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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