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 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 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 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 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 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 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 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 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 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
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
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 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 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
Possible Innohep side effects in
Reported by a health professional (non-physician/pharmacist) from Russian Federation on 2012-05-30
Patient:
Reactions: Caesarean Section, Premature Separation of Placenta, Maternal Exposure During Pregnancy, Hypercoagulation
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Innohep
Other drugs received by patient: Vitamins NOS (Vitamins Nos); Antioxidant NOS (Seletop-C); Folic Acid
|