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Novolin R (Insulin Human) - Hypoglycaemia - Suspected Cause - Side Effect Reports

 
 



Index of reports > Cases with Hypoglycaemia (17)

Below is the selection of side effect reports (a.k.a. adverse event reports) related to Novolin R (Insulin Human) where reactions include hypoglycaemia. The selected reports were submitted to the FDA during the sample period of about a year.

Possible Novolin R side effects in 15 year old female

Reported by a physician from Japan on 2012-08-23

Patient: 15 year old female, weighing 48.0 kg (105.6 pounds)

Reactions: Intentional Overdose, Hypoglycaemia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Novolin N
    Dosage: 600 u, qd
    Indication: Type 1 Diabetes Mellitus
    Start date: 2012-01-03

Novolin R
    Dosage: 360 u, qd
    Indication: Type 1 Diabetes Mellitus
    Start date: 2012-01-03



Possible Novolin R side effects in 15 year old female

Reported by a physician from Japan on 2012-08-16

Patient: 15 year old female, weighing 48.0 kg (105.6 pounds)

Reactions: Intentional Overdose, Hypoglycaemia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Novolin R
    Dosage: 360 u, qd
    Indication: Type 1 Diabetes Mellitus
    Start date: 2012-01-03

Novolin N
    Dosage: 600 u, qd
    Indication: Type 1 Diabetes Mellitus
    Start date: 2012-01-03



Possible Novolin R side effects in 15 year old female

Reported by a physician from Japan on 2012-07-24

Patient: 15 year old female, weighing 48.0 kg (105.6 pounds)

Reactions: Intentional Overdose, Hypoglycaemia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Novolin R
    Dosage: 360 u, qd
    Indication: Type 1 Diabetes Mellitus
    Start date: 2012-01-03

Novolin N
    Dosage: 600 u, qd
    Indication: Type 1 Diabetes Mellitus
    Start date: 2012-01-03



Possible Novolin R side effects in 51 year old male

Reported by a physician from Japan on 2012-07-05

Patient: 51 year old male

Reactions: Anti-Insulin Antibody Positive, Hypoglycaemia

Drug(s) suspected as cause:
Novolin R
    Dosage: 80 u, qd
    Indication: Type 2 Diabetes Mellitus
    Start date: 2003-11-01

Novolin R
    Dosage: unk
    Indication: Type 2 Diabetes Mellitus
    Start date: 2002-12-01



Possible Novolin R side effects in 51 year old male

Reported by a physician from Japan on 2012-07-02

Patient: 51 year old male

Reactions: Anti-Insulin Antibody Positive, Hypoglycaemia

Drug(s) suspected as cause:
Novolin R
    Dosage: unk
    Indication: Type 2 Diabetes Mellitus
    Start date: 2002-12-01

Novolin R
    Dosage: 80 u, qd
    Indication: Type 2 Diabetes Mellitus
    Start date: 2003-11-01



Possible Novolin R side effects in 61 year old male

Reported by a physician from Japan on 2012-06-18

Patient: 61 year old male, weighing 82.0 kg (180.4 pounds)

Reactions: Anti-Insulin Antibody Positive, Hypoglycaemia, Diabetes Mellitus Inadequate Control

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Novolin R
    Dosage: 34 u, qd (18-12-4ut)
    Indication: Type 2 Diabetes Mellitus

Novorapid CHU Flexpen
    Dosage: 90 u, qd (28-30-32ut)
    Indication: Type 2 Diabetes Mellitus

Novorapid CHU Flexpen
    Dosage: 50 u, qd

Other drugs received by patient: Diovan; Amlodipine; Actos; Rasilez; Pravastatin Sodium; Lantus; Voglibose



Possible Novolin R side effects in 61 year old male

Reported by a physician from Japan on 2012-05-17

Patient: 61 year old male, weighing 82.0 kg (180.4 pounds)

Reactions: Anti-Insulin Antibody Positive, Hypoglycaemia, Diabetes Mellitus Inadequate Control

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Novorapid CHU Flexpen
    Dosage: 50 u, qd

Novorapid CHU Flexpen
    Dosage: 90 u, qd (28-30-32ut)
    Indication: Type 2 Diabetes Mellitus

Novolin R
    Dosage: 34 u, qd (18-12-4ut)
    Indication: Type 2 Diabetes Mellitus

Other drugs received by patient: Amlodipine Besylate; Lantus; Pravastatin Sodium



Possible Novolin R side effects in 73 year old male

Reported by a physician from Japan on 2012-03-30

Patient: 73 year old male, weighing 52.0 kg (114.4 pounds)

Reactions: Anti-Insulin Antibody Positive, Hyperglycaemia, Hypoglycaemia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Novolin N
    Dosage: unk
    Indication: Type 2 Diabetes Mellitus
    Start date: 2011-05-06

Novorapid CHU Flexpen
    Dosage: unk
    Indication: Type 2 Diabetes Mellitus
    Start date: 2010-02-12
    End date: 2011-05-06

Novolin R
    Dosage: unk
    Indication: Type 2 Diabetes Mellitus
    Start date: 2011-05-06

Other drugs received by patient: Humalog; Lantus; Humulin N; Urso / 00465701 /; Candesartan Cilexetil; Adalat CC



Possible Novolin R side effects in 70 year old male

Reported by a consumer/non-health professional from United States on 2012-02-29

Patient: 70 year old male

Reactions: Wrong Drug Administered, Hypoglycaemia

Drug(s) suspected as cause:
Novolin R
    Dosage: sliding scale, qid, subcutaneous
    Indication: Type 2 Diabetes Mellitus

Levemir
    Dosage: 110 u, qd at bedtime, subcutaneous
    Indication: Type 2 Diabetes Mellitus



Possible Novolin R side effects in 84 year old male

Reported by a physician from Japan on 2012-02-16

Patient: 84 year old male, weighing 42.0 kg (92.4 pounds)

Reactions: Anti-Insulin Antibody Positive, Hypoglycaemia, Hyperglycaemia, Anti-Insulin Antibody Increased, Diabetes Mellitus Inadequate Control

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Novolin R
    Dosage: 120 u, qd

Humalog
    Dosage: 20 ut, qd
    Indication: Type 2 Diabetes Mellitus
    Start date: 2010-03-17
    End date: 2011-02-21

Apidra
    Dosage: 12 ut, qd
    Indication: Type 2 Diabetes Mellitus
    Start date: 2011-02-21

Novolin R
    Dosage: 10 ut, qd
    Indication: Type 2 Diabetes Mellitus
    Start date: 2010-03-25
    End date: 2011-02-21

Novorapid 30 MIX CHU Flexpen
    Dosage: 8 u, qd
    Indication: Type 2 Diabetes Mellitus
    Start date: 2010-02-18
    End date: 2011-02-21

Other drugs received by patient: Pletal; Nicoranta; Aspirin; Sitagliptin Phosphate; Diart; Lipitor; Amaryl; Allopurinol; Millis; Magmitt; Mucosta



Possible Novolin R side effects in 34 year old female

Reported by a physician from Japan on 2012-02-09

Patient: 34 year old female, weighing 63.0 kg (138.6 pounds)

Reactions: Hypoglycaemia, Epilepsy, Convulsion, Blood Glucose Increased, Loss of Consciousness

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Novorapid CHU Flexpen
    Dosage: 17 u, qd
    Indication: Type 1 Diabetes Mellitus
    Start date: 2010-03-11

Penfill R CHU
    Dosage: 26 u, qd
    Indication: Type 1 Diabetes Mellitus
    Start date: 1993-03-01
    End date: 2009-11-01

Novolin R
    Dosage: 31-29 u/qd
    Indication: Type 1 Diabetes Mellitus
    Start date: 2009-11-01
    End date: 2010-03-10

Penfill N CHU
    Dosage: 24 u, qd
    Indication: Type 1 Diabetes Mellitus
    Start date: 1993-03-01
    End date: 2009-01-01

Novolin N
    Dosage: 20 u, qd
    Indication: Type 1 Diabetes Mellitus
    Start date: 2009-11-01
    End date: 2010-01-26

Other drugs received by patient: Lantus



Possible Novolin R side effects in 34 year old female

Reported by a physician from Japan on 2012-02-06

Patient: 34 year old female, weighing 63.0 kg (138.6 pounds)

Reactions: Hypoglycaemia, Epilepsy, Loss of Consciousness, Convulsion, Blood Glucose Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Novolin N
    Dosage: 20 u, qd
    Indication: Type 1 Diabetes Mellitus
    Start date: 2009-11-01
    End date: 2010-01-26

Novorapid CHU Flexpen
    Dosage: 17 u, qd
    Indication: Type 1 Diabetes Mellitus
    Start date: 2010-03-11

Novolin R
    Dosage: 31-29 u/qd
    Indication: Type 1 Diabetes Mellitus
    Start date: 2009-11-01
    End date: 2010-03-10

Other drugs received by patient: Lantus



Possible Novolin R side effects in 84 year old male

Reported by a physician from Japan on 2012-02-06

Patient: 84 year old male, weighing 42.0 kg (92.4 pounds)

Reactions: Anti-Insulin Antibody Positive, Hypoglycaemia, Hyperglycaemia, Anti-Insulin Antibody Increased, Diabetes Mellitus Inadequate Control

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Apidra
    Dosage: 12 ut, qd
    Indication: Type 2 Diabetes Mellitus
    Start date: 2011-02-21

Novolin R
    Dosage: 120 u, qd

Novorapid 30 MIX CHU Flexpen
    Dosage: 8 u, qd
    Indication: Type 2 Diabetes Mellitus
    Start date: 2010-02-18
    End date: 2011-02-21

Novolin R
    Dosage: 10 ut, qd
    Indication: Type 2 Diabetes Mellitus
    Start date: 2010-03-25
    End date: 2011-02-21

Humalog
    Dosage: 20 ut, qd
    Indication: Type 2 Diabetes Mellitus
    Start date: 2010-03-17
    End date: 2011-02-21

Other drugs received by patient: Aspirin; Pletal; Amaryl; Nicoranta; Mucosta; Diart; Millis; Magmitt; Sitagliptin Phosphate; Allopurinol; Lipitor



Possible Novolin R side effects in male

Reported by a consumer/non-health professional from China on 2012-01-18

Patient: male

Reactions: Hypoglycaemia, Intentional Drug Misuse, Victim of Homicide

Adverse event resulted in: death

Drug(s) suspected as cause:
Novolin R



Possible Novolin R side effects in 70 year old male

Reported by a consumer/non-health professional from United States on 2011-12-23

Patient: 70 year old male

Reactions: Wrong Drug Administered, Hypoglycaemia

Drug(s) suspected as cause:
Levemir
    Dosage: 110 u, qd at bedtime, subcutaneous
    Indication: Type 2 Diabetes Mellitus

Novolin R
    Dosage: sliding scale, qid, subcutaneous
    Indication: Type 2 Diabetes Mellitus



Possible Novolin R side effects in 70 year old male

Reported by a physician from Japan on 2011-12-23

Patient: 70 year old male

Reactions: Anti-Insulin Antibody, Hypoglycaemia, Hyperglycaemia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Levemir
    Dosage: 6 u, qd
    Indication: Type 2 Diabetes Mellitus
    Start date: 2009-06-10
    End date: 2009-06-24

Novolin R
    Indication: Type 2 Diabetes Mellitus

Other drugs received by patient: Humalog MIX 50; Humacart N; Humalog



Possible Novolin R side effects in

Reported by a consumer/non-health professional from Brazil on 2011-11-02

Patient:

Reactions: Hypoglycaemia, Hyperglycaemia, Hypoglycaemic Unconsciousness, Diabetic Ketoacidosis, Craniocerebral Injury

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Novorapid Flexpen
    Dosage: unk
    Indication: Diabetes Mellitus
    Start date: 2008-07-01

Novolin N
    Dosage: unk
    Start date: 2007-09-01

Novolin N
    Dosage: unk
    Indication: Diabetes Mellitus
    Start date: 2004-01-01

Novolin R
    Dosage: unk
    Indication: Diabetes Mellitus
    Start date: 2007-09-01

Other drugs received by patient: Captopril; Digoxin; Furosemide; Galvus; Carvedilol; Insulin Glargine; Spironolactone

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