Index of reports
> Cases with Off Label Use (26)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Innohep (Tinzaparin) where reactions include off label use. The selected reports were submitted to the FDA during the sample period of about a year.
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
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 76 year old male
Reported by a health professional (non-physician/pharmacist) from France on 2012-05-22
Patient: 76 year old male
Reactions: Off Label Use, Anaemia, Oesophagitis Ulcerative, Haematemesis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Innohep
Indication: Phlebitis
Sutent
Indication: Prostate Cancer Metastatic
Possible Innohep side effects in 68 year old female
Reported by a health professional (non-physician/pharmacist) from France on 2012-04-13
Patient: 68 year old female, weighing 55.0 kg (121.0 pounds)
Reactions: Off Label Use, Thrombophlebitis Superficial
Drug(s) suspected as cause:
Innohep
Dosage: 0.55 ml (1 in 1 d), subcutaneous
Indication: Thrombophlebitis Superficial
Start date: 2012-01-09
End date: 2012-02-24
Innohep
Dosage: 0.55 ml (1 in 1 d), subcutaneous
Indication: Off Label Use
Start date: 2012-01-09
End date: 2012-02-24
Possible Innohep side effects in 17 year old
Reported by a health professional (non-physician/pharmacist) from Canada on 2012-04-04
Patient: 17 year old , weighing 53.8 kg (118.4 pounds)
Reactions: Off Label Use, Drug Ineffective, Disease Recurrence, Pulmonary Embolism
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Innohep
Possible Innohep side effects in 51 year old female
Reported by a health professional (non-physician/pharmacist) from France on 2012-03-26
Patient: 51 year old female
Reactions: Haemoglobin Decreased, Bronchial Neoplasm, Off Label Use, Incorrect Drug Administration Duration, Haemoptysis, Neoplasm Progression
Adverse event resulted in: death
Drug(s) suspected as cause:
Innohep
Dosage: 0.5 ml (1 in 1 d),subcutaneous
Indication: Superior Vena Cava Syndrome
Start date: 2011-04-28
End date: 2011-06-11
Tarceva
Dosage: 150 mg,oral
Administration route: Oral
Indication: Lung Adenocarcinoma
Start date: 2011-04-22
End date: 2011-06-11
Other drugs received by patient: Spiriva; Mucomyst; Augmentin '125'; Protifar (Protifar); Fluticasone Propionate / Salmeterol; Nexium IV; Amoxicillini (Amoxi-Clavulanico); Tolexine (Doxycycline); Spasfon (Spasfon / 00765801 / ); Celluvisc (Carmellose Sodium)
Possible Innohep side effects in male
Reported by a health professional (non-physician/pharmacist) from France on 2012-03-26
Patient: male
Reactions: Thrombosis, Off Label Use, Disease Recurrence, Medication Error
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Innohep
Possible Innohep side effects in 68 year old female
Reported by a individual with unspecified qualification from France on 2012-03-22
Patient: 68 year old female, weighing 55.0 kg (121.0 pounds)
Reactions: Off Label Use, Thrombophlebitis Superficial, Condition Aggravated
Drug(s) suspected as cause:
Innohep
Possible Innohep side effects in 75 year old female
Reported by a health professional (non-physician/pharmacist) from Germany on 2012-02-21
Patient: 75 year old female
Reactions: Off Label Use, Intra-Abdominal Haemorrhage, Shock Haemorrhagic, Acute Respiratory Distress Syndrome, Accidental Overdose
Adverse event resulted in: death
Drug(s) suspected as cause:
Innohep
Possible Innohep side effects in male
Reported by a health professional (non-physician/pharmacist) from France on 2012-02-13
Patient: male
Reactions: Off Label Use, Thrombosis, Incorrect Drug Administration Duration, Overdose, Disease Recurrence, Medication Error
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 Ireland on 2012-01-30
Patient: female
Reactions: Off Label Use, Maternal Exposure During Pregnancy, Abortion Spontaneous
Drug(s) suspected as cause:
Innohep
Possible Innohep side effects in male
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2011-12-27
Patient: male, weighing 80.0 kg (176.0 pounds)
Reactions: Off Label Use, Incorrect Drug Administration Duration, Needle Issue
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 2011-12-27
Patient: female
Reactions: Off Label Use, Disease Recurrence, Drug Ineffective, Embolism Venous
Drug(s) suspected as cause:
Innohep
Possible Innohep side effects in 57 year old male
Reported by a physician from France on 2011-11-30
Patient: 57 year old male
Reactions: Off Label Use, Thrombosis, Drug Dispensing Error
Drug(s) suspected as cause:
Innohep
Possible Innohep side effects in 36 year old female
Reported by a pharmacist from France on 2011-11-30
Patient: 36 year old female
Reactions: Nausea, Alanine Aminotransferase Increased, Hepatic Steatosis, Off Label Use, Hot Flush, Hepatotoxicity, Aspartate Aminotransferase Increased, Dizziness, Decreased Appetite
Drug(s) suspected as cause:
Innohep
Other drugs received by patient: Propranolol; Betablocker; Alprazolam; Cerazette (Cefaloridine)
Possible Innohep side effects in male
Reported by a pharmacist from United States on 2011-11-29
Patient: male, weighing 80.0 kg (176.0 pounds)
Reactions: Off Label Use, Needle Issue
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 Ireland on 2011-11-15
Patient: female
Reactions: Off Label Use, Post Procedural Complication, Pulmonary Embolism, Condition Aggravated
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Innohep
Possible Innohep side effects in 31 year old female
Reported by a health professional (non-physician/pharmacist) from Ireland on 2011-11-09
Patient: 31 year old female, weighing 73.6 kg (161.9 pounds)
Reactions: Off Label Use, Caesarean Section, Foetal Exposure During Pregnancy, Pulmonary Embolism
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Innohep
Dosage: 4500 iu (4500 iu,1 in 1 d),subcutaneous ; 13000 iu (13000 iu,1 in 1 d),subcutaneous
Indication: Thrombosis Prophylaxis
Start date: 2011-04-04
End date: 2011-10-07
Innohep
Dosage: 4500 iu (4500 iu,1 in 1 d),subcutaneous ; 13000 iu (13000 iu,1 in 1 d),subcutaneous
Indication: Pregnancy
Start date: 2011-04-04
End date: 2011-10-07
Innohep
Dosage: 4500 iu (4500 iu,1 in 1 d),subcutaneous ; 13000 iu (13000 iu,1 in 1 d),subcutaneous
Indication: Pulmonary Embolism
Start date: 2011-04-04
End date: 2011-10-07
Innohep
Dosage: 4500 iu (4500 iu,1 in 1 d),subcutaneous ; 13000 iu (13000 iu,1 in 1 d),subcutaneous
Indication: Thrombosis Prophylaxis
Start date: 2011-10-07
Innohep
Dosage: 4500 iu (4500 iu,1 in 1 d),subcutaneous ; 13000 iu (13000 iu,1 in 1 d),subcutaneous
Indication: Pregnancy
Start date: 2011-10-07
Innohep
Dosage: 4500 iu (4500 iu,1 in 1 d),subcutaneous ; 13000 iu (13000 iu,1 in 1 d),subcutaneous
Indication: Pulmonary Embolism
Start date: 2011-10-07
Possible Innohep side effects in 36 year old female
Reported by a pharmacist from France on 2011-11-07
Patient: 36 year old female
Reactions: Off Label Use, Hot Flush, Nausea, Aspartate Aminotransferase Increased, Alanine Aminotransferase Increased, Dizziness, Decreased Appetite
Drug(s) suspected as cause:
Innohep
Other drugs received by patient: Alprazolam; Cerazette (Cefaloridine); Propanolol (Propanolol) (40 Milligram); Betablocker (Betablocking Agents)
Possible Innohep side effects in 30 year old female
Reported by a physician from France on 2011-11-03
Patient: 30 year old female, weighing 100.0 kg (220.0 pounds)
Reactions: Off Label Use, Phlebitis, Dyspnoea, Oedema Peripheral, Cardiac Arrest
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Innohep
Possible Innohep side effects in 40 year old male
Reported by a physician from France on 2011-11-02
Patient: 40 year old male
Reactions: Off Label Use, Thrombocytosis
Drug(s) suspected as cause:
Innohep
Possible Innohep side effects in male
Reported by a physician from France on 2011-11-01
Patient: male
Reactions: Off Label Use, Pulmonary Embolism
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Innohep
Dosage: subcutaneous
Indication: Prophylaxis
Innohep
Dosage: subcutaneous
Indication: Ankle Fracture
Possible Innohep side effects in male
Reported by a physician from France on 2011-10-24
Patient: male
Reactions: Off Label Use, Phlebitis, Disease Recurrence
Drug(s) suspected as cause:
Innohep
Other drugs received by patient: Chemotherapy (Chem - Otherapeutics)
Possible Innohep side effects in female
Reported by a pharmacist from France on 2011-10-24
Patient: female
Reactions: Nausea, Alanine Aminotransferase Increased, Hepatic Steatosis, Off Label Use, Hot Flush, Aspartate Aminotransferase Increased, Dizziness, Decreased Appetite
Drug(s) suspected as cause:
Innohep
Other drugs received by patient: Betablocker (Beta Blocking Agents)
Possible Innohep side effects in 31 year old female
Reported by a health professional (non-physician/pharmacist) from Ireland on 2011-10-19
Patient: 31 year old female, weighing 73.6 kg (161.9 pounds)
Reactions: Off Label Use, Hypopnoea, Drug Ineffective, Maternal Exposure During Pregnancy, Pulmonary Embolism
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Innohep
Dosage: 4500 iu (4500iu, 1 in 1 d), subcutaneous 13000 iu (13000 iu, 1 in 1 d), subcutaneous
Indication: Thrombosis Prophylaxis
Start date: 2011-10-07
Innohep
Dosage: 4500 iu (4500iu, 1 in 1 d), subcutaneous 13000 iu (13000 iu, 1 in 1 d), subcutaneous
Indication: Pulmonary Embolism
Start date: 2011-10-07
Innohep
Dosage: 4500 iu (4500iu, 1 in 1 d), subcutaneous 13000 iu (13000 iu, 1 in 1 d), subcutaneous
Indication: Thrombosis Prophylaxis
Start date: 2011-04-04
End date: 2011-10-07
Innohep
Dosage: 4500 iu (4500iu, 1 in 1 d), subcutaneous 13000 iu (13000 iu, 1 in 1 d), subcutaneous
Indication: Pulmonary Embolism
Start date: 2011-04-04
End date: 2011-10-07
Possible Innohep side effects in 40 year old male
Reported by a physician from France on 2011-10-03
Patient: 40 year old male
Reactions: Off Label Use, Thrombocytosis
Drug(s) suspected as cause:
Innohep
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