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 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 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 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 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 70 / 30
Dosage: subcutaneous
Indication: Type 1 Diabetes Mellitus
Start date: 2008-01-01
Novolin R
Dosage: subcutaneous
Indication: Type 1 Diabetes Mellitus
Start date: 2008-01-01
Possible Novolin R side effects in 83 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-02-29
Patient: 83 year old male, weighing 105.7 kg (232.5 pounds)
Reactions: Off Label Use, Blood Glucose Decreased, Incorrect Dose Administered
Drug(s) suspected as cause:
Novolin R
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
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