococcal Bacteraemia, Septic Shock

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Doxorubicin HCL
    Dosage: unk
    Indication: Acute Lymphocytic Leukaemia

Heparin

Vincristine
    Dosage: unk
    Indication: Acute Lymphocytic Leukaemia



Possible Heparin side effects in

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient: , weighing 122.6 kg (269.7 pounds)

Reactions: Atelectasis, Tinnitus, Contusion, Haemorrhage, Rectal Haemorrhage, Bundle Branch Block Right, Chronic Obstructive Pulmonary Disease, Viith Nerve Paralysis, Colonic Fistula, Hypoxia, Blood Testosterone Decreased, Unevaluable Event, Spinal Laminectomy, Cervical Spinal Stenosis, Transient Ischaemic Attack, Oxygen Saturation Decreased, White Blood Cell Count Increased, Vomiting, Cataract, Bone Graft, Gout, Atrial Fibrillation, Precancerous Cells Present, Anal Fissure, Gastrointestinal Pain, Platelet Count Decreased, Sleep Apnoea Syndrome

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Heparin
    Indication: Contusion

Humira

Humira
    Indication: Psoriatic Arthropathy

Other drugs received by patient: Astepro; Albuterol; Furosemide; Levothyroxine Sodium; Oxygen; Magnesium with Zinc; Diovan; Aspirin; Sertraline Hydrochloride; Fish OIL; Fluticasone Propionate; Methotrexate; Cholcyrs; Allegra; Triamcinolone; Hydrocodone; Alprazolam; Calcium with D; Fluticasone Propionate; Zirtec D; Alprazolam; Vitamin E; Lidex Gel; Naproxen; Diltiazem; Allegra-D 12 Hour; Spiriva; Metoprolol Tartrate; Sertraline Hydrochloride; Mens Multi Vitamin; Cetirizine HCL; Flax Seed; Ascorbic Acid



Possible Heparin side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-22

Patient: female

Reactions: Blood Pressure Increased, Dyspnoea, Flatulence, Peritoneal Dialysis Complication, Weight Increased, Abdominal Distension, Umbilical Hernia, Feeling Abnormal, Cardiac Arrest

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Dianeal
    Start date: 2009-07-19
    End date: 2009-07-28

Dianeal
    Indication: Peritoneal Dialysis

Dianeal LOW Calcium W / Dextrose 1.5%
    Indication: Peritoneal Dialysis

Heparin

Vancomycin



Possible Heparin side effects in female

Reported by a health professional (non-physician/pharmacist) from Finland on 2012-08-22

Patient: female

Reactions: Cerebral Haemorrhage

Adverse event resulted in: death

Drug(s) suspected as cause:
Alteplase
    Dosage: 5 mg + 0.5 mg/hr
    Indication: Thrombolysis
    Start date: 2010-01-01
    End date: 2010-01-01

Enoxaparin Sodium

Enoxaparin Sodium
    Indication: Thrombolysis
    Start date: 2010-01-01
    End date: 2010-01-01

Heparin
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-01-01
    End date: 2010-01-01

Warfarin Sodium
    Indication: Product Used FOR Unknown Indication



Possible Heparin side effects in

Reported by a pharmacist from United States on 2012-08-20

Patient:

Reactions: Haemorrhage, Coagulation Time Abnormal

Drug(s) suspected as cause:
Heparin
    Dosage: unk

Heparin Sodium
    Dosage: unk



Possible Heparin side effects in 88 year old female

Reported by a physician from Japan on 2012-08-16

Patient: 88 year old female

Reactions: Cardiac Failure, Heparin-Induced Thrombocytopenia, Renal Failure Chronic, Anti-Neutrophil Cytoplasmic Antibody Positive Vasculitis

Adverse event resulted in: death, life threatening event

Drug(s) suspected as cause:
Azulfidine
    Dosage: 500 mg/day
    Administration route: Oral
    Indication: Rheumatoid Arthritis
    End date: 2011-11-07

Heparin
    Dosage: unk



Possible Heparin side effects in male

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-15

Patient: male

Reactions: Abdominal Wall Haematoma, Metabolic Acidosis, Compartment Syndrome, Neutrophilia

Adverse event resulted in: death

Drug(s) suspected as cause:
Heparin

Warfarin Sodium



Possible Heparin side effects in 79 year old male

Reported by a pharmacist from United States on 2012-08-14

Patient: 79 year old male, weighing 86.0 kg (189.2 pounds)

Reactions: Heparin-Induced Thrombocytopenia, Atrial Flutter, Atrial Fibrillation

Drug(s) suspected as cause:
Heparin



Possible Heparin side effects in 80 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-14

Patient: 80 year old female

Reactions: Heparin-Induced Thrombocytopenia, Embolism, Diverticular Perforation

Adverse event resulted in: death

Drug(s) suspected as cause:
Anastrozole
    Administration route: Oral
    Indication: Breast Cancer Metastatic

Fulvestrant
    Dosage: 500mg on day1, and 250mg on day 14 and 28, and thereafter every 28 days
    Indication: Breast Cancer Metastatic

Heparin
    Indication: Breast Cancer Metastatic



Possible Heparin side effects in male

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-13

Patient: male

Reactions: Abdominal Pain, Metabolic Acidosis, Urine Output Decreased, Tachycardia, Neutrophilia, Pallor, Abdominal Compartment Syndrome, Abdominal Tenderness, Abdominal Wall Haematoma, Blood Creatinine Increased

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Heparin

Heparin

Warfarin Sodium



Possible Heparin side effects in 66 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-13

Patient: 66 year old male

Reactions: Thrombotic Microangiopathy

Adverse event resulted in: death

Drug(s) suspected as cause:
Albumin
    Dosage: form: solution
    End date: 2012-03-06

Bactrim DS
    Administration route: Oral
    End date: 2012-03-22

Delursan
    Administration route: Oral
    Indication: Cholestasis
    End date: 2012-05-11

Effexor
    Administration route: Oral
    Start date: 2012-03-13
    End date: 2012-03-22

Folic Acid
    Administration route: Oral
    Indication: Vitamin B12 Deficiency
    End date: 2012-04-05

Heparin
    End date: 2012-03-21

Levothyroxine Sodium
    Administration route: Oral
    Indication: Hypothyroidism
    End date: 2012-05-11

Nicardipine HCL
    Administration route: Oral
    Indication: Hypertension
    End date: 2012-04-15

Omeprazole
    Administration route: Oral
    End date: 2012-05-11

Phenoxymethyl Penicillin
    Dosage: 2 millions iu daily
    End date: 2012-03-22

Plitican
    Start date: 2012-03-14
    End date: 2012-03-19

Sandimmune
    Start date: 2012-01-23
    End date: 2012-04-04

Solu-Medrol
    Indication: Immunosuppression
    End date: 2012-05-11

Tiorfan
    Administration route: Oral
    End date: 2012-04-25

Tranxene
    Administration route: Oral
    Start date: 2012-03-13
    End date: 2012-03-16

Valganciclovir
    Administration route: Oral
    Start date: 2012-03-10
    End date: 2012-03-16

Vfend
    Dosage: powder for solution for perfusion
    End date: 2012-05-11

Zolpidem Tartrate
    Administration route: Oral
    Indication: Insomnia
    End date: 2012-03-18



Possible Heparin side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-10

Patient: female

Reactions: Osteoporosis, Multiple Fractures

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Albuterol
    Indication: Product Used FOR Unknown Indication

Fluticasone Propionate
    Indication: Product Used FOR Unknown Indication

Heparin
    Indication: Thrombosis Prophylaxis

Steroids
    Indication: Product Used FOR Unknown Indication



Possible Heparin side effects in 70 year old male

Reported by a physician from Japan on 2012-08-10

Patient: 70 year old male, weighing 70.3 kg (154.7 pounds)

Reactions: Haematochezia, Hepatic Function Abnormal, Haemorrhagic Cerebral Infarction, Cardiac Failure Acute, Cardiogenic Shock, Acute Myocardial Infarction

Adverse event resulted in: life threatening event, hospitalization, disablity

Drug(s) suspected as cause:
Aspirin
    Dosage: 100 mg
    Indication: Myocardial Infarction
    End date: 2012-06-22

Heparin
    End date: 2012-06-22

Plavix
    Dosage: 75 mg
    Indication: Myocardial Infarction
    End date: 2012-06-22

Pradaxa
    Dosage: 220 mg
    Start date: 2012-06-01
    End date: 2012-06-22

Pradaxa
    Dosage: 300 mg
    Administration route: Oral
    Indication: Atrial Fibrillation
    Start date: 2011-11-01
    End date: 2012-06-22

Other drugs received by patient: Lansoprazole; Dobupum; Cefotiam Hydrochloride; Hanp; Lasix; Amiodarone Hydrochloride; Fentanyl; Lipitor; Soldactone; Milrinone Lactate; Diprivan



Possible Heparin side effects in 85 year old female

Reported by a pharmacist from United States on 2012-08-10

Patient: 85 year old female, weighing 78.0 kg (171.6 pounds)

Reactions: Thrombocytopenia, Epistaxis

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Eptifibatide
    Dosage: iv drip
    Indication: Acute Myocardial Infarction

Heparin
    Dosage: 1290 units/hr iv drip



Possible Heparin side effects in 68 year old male

Reported by a pharmacist from United States on 2012-08-09

Patient: 68 year old male, weighing 109.6 kg (241.1 pounds)

Reactions: Thrombocytopenia, Deep Vein Thrombosis

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Heparin



Possible Heparin side effects in 67 year old female

Reported by a health professional (non-physician/pharmacist) from Taiwan, Province of China on 2012-08-07

Patient: 67 year old female

Reactions: Hyperphosphataemia, Bursitis

Drug(s) suspected as cause:
Heparin



Possible Heparin side effects in male

Reported by a physician from United States on 2012-08-07

Patient: male, weighing 48.7 kg (107.1 pounds)

Reactions: Product Quality Issue, Haemorrhagic Stroke

Adverse event resulted in: death, life threatening event, hospitalization

Drug(s) suspected as cause:
Heparin
    Dosage: 2500 units once intra-arterially unsure which vial
    Indication: Angioplasty
    Start date: 2012-07-18

Heparin
    Dosage: 2500 units once intra-arterially unsure which vial
    Indication: Renal Artery Stent Placement
    Start date: 2012-07-18

Heparin
    Dosage: 2500 units once intra-arterially unsure which vial
    Indication: Thrombosis Prophylaxis



Possible Heparin side effects in 77 year old male

Reported by a health professional (non-physician/pharmacist) from Australia on 2012-08-07

Patient: 77 year old male

Reactions: Heparin-Induced Thrombocytopenia, Bacterial Sepsis, Post Procedural Haemorrhage, Epistaxis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Heparin

Other drugs received by patient: Vasopressin and Analogues; Verapamil; Epinephrine



Possible Heparin side effects in 57 year old female

Reported by a physician from United States on 2012-08-06

Patient: 57 year old female

Reactions: Drug Hypersensitivity

Drug(s) suspected as cause:
Alcohol
    Dosage: unk

Ambien
    Dosage: unk

Caffeine Citrate
    Dosage: unk

Ceclor
    Dosage: unk

Ceftin
    Dosage: unk

Ciprofloxacin HCL
    Dosage: unk

Cleocin Hydrochloride
    Dosage: unk

Compazine
    Dosage: unk

Duricef
    Dosage: unk

Epinephrine
    Dosage: unk

Gadolinium
    Dosage: unk

Heparin
    Dosage: unk

Indocin
    Dosage: unk

Iodine
    Dosage: unk

Monistat
    Dosage: unk

Mycelex
    Dosage: unk

Nizoral
    Dosage: unk

Oxymetazoline HCL
    Dosage: unk

Relafen
    Dosage: unk



Possible Heparin side effects in 67 year old male

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

Patient: 67 year old male

Reactions: Haemorrhagic Transformation Stroke, Intraventricular Haemorrhage, Unresponsive To Stimuli, Aphasia, Hemiparesis, Cerebral Haemorrhage

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Acetylsalicylic Acid SRT
    Indication: Antiplatelet Therapy

Alteplase
    Dosage: 90 mg, unk

Clopidogrel
    Indication: Antiplatelet Therapy

Heparin

Tirofibran

Tirofibran

Other drugs received by patient: Lisinopril; Insulin; Gemfibrozil



Possible Heparin side effects in

Reported by a physician from Canada on 2012-08-03

Patient:

Reactions: Electrocardiogram ST Segment Abnormal, Drug Ineffective, Chest Pain, Myocardial Ischaemia, Electrocardiogram T Wave Abnormal, Condition Aggravated, Electrocardiogram ST Segment Elevation

Drug(s) suspected as cause:
Aspirin
    Indication: Product Used FOR Unknown Indication

Heparin
    Dosage: unk
    Indication: Acute Myocardial Infarction

Tenecteplase
    Dosage: unk
    Indication: Acute Myocardial Infarction



Possible Heparin side effects in 67 year old male

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

Patient: 67 year old male

Reactions: Intraventricular Haemorrhage, Haemorrhagic Transformation Stroke, Unresponsive To Stimuli, Aphasia, Hemiparesis, Cerebral Haemorrhage

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Acetylsalicylic Acid
    Indication: Antiplatelet Therapy

Alteplase
    Dosage: 90 mg, unk

Clopidogrel
    Indication: Antiplatelet Therapy

Heparin

Tirofibran

Tirofibran

Other drugs received by patient: Lisinopril; Gemfibrozil; Insulin



Possible Heparin side effects in 38 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-02

Patient: 38 year old female

Reactions: Spinal Cord Infarction, Nausea, Loss of Consciousness, Hypoxic-Ischaemic Encephalopathy, Cardio-Respiratory Arrest, Neck Pain, Vertebral Artery Dissection, Subarachnoid Haemorrhage, Ventricular Tachycardia, Asthenia, Sinus Tachycardia

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Heparin

Other drugs received by patient: Cyanocobalamin; Lidocaine



Possible Heparin side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-02

Patient:

Reactions: Caesarean Section, Maternal Exposure During Pregnancy

Drug(s) suspected as cause:
Aspirin
    Dosage: maternal dose

Carvedilol
    Dosage: maternal dose

Carvedilol
    Dosage: maternal dose

Carvedilol
    Dosage: maternal dose

Clopidogrel
    Dosage: maternal dose

Ferrous Sulfate TAB
    Dosage: maternal dose

Heparin

Hydralazine HCL
    Dosage: maternal dose

Hydralazine HCL
    Dosage: maternal dose

Metoprolol Tartrate
    Dosage: maternal dose

Morphine Sulfate

Vitamins (Unspecified)

Zocor
    Dosage: maternal dose

[composition Unspecified]



Possible Heparin side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-02

Patient:

Reactions: Maternal Drugs Affecting Foetus, Premature Baby, Foetal Exposure During Pregnancy

Drug(s) suspected as cause:
Aspirin
    Dosage: maternal dose

Carvedilol
    Dosage: maternal dose

Carvedilol
    Dosage: maternal dose

Carvedilol
    Dosage: maternal dose

Clopidogrel
    Dosage: maternal dose

Ferrous Sulfate TAB
    Dosage: maternal dose

Heparin

Hydralazine HCL
    Dosage: maternal dose

Hydralazine HCL
    Dosage: maternal dose

Metoprolol Tartrate
    Dosage: maternal dose

Morphine Sulfate

Vitamins (Unspecified)

Zocor
    Dosage: maternal dose

[composition Unspecified]



Possible Heparin side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-01

Patient: male

Reactions: Neurological Decompensation, Headache, Hemiparesis, Cerebral Ventricle Dilatation, Subdural Haemorrhage, Cerebral Haemorrhage, Cerebral Infarction, Intracranial Pressure Increased, Intracranial Venous Sinus Thrombosis

Drug(s) suspected as cause:
Alteplase
    Indication: Superior Sagittal Sinus Thrombosis

Heparin
    Indication: Superior Sagittal Sinus Thrombosis



Possible Heparin side effects in 53 year old male

Reported by a pharmacist from United States on 2012-07-31

Patient: 53 year old male, weighing 102.0 kg (224.4 pounds)

Reactions: Product Measured Potency Issue, Coagulation Time Shortened

Drug(s) suspected as cause:
Heparin



Possible Heparin side effects in 60 year old female

Reported by a physician from Poland on 2012-07-31

Patient: 60 year old female

Reactions: Thrombosis

Drug(s) suspected as cause:
Boniva
    Dosage: dose reported as 3mg/3ml
    Indication: Osteoporosis Postmenopausal
    Start date: 2012-01-01

Heparin
    Indication: Thrombosis

Other drugs received by patient: Enoxaparin Sodium; Vitamin D



Possible Heparin side effects in 83 year old male

Reported by a consumer/non-health professional from United States on 2012-07-30

Patient: 83 year old male, weighing 78.0 kg (171.6 pounds)

Reactions: Pneumonia, Renal Failure Acute

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Amlodipine
    Dosage: unk
    End date: 2010-12-16

Heparin
    Dosage: 0.02 mg/kg bolus
    Start date: 2010-12-16
    End date: 2010-12-16

Heparin
    Dosage: 0.01 mg/kg, hr
    Start date: 2010-12-16
    End date: 2010-12-17

Heparin
    Dosage: 66 iu/kg, bolus
    Indication: Percutaneous Coronary Intervention
    Start date: 2010-12-16
    End date: 2010-12-16

Iopromide
    Dosage: 222 ml, once
    Indication: Angiogram
    Start date: 2010-12-16
    End date: 2010-12-16

Other drugs received by patient: Aspirin; Tirofiban; Bisoprolol Fumarate; Acetylcysteine; Aspirin; Clopidogrel; Valsartan; Aspirin; Clopidogrel; Clopidogrel; Heparin; Sinvastatina Mepha; Pantoprazole



Possible Heparin side effects in

Reported by a individual with unspecified qualification from Canada on 2012-07-30

Patient:

Reactions: Haemorrhage, Myocardial Ischaemia, Haemorrhage Intracranial, Catheter Site Haemorrhage, Cardiogenic Shock, Death, Cardiac Failure, Myocardial Infarction

Adverse event resulted in: death

Drug(s) suspected as cause:
Aspirin
    Dosage: unk
    Indication: Acute Myocardial Infarction

Clopidogrel
    Dosage: 300 mg, unk
    Indication: Acute Myocardial Infarction

Clopidogrel
    Dosage: 75 mg, unk

GP IIB / Iiia Inhibitor (Study Drug)
    Dosage: unk
    Indication: Acute Myocardial Infarction

Heparin
    Dosage: unk
    Indication: Acute Myocardial Infarction

Tnkase
    Dosage: unk
    Indication: Acute Myocardial Infarction

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