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Review Novorapid Safety Reports submitted to FDA

Total Novorapid reports: 122.
Novorapid FDA safety alerts: No.
Reported deaths: 4    Reported hospitalizations: 101.
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FDA Reported Novorapid Side Effects: hypoglycaemia, blood glucose increased, anti-insulin antibody positive, blood glucose fluctuation, anti-insulin antibody increased, suicide attempt, nausea, vomiting, diabetes mellitus inadequate control, headache, diarrhoea.
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Showing 1-100 of 122 Next >

Novorapid Side Effects Report #5375933-2
Physician from NETHERLANDS reported NOVORAPID problem on June 26, 2007. Female patient, 60 years of age, weighting 220.5 lb, was diagnosed with type 1 diabetes mellitus and was treated with NOVORAPID. After drug was administered, patient experienced the following problems/side effects: hypoglycaemia. NOVORAPID dosage: unknown. During the same period patient was treated with HUMIRA, INSULIN GLARGINE. Patient recovered.

Novorapid Side Effects Report #5379938-7
NOVORAPID problem was reported by a Physician from JAPAN on June 28, 2007. Male patient, weighting 132.3 lb, was diagnosed with insulin-requiring type ii diabetes mellitus, hypertension, hyperuricaemia and was treated with NOVORAPID. After drug was administered, patient experienced the following problems/side effects: dilatation intrahepatic duct acquired, hepatic function abnormal, hepatitis, malaise. NOVORAPID dosage: unknown. During the same period patient was treated with NOVOLIN, DAONIL, MELBIN, BASEN, ADALAT, MICARDIS, ZYLORIC, ZANTAC. Patient recovered.

Novorapid Side Effects Report #5379939-9
Physician from JAPAN reported NOVORAPID problem on June 28, 2007. Female patient, weighting 132.3 lb, was diagnosed with diabetes mellitus and was treated with NOVORAPID. After drug was administered, patient experienced the following problems/side effects: suicide attempt. NOVORAPID dosage: unknown. Patient was hospitalized. Patient recovered.

Novorapid Side Effects Report #5379941-7
NOVORAPID problem was reported by a Health Professional from UNITED KINGDOM on June 25, 2007. Female patient, 57 years of age, weighting 250.4 lb, was diagnosed with insulin-requiring type ii diabetes mellitus and was treated with NOVORAPID. After drug was administered, patient experienced the following problems/side effects: palpitations, paraesthesia oral. NOVORAPID dosage: unknown. During the same period patient was treated with LANTUS, DOTHIEPIN, FRUSEMIDE, SIMVASTATIN, CLOPIDOGREL, ISOSORBIDE MONONITRATE, NICORANDIL, OMEPRAZOLE. Patient recovered.

Novorapid Side Effects Report #5379942-9
Physician from NETHERLANDS reported NOVORAPID problem on June 26, 2007. Female patient, 60 years of age, weighting 220.5 lb, was diagnosed with type 1 diabetes mellitus, rheumatoid arthritis and was treated with NOVORAPID. After drug was administered, patient experienced the following problems/side effects: hypoglycaemia. NOVORAPID dosage: unknown. During the same period patient was treated with HUMIRA, INSULIN GLARGINE, FLIXOTIDE, COSOPT, CELLUVISC, TEARS PLUS, METHOTREXATE, DICLOFENAC. Patient recovered.

Novorapid Side Effects Report #5383882-9
NOVORAPID problem was reported by a Pharmacist from SWEDEN on July 04, 2007. Male patient, 47 years of age, was diagnosed with type 1 diabetes mellitus and was treated with NOVORAPID. After drug was administered, patient experienced the following problems/side effects: blood glucose increased, fatigue, nausea, vomiting. NOVORAPID dosage: unknown. During the same period patient was treated with COZAAR, SIMVASTATIN, TROMBYL. Patient was hospitalized. Patient recovered.

Novorapid Side Effects Report #5387370-5
Pharmacist from SWEDEN reported NOVORAPID problem on July 12, 2007. Male patient, 47 years of age, was diagnosed with type 1 diabetes mellitus and was treated with NOVORAPID. After drug was administered, patient experienced the following problems/side effects: diabetic ketoacidosis. NOVORAPID dosage: unknown. During the same period patient was treated with COZAAR, SIMVASTATIN, TROMBYL. Patient was hospitalized. Patient recovered.

Novorapid Side Effects Report #5389949-3
NOVORAPID problem was reported by a Physician from JAPAN on July 06, 2007. Male patient, weighting 132.3 lb, was diagnosed with insulin-requiring type ii diabetes mellitus, hypertension, hyperuricaemia and was treated with NOVORAPID. After drug was administered, patient experienced the following problems/side effects: dilatation intrahepatic duct acquired, hepatic function abnormal, hepatitis, malaise. NOVORAPID dosage: unknown. During the same period patient was treated with NOVOLIN, DAONIL, MELBIN, BASEN, ADALAT, MICARDIS, ZYLORIC, ZANTAC. Patient recovered.

Novorapid Side Effects Report #5392054-3
Physician from UNITED KINGDOM reported NOVORAPID problem on July 17, 2007. Female patient, 49 years of age, weighting 235.5 lb, was diagnosed with insulin-requiring type ii diabetes mellitus and was treated with NOVORAPID. After drug was administered, patient experienced the following problems/side effects: pneumonia. NOVORAPID dosage: unknown. During the same period patient was treated with INSULIN GLARGINE, ROSIGLITAZONE, BECLOMETHASONE DIPROPIONATE, CETIRIZINE, FLUOXETINE, FUROSEMIDE, IPRATROPIUM BROMIDE, OMEPRAZOLE. Patient died on 12/25/2006.

Novorapid Side Effects Report #5400061-7
NOVORAPID problem was reported by a Physician from SERBIA AND MONTENEGRO on July 17, 2007. Female patient was diagnosed with type 1 diabetes mellitus and was treated with NOVORAPID. After drug was administered, patient experienced the following problems/side effects: asthenia, diarrhoea, headache, hypoglycaemia, vomiting. NOVORAPID dosage: unknown. During the same period patient was treated with LEVEMIR. Patient was hospitalized. Patient recovered.

Novorapid Side Effects Report #5401125-4
Physician from FRANCE reported NOVORAPID problem on July 20, 2007. Female patient, 22 years of age, was diagnosed with type 1 diabetes mellitus and was treated with NOVORAPID. After drug was administered, patient experienced the following problems/side effects: hypoglycaemia, intentional overdose, suicide attempt. NOVORAPID dosage: unknown. During the same period patient was treated with INSULIN GLARGINE. Patient was hospitalized. Patient recovered.

Novorapid Side Effects Report #5375933-2
NOVORAPID problem was reported by a Physician from NETHERLANDS on June 26, 2007. Female patient, 60 years of age, weighting 220.5 lb, was diagnosed with type 1 diabetes mellitus and was treated with NOVORAPID. After drug was administered, patient experienced the following problems/side effects: hypoglycaemia. NOVORAPID dosage: unknown. During the same period patient was treated with HUMIRA, INSULIN GLARGINE. Patient recovered.

Novorapid Side Effects Report #5379938-7
Physician from JAPAN reported NOVORAPID problem on June 28, 2007. Male patient, weighting 132.3 lb, was diagnosed with insulin-requiring type ii diabetes mellitus, hypertension, hyperuricaemia and was treated with NOVORAPID. After drug was administered, patient experienced the following problems/side effects: dilatation intrahepatic duct acquired, hepatic function abnormal, hepatitis, malaise. NOVORAPID dosage: unknown. During the same period patient was treated with NOVOLIN, DAONIL, MELBIN, BASEN, ADALAT, MICARDIS, ZYLORIC, ZANTAC. Patient recovered.

Novorapid Side Effects Report #5379939-9
NOVORAPID problem was reported by a Physician from JAPAN on June 28, 2007. Female patient, weighting 132.3 lb, was diagnosed with diabetes mellitus and was treated with NOVORAPID. After drug was administered, patient experienced the following problems/side effects: suicide attempt. NOVORAPID dosage: unknown. Patient was hospitalized. Patient recovered.

Novorapid Side Effects Report #5379941-7
Health Professional from UNITED KINGDOM reported NOVORAPID problem on June 25, 2007. Female patient, 57 years of age, weighting 250.4 lb, was diagnosed with insulin-requiring type ii diabetes mellitus and was treated with NOVORAPID. After drug was administered, patient experienced the following problems/side effects: palpitations, paraesthesia oral. NOVORAPID dosage: unknown. During the same period patient was treated with LANTUS, DOTHIEPIN, FRUSEMIDE, SIMVASTATIN, CLOPIDOGREL, ISOSORBIDE MONONITRATE, NICORANDIL, OMEPRAZOLE. Patient recovered.

Novorapid Side Effects Report #5379942-9
NOVORAPID problem was reported by a Physician from NETHERLANDS on June 26, 2007. Female patient, 60 years of age, weighting 220.5 lb, was diagnosed with type 1 diabetes mellitus, rheumatoid arthritis and was treated with NOVORAPID. After drug was administered, patient experienced the following problems/side effects: hypoglycaemia. NOVORAPID dosage: unknown. During the same period patient was treated with HUMIRA, INSULIN GLARGINE, FLIXOTIDE, COSOPT, CELLUVISC, TEARS PLUS, METHOTREXATE, DICLOFENAC. Patient recovered.

Novorapid Side Effects Report #5383882-9
Pharmacist from SWEDEN reported NOVORAPID problem on July 04, 2007. Male patient, 47 years of age, was diagnosed with type 1 diabetes mellitus and was treated with NOVORAPID. After drug was administered, patient experienced the following problems/side effects: blood glucose increased, fatigue, nausea, vomiting. NOVORAPID dosage: unknown. During the same period patient was treated with COZAAR, SIMVASTATIN, TROMBYL. Patient was hospitalized. Patient recovered.

Novorapid Side Effects Report #5387370-5
NOVORAPID problem was reported by a Pharmacist from SWEDEN on July 12, 2007. Male patient, 47 years of age, was diagnosed with type 1 diabetes mellitus and was treated with NOVORAPID. After drug was administered, patient experienced the following problems/side effects: diabetic ketoacidosis. NOVORAPID dosage: unknown. During the same period patient was treated with COZAAR, SIMVASTATIN, TROMBYL. Patient was hospitalized. Patient recovered.

Novorapid Side Effects Report #5389949-3
Physician from JAPAN reported NOVORAPID problem on July 06, 2007. Male patient, weighting 132.3 lb, was diagnosed with insulin-requiring type ii diabetes mellitus, hypertension, hyperuricaemia and was treated with NOVORAPID. After drug was administered, patient experienced the following problems/side effects: dilatation intrahepatic duct acquired, hepatic function abnormal, hepatitis, malaise. NOVORAPID dosage: unknown. During the same period patient was treated with NOVOLIN, DAONIL, MELBIN, BASEN, ADALAT, MICARDIS, ZYLORIC, ZANTAC. Patient recovered.

Novorapid Side Effects Report #5392054-3
NOVORAPID problem was reported by a Physician from UNITED KINGDOM on July 17, 2007. Female patient, 49 years of age, weighting 235.5 lb, was diagnosed with insulin-requiring type ii diabetes mellitus and was treated with NOVORAPID. After drug was administered, patient experienced the following problems/side effects: pneumonia. NOVORAPID dosage: unknown. During the same period patient was treated with INSULIN GLARGINE, ROSIGLITAZONE, BECLOMETHASONE DIPROPIONATE, CETIRIZINE, FLUOXETINE, FUROSEMIDE, IPRATROPIUM BROMIDE, OMEPRAZOLE. Patient died on 12/25/2006.

Novorapid Side Effects Report #5400061-7
Physician from SERBIA AND MONTENEGRO reported NOVORAPID problem on July 17, 2007. Female patient was diagnosed with type 1 diabetes mellitus and was treated with NOVORAPID. After drug was administered, patient experienced the following problems/side effects: asthenia, diarrhoea, headache, hypoglycaemia, vomiting. NOVORAPID dosage: unknown. During the same period patient was treated with LEVEMIR. Patient was hospitalized. Patient recovered.

Novorapid Side Effects Report #5401125-4
NOVORAPID problem was reported by a Physician from FRANCE on July 20, 2007. Female patient, 22 years of age, was diagnosed with type 1 diabetes mellitus and was treated with NOVORAPID. After drug was administered, patient experienced the following problems/side effects: hypoglycaemia, intentional overdose, suicide attempt. NOVORAPID dosage: unknown. During the same period patient was treated with INSULIN GLARGINE. Patient was hospitalized. Patient recovered.

Showing 1-100 of 122 Next >


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hypoglycaemia, dilatation intrahepatic duct acquired, hepatic function abnormal, hepatitis, malaise, , was diagnosed with type 1 diabetes mellitus and was diagnosed with insulin-requiring type ii diabetes mellitus, hypertension, hyperuricaemia and