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Actrapid Safety Reports

Total Actrapid reports: 27.
Actrapid FDA safety alerts: No.
Reported deaths: 5    Reported hospitalizations: 13.
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Reported Actrapid Side Effects: hypoglycaemia, hepatic steatosis, hypoglycaemic coma, respiratory tract malformation, congenital diaphragmatic hernia, atrial septal defect, brain damage, muscle spasms, hyperhidrosis, blood glucose decreased, loss of consciousness.
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Actrapid Side Effects Report #5205709-8
Health Professional from UNITED KINGDOM reported ACTRAPID problem on Jan 09, 2007. Male patient, 59 years of age, weighting 149.9 lb, was treated with ACTRAPID. After drug was administered, patient experienced the following problems/side effects: bronchospasm, circulatory collapse, renal failure. ACTRAPID dosage: unknown. During the same period patient was treated with ASPIRIN, LIPITOR, BECLOMETHASONE DIPROPIONATE, DILTIAZEM. Patient was hospitalized. Patient recovered.

Actrapid Side Effects Report #5206061-4
ACTRAPID problem was reported by a Consumer or non-health professional from UNITED KINGDOM on Jan 02, 2007. Male patient, 54 years of age, was treated with ACTRAPID. After drug was administered, patient experienced the following problems/side effects: toxic epidermal necrolysis. ACTRAPID dosage: unknown. During the same period patient was treated with ALFENTANIL, AMOXICILLIN, AQUASEPT, BACTROBAN, CALCIUM CHLORIDE, CALCIUM GLUCONATE, CEFTRIAXONE, CLEXANE. Patient recovered.

Actrapid Side Effects Report #5210593-2
Health Professional from UNITED KINGDOM reported ACTRAPID problem on Jan 03, 2007. Male patient, 54 years of age, was diagnosed with toxic epidermal necrolysis and was treated with ACTRAPID. After drug was administered, patient experienced the following problems/side effects: toxic epidermal necrolysis. ACTRAPID dosage: unknown. During the same period patient was treated with ALFENTANIL, AMOXICILLIN, AQUASEPT, BACTROBAN, CALCIUM CHLORIDE, CALCIUM GLUCONATE, CEFTRIAXONE. Patient recovered.

Actrapid Side Effects Report #5230892-8
ACTRAPID problem was reported by a Health Professional from FRANCE on Jan 25, 2007. Female patient, weighting 4.43 lb, was diagnosed with diabetes mellitus insulin-dependent, epilepsy and was treated with ACTRAPID. After drug was administered, patient experienced the following problems/side effects: atrial septal defect, congenital diaphragmatic hernia, polyhydramnios, respiratory tract malformation. ACTRAPID dosage: unknown. During the same period patient was treated with INSULATARD FLEXPEN, DEPAKENE, LANTUS, HUMALOG. Patient died.

Actrapid Side Effects Report #5255169-6
Health Professional from FRANCE reported ACTRAPID problem on Feb 20, 2007. Female patient, weighting 4.43 lb, was diagnosed with diabetes mellitus insulin-dependent, epilepsy and was treated with ACTRAPID. After drug was administered, patient experienced the following problems/side effects: atrial septal defect, congenital diaphragmatic hernia, polyhydramnios, respiratory tract malformation. ACTRAPID dosage: unknown. During the same period patient was treated with INSULATARD FLEXPEN, DEPAKENE, LANTUS, HUMALOG. Patient died.

Actrapid Side Effects Report #5262244-9
ACTRAPID problem was reported by a Health Professional from FRANCE on Feb 27, 2007. Male patient, 36 years of age, was diagnosed with venous thrombosis, candidiasis and was treated with ACTRAPID. After drug was administered, patient experienced the following problems/side effects: hepatitis. ACTRAPID dosage: unknown. During the same period patient was treated with LOVENOX, TRIFLUCAN, NOVORAPID, LANTUS. Patient was hospitalized. Patient recovered.

Actrapid Side Effects Report #5262876-8
Physician from UNITED KINGDOM reported ACTRAPID problem on Feb 28, 2007. Male patient, 42 years of age, was diagnosed with diabetes mellitus and was treated with ACTRAPID. After drug was administered, patient experienced the following problems/side effects: chest pain, dyspnoea. ACTRAPID dosage: unknown. During the same period patient was treated with ACETAMINOPHEN, HUMALOG. Patient recovered.

Actrapid Side Effects Report #5268187-9
ACTRAPID problem was reported by a Health Professional from UNITED KINGDOM on Jan 09, 2007. Male patient, 59 years of age, weighting 149.9 lb, was treated with ACTRAPID. After drug was administered, patient experienced the following problems/side effects: bronchospasm, circulatory collapse, renal failure. ACTRAPID dosage: unknown. During the same period patient was treated with ASPIRIN, LIPITOR, BECLOMETHASONE DIPROPIONATE, DILTIAZEM. Patient was hospitalized. Patient recovered.

Actrapid Side Effects Report #5285926-1
Health Professional from FRANCE reported ACTRAPID problem on Mar 22, 2007. Male patient, 36 years of age, was diagnosed with venous thrombosis, candidiasis and was treated with ACTRAPID. After drug was administered, patient experienced the following problems/side effects: hepatitis. ACTRAPID dosage: unknown. During the same period patient was treated with LOVENOX, TRIFLUCAN, NOVORAPID, LANTUS. Patient was hospitalized. Patient recovered.

Actrapid Side Effects Report #5290968-6
ACTRAPID problem was reported by a Pharmacist from BELGIUM on Mar 27, 2007. Female patient, 50 years of age, was diagnosed with suicide attempt and was treated with ACTRAPID. After drug was administered, patient experienced the following problems/side effects: hypoglycaemia, suicide attempt. ACTRAPID dosage: unknown. Patient was hospitalized. Patient recovered.

Actrapid Side Effects Report #5298856-6
Pharmacist from BELGIUM reported ACTRAPID problem on Apr 05, 2007. Female patient, 50 years of age, was diagnosed with off label use and was treated with ACTRAPID. After drug was administered, patient experienced the following problems/side effects: hypoglycaemia, suicide attempt. ACTRAPID dosage: unknown. Patient was hospitalized. Patient recovered.

Actrapid Side Effects Report #5313410-5
ACTRAPID problem was reported by a Health Professional from FRANCE on Apr 25, 2007. Female patient, 73 years of age, was diagnosed with diabetes mellitus and was treated with ACTRAPID. After drug was administered, patient experienced the following problems/side effects: hypoglycaemic coma, status epilepticus. ACTRAPID dosage: unknown. During the same period patient was treated with NOVOLOG, LYRICA, PROPRANOLOL, FUROSEMIDE. Patient was hospitalized. Patient recovered.

Actrapid Side Effects Report #5324332-8
Health Professional from FRANCE reported ACTRAPID problem on Feb 20, 2007. Female patient, weighting 4.41 lb, was diagnosed with diabetes mellitus insulin-dependent, epilepsy and was treated with ACTRAPID. After drug was administered, patient experienced the following problems/side effects: abortion induced, atrial septal defect, congenital diaphragmatic hernia, respiratory tract malformation. ACTRAPID dosage: unknown. During the same period patient was treated with INSULATARD FLEXPEN, DEPAKENE, LANTUS, HUMALOG. Patient died.

Actrapid Side Effects Report #5329721-3
ACTRAPID problem was reported by a Consumer or non-health professional from UNITED KINGDOM on May 08, 2007. Female patient, 32 years of age, was diagnosed with diabetes mellitus insulin-dependent, respiratory distress and was treated with ACTRAPID. After drug was administered, patient experienced the following problems/side effects: adrenal insufficiency, anorexia, blood cortisol decreased, blood prolactin decreased, depressed mood, fatigue, feeling abnormal, foetal movements decreased, headache. ACTRAPID dosage: unknown. During the same period patient was treated with INSULATARD, BETAMETHASONE, HYDROCORTISONE. Patient was hospitalized. Patient recovered.

Actrapid Side Effects Report #5334417-8
Health Professional from FRANCE reported ACTRAPID problem on May 16, 2007. Female patient, 73 years of age, was diagnosed with diabetes mellitus and was treated with ACTRAPID. After drug was administered, patient experienced the following problems/side effects: hypoglycaemic coma, status epilepticus. ACTRAPID dosage: unknown. During the same period patient was treated with NOVOLOG, LYRICA, PROPRANOLOL, FUROSEMIDE. Patient was hospitalized. Patient recovered.

Actrapid Side Effects Report #5349033-1
ACTRAPID problem was reported by a Consumer or non-health professional from AUSTRALIA on May 25, 2007. Female patient was diagnosed with diabetes mellitus and was treated with ACTRAPID. After drug was administered, patient experienced the following problems/side effects: hepatic steatosis. ACTRAPID dosage: unknown. During the same period patient was treated with PROTAPHANE. Patient recovered.

Actrapid Side Effects Report #5358613-9
Consumer or non-health professional from AUSTRALIA reported ACTRAPID problem on May 25, 2007. Female patient was diagnosed with diabetes mellitus and was treated with ACTRAPID. After drug was administered, patient experienced the following problems/side effects: hepatic steatosis. ACTRAPID dosage: unknown. During the same period patient was treated with PROTAPHANE. Patient recovered.

Actrapid Side Effects Report #5044304-0
ACTRAPID problem was reported by a Physician from BELGIUM on Sept 05, 2002. Male patient, 28 years of age, was diagnosed with diabetes mellitus, hyperglycaemia and was treated with ACTRAPID. After drug was administered, patient experienced the following problems/side effects: diabetes mellitus inadequate control, disease recurrence, hypersensitivity, immunosuppression, malaise, palpitations, syncope. ACTRAPID dosage: unknown. During the same period patient was treated with MONOTARD, TENORMIN, INSULIN. Patient was hospitalized. Patient recovered.

Actrapid Side Effects Report #5087892-0
Physician from SWEDEN reported ACTRAPID problem on May 29, 2006. Male patient, child 9 years of age, weighting 119.0 lb, was diagnosed with diabetes mellitus insulin-dependent and was treated with ACTRAPID. After drug was administered, patient experienced the following problems/side effects: hypoglycaemia, loss of consciousness. ACTRAPID dosage: unknown. During the same period patient was treated with INSULATARD HM. Patient recovered.

Actrapid Side Effects Report #5087904-4
ACTRAPID problem was reported by a Physician from SWEDEN on May 29, 2006. Male patient, child 9 years of age, weighting 119.0 lb, was diagnosed with diabetes mellitus insulin-dependent and was treated with ACTRAPID. After drug was administered, patient experienced the following problems/side effects: hypoglycaemia, loss of consciousness. ACTRAPID dosage: unknown. During the same period patient was treated with INSULATARD HM. Patient recovered.

Actrapid Side Effects Report #5128419-4
Consumer or non-health professional from GERMANY reported ACTRAPID problem on Sept 22, 2006. Male patient, 39 years of age, was diagnosed with diabetes mellitus and was treated with ACTRAPID. After drug was administered, patient experienced the following problems/side effects: blood glucose decreased, hyperhidrosis, muscle spasms. ACTRAPID dosage: unknown. Patient recovered.

Actrapid Side Effects Report #5143613-4
ACTRAPID problem was reported by a Physician from NORWAY on Oct 31, 2006. Male patient, 66 years of age, was diagnosed with diabetes mellitus insulin-dependent and was treated with ACTRAPID. After drug was administered, patient experienced the following problems/side effects: brain damage, hypoglycaemic coma, pneumonia. ACTRAPID dosage: unknown. During the same period patient was treated with INSULATARD NPH. Patient was hospitalized. Patient died on 08/16/2006.

Actrapid Side Effects Report #5145852-5
Consumer or non-health professional from GERMANY reported ACTRAPID problem on Sept 22, 2006. Male patient, 39 years of age, was diagnosed with diabetes mellitus and was treated with ACTRAPID. After drug was administered, patient experienced the following problems/side effects: blood glucose decreased, hyperhidrosis, muscle spasms. ACTRAPID dosage: unknown. Patient recovered.

Actrapid Side Effects Report #5160145-8
ACTRAPID problem was reported by a Consumer or non-health professional from AUSTRALIA on Oct 30, 2006. Female patient, 85 years of age, weighting 99.21 lb, was diagnosed with diabetes mellitus insulin-dependent, blood pressure and was treated with ACTRAPID. After drug was administered, patient experienced the following problems/side effects: hypoglycaemia, radius fracture. ACTRAPID dosage: unknown. During the same period patient was treated with MIXTARD, ALPHAPRESS, FOSAMAX. Patient recovered.

Actrapid Side Effects Report #5192009-8
Pharmacist from AUSTRALIA reported ACTRAPID problem on Nov 28, 2006. Female patient was treated with ACTRAPID. After drug was administered, patient experienced the following problems/side effects: fall, hypoglycaemia. ACTRAPID dosage: unknown. Patient was hospitalized. Patient recovered.

Actrapid Side Effects Report #5379933-8
ACTRAPID problem was reported by a Physician from AUSTRALIA on June 26, 2007. Female patient was diagnosed with diabetes mellitus and was treated with ACTRAPID. After drug was administered, patient experienced the following problems/side effects: hepatic steatosis. ACTRAPID dosage: unknown. During the same period patient was treated with PROTAPHANE. Patient recovered.

Actrapid Side Effects Report #5452581-7
Physician from UNITED KINGDOM reported ACTRAPID problem on Sept 04, 2007. Female patient, 85 years of age, was diagnosed with hypothyroidism, hypertension, hypercholesterolaemia, cerebrovascular accident, diverticulum intestinal and was treated with ACTRAPID. After drug was administered, patient experienced the following problems/side effects: accidental overdose, bradycardia, brain damage, facial palsy, hypoglycaemia, hypotension, neuroglycopenia, unresponsive to stimuli. ACTRAPID dosage: unknown. During the same period patient was treated with GLUCOSE, LEVOTHYROXINE, AMLODIPINE, LIPITOR, ASPIRIN, LAXATIVES, HYDROCORTISONE, PANTOPRAZOLE. Patient was hospitalized. Patient died.


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