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Review Novolin Safety Reports submitted to FDA

Total Novolin reports: 85.
Novolin FDA safety alerts: No.
Reported deaths: 4    Reported hospitalizations: 59.
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FDA Reported Novolin Side Effects: blood glucose increased, hypoglycaemia, anti-insulin antibody increased, blood glucose decreased, blood glucose fluctuation, anti-insulin antibody positive, hypoglycaemic unconsciousness, hypoglycaemic coma, aspartate aminotransferase increased, alanine aminotransferase increased, diabetic ketoacidosis.
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Novolin Side Effects Report #5646496-9
Health Professional from UNITED STATES reported NOVOLIN problem on Feb 19, 2008. Male patient, weighting 234.6 lb, was diagnosed with diabetes mellitus and was treated with NOVOLIN. After drug was administered, patient experienced the following problems/side effects: blood glucose increased, gastrooesophageal reflux disease. NOVOLIN dosage: unknown. During the same period patient was treated with LANTUS. Patient was hospitalized. Patient recovered.

Novolin Side Effects Report #5664053-5
NOVOLIN problem was reported by a Health Professional from UNITED STATES on Mar 07, 2008. Male patient, 60 years of age, was diagnosed with diabetic ketoacidosis, hyperglycaemia and was treated with NOVOLIN. After drug was administered, patient experienced the following problems/side effects: diabetic ketoacidosis, organ failure. NOVOLIN dosage: unknown. During the same period patient was treated with NOVOLIN R. Patient was hospitalized. Patient died on 03/03/2008.

Novolin Side Effects Report #5664058-4
Consumer or non-health professional from UNITED STATES reported NOVOLIN problem on Mar 05, 2008. Female patient, 53 years of age, was diagnosed with type 1 diabetes mellitus and was treated with NOVOLIN. After drug was administered, patient experienced the following problems/side effects: blood glucose increased, dehydration, dizziness, fatigue. NOVOLIN dosage: unknown. Patient was hospitalized. Patient recovered.

Novolin Side Effects Report #5668919-1
NOVOLIN problem was reported by a Physician from JAPAN on Mar 06, 2008. Male patient, 68 years of age, weighting 143.3 lb, was diagnosed with insulin-requiring type 2 diabetes mellitus, type 1 diabetes mellitus and was treated with NOVOLIN. After drug was administered, patient experienced the following problems/side effects: anti-insulin antibody positive, oedema peripheral, polyneuropathy. NOVOLIN dosage: unknown. During the same period patient was treated with NOVORAPID CHU FLEXPEN, NOVOLIN R, HUMALOG. Patient was hospitalized. Patient recovered.

Novolin Side Effects Report #5669066-5
Pharmacist from JAPAN reported NOVOLIN problem on Mar 05, 2008. Female patient, 73 years of age, weighting 94.80 lb, was diagnosed with type 2 diabetes mellitus, cardiac failure chronic and was treated with NOVOLIN. After drug was administered, patient experienced the following problems/side effects: decubitus ulcer, diabetic hyperosmolar coma, injection site induration. NOVOLIN dosage: unknown. During the same period patient was treated with NOVOLIN R, WARFARIN, LANIRAPID, NOIDOUBLE, DIART, SOLUTIONS PARENTERAL NUTRITION, SOLUTIONS PARENTERAL NUTRITION, SOLUTIONS PARENTERAL NUTRITION. Patient was hospitalized. Patient recovered.

Novolin Side Effects Report #5672129-1
NOVOLIN problem was reported by a Health Professional from UNITED STATES on Mar 12, 2008. Male patient, weighting 234.6 lb, was diagnosed with diabetes mellitus, hypertension and was treated with NOVOLIN. After drug was administered, patient experienced the following problems/side effects: alcohol abuse, diabetic ketoacidosis, pneumonia. NOVOLIN dosage: unknown. During the same period patient was treated with LANTUS, LEVEMIR, METOPROLOL TARTRATE, HYDROCHLOROTHIAZIDE, LISINOPRIL. Patient was hospitalized. Patient recovered.

Novolin Side Effects Report #5674122-1
Consumer or non-health professional from reported NOVOLIN problem on Mar 13, 2008. Female patient, weighting 4.26 lb, was diagnosed with gestational diabetes and was treated with NOVOLIN. After drug was administered, patient experienced the following problems/side effects: asphyxia. NOVOLIN dosage: unknown. During the same period patient was treated with NOVOLIN N. Patient was hospitalized. Patient recovered.

Novolin Side Effects Report #5674124-5
NOVOLIN problem was reported by a Physician from JAPAN on Mar 13, 2008. Female patient was diagnosed with type 2 diabetes mellitus and was treated with NOVOLIN. After drug was administered, patient experienced the following problems/side effects: hyperthyroidism, ketoacidosis, nasopharyngitis. NOVOLIN dosage: unknown. During the same period patient was treated with NOVOLIN N. Patient was hospitalized. Patient recovered.

Novolin Side Effects Report #5688598-7
Consumer or non-health professional from UNITED STATES reported NOVOLIN problem on Mar 19, 2008. Female patient, 65 years of age, was diagnosed with insulin-requiring type 2 diabetes mellitus and was treated with NOVOLIN. After drug was administered, patient experienced the following problems/side effects: bacterial infection, blood glucose decreased. NOVOLIN dosage: unknown. Patient was hospitalized. Patient recovered.

Novolin Side Effects Report #5625763-9
NOVOLIN problem was reported by a Physician from JAPAN on Feb 07, 2008. Female patient, 72 years of age, was diagnosed with diabetes mellitus and was treated with NOVOLIN. After drug was administered, patient experienced the following problems/side effects: coma, hypoglycaemia, suicide attempt. NOVOLIN dosage: unknown. During the same period patient was treated with ETIZOLAM, NITRAZEPAM. Patient was hospitalized. Patient recovered.

Novolin Side Effects Report #5629435-6
Physician from JAPAN reported NOVOLIN problem on Feb 08, 2008. Female patient, 65 years of age, weighting 97.00 lb, was diagnosed with insulin-requiring type 2 diabetes mellitus, gastric ulcer and was treated with NOVOLIN. After drug was administered, patient experienced the following problems/side effects: cholecystitis chronic, hepatic function abnormal. NOVOLIN dosage: unknown. During the same period patient was treated with STOGAR, GLUCOBAY, EPATAT, PROHEPARUM. Patient was hospitalized. Patient recovered.

Novolin Side Effects Report #5636781-9
NOVOLIN problem was reported by a Physician from JAPAN on Nov 28, 2007. Female patient, 67 years of age, was treated with NOVOLIN. After drug was administered, patient experienced the following problems/side effects: brain oedema, hypoglycaemic coma, intentional overdose. NOVOLIN dosage: unknown. Patient was hospitalized. Patient recovered.

Novolin Side Effects Report #5646499-4
Pharmacist from UNITED STATES reported NOVOLIN problem on Feb 28, 2008. Female patient, weighting 140.0 lb, was diagnosed with diabetes mellitus and was treated with NOVOLIN. After drug was administered, patient experienced the following problems/side effects: blood glucose decreased, dizziness, loss of consciousness, road traffic accident, treatment noncompliance. NOVOLIN dosage: unknown. During the same period patient was treated with DIGOXIN, PHOSLO, HYDRALAZINE, COREG, PRILOSEC, FOLIC ACID, PLAVIX, COLACE. Patient was hospitalized. Patient recovered.

Novolin Side Effects Report #5646548-3
NOVOLIN problem was reported by a Pharmacist from UNITED STATES on Feb 28, 2008. Female patient was diagnosed with diabetes mellitus and was treated with NOVOLIN. After drug was administered, patient experienced the following problems/side effects: aggression, screaming, unresponsive to stimuli. NOVOLIN dosage: unknown. During the same period patient was treated with NOVOLOG, HUMALOG, METOPROLOL TARTRATE, ALTACE, ZETIA, ACTOS, NIFEDIPINE, HYDROCHLOROTHIAZIDE. Patient was hospitalized. Patient recovered.

Novolin Side Effects Report #5648251-2
Pharmacist from CHINA reported NOVOLIN problem on Feb 14, 2008. Female patient, 66 years of age, weighting 99.21 lb, was diagnosed with type 2 diabetes mellitus and was treated with NOVOLIN. After drug was administered, patient experienced the following problems/side effects: blood glucose decreased, chest discomfort, palpitations, vision blurred. NOVOLIN dosage: unknown. During the same period patient was treated with PROPAFENONE, ISOSORBIDE DINITRATE. Patient was hospitalized. Patient recovered.

Novolin Side Effects Report #5578879-X
NOVOLIN problem was reported by a Consumer or non-health professional from JAPAN on Dec 20, 2007. Female patient, 33 years of age, was diagnosed with diabetes mellitus and was treated with NOVOLIN. After drug was administered, patient experienced the following problems/side effects: anaemia, hypoalbuminaemia, oedema peripheral, pregnancy, protein urine present. NOVOLIN dosage: unknown. During the same period patient was treated with NOVOLIN R, ERYTHROPOIETIN, GLYBURIDE. Patient was hospitalized. Patient recovered.

Novolin Side Effects Report #5580102-7
Physician from JAPAN reported NOVOLIN problem on Dec 25, 2007. Female patient, 72 years of age, was diagnosed with diabetes mellitus and was treated with NOVOLIN. After drug was administered, patient experienced the following problems/side effects: coma, intentional overdose, suicide attempt. NOVOLIN dosage: unknown. During the same period patient was treated with ETIZOLAM, NITRAZEPAM. Patient was hospitalized. Patient recovered.

Novolin Side Effects Report #5580120-9
NOVOLIN problem was reported by a Consumer or non-health professional from JAPAN on Dec 21, 2007. Female patient, child 7 years of age, weighting 61.73 lb, was diagnosed with type 1 diabetes mellitus and was treated with NOVOLIN. After drug was administered, patient experienced the following problems/side effects: anti-insulin antibody, hyperglycaemia, hypoglycaemia. NOVOLIN dosage: unknown. During the same period patient was treated with NOVOLIN N, NOVORAPID, NOVORAPID CHU, LANTUS. Patient recovered.

Novolin Side Effects Report #5591199-2
Consumer or non-health professional from JAPAN reported NOVOLIN problem on Jan 07, 2008. Female patient, child 7 years of age, weighting 61.73 lb, was diagnosed with type 1 diabetes mellitus and was treated with NOVOLIN. After drug was administered, patient experienced the following problems/side effects: anti-insulin antibody, hyperglycaemia, hypoglycaemia, hypoglycaemic seizure. NOVOLIN dosage: unknown. During the same period patient was treated with NOVOLIN N, NOVORAPID, NOVORAPID CHU, LANTUS. Patient recovered.

Novolin Side Effects Report #5591241-9
NOVOLIN problem was reported by a Consumer or non-health professional from UNITED STATES on Jan 07, 2008. Female patient was diagnosed with type 1 diabetes mellitus, blood pressure increased, oedema peripheral, multiple sclerosis and was treated with NOVOLIN. After drug was administered, patient experienced the following problems/side effects: blood glucose increased, blood phosphorus decreased, influenza. NOVOLIN dosage: unknown. During the same period patient was treated with NOVOLIN N, NOVOLIN N, NOVOLIN R, NOVOLIN R, NOVOLIN R, ALTACE, FUROSEMIDE, VITAMIN B. Patient was hospitalized. Patient recovered.

Novolin Side Effects Report #5597370-8
Physician from JAPAN reported NOVOLIN problem on Jan 09, 2008. Female patient, 65 years of age, weighting 97.00 lb, was diagnosed with insulin-requiring type 2 diabetes mellitus, gastric ulcer and was treated with NOVOLIN. After drug was administered, patient experienced the following problems/side effects: hepatic function abnormal. NOVOLIN dosage: unknown. During the same period patient was treated with STOGAR, GLUCOBAY, EPATAT, PROHEPARUM. Patient was hospitalized. Patient recovered.

Novolin Side Effects Report #5599954-X
NOVOLIN problem was reported by a Physician from JAPAN on Jan 18, 2008. Female patient, 73 years of age, was diagnosed with diabetes mellitus and was treated with NOVOLIN. After drug was administered, patient experienced the following problems/side effects: anti-insulin antibody positive, glycosylated haemoglobin increased, injection site pruritus, urticaria. NOVOLIN dosage: unknown. During the same period patient was treated with NOVOLIN R, NOVORAPID CHU, STARSIS. Patient was hospitalized. Patient recovered.

Novolin Side Effects Report #5532832-0
Consumer or non-health professional from JAPAN reported NOVOLIN problem on Nov 29, 2007. Male patient, weighting 132.3 lb, was diagnosed with insulin-requiring type ii diabetes mellitus, gastric ulcer, cerebral infarction, diabetic neuropathy, benign prostatic hyperplasia and was treated with NOVOLIN. After drug was administered, patient experienced the following problems/side effects: anti-insulin antibody positive, blood glucose fluctuation, hypoglycaemia. NOVOLIN dosage: unknown. During the same period patient was treated with NOVOLIN N, NOVORAPID CHU FLEXPEN, MUCOSTA, CEROCRAL, METHYCOBAL, KINEDAK, EBRANTIL. Patient recovered.

Novolin Side Effects Report #5542037-5
NOVOLIN problem was reported by a Physician from JAPAN on Nov 28, 2007. Female patient, 67 years of age, was diagnosed with suicide attempt and was treated with NOVOLIN. After drug was administered, patient experienced the following problems/side effects: brain oedema, hypoglycaemic coma, intentional overdose. NOVOLIN dosage: unknown. Patient was hospitalized. Patient recovered.

Novolin Side Effects Report #5545455-4
Physician from JAPAN reported NOVOLIN problem on Nov 29, 2007. Male patient, weighting 92.59 lb, was diagnosed with type 1 diabetes mellitus, diabetic neuropathy, dental caries and was treated with NOVOLIN. After drug was administered, patient experienced the following problems/side effects: diabetic ketoacidosis, erythema, hepatic function abnormal, rash. NOVOLIN dosage: unknown. During the same period patient was treated with NOVOLIN N, NOVORAPID CHU FLEXPEN, LANTUS, METHYCOBAL, MONEDAX, PASETOCIN. Patient was hospitalized. Patient recovered.

Novolin Side Effects Report #5562781-3
NOVOLIN problem was reported by a Consumer or non-health professional from JAPAN on Dec 07, 2007. Female patient, 79 years of age, weighting 110.2 lb, was diagnosed with type 1 diabetes mellitus and was treated with NOVOLIN. After drug was administered, patient experienced the following problems/side effects: anti-insulin antibody increased, autoantibody positive, blood glucose fluctuation, thyroiditis. NOVOLIN dosage: unknown. During the same period patient was treated with NOVORAPID, HUMACART, NOVORAPID CHU. Patient was hospitalized. Patient recovered.

Novolin Side Effects Report #5566532-8
Physician from JAPAN reported NOVOLIN problem on Dec 07, 2007. Male patient, weighting 92.59 lb, was diagnosed with type 1 diabetes mellitus, diabetic neuropathy, dental caries and was treated with NOVOLIN. After drug was administered, patient experienced the following problems/side effects: diabetic ketoacidosis, erythema, hepatic function abnormal, rash. NOVOLIN dosage: unknown. During the same period patient was treated with NOVOLIN N, NOVORAPID CHU FLEXPEN, LANTUS, METHYCOBAL, MONEDAX, PASETOCIN. Patient was hospitalized. Patient recovered.

Novolin Side Effects Report #5570590-4
NOVOLIN problem was reported by a Consumer or non-health professional from UNITED STATES on Dec 10, 2007. Female patient, 55 years of age, weighting 242.5 lb, was diagnosed with insulin-requiring type ii diabetes mellitus and was treated with NOVOLIN. After drug was administered, patient experienced the following problems/side effects: acute respiratory failure, anti-insulin antibody increased, hyperglycaemia, insulin resistance, renal failure acute. NOVOLIN dosage: unknown. During the same period patient was treated with NOVOLIN N, INSULIN LISPRO, NOVOLOG, PREDNISONE, ATENOLOL, FUROSEMIDE, LEVOTHYROXINE. Patient was hospitalized. Patient recovered.

Novolin Side Effects Report #5570607-7
Consumer or non-health professional from JAPAN reported NOVOLIN problem on Dec 13, 2007. Female patient, 33 years of age, was diagnosed with diabetes mellitus and was treated with NOVOLIN. After drug was administered, patient experienced the following problems/side effects: anaemia, hypoalbuminaemia, oedema peripheral, pregnancy, protein urine present. NOVOLIN dosage: unknown. During the same period patient was treated with NOVOLIN R, EPOGEN, GLYBURIDE. Patient was hospitalized. Patient recovered.

Novolin Side Effects Report #5571530-4
NOVOLIN problem was reported by a Physician from JAPAN on Dec 07, 2007. Male patient, weighting 92.59 lb, was diagnosed with type 1 diabetes mellitus, diabetic neuropathy, dental caries and was treated with NOVOLIN. After drug was administered, patient experienced the following problems/side effects: diabetic ketoacidosis, erythema, hepatic function abnormal, rash. NOVOLIN dosage: unknown. During the same period patient was treated with NOVOLIN N, NOVORAPID CHU FLEXPEN, LANTUS, METHYCOBAL, MONEDAX, PASETOCIN. Patient was hospitalized. Patient recovered.

Novolin Side Effects Report #5572910-3
Consumer or non-health professional from JAPAN reported NOVOLIN problem on Dec 13, 2007. Female patient, weighting 3.96 lb, was diagnosed with diabetes mellitus and was treated with NOVOLIN. After drug was administered, patient experienced the following problems/side effects: hyperbilirubinaemia neonatal, small for dates baby. NOVOLIN dosage: unknown. During the same period patient was treated with NOVOLIN R, EPOGEN. Patient recovered.

Novolin Side Effects Report #5507648-1
NOVOLIN problem was reported by a Physician from JAPAN on Oct 25, 2007. Male patient, 86 years of age, weighting 143.3 lb, was diagnosed with insulin-requiring type ii diabetes mellitus and was treated with NOVOLIN. After drug was administered, patient experienced the following problems/side effects: anti-insulin antibody positive, blood glucose fluctuation, hypoglycaemia, insulin autoimmune syndrome. NOVOLIN dosage: unknown. During the same period patient was treated with NOVOLIN N, NOVORAPID CHU FLEXPEN. Patient recovered.

Novolin Side Effects Report #5518028-7
Consumer or non-health professional from JAPAN reported NOVOLIN problem on Nov 05, 2007. Male patient, 86 years of age, weighting 143.3 lb, was diagnosed with insulin-requiring type ii diabetes mellitus and was treated with NOVOLIN. After drug was administered, patient experienced the following problems/side effects: anti-insulin antibody positive, blood glucose fluctuation, hypoglycaemia. NOVOLIN dosage: unknown. During the same period patient was treated with NOVOLIN N, NOVORAPID CHU FLEXPEN. Patient recovered.

Novolin Side Effects Report #5521514-7
NOVOLIN problem was reported by a Physician from JAPAN on Nov 08, 2007. Male patient, 46 years of age, weighting 74.96 lb, was diagnosed with type 1 diabetes mellitus and was treated with NOVOLIN. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, aspartate aminotransferase increased, erythema, hepatic function abnormal. NOVOLIN dosage: unknown. During the same period patient was treated with NOVOLIN N, NOVORAPID CHU FLEXPEN, LANTUS, METHYCOBAL, KINEDAK. Patient was hospitalized. Patient recovered.

Novolin Side Effects Report #5530210-1
Physician from JAPAN reported NOVOLIN problem on Nov 19, 2007. Male patient, weighting 92.59 lb, was diagnosed with type 1 diabetes mellitus, diabetic neuropathy, dental caries and was treated with NOVOLIN. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, aspartate aminotransferase increased, erythema, hepatic function abnormal, rash. NOVOLIN dosage: unknown. During the same period patient was treated with NOVOLIN N, NOVORAPID CHU FLEXPEN, LANTUS, METHYCOBAL, MONEDAX, PASETOCIN. Patient was hospitalized. Patient recovered.

Novolin Side Effects Report #5530230-7
NOVOLIN problem was reported by a Physician from JAPAN on Nov 21, 2007. Female patient, 73 years of age, was diagnosed with diabetes mellitus and was treated with NOVOLIN. After drug was administered, patient experienced the following problems/side effects: anti-insulin antibody positive, glycosylated haemoglobin increased, injection site pruritus, urticaria. NOVOLIN dosage: unknown. During the same period patient was treated with NOVOLIN R. Patient was hospitalized. Patient recovered.

Novolin Side Effects Report #5530234-4
Consumer or non-health professional from JAPAN reported NOVOLIN problem on Nov 21, 2007. Female patient, 79 years of age, was diagnosed with type 1 diabetes mellitus and was treated with NOVOLIN. After drug was administered, patient experienced the following problems/side effects: anti-insulin antibody increased, blood glucose fluctuation, thyroiditis. NOVOLIN dosage: unknown. During the same period patient was treated with NOVORAPID, HUMACART, NOVORAPID CHU. Patient was hospitalized. Patient recovered.

Novolin Side Effects Report #5474318-8
NOVOLIN problem was reported by a Consumer or non-health professional from UNITED STATES on Aug 29, 2007. Female patient was diagnosed with type 1 diabetes mellitus and was treated with NOVOLIN. After drug was administered, patient experienced the following problems/side effects: back pain, blood glucose increased, muscle spasms, myalgia. NOVOLIN dosage: unknown. During the same period patient was treated with NOVOLOG. Patient recovered.

Novolin Side Effects Report #5484998-9
Physician from JAPAN reported NOVOLIN problem on Oct 04, 2007. Female patient, 38 years of age, was diagnosed with type 1 diabetes mellitus and was treated with NOVOLIN. After drug was administered, patient experienced the following problems/side effects: hypoglycaemic encephalopathy. NOVOLIN dosage: unknown. Patient was hospitalized. Patient recovered.

Novolin Side Effects Report #5498693-3
NOVOLIN problem was reported by a Consumer or non-health professional from UNITED STATES on Oct 16, 2007. Female patient was diagnosed with insulin-requiring type ii diabetes mellitus, hypertension and was treated with NOVOLIN. After drug was administered, patient experienced the following problems/side effects: hypoglycaemia, hypotension. NOVOLIN dosage: unknown. During the same period patient was treated with ANTIHYPERTENSIVES. Patient was hospitalized. Patient recovered.

Novolin Side Effects Report #5443109-6
Physician from UNITED STATES reported NOVOLIN problem on May 02, 2007. Female patient was diagnosed with insulin-requiring type ii diabetes mellitus and was treated with NOVOLIN. After drug was administered, patient experienced the following problems/side effects: blood glucose increased, eye pain, headache, vision blurred. NOVOLIN dosage: unknown. During the same period patient was treated with HUMALOG. Patient recovered.

Novolin Side Effects Report #5447272-2
NOVOLIN problem was reported by a Consumer or non-health professional from UNITED STATES on Aug 29, 2007. Female patient was diagnosed with type 1 diabetes mellitus and was treated with NOVOLIN. After drug was administered, patient experienced the following problems/side effects: asthenia, back pain, blood glucose increased, dysarthria, muscle spasms, myalgia, presyncope. NOVOLIN dosage: unknown. During the same period patient was treated with NOVOLOG. Patient recovered.

Novolin Side Effects Report #5452656-2
Physician from JAPAN reported NOVOLIN problem on Sept 05, 2007. Female patient, 38 years of age, was diagnosed with type 1 diabetes mellitus and was treated with NOVOLIN. After drug was administered, patient experienced the following problems/side effects: hypoglycaemic encephalopathy. NOVOLIN dosage: unknown. Patient was hospitalized. Patient recovered.

Novolin Side Effects Report #5455319-2
NOVOLIN problem was reported by a Physician from UNITED STATES on May 02, 2007. Female patient was diagnosed with insulin-requiring type ii diabetes mellitus and was treated with NOVOLIN. After drug was administered, patient experienced the following problems/side effects: blood glucose increased, eye pain, headache, vision blurred. NOVOLIN dosage: unknown. During the same period patient was treated with HUMALOG. Patient recovered.

Novolin Side Effects Report #5458183-0
Consumer or non-health professional from UNITED STATES reported NOVOLIN problem on Sept 10, 2007. Female patient was diagnosed with insulin-requiring type ii diabetes mellitus, hypertension and was treated with NOVOLIN. After drug was administered, patient experienced the following problems/side effects: hypoglycaemia, hypotension. NOVOLIN dosage: unknown. During the same period patient was treated with ANTIHYPERTENSIVES. Patient was hospitalized. Patient recovered.

Novolin Side Effects Report #5466769-2
NOVOLIN problem was reported by a Physician from JAPAN on Sept 14, 2007. Female patient, 38 years of age, was diagnosed with type 1 diabetes mellitus and was treated with NOVOLIN. After drug was administered, patient experienced the following problems/side effects: hypoglycaemic encephalopathy. NOVOLIN dosage: unknown. Patient was hospitalized. Patient recovered.

Novolin Side Effects Report #5406874-X
Consumer or non-health professional from UNITED STATES reported NOVOLIN problem on July 27, 2007. Male patient, 57 years of age, was diagnosed with insulin-requiring type ii diabetes mellitus and was treated with NOVOLIN. After drug was administered, patient experienced the following problems/side effects: localised infection. NOVOLIN dosage: unknown. Patient recovered.

Novolin Side Effects Report #5410900-1
NOVOLIN problem was reported by a Physician from JAPAN on July 31, 2007. Female patient, 65 years of age, weighting 97.00 lb, was diagnosed with insulin-requiring type ii diabetes mellitus, gastric ulcer and was treated with NOVOLIN. After drug was administered, patient experienced the following problems/side effects: hepatic function abnormal. NOVOLIN dosage: unknown. During the same period patient was treated with STOGAR, GLUCOBAY, EPATAT, PROHEPARUM. Patient recovered.

Novolin Side Effects Report #5416490-1
Physician from JAPAN reported NOVOLIN problem on Aug 09, 2007. Male patient, 59 years of age, was treated with NOVOLIN. After drug was administered, patient experienced the following problems/side effects: hypoglycaemia, suicide attempt. NOVOLIN dosage: unknown. During the same period patient was treated with NOVOLIN N, ANTIDEPRESSANTS. Patient was hospitalized. Patient recovered.

Novolin Side Effects Report #5416491-3
NOVOLIN problem was reported by a Physician from UNITED STATES on Aug 07, 2007. Male patient, 48 years of age, weighting 424.9 lb, was diagnosed with insulin-requiring type ii diabetes mellitus and was treated with NOVOLIN. After drug was administered, patient experienced the following problems/side effects: blood glucose increased, eye pain, headache, vision blurred. NOVOLIN dosage: unknown. During the same period patient was treated with HUMALOG. Patient recovered.

Novolin Side Effects Report #5417737-8
Pharmacist from UNITED STATES reported NOVOLIN problem on Aug 15, 2007. Female patient, weighting 130.0 lb, was diagnosed with diabetes mellitus and was treated with NOVOLIN. After drug was administered, patient experienced the following problems/side effects: hypoglycaemia, mental status changes. NOVOLIN dosage: unknown. During the same period patient was treated with ATACAND HCT, CARDIZEM, FISH OIL. Patient was hospitalized. Patient recovered.

Novolin Side Effects Report #5417962-6
NOVOLIN problem was reported by a Physician from JAPAN on Aug 08, 2007. Female patient, 65 years of age, weighting 97.00 lb, was diagnosed with insulin-requiring type ii diabetes mellitus, gastric ulcer and was treated with NOVOLIN. After drug was administered, patient experienced the following problems/side effects: hepatic function abnormal. NOVOLIN dosage: unknown. During the same period patient was treated with STOGAR, GLUCOBAY, EPATAT, PROHEPARUM. Patient recovered.

Novolin Side Effects Report #5425967-4
Consumer or non-health professional from UNITED STATES reported NOVOLIN problem on Aug 14, 2007. Male patient, 61 years of age, was diagnosed with type 1 diabetes mellitus and was treated with NOVOLIN. After drug was administered, patient experienced the following problems/side effects: diabetic ketoacidosis, impaired gastric emptying, myocardial infarction. NOVOLIN dosage: unknown. Patient was hospitalized. Patient recovered.

Novolin Side Effects Report #5427274-2
NOVOLIN problem was reported by a Consumer or non-health professional from UNITED STATES on Aug 17, 2007. Female patient was diagnosed with insulin-requiring type ii diabetes mellitus and was treated with NOVOLIN. After drug was administered, patient experienced the following problems/side effects: blood glucose decreased, fall. NOVOLIN dosage: unknown. During the same period patient was treated with LANTUS. Patient recovered.

Novolin Side Effects Report #5474623-5
Health Professional from UNITED STATES reported NOVOLIN problem on Aug 21, 2006. Female patient, 58 years of age, weighting 119.9 lb, was diagnosed with insulin-requiring type ii diabetes mellitus and was treated with NOVOLIN. After drug was administered, patient experienced the following problems/side effects: blood glucose fluctuation. NOVOLIN dosage: unknown. During the same period patient was treated with IMITREX. Patient recovered.

Novolin Side Effects Report #5474627-2
NOVOLIN problem was reported by a Consumer or non-health professional from UNITED STATES on Aug 07, 2007. Female patient, 77 years of age, weighting 102.1 lb, was diagnosed with insulin-requiring type ii diabetes mellitus and was treated with NOVOLIN. After drug was administered, patient experienced the following problems/side effects: hypoglycaemic unconsciousness. NOVOLIN dosage: unknown. Patient recovered.

Novolin Side Effects Report #5474629-6
Consumer or non-health professional from UNITED STATES reported NOVOLIN problem on Oct 06, 2006. Female patient, 81 years of age, weighting 119.9 lb, was diagnosed with insulin-requiring type ii diabetes mellitus and was treated with NOVOLIN. After drug was administered, patient experienced the following problems/side effects: hypoglycaemia, loss of consciousness. NOVOLIN dosage: unknown. During the same period patient was treated with NOVOPEN. Patient was hospitalized. Patient recovered.

Novolin Side Effects Report #5474633-8
NOVOLIN problem was reported by a Consumer or non-health professional from UNITED STATES on Aug 08, 2007. Female patient, 80 years of age, weighting 145.1 lb, was diagnosed with insulin-requiring type ii diabetes mellitus and was treated with NOVOLIN. After drug was administered, patient experienced the following problems/side effects: hypoglycaemic unconsciousness. NOVOLIN dosage: unknown. During the same period patient was treated with NOVOFINE, NOVOLOG, MACROBID, LASIX, LIPITOR, COREG, SENNA. Patient was hospitalized. Patient recovered.

Novolin Side Effects Report #5474637-5
Consumer or non-health professional from UNITED STATES reported NOVOLIN problem on June 01, 2007. Male patient, 55 years of age, weighting 190.0 lb, was diagnosed with insulin-requiring type ii diabetes mellitus and was treated with NOVOLIN. After drug was administered, patient experienced the following problems/side effects: hypoglycaemia. NOVOLIN dosage: unknown. During the same period patient was treated with GLIMEPIRIDE, DIOVAN, COREG, METFORMIN, LISINOPRIL, STATIN, ACTOS. Patient was hospitalized. Patient recovered.

Novolin Side Effects Report #5474639-9
NOVOLIN problem was reported by a Consumer or non-health professional from UNITED STATES on Apr 02, 2007. Female patient, 80 years of age, was diagnosed with insulin-requiring type ii diabetes mellitus and was treated with NOVOLIN. After drug was administered, patient experienced the following problems/side effects: blood glucose decreased, hypoglycaemic unconsciousness. NOVOLIN dosage: unknown. During the same period patient was treated with FUROSEMIDE, SIMVASTATIN, GEMFIBROZIL, TOPROL, ENTERIC ASPIRIN, LEVOXYL, CLARITIN, CENTRUM. Patient recovered.

Novolin Side Effects Report #5474641-7
Consumer or non-health professional from UNITED STATES reported NOVOLIN problem on Apr 02, 2007. Female patient, 80 years of age, was diagnosed with insulin-requiring type ii diabetes mellitus and was treated with NOVOLIN. After drug was administered, patient experienced the following problems/side effects: hypoglycaemic unconsciousness. NOVOLIN dosage: unknown. During the same period patient was treated with FUROSEMIDE, SIMVASTATIN, GEMFIBROZIL, TOPROL, ENTERIC PAIN, CLARITIN, LEVOXYL, CENTRUM. Patient recovered.

Novolin Side Effects Report #5474642-9
NOVOLIN problem was reported by a Consumer or non-health professional from UNITED STATES on Apr 23, 2007. Male patient, 58 years of age, was diagnosed with insulin-requiring type ii diabetes mellitus and was treated with NOVOLIN. After drug was administered, patient experienced the following problems/side effects: hypoglycaemic unconsciousness. NOVOLIN dosage: unknown. During the same period patient was treated with LANTUS, LISINOPRIL. Patient recovered.

Novolin Side Effects Report #5474656-9
Consumer or non-health professional from UNITED STATES reported NOVOLIN problem on June 01, 2007. Male patient, 75 years of age, was diagnosed with insulin-requiring type ii diabetes mellitus and was treated with NOVOLIN. After drug was administered, patient experienced the following problems/side effects: blood glucose decreased. NOVOLIN dosage: unknown. During the same period patient was treated with ALENDRONATE, HYDROCHLOROTHIAZIDE, SYNTHROID, LISINOPRIL, SIMVASTATIN, METFORMIN, ASPIRIN, CALCIUM. Patient was hospitalized. Patient recovered.

Novolin Side Effects Report #5474661-2
NOVOLIN problem was reported by a Pharmacist from UNITED STATES on Nov 27, 2006. Female patient, 70 years of age, weighting 144.0 lb, was diagnosed with insulin-requiring type ii diabetes mellitus and was treated with NOVOLIN. After drug was administered, patient experienced the following problems/side effects: rash pruritic. NOVOLIN dosage: unknown. During the same period patient was treated with NOVOLIN N. Patient recovered.

Novolin Side Effects Report #5474662-4
Health Professional from UNITED STATES reported NOVOLIN problem on Jan 02, 2007. Male patient, 58 years of age, was diagnosed with type 1 diabetes mellitus and was treated with NOVOLIN. After drug was administered, patient experienced the following problems/side effects: hypoglycaemic unconsciousness. NOVOLIN dosage: unknown. During the same period patient was treated with NOVOLIN N, LISINOPRIL, SYNTHROID, ZOCOR. Patient recovered.

Novolin Side Effects Report #5474665-X
NOVOLIN problem was reported by a Pharmacist from UNITED STATES on Jan 04, 2007. Female patient was diagnosed with diabetes mellitus and was treated with NOVOLIN. After drug was administered, patient experienced the following problems/side effects: blood glucose decreased, incorrect dose administered. NOVOLIN dosage: unknown. Patient recovered.

Novolin Side Effects Report #5474667-3
Consumer or non-health professional from UNITED STATES reported NOVOLIN problem on Feb 23, 2007. Male patient, 72 years of age, weighting 203.0 lb, was treated with NOVOLIN. After drug was administered, patient experienced the following problems/side effects: hypersensitivity. NOVOLIN dosage: unknown. During the same period patient was treated with NOVOLIN R. Patient was hospitalized. Patient recovered.

Novolin Side Effects Report #5474668-5
NOVOLIN problem was reported by a Consumer or non-health professional from UNITED STATES on Mar 28, 2007. Female patient, 59 years of age, weighting 110.0 lb, was diagnosed with type 1 diabetes mellitus and was treated with NOVOLIN. After drug was administered, patient experienced the following problems/side effects: blood glucose decreased. NOVOLIN dosage: unknown. During the same period patient was treated with NOVOLIN R, FOSAMAX, CALCIUM, PREMARIN. Patient recovered.

Novolin Side Effects Report #5474669-7
Consumer or non-health professional from UNITED STATES reported NOVOLIN problem on May 07, 2007. Male patient, 25 years of age, was diagnosed with type 1 diabetes mellitus and was treated with NOVOLIN. After drug was administered, patient experienced the following problems/side effects: hypoglycaemic coma. NOVOLIN dosage: unknown. During the same period patient was treated with INSULIN. Patient was hospitalized. Patient recovered.

Novolin Side Effects Report #5474672-7
NOVOLIN problem was reported by a Consumer or non-health professional from UNITED STATES on July 05, 2007. Female patient, 61 years of age, was diagnosed with insulin-requiring type ii diabetes mellitus and was treated with NOVOLIN. After drug was administered, patient experienced the following problems/side effects: burning sensation, lip swelling, pharyngeal oedema, pruritus. NOVOLIN dosage: unknown. Patient recovered.

Novolin Side Effects Report #5474673-9
Consumer or non-health professional from UNITED STATES reported NOVOLIN problem on Aug 13, 2007. Male patient, 54 years of age, weighting 160.1 lb, was diagnosed with type 1 diabetes mellitus and was treated with NOVOLIN. After drug was administered, patient experienced the following problems/side effects: fall, head injury, hypoglycaemic unconsciousness. NOVOLIN dosage: unknown. During the same period patient was treated with NOVOLOG, BENICAR, ATENOLOL, ALTACE, TOPROL. Patient recovered.

Novolin Side Effects Report #5475036-2
NOVOLIN problem was reported by a Pharmacist from UNITED STATES on Sept 11, 2006. Female patient, 34 years of age, was diagnosed with gestational diabetes and was treated with NOVOLIN. After drug was administered, patient experienced the following problems/side effects: blood glucose increased, diabetic ketoacidosis. NOVOLIN dosage: unknown. Patient was hospitalized. Patient recovered.

Novolin Side Effects Report #5475037-4
Consumer or non-health professional from UNITED STATES reported NOVOLIN problem on Apr 23, 2007. Female patient, 49 years of age, weighting 190.9 lb, was diagnosed with diabetes mellitus and was treated with NOVOLIN. After drug was administered, patient experienced the following problems/side effects: blood glucose increased, influenza like illness. NOVOLIN dosage: unknown. Patient was hospitalized. Patient recovered.

Novolin Side Effects Report #5475038-6
NOVOLIN problem was reported by a Physician from UNITED STATES on Apr 09, 2007. Male patient, 91 years of age, was diagnosed with insulin-requiring type ii diabetes mellitus and was treated with NOVOLIN. After drug was administered, patient experienced the following problems/side effects: blood glucose increased, hypersensitivity. NOVOLIN dosage: unknown. Patient recovered.

Novolin Side Effects Report #5475039-8
Health Professional from UNITED STATES reported NOVOLIN problem on May 30, 2007. Male patient, 19 years of age, was diagnosed with diabetic ketoacidosis and was treated with NOVOLIN. After drug was administered, patient experienced the following problems/side effects: blood glucose decreased, headache, overdose. NOVOLIN dosage: 6 ML/HR., INTRAVENOUS. Patient was hospitalized. Patient recovered.

Novolin Side Effects Report #5475055-6
NOVOLIN problem was reported by a Health Professional from UNITED STATES on June 13, 2007. Female patient was diagnosed with diabetes mellitus and was treated with NOVOLIN. After drug was administered, patient experienced the following problems/side effects: blood glucose decreased, overdose. NOVOLIN dosage: unknown. Patient was hospitalized. Patient recovered.

Novolin Side Effects Report #5475059-3
Pharmacist from UNITED STATES reported NOVOLIN problem on June 26, 2007. Female patient, 89 years of age, was diagnosed with diabetes mellitus and was treated with NOVOLIN. After drug was administered, patient experienced the following problems/side effects: hypoglycaemia. NOVOLIN dosage: unknown. Patient was hospitalized. Patient recovered.

Novolin Side Effects Report #5375929-0
NOVOLIN problem was reported by a Pharmacist from UNITED STATES on June 26, 2007. Female patient, 82 years of age, was diagnosed with diabetes mellitus and was treated with NOVOLIN. After drug was administered, patient experienced the following problems/side effects: cardiac arrest, hypoglycaemia. NOVOLIN dosage: unknown. Patient was hospitalized. Patient died on 06/10/2007.

Novolin Side Effects Report #5383887-8
Physician from JAPAN reported NOVOLIN problem on July 03, 2007. Male patient, 54 years of age, was treated with NOVOLIN. After drug was administered, patient experienced the following problems/side effects: hypoglycaemia, suicide attempt. NOVOLIN dosage: unknown. During the same period patient was treated with NOVOLIN N, ANTIDEPRESSANTS. Patient was hospitalized. Patient recovered.

Novolin Side Effects Report #5389851-7
NOVOLIN problem was reported by a Physician from JAPAN on July 09, 2007. Female patient, 63 years of age, was diagnosed with diabetes mellitus and was treated with NOVOLIN. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased, blood glucose fluctuation, blood lactate dehydrogenase increased, gamma-glutamyltransferase increased, hepatic function abnormal, hepatocellular damage. NOVOLIN dosage: unknown. During the same period patient was treated with NATEGLINIDE, BASEN, MIGLITOL. Patient was hospitalized. Patient recovered.

Novolin Side Effects Report #5392053-1
Consumer or non-health professional from JAPAN reported NOVOLIN problem on July 11, 2007. Male patient, 70 years of age, weighting 97.00 lb, was diagnosed with insulin-requiring type ii diabetes mellitus, insomnia, anaemia, hepatic function abnormal and was treated with NOVOLIN. After drug was administered, patient experienced the following problems/side effects: anti-insulin antibody positive, diabetic ketoacidosis, injection site erythema, injection site pruritus, skin test positive. NOVOLIN dosage: unknown. During the same period patient was treated with HUMACART R, NOVOLIN N, NOVOLIN R, NOVORAPID CHU, HALCION, FERROMIA, URSO. Patient was hospitalized. Patient recovered.

Novolin Side Effects Report #5375929-0
NOVOLIN problem was reported by a Pharmacist from UNITED STATES on June 26, 2007. Female patient, 82 years of age, was diagnosed with diabetes mellitus and was treated with NOVOLIN. After drug was administered, patient experienced the following problems/side effects: cardiac arrest, hypoglycaemia. NOVOLIN dosage: unknown. Patient was hospitalized. Patient died on 06/10/2007.

Novolin Side Effects Report #5383887-8
Physician from JAPAN reported NOVOLIN problem on July 03, 2007. Male patient, 54 years of age, was treated with NOVOLIN. After drug was administered, patient experienced the following problems/side effects: hypoglycaemia, suicide attempt. NOVOLIN dosage: unknown. During the same period patient was treated with NOVOLIN N, ANTIDEPRESSANTS. Patient was hospitalized. Patient recovered.

Novolin Side Effects Report #5389851-7
NOVOLIN problem was reported by a Physician from JAPAN on July 09, 2007. Female patient, 63 years of age, was diagnosed with diabetes mellitus and was treated with NOVOLIN. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased, blood glucose fluctuation, blood lactate dehydrogenase increased, gamma-glutamyltransferase increased, hepatic function abnormal, hepatocellular damage. NOVOLIN dosage: unknown. During the same period patient was treated with NATEGLINIDE, BASEN, MIGLITOL. Patient was hospitalized. Patient recovered.

Novolin Side Effects Report #5392053-1
Consumer or non-health professional from JAPAN reported NOVOLIN problem on July 11, 2007. Male patient, 70 years of age, weighting 97.00 lb, was diagnosed with insulin-requiring type ii diabetes mellitus, insomnia, anaemia, hepatic function abnormal and was treated with NOVOLIN. After drug was administered, patient experienced the following problems/side effects: anti-insulin antibody positive, diabetic ketoacidosis, injection site erythema, injection site pruritus, skin test positive. NOVOLIN dosage: unknown. During the same period patient was treated with HUMACART R, NOVOLIN N, NOVOLIN R, NOVORAPID CHU, HALCION, FERROMIA, URSO. Patient was hospitalized. Patient recovered.


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