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Novolin R (Insulin Human) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Novolin R (Insulin Human) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (65)
Death (2)
Life Threatening Events (2)
Disability (1)

Reports by Reaction Type

Hypoglycaemia (17)Blood Glucose Increased (12)Anti-Insulin Antibody Positive (9)Product Quality Issue (8)Diabetes Mellitus Inadequate Control (7)Hyperglycaemia (5)Convulsion (5)Hypoglycaemic Unconsciousness (5)Intentional Overdose (4)Blood Glucose Decreased (4)Altered State of Consciousness (4)Infection (3)

Below are a few examples of reports where side effects / adverse reactions may be related to Novolin R (Insulin Human). For a complete list or a specific selection of reports, please use the links above.

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 36 year old male

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-08-16

Patient: 36 year old male

Reactions: Anterograde Amnesia, Restlessness, Central Nervous System Lesion, Hypoglycaemic Encephalopathy, Encephalitis, Memory Impairment, Disorientation, Altered State of Consciousness, Convulsion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Solostar
    Indication: Device Therapy
    Start date: 2009-09-01

Lantus Solostar
    Indication: Type 1 Diabetes Mellitus
    Start date: 2009-09-01

Novolin R



Possible Novolin R side effects in male

Reported by a physician from United States on 2012-08-13

Patient: male, weighing 2.8 kg (6.1 pounds)

Reactions: Foetal Distress Syndrome, Foetal Heart Rate Disorder, Foetal Exposure During Pregnancy

Drug(s) suspected as cause:
Novolin R
    Dosage: 23 u, qd (13 units am and 10 units pm)
    Indication: Gestational Diabetes
    Start date: 2012-03-21
    End date: 2012-06-07

Novolin N
    Dosage: 35 u, qd (25 units am and 10 units pm)
    Indication: Gestational Diabetes
    Start date: 2012-03-21
    End date: 2012-06-07



Possible Novolin R side effects in 30 year old female

Reported by a physician from United States on 2012-08-13

Patient: 30 year old female, weighing 75.9 kg (167.0 pounds)

Reactions: Failed Induction of Labour, Maternal Exposure During Pregnancy

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Novolin R
    Dosage: 13 u in am and 10 u in pm
    Indication: Gestational Diabetes
    Start date: 2012-03-21
    End date: 2012-06-07

Novolin N
    Dosage: 25 u in am, 10 u in pm
    Start date: 2012-03-21
    End date: 2012-06-07



Possible Novolin R side effects in 67 year old female

Reported by a consumer/non-health professional from Brazil on 2012-08-13

Patient: 67 year old female, weighing 60.0 kg (132.0 pounds)

Reactions: TOE Amputation

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Novolin N
    Dosage: 50 u, qd
    Indication: Diabetes Mellitus
    Start date: 2011-01-12

Novolin R
    Dosage: unk
    Indication: Diabetes Mellitus



Possible Novolin R side effects in female

Reported by a consumer/non-health professional from China on 2012-08-06

Patient: female

Reactions: Tooth Loss, Product Counterfeit, Drug Ineffective, Dizziness, Product Odour Abnormal, Product Container Issue, Asthenia, Cardiac Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Novolin R
    Dosage: 40 iu, bid

Novolin R
    Dosage: 40 iu, bid
    Indication: Product Used FOR Unknown Indication
    Start date: 2007-01-01



Possible Novolin R side effects in 36 year old male

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-08-03

Patient: 36 year old male

Reactions: Anterograde Amnesia, Restlessness, Hypoglycaemic Encephalopathy, Central Nervous System Lesion, Encephalitis, Memory Impairment, Disorientation, Altered State of Consciousness, Convulsion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lantus Solostar
    Indication: Type 1 Diabetes Mellitus
    Start date: 2009-09-01

Novolin R

Solostar
    Indication: Device Therapy
    Start date: 2009-09-01



Possible Novolin R side effects in male

Reported by a physician from United States on 2012-07-27

Patient: male

Reactions: Syncope, Hyperkalaemia, Infective Exacerbation of Chronic Obstructive Airways Disease

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Valsartan

Terazosin Hydrochloride
    Dosage: unk
    Start date: 2012-03-30
    End date: 2012-04-06

Humalog
    Dosage: 500 iu, unk
    Indication: Type 2 Diabetes Mellitus

Insulin Glargine
    Dosage: 100 iu, unk
    Indication: Type 2 Diabetes Mellitus

Novolin R
    Dosage: 100 iu, unk
    Indication: Type 2 Diabetes Mellitus

Insulin Aspart
    Dosage: 100 iu, unk
    Indication: Type 2 Diabetes Mellitus

Aldactone

Blinded Therapy

Other drugs received by patient: Nicotinic Acid; Acetylsalicylic Acid



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 53 year old female

Reported by a consumer/non-health professional from United States on 2012-07-19

Patient: 53 year old female, weighing 77.1 kg (169.6 pounds)

Reactions: Blood Glucose Decreased, Pneumothorax, RIB Fracture

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Novolin N
    Dosage: 30 units in am
    Indication: Type 1 Diabetes Mellitus
    Start date: 2010-11-01

Novolin N
    Dosage: 15 units in pm
    Start date: 2010-11-01

Novolin R
    Dosage: sliding scale
    Indication: Type 1 Diabetes Mellitus
    Start date: 2010-11-01



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 75 year old female

Reported by a individual with unspecified qualification from Japan on 2012-06-14

Patient: 75 year old female, weighing 61.0 kg (134.2 pounds)

Reactions: Anti-GAD Antibody Positive, Blood Glucose Fluctuation, Blood Glucose Increased, Diabetes Mellitus Inadequate Control

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Novorapid 30 MIX CHU Flexpen
    Dosage: 1 iu/kg, qd
    Indication: Type 2 Diabetes Mellitus
    Start date: 2005-08-01
    End date: 2008-03-01

Novolin 20R CHU Flexpen
    Dosage: 0.49 iu/kg, qd
    Indication: Type 2 Diabetes Mellitus
    Start date: 1998-09-01
    End date: 2003-06-01

Novolet 20R CHU
    Indication: Product Used FOR Unknown Indication

Novolin N
    Dosage: unknown
    Indication: Type 2 Diabetes Mellitus

Novolin R
    Dosage: 0.64 iu/kg, qd
    Indication: Type 2 Diabetes Mellitus
    Start date: 2003-07-01
    End date: 2005-08-01

Novorapid CHU Flexpen
    Dosage: 24 iu, qd
    Indication: Type 2 Diabetes Mellitus
    Start date: 2008-04-01

Other drugs received by patient: Lantus



Possible Novolin R side effects in male

Reported by a physician from United States on 2012-06-14

Patient: male

Reactions: Syncope, Hyperkalaemia, Infective Exacerbation of Chronic Obstructive Airways Disease

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Valsartan

Blinded Therapy

Aldactone

Novolin R
    Dosage: 100 iu, unk
    Indication: Type 2 Diabetes Mellitus

Terazosin HCL
    Dosage: unk
    Start date: 2012-03-30
    End date: 2012-04-06

Humalog
    Dosage: 500 iu, unk
    Indication: Type 2 Diabetes Mellitus

Insulin Glargine
    Dosage: 100 iu, unk
    Indication: Type 2 Diabetes Mellitus

Insulin Aspart
    Dosage: 100 iu, unk
    Indication: Type 2 Diabetes Mellitus

Other drugs received by patient: Acetylsalicylic Acid; Nicotinic Acid



Possible Novolin R side effects in 53 year old male

Reported by a consumer/non-health professional from Brazil on 2012-06-05

Patient: 53 year old male

Reactions: Renal Transplant, Drug Ineffective, Visual Impairment

Drug(s) suspected as cause:
Novolin R
    Dosage: unk

Levemir
    Dosage: unk
    Indication: Product Used FOR Unknown Indication



Possible Novolin R side effects in 21 year old female

Reported by a physician from Japan on 2012-05-24

Patient: 21 year old female, weighing 43.0 kg (94.6 pounds)

Reactions: Aspartate Aminotransferase Increased, Alanine Aminotransferase Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Novolin R

Other drugs received by patient: Novolin R



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 60 year old male

Reported by a physician from Japan on 2012-05-16

Patient: 60 year old male, weighing 48.0 kg (105.6 pounds)

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

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Novolin R

Other drugs received by patient: Nichiaspirin; Reticolan; Corinael; Amlodipine Besylate; Metformin HCL



Possible Novolin R side effects in 60 year old male

Reported by a physician from Japan on 2012-05-08

Patient: 60 year old male, weighing 48.0 kg (105.6 pounds)

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

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Novolin R

Other drugs received by patient: Corinael; Nichiaspirin; Amlodipine; Metformin HCL; Reticolan



Possible Novolin R side effects in

Reported by a pharmacist from United States on 2012-05-04

Patient:

Reactions: Hospitalisation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Novolin R
    Indication: Diabetes Mellitus

Novolin N
    Indication: Diabetes Mellitus



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 36 year old male

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-03-16

Patient: 36 year old male

Reactions: Anterograde Amnesia, Hypoglycaemic Encephalopathy, Central Nervous System Lesion, Encephalitis, Memory Impairment, Altered State of Consciousness, Convulsion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Novolin R

Lantus
    Indication: Type 1 Diabetes Mellitus
    Start date: 2009-09-01

Solostar
    Indication: Device Therapy
    Start date: 2009-09-01



Possible Novolin R side effects in 50 year old male

Reported by a consumer/non-health professional from China on 2012-03-14

Patient: 50 year old male, weighing 60.0 kg (132.0 pounds)

Reactions: Product Quality Issue, Skin Ulcer, Sepsis, Blood Glucose Increased

Drug(s) suspected as cause:
Novolin R
    Dosage: 18 iu in the morning and 18 iu in the evening
    Indication: Type 2 Diabetes Mellitus
    Start date: 2009-10-02

Novolin R
    Dosage: 18 iu in the morning and 18 iu in the evening
    End date: 2011-12-20

Novolin R
    Dosage: 18 iu in the morning and 18 iu in the evening

Other drugs received by patient: Adefovir Dipivoxil



Possible Novolin R side effects in 69 year old male

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

Patient: 69 year old male

Reactions: Blood Glucose Decreased, Hypoglycaemic Unconsciousness, Blood Glucose Increased

Drug(s) suspected as cause:
Novolin R
    Dosage: subcutaneous
    Indication: Type 1 Diabetes Mellitus

Novolin R
    Dosage: subcutaneous
    Indication: Type 1 Diabetes Mellitus



Possible Novolin R side effects in 60 year old male

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

Patient: 60 year old male, weighing 73.5 kg (161.7 pounds)

Reactions: Blood Glucose Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Novolin R
    Dosage: subcutaneous
    Indication: Type 1 Diabetes Mellitus
    Start date: 2011-10-01

Humalog
    Dosage: subcutaneous
    Indication: Type 1 Diabetes Mellitus
    Start date: 2011-10-01



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 15 year old female

Reported by a pharmacist from United States on 2012-02-29

Patient: 15 year old female, weighing 67.1 kg (147.6 pounds)

Reactions: Blood Glucose Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Novolin R



Possible Novolin R side effects in 41 year old male

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

Patient: 41 year old male

Reactions: Hypoglycaemic Unconsciousness

Drug(s) suspected as cause:
Novolin R
    Dosage: subcutaneous
    Indication: Type 1 Diabetes Mellitus
    Start date: 2008-01-01

Novolin 70 / 30
    Dosage: subcutaneous
    Indication: Type 1 Diabetes Mellitus
    Start date: 2008-01-01

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