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Danaparoid Side Effects submitted to FDA

Total Danaparoid reports: 14.
Danaparoid FDA safety alerts: No.
Reported deaths: 3    Reported hospitalizations: 10.
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FDA Reported Danaparoid Side Effects: condition aggravated, activated partial thromboplastin time prolonged, blood lactate dehydrogenase increased, haemoglobin decreased, haemorrhage, heparin-induced thrombocytopenia, hepatic function abnormal, multi-organ failure, disseminated intravascular coagulation, anaemia, sepsis,
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Danaparoid Side Effects Report #5670125-1
Health Professional from GERMANY reported DANAPAROID problem on Mar 03, 2008. Female patient, 56 years of age, was treated with DANAPAROID. After drug was administered, patient experienced the following problems/side effects: cardiovascular disorder, dysstasia, haemangioma of liver, hypotension, nausea, somnolence. DANAPAROID dosage: unknown. During the same period patient was treated with OLMESARTAN MEDOXOMIL, LEVOTHYROXINE, HEPARIN, FONDAPARINUX. Patient was hospitalized. Patient recovered.



Danaparoid Side Effects Report #5536962-9
DANAPAROID problem was reported by a Health Professional from FRANCE on Nov 28, 2007. Male patient, 48 years of age, was diagnosed with thrombocytopenia and was treated with DANAPAROID. After drug was administered, patient experienced the following problems/side effects: cerebral haemorrhage, cerebral ischaemia, coma. DANAPAROID dosage: unknown. During the same period patient was treated with FONDAPARINUX, HEPARIN, FUROSEMIDE, MIDAZOLAM HYDROCHLORIDE, REMIFENTANIL HYDROCHLORIDE, OMEPRAZOLE, NICARDIPINE HYDROCHLORIDE, CEFOTAXIME. Patient died.



Danaparoid Side Effects Report #5528029-0
Consumer or non-health professional from FRANCE reported DANAPAROID problem on Nov 06, 2007. Female patient, 81 years of age, was diagnosed with thrombocytopenia and was treated with DANAPAROID. After drug was administered, patient experienced the following problems/side effects: bronchitis bacterial, haematoma, haemorrhagic transformation stroke, ischaemic cerebral infarction, leukocytosis, quadriparesis. DANAPAROID dosage: unknown. During the same period patient was treated with NICARDIPINE HYDROCHLORIDE, PANTOPRAZOLE, FUROSEMIDE, LEVOCARNITINE, VALPROATE, PYRIDOSTIGMINE BROMIDE, INSULIN. Patient was hospitalized. Patient died.



Danaparoid Side Effects Report #5427402-9
DANAPAROID problem was reported by a Consumer or non-health professional from FRANCE on Aug 13, 2007. Female patient, 69 years of age, was treated with DANAPAROID. After drug was administered, patient experienced the following problems/side effects: stevens-johnson syndrome. DANAPAROID dosage: unknown. During the same period patient was treated with ESOMEPRAZOLE MAGNESIUM, AMIODARONE HYDROCHLORIDE, CASPOFUNGIN ACETATE, NEFOPAM HYDROCHLORIDE. Patient was hospitalized. Patient recovered.




Danaparoid Side Effects Report #5427650-8
Consumer or non-health professional from FRANCE reported DANAPAROID problem on Aug 13, 2007. Male patient, 65 years of age, was diagnosed with haemorrhagic stroke and was treated with DANAPAROID. After drug was administered, patient experienced the following problems/side effects: hepatitis acute. DANAPAROID dosage: unknown. Patient was hospitalized. Patient recovered.



Danaparoid Side Effects Report #5443090-X
DANAPAROID problem was reported by a Consumer or non-health professional from JAPAN on Aug 17, 2007. Male patient, 23 years of age, was treated with DANAPAROID. After drug was administered, patient experienced the following problems/side effects: hepatitis fulminant. DANAPAROID dosage: unknown. During the same period patient was treated with GABEXATE MESILATE, MIDAZOLAM, BUPRENORPHINE. Patient recovered.



Danaparoid Side Effects Report #5443283-1
Consumer or non-health professional from FRANCE reported DANAPAROID problem on Aug 20, 2007. Male patient, 65 years of age, was diagnosed with haemorrhagic stroke and was treated with DANAPAROID. After drug was administered, patient experienced the following problems/side effects: hepatitis acute. DANAPAROID dosage: unknown. Patient was hospitalized. Patient recovered.



Danaparoid Side Effects Report #5400206-9
DANAPAROID problem was reported by a Consumer or non-health professional from GERMANY on July 10, 2007. Male patient, 33 years of age, was diagnosed with heparin-induced thrombocytopenia and was treated with DANAPAROID. After drug was administered, patient experienced the following problems/side effects: addison's disease, adrenal haemorrhage, anorexia, asthenia, back pain, confusional state, diarrhoea, inflammation, injection site erythema. DANAPAROID dosage: unknown. During the same period patient was treated with HEPARIN. Patient was hospitalized. Patient recovered.



Danaparoid Side Effects Report #5400206-9
Consumer or non-health professional from GERMANY reported DANAPAROID problem on July 10, 2007. Male patient, 33 years of age, was diagnosed with heparin-induced thrombocytopenia and was treated with DANAPAROID. After drug was administered, patient experienced the following problems/side effects: addison's disease, adrenal haemorrhage, anorexia, asthenia, back pain, confusional state, diarrhoea, inflammation, injection site erythema. DANAPAROID dosage: unknown. During the same period patient was treated with HEPARIN. Patient was hospitalized. Patient recovered.




Danaparoid Side Effects Report #5797285-6
DANAPAROID problem was reported by a Consumer or non-health professional from FRANCE on June 16, 2008. Male patient, 80 years of age, was diagnosed with hypokalaemia and was treated with DANAPAROID. After drug was administered, patient experienced the following problems/side effects: colitis ulcerative, hypokalaemia, inflammation, rectal haemorrhage, splenectomy. DANAPAROID dosage: unknown. During the same period patient was treated with ACETYLSALICYLATE LYSINE, WARFARIN, POTASSIUM CHLORIDE, CLOPIDOGREL BISULPHATE, IRBESARTAN, NITRENDIPINE, FLUVASTATIN, LOPERAMIDE OXIDE. Patient was hospitalized. Patient recovered.



Danaparoid Side Effects Report #5329691-8
Consumer or non-health professional from FRANCE reported DANAPAROID problem on May 10, 2007. Male patient, 58 years of age, was treated with DANAPAROID. After drug was administered, patient experienced the following problems/side effects: haemorrhage. DANAPAROID dosage: unknown. Patient died.



Danaparoid Side Effects Report #5314613-6
DANAPAROID problem was reported by a Consumer or non-health professional from FRANCE on Apr 22, 2004. Male patient, 64 years of age, was diagnosed with heparin-induced thrombocytopenia and was treated with DANAPAROID. After drug was administered, patient experienced the following problems/side effects: abdominal pain, adrenal insufficiency, circulatory collapse, confusional state, haemorrhage, heparin-induced thrombocytopenia, necrosis, pyrexia, urine sodium increased. DANAPAROID dosage: unknown. During the same period patient was treated with HEPARIN. Patient recovered.



Danaparoid Side Effects Report #5263382-7
Consumer or non-health professional from FRANCE reported DANAPAROID problem on Feb 27, 2007. Female patient, 57 years of age, was diagnosed with thrombosis and was treated with DANAPAROID. After drug was administered, patient experienced the following problems/side effects: thrombocytopenia, thrombosis, vascular procedure complication. DANAPAROID dosage: unknown. During the same period patient was treated with FLUINDIONE. Patient was hospitalized. Patient recovered.



Danaparoid Side Effects Report #5275224-4
DANAPAROID problem was reported by a Consumer or non-health professional from FRANCE on Mar 08, 2007. Female patient, 78 years of age, was diagnosed with heparin-induced thrombocytopenia and was treated with DANAPAROID. After drug was administered, patient experienced the following problems/side effects: deep vein thrombosis, disease recurrence, heparin-induced thrombocytopenia, pulmonary embolism. DANAPAROID dosage: unknown. During the same period patient was treated with TRIMEBUTINE MALEATE, ACETAMINOPHEN, MORPHINE SULPHATE, MACROGOL, MORPHINE SULPHATE. Patient was hospitalized. Patient recovered.




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