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Innohep (Tinzaparin) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Innohep (Tinzaparin) 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 (215)
Death (29)
Life Threatening Events (24)
Disability (7)

Reports by Reaction Type

Pulmonary Embolism (28)Off Label Use (26)Drug Ineffective (20)Deep Vein Thrombosis (14)Thrombosis in Device (13)Incorrect Drug Administration Duration (13)Maternal Exposure During Pregnancy (12)Thrombosis (11)Haemoglobin Decreased (11)Haematoma (9)Caesarean Section (8)Anaemia (8)

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

Possible Innohep side effects in 69 year old male

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

Patient: 69 year old male

Reactions: Drug Interaction, Haematoma

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Innohep
    Indication: Deep Vein Thrombosis
    Start date: 2012-05-01
    End date: 2012-05-01

Arixtra
    Indication: Deep Vein Thrombosis
    Start date: 2012-05-01
    End date: 2012-05-01



Possible Innohep side effects in 56 year old male

Reported by a physician from France on 2012-08-08

Patient: 56 year old male, weighing 59.0 kg (129.8 pounds)

Reactions: Phlebitis, Transaminases Increased

Drug(s) suspected as cause:
Cimzia
    Dosage: 400 mg every two weeks and then 200 mg every two weeks
    Indication: Rheumatoid Arthritis
    Start date: 2012-03-22

Innohep
    Indication: Phlebitis

Other drugs received by patient: Prednisone TAB; Ketoprofen; Methotrexate



Possible Innohep side effects in 90 year old male

Reported by a physician from Greece on 2012-07-27

Patient: 90 year old male, weighing 70.0 kg (154.0 pounds)

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Levophed
    Dosage: 3 amp/24hrs
    Start date: 2009-05-19

Moxifloxacin
    Dosage: 400 mg, 2x/day
    Indication: Abdominal Infection
    Start date: 2009-05-16
    End date: 2009-05-18

Metronidazole
    Dosage: 500 mg, 3x/day
    Start date: 2009-05-19
    End date: 2009-05-23

Innohep
    Dosage: unk
    Indication: Anticoagulant Therapy
    Start date: 2009-05-19

Daptomycin
    Dosage: 350 mg, 1x/day
    Indication: Abdominal Infection
    Start date: 2009-05-24
    End date: 2009-05-25

Netilmicin
    Dosage: 300 mg, 1x/day
    Indication: Abdominal Infection
    Start date: 2009-05-29
    End date: 2009-06-08

Colimycine
    Dosage: 1000000 unk, 4x/day
    Indication: Abdominal Infection
    Start date: 2009-05-26
    End date: 2009-05-28

Piperacillin and Tazobactam
    Dosage: 4.5 mg, 3x/day
    Start date: 2009-05-16
    End date: 2009-05-25

Tigecycline
    Dosage: 50 mg, 2x/day
    Start date: 2009-05-28
    End date: 2009-06-09



Possible Innohep side effects in 80 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-07-24

Patient: 80 year old female

Reactions: Depressed Level of Consciousness, Coma, Respiratory Distress, Cerebral Haemorrhage

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Innohep
    Dosage: 1 df, 1x/day
    End date: 2012-04-06

Sutent
    Dosage: 25 mg, 1x/day
    Administration route: Oral
    Indication: Metastatic Renal Cell Carcinoma
    End date: 2012-04-06

Other drugs received by patient: Exforge; Xanax; Athymil; Duragesic-100; Morphine Sulfate; Nexium; Imovane; Ferrous Sulfate TAB



Possible Innohep side effects in female

Reported by a health professional (non-physician/pharmacist) from Spain on 2012-06-29

Patient: female

Reactions: Venous Thrombosis in Pregnancy, Thrombosis, Systemic Lupus Erythematosus, Maternal Exposure During Pregnancy

Drug(s) suspected as cause:
Innohep

Other drugs received by patient: Aspirin; Prednisone TAB



Possible Innohep side effects in 83 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-06-29

Patient: 83 year old female

Reactions: Chest Pain, Thrombocytosis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Innohep
    Indication: Prophylaxis
    Start date: 2012-02-03
    End date: 2012-03-26

Enoxaparin Sodium
    Indication: Prophylaxis
    Start date: 2012-02-03
    End date: 2012-03-26



Possible Innohep side effects in 65 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-29

Patient: 65 year old male

Reactions: Lymphadenopathy, Incorrect Drug Administration Duration, Spinal Compression Fracture, Dyspepsia, Tachycardia, Underdose, Lower Urinary Tract Symptoms, Calculus Urinary

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Rituximab (Rituximab)
    Dosage: 800 mg day 1 of each 28 cycle,intravenous
    Indication: non-Hodgkin's Lymphoma
    Start date: 2012-02-02

Bendamustine Hydrochloride
    Dosage: 255 mg days 1 and 2 of each 28 day cycle,intravenous
    Indication: non-Hodgkin's Lymphoma
    Start date: 2012-02-02

Prednisolone
    Dosage: 10 mg (1 in 1 d),oral
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Innohep
    Dosage: 14000 units daily,subcutaneous ; 0.6 mg (1 in 1 d),subcutaneous ; (1 in 1 d),subcutaneous
    Indication: Pulmonary Embolism
    Start date: 2011-05-09
    End date: 2012-04-05

Innohep
    Dosage: 14000 units daily,subcutaneous ; 0.6 mg (1 in 1 d),subcutaneous ; (1 in 1 d),subcutaneous
    Indication: Pulmonary Embolism
    Start date: 2011-06-10
    End date: 2011-06-18

Innohep
    Dosage: 14000 units daily,subcutaneous ; 0.6 mg (1 in 1 d),subcutaneous ; (1 in 1 d),subcutaneous
    Indication: Pulmonary Embolism
    Start date: 2011-06-20

Other drugs received by patient: Valacyclovir; Allopurinol; Tamsulosin HCL; Esomeprazole Magnesium; Bisoprolol Fumarate



Possible Innohep side effects in 29 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-06-29

Patient: 29 year old male, weighing 130.0 kg (286.0 pounds)

Reactions: Chest Pain, Pulmonary Embolism, Deep Vein Thrombosis

Drug(s) suspected as cause:
Innohep
    Dosage: 4500 iu (4500 iu, 1 in 1 d), subcutaneous 18000 iu (18000 iu, 1 in 1 d), subcutaneous
    Indication: Thrombosis Prophylaxis

Innohep
    Dosage: 4500 iu (4500 iu, 1 in 1 d), subcutaneous 18000 iu (18000 iu, 1 in 1 d), subcutaneous
    Indication: Thrombosis Prophylaxis
    Start date: 2012-03-04



Possible Innohep side effects in

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-06-29

Patient:

Reactions: Cytogenetic Abnormality, Haemorrhage, Embolism Venous, Infection

Drug(s) suspected as cause:
Lenalidomide
    Dosage: 25 mg/day dayl-21
    Indication: Multiple Myeloma

Dexamethasone
    Dosage: 40mg day 1-4 and day 17-20
    Indication: Multiple Myeloma

Adriamycin PFS
    Dosage: 9mg/m2 day 1-4
    Indication: Multiple Myeloma

Pegfilgrastim (Pegfilgrastim)
    Dosage: 6mg day6
    Indication: Product Used FOR Unknown Indication

Etoposide
    Indication: Product Used FOR Unknown Indication

Cyclophosphamide
    Indication: Product Used FOR Unknown Indication

Innohep
    Indication: Thrombosis Prophylaxis



Possible Innohep side effects in 57 year old male

Reported by a health professional (non-physician/pharmacist) from Sweden on 2012-06-29

Patient: 57 year old male

Reactions: Fluid Overload, Anaphylactic Reaction, Respiratory Distress, Haemodialysis, Feeling Cold, Hypoxia, Bronchospasm, Sinus Tachycardia, Cardiac Arrest

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Innohep



Possible Innohep side effects in 68 year old female

Reported by a health professional (non-physician/pharmacist) from Martinique on 2012-06-21

Patient: 68 year old female, weighing 58.0 kg (127.6 pounds)

Reactions: Off Label Use, Thrombophlebitis Superficial

Drug(s) suspected as cause:
Innohep



Possible Innohep side effects in 74 year old female

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-06-21

Patient: 74 year old female, weighing 82.0 kg (180.4 pounds)

Reactions: Humerus Fracture, Osteoarthritis, Osteoporosis, Gait Disturbance, Fall, Haematoma

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Innohep
    Dosage: 15000 iu (15000 iu,1 in 1 d),subcutaneous
    Indication: Pulmonary Embolism
    Start date: 2012-02-22

Innohep
    Dosage: 15000 iu (15000 iu,1 in 1 d),subcutaneous
    Indication: Deep Vein Thrombosis
    Start date: 2012-02-22

Other drugs received by patient: Carmen (Lercanidipine)(10 MG); Ramipril; Beloc ZOK (Metoprolol Succinate)(23.75 MG; Ibuprofen (Ibuprofen)(600 MG)



Possible Innohep side effects in 63 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-06-21

Patient: 63 year old male

Reactions: Phlebitis, Incorrect Drug Administration Duration

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Innohep

Other drugs received by patient: Inegy (Inegy); Naftidrofuryl (Naftidrofuryl); Cozaar; Kardegic (Acetylsalicylate Lysine)



Possible Innohep side effects in 61 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-06-14

Patient: 61 year old male, weighing 70.0 kg (154.0 pounds)

Reactions: Inappropriate Schedule of Drug Administration, Medication Error, Drug Ineffective FOR Unapproved Indication

Drug(s) suspected as cause:
Innohep



Possible Innohep side effects in 74 year old male

Reported by a health professional (non-physician/pharmacist) from Brazil on 2012-06-14

Patient: 74 year old male, weighing 78.0 kg (171.6 pounds)

Reactions: Metastases To Central Nervous System, Convulsion

Adverse event resulted in: death

Drug(s) suspected as cause:
Innohep

Other drugs received by patient: Gutalax (Sodium Picosulfate); Dexamethasone; Dacarbazine; Atenolol



Possible Innohep side effects in 77 year old male

Reported by a health professional (non-physician/pharmacist) from Denmark on 2012-06-13

Patient: 77 year old male

Reactions: Product Quality Issue, Drug Ineffective, Pulmonary Embolism

Drug(s) suspected as cause:
Innohep

Other drugs received by patient: Pantoloc (Pantoprazole); Burana (Ibuprofen)



Possible Innohep side effects in 37 year old female

Reported by a individual with unspecified qualification from United Kingdom on 2012-06-13

Patient: 37 year old female, weighing 83.0 kg (182.6 pounds)

Reactions: Hypertension, Paraesthesia, Tremor, Infusion Related Reaction, Infusion Site Erythema

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Innohep

Other drugs received by patient: Metronidazole; Ibuprofen; Sertraline Hydrochloride; Yasmin; Ventolin; Qvar



Possible Innohep side effects in 125 month old male

Reported by a health professional (non-physician/pharmacist) from Ireland on 2012-06-13

Patient: 125 month old male

Reactions: Transplant Failure, Renal Transplant, Pulmonary Embolism, Thrombosis in Device

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Innohep



Possible Innohep side effects in 61 year old female

Reported by a health professional (non-physician/pharmacist) from Denmark on 2012-06-13

Patient: 61 year old female

Reactions: Product Quality Issue, Drug Ineffective, Pulmonary Embolism

Drug(s) suspected as cause:
Innohep
    Dosage: dose: 3500 ie daily, strength: 10,000 anti-xa ie/ml, subcutaneous
    Indication: Thrombosis Prophylaxis
    Start date: 2012-05-07

Innohep

Other drugs received by patient: Pantoprazol ^actavis^ (Pantoprazole Sodium); Pinex (Paracetamol); Ibuprofen; Levothyroxine Sodium; Zolpidem Tartrat (Zolpidem Tartrate)



Possible Innohep side effects in 65 year old female

Reported by a physician from France on 2012-06-13

Patient: 65 year old female

Reactions: Drug Rash With Eosinophilia and Systemic Symptoms

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cytarabine
    Dosage: 07 to 20-mar-2012, then from 28 to 29-mar-2012: methotrexate + cytarabine + methylprednisolone
    Start date: 2012-03-07

Lasix
    Start date: 2012-04-06

Innohep

Imipenem and Cilastatin Sodium
    Indication: Acute Leukaemia
    Start date: 2012-04-01
    End date: 2012-04-06

Fluconazole

Sprycel
    Dosage: to 30-mar-2012, then from 28 to 29mar12 and on 01-apr-2012: sprycel + vincristine
    Indication: Acute Leukaemia
    Start date: 2012-03-07

Vincristine Sulfate
    Indication: Acute Leukaemia
    Start date: 2012-03-07
    End date: 2012-03-30

Methylprednisolone
    Dosage: 07 to 20-mar-2012, then from 28 to 29-mar-2012: methotrexate + cytarabine + methylprednisolone
    Start date: 2012-03-07

Acupan
    Indication: Acute Leukaemia
    Start date: 2012-04-01
    End date: 2012-04-06

Methotrexate
    Dosage: 07 to 20-mar-2012, then from 28 to 29-mar-2012: methotrexate + cytarabine + methylprednisolone
    Start date: 2012-03-07

Other drugs received by patient: Xanax



Possible Innohep side effects in 71 year old female

Reported by a health professional (non-physician/pharmacist) from Denmark on 2012-06-13

Patient: 71 year old female

Reactions: Product Quality Issue, Drug Ineffective, Pulmonary Embolism

Drug(s) suspected as cause:
Innohep

Other drugs received by patient: Ibuprofen ^orifarm^; Acetaminophen; Lithium Citrate; Clonazepam; Propranolol; Sertralin ^actavis^ (Sertraline); Lamotrigine



Possible Innohep side effects in 74 year old female

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-06-07

Patient: 74 year old female, weighing 82.0 kg (180.4 pounds)

Reactions: Humerus Fracture, Haemorrhage, Skin Lesion, Wound, Gait Disturbance, Fall

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Innohep

Other drugs received by patient: Ramipril; Lercanidipine; Metoprolol Succinate; Ibuprofen



Possible Innohep side effects in 74 year old male

Reported by a health professional (non-physician/pharmacist) from Brazil on 2012-06-07

Patient: 74 year old male, weighing 78.0 kg (171.6 pounds)

Reactions: Metastatic Malignant Melanoma, Neoplasm Progression, Intracranial Pressure Increased, Constipation, Cerebral Haemorrhage, Convulsion

Adverse event resulted in: death

Drug(s) suspected as cause:
Innohep

Other drugs received by patient: Dacarbazine; Atenolol; Dexamethasone; Gutalax (Sodium Picosulfate)



Possible Innohep side effects in

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-06-04

Patient:

Reactions: Off Label Use, Incorrect Drug Administration Duration, Osteoporosis, Haemorrhage, Heparin-Induced Thrombocytopenia

Drug(s) suspected as cause:
Innohep



Possible Innohep side effects in

Reported by a health professional (non-physician/pharmacist) from Canada on 2012-06-04

Patient:

Reactions: Pulmonary Embolism

Adverse event resulted in: death

Drug(s) suspected as cause:
Innohep

Other drugs received by patient: Aspirin



Possible Innohep side effects in 125 month old male

Reported by a health professional (non-physician/pharmacist) from Ireland on 2012-05-31

Patient: 125 month old male

Reactions: Transplant Failure, Renal Transplant, Pulmonary Embolism, Thrombosis in Device

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Innohep
    Dosage: 175 iu/kg
    Indication: Thrombosis in Device

Innohep
    Dosage: 175 iu/kg
    Indication: Haemodialysis



Possible Innohep side effects in 74 year old male

Reported by a health professional (non-physician/pharmacist) from Brazil on 2012-05-31

Patient: 74 year old male, weighing 78.0 kg (171.6 pounds)

Reactions: Intracranial Pressure Increased, Cerebral Haemorrhage, Convulsion

Adverse event resulted in: death

Drug(s) suspected as cause:
Innohep

Other drugs received by patient: Dexamethasone; Atenolol; Dacarbazine; Gutalax(sodium Picosulfate)



Possible Innohep side effects in

Reported by a health professional (non-physician/pharmacist) from Italy on 2012-05-31

Patient:

Reactions: Pulmonary Embolism, Troponin Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Innohep



Possible Innohep side effects in female

Reported by a health professional (non-physician/pharmacist) from Canada on 2012-05-30

Patient: female

Reactions: Placental Disorder, Maternal Exposure During Pregnancy

Drug(s) suspected as cause:
Innohep
    Indication: Prophylaxis

Innohep
    Indication: Complication of Pregnancy



Possible Innohep side effects in

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-05-30

Patient:

Reactions: Surgical Procedure Repeated, Embolism, Thoracotomy, Nervous System Disorder, Post Procedural Haemorrhage

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Innohep

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