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Novolog (Insulin Aspart Injection) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Novolog (Insulin Aspart Injection) 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 (344)
Death (10)
Life Threatening Events (4)
Disability (6)

Reports by Reaction Type

Blood Glucose Increased (91)Blood Glucose Decreased (43)Diabetic Ketoacidosis (23)Hypoglycaemia (21)Hypoglycaemic Unconsciousness (21)Nausea (17)Drug Ineffective (16)Vomiting (16)Dyspnoea (16)Dehydration (16)Blood Glucose Fluctuation (12)Device Malfunction (11)

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

Possible Novolog side effects in 60 year old female

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: 60 year old female

Reactions: Cerebrovascular Accident, Blood Glucose Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lantus
    Dosage: 15 - 18 units twice daily.
    Indication: Type 2 Diabetes Mellitus
    Start date: 2012-07-01

Novolog
    End date: 2012-01-01

Solostar
    Start date: 2012-07-01



Possible Novolog side effects in 67 year old female

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient: 67 year old female

Reactions: Limb Operation, Headache, Tooth Disorder

Drug(s) suspected as cause:
Lantus
    Dosage: dose:40 unit(s)
    Start date: 2000-01-01

Novolog

Solostar
    Start date: 2000-01-01



Possible Novolog side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-21

Patient: male

Reactions: Weight Decreased, Neoplasm Malignant, Deafness

Drug(s) suspected as cause:
Lantus
    Dosage: dose:10 unit(s)
    Indication: Type 2 Diabetes Mellitus

Novolog

Solostar
    Indication: Type 2 Diabetes Mellitus



Possible Novolog side effects in 50 year old male

Reported by a consumer/non-health professional from United States on 2012-08-20

Patient: 50 year old male, weighing 83.9 kg (184.6 pounds)

Reactions: Peripheral Arterial Occlusive Disease, Wound Infection Staphylococcal, Blood Glucose Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Novolog

Other drugs received by patient: Lisinopril; Allopurinol; Pravastatin; Furosemide; Lantus; Amlodipine; Metoprolol Tartrate



Possible Novolog side effects in 71 year old male

Reported by a consumer/non-health professional from United States on 2012-08-17

Patient: 71 year old male, weighing 97.5 kg (214.5 pounds)

Reactions: Weight Decreased, Blood Glucose Decreased, Road Traffic Accident, Laceration, Blood Pressure Decreased, Loss of Consciousness

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lantus
    Dosage: 40 u, qd
    Start date: 2012-01-01

Lantus
    Dosage: 50 units qd in morning
    Indication: Diabetes Mellitus
    Start date: 2005-06-01
    End date: 2012-01-01

Minoxidil
    Dosage: 15 mg, unk
    Indication: Product Used FOR Unknown Indication
    End date: 2012-07-16

Novolog
    Dosage: 1 u before meals
    Indication: Diabetes Mellitus

Other drugs received by patient: Simvastatin; Fish OIL; Benazepril Hydrochloride; Carvedilol; Losartan Potassium and Hydrochlorothiazide; Aspirin; Centrum Silver / 01292501 /; Tricor; Amlodipine Besylate



Possible Novolog side effects in 72 year old female

Reported by a consumer/non-health professional from United States on 2012-08-16

Patient: 72 year old female, weighing 59.0 kg (129.7 pounds)

Reactions: Myalgia, Myocardial Infarction

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Levemir
    Dosage: 20 u, qd
    Indication: Type 2 Diabetes Mellitus
    Start date: 2011-01-01
    End date: 2012-08-03

Levemir
    Dosage: 20 u, qd
    Start date: 2012-08-05

Novolog
    Dosage: 30-35 u per day
    Indication: Type 2 Diabetes Mellitus
    Start date: 2012-06-01
    End date: 2012-08-03

Novolog
    Dosage: 30-35 u per day
    Start date: 2012-08-05

Other drugs received by patient: Glyburide



Possible Novolog side effects in 67 year old male

Reported by a consumer/non-health professional from United States on 2012-08-14

Patient: 67 year old male

Reactions: Syncope, Bundle Branch Block Left

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Levemir
    Dosage: 40 iu, qd
    Indication: Type 2 Diabetes Mellitus

Novolog
    Dosage: 40 iu, qd
    Indication: Type 2 Diabetes Mellitus

Saxagliptin
    Dosage: unk
    Indication: Type 2 Diabetes Mellitus
    Start date: 2011-08-12

Other drugs received by patient: Aspirin



Possible Novolog side effects in male

Reported by a pharmacist from United States on 2012-08-14

Patient: male

Reactions: Intentional Overdose, Self Injurious Behaviour

Drug(s) suspected as cause:
Novolog



Possible Novolog side effects in 66 year old female

Reported by a consumer/non-health professional from United States on 2012-08-09

Patient: 66 year old female, weighing 63.5 kg (139.7 pounds)

Reactions: Road Traffic Accident, Hypoglycaemic Unconsciousness, Device Malfunction

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Novolog
    Dosage: sliding scale
    Indication: Type 1 Diabetes Mellitus
    Start date: 2007-01-01
    End date: 2011-12-30

Novolog
    Dosage: sliding scale
    Start date: 2011-12-31

Other drugs received by patient: Pravastatin; Enalapril Maleate; Aspirin



Possible Novolog side effects in 85 year old male

Reported by a physician from United States on 2012-08-09

Patient: 85 year old male

Reactions: Circumstance or Information Capable of Leading To Medication Error, Blood Glucose Increased

Drug(s) suspected as cause:
Novolin 70 / 30

Novolog



Possible Novolog side effects in 73 year old male

Reported by a consumer/non-health professional from United States on 2012-08-08

Patient: 73 year old male, weighing 68.2 kg (150.0 pounds)

Reactions: Wrong Drug Administered, Diabetic Coma

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Lantus
    Dosage: dose: 10 units in morning and 30 units at night.

Novolog



Possible Novolog side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-07

Patient: male

Reactions: Dyspnoea, Trigger Finger, Blood Glucose Increased

Drug(s) suspected as cause:
Lantus
    Dosage: dose:30 unit(s)
    Start date: 2012-07-31
    End date: 2012-07-31

Lantus

Novolog

Solostar



Possible Novolog side effects in 64 year old male

Reported by a health professional (non-physician/pharmacist) from Netherlands on 2012-08-06

Patient: 64 year old male

Reactions: Adenocarcinoma Pancreas, Pancreatitis Chronic, Constipation, Pancreatic Calcification

Drug(s) suspected as cause:
Aceon
    Indication: Product Used FOR Unknown Indication

Levemir
    Dosage: 30 iu
    Indication: Type 2 Diabetes Mellitus

Novolog
    Dosage: 64 iu
    Indication: Type 2 Diabetes Mellitus

Placebo
    Start date: 2011-01-27

Saxagliptin (Saxagliptin)
    Dosage: df, unk
    Indication: Type 2 Diabetes Mellitus

Other drugs received by patient: Ezetimibe; Metamucil-2; Aspirin; Spiriva; Amylase (Amylase); Flixonase (Flucticasone Propionate); Seretide (Fluticasone Propionate, Salmeterol Xinafoate); Tamsulosin HCL; Ventolin; Lipase (Lipase); Nexium



Possible Novolog side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-02

Patient: male, weighing 119.8 kg (263.5 pounds)

Reactions: Diabetes Mellitus, Abasia, Perineal Cyst, Decreased Immune Responsiveness, Intervertebral Disc Degeneration, Abnormal Loss of Weight, Oxygen Saturation Decreased, Intervertebral Disc Protrusion, Fistula, Gout, Convulsion, Cholelithiasis, Diarrhoea, Sepsis, Heart Rate Increased, Arthritis, Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Colchicine
    Administration route: Oral
    Indication: Gout
    Start date: 2012-05-01

Levemir
    Dosage: 52 units/ at night/subcutaneous
    Indication: Diabetes Mellitus

Methotrexate
    Administration route: Oral
    Indication: Intervertebral Disc Protrusion
    Start date: 2011-01-01
    End date: 2011-01-01

Novolog
    Dosage: 40 units/solution before meals
    Indication: Diabetes Mellitus
    Start date: 2011-01-01
    End date: 2011-01-01

Remicade
    Indication: Crohn's Disease
    Start date: 2004-09-09
    End date: 2010-01-01

Remicade
    Start date: 2010-01-01

Other drugs received by patient: Flomax; Dilaudid; Ambien; Valium; Hydrochlorothiazide; Cymbalta; Lyrica; Lisinopril; Simvastatin; Nexium; Humalog; Onglyza



Possible Novolog side effects in 89 year old female

Reported by a physician from United States on 2012-08-02

Patient: 89 year old female

Reactions: Syncope, Blood Glucose Fluctuation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Novolog



Possible Novolog side effects in 66 year old female

Reported by a consumer/non-health professional from United States on 2012-08-01

Patient: 66 year old female, weighing 108.8 kg (239.4 pounds)

Reactions: Cardio-Respiratory Arrest, Diabetic Coma

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Levemir
    Dosage: 57 u, qd, at night
    Indication: Type 2 Diabetes Mellitus
    Start date: 2009-01-01

Novolog
    Dosage: 35 u, tid, before each meal
    Indication: Type 2 Diabetes Mellitus
    Start date: 2009-01-01



Possible Novolog side effects in 32 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-30

Patient: 32 year old male

Reactions: Gastrointestinal Haemorrhage, Asthenia, Tremor

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Aspirin
    Dosage: unk
    Start date: 1998-01-01

Dapagliflozin
    Dosage: unk
    Administration route: Oral
    Indication: Type 1 Diabetes Mellitus
    Start date: 2012-05-03
    End date: 2012-05-16

Lantus
    Dosage: unk
    Start date: 2010-01-01

Novolog
    Dosage: unk
    Start date: 2010-01-01

Placebo
    Dosage: unk
    Indication: Type 1 Diabetes Mellitus
    Start date: 2012-05-03
    End date: 2012-05-16

Other drugs received by patient: Ibuprofen; Accupril



Possible Novolog side effects in 72 year old male

Reported by a consumer/non-health professional from United States on 2012-07-30

Patient: 72 year old male

Reactions: Blood Glucose Decreased, Road Traffic Accident, Laceration, Loss of Consciousness

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lantus
    Dosage: 40 units qd
    Start date: 2012-01-01

Lantus
    Dosage: 50 units qd in morning
    Indication: Diabetes Mellitus
    End date: 2012-01-01

Novolog
    Dosage: unknown
    Indication: Diabetes Mellitus



Possible Novolog side effects in 66 year old female

Reported by a consumer/non-health professional from United States on 2012-07-27

Patient: 66 year old female, weighing 63.5 kg (139.7 pounds)

Reactions: Road Traffic Accident, Hypoglycaemic Unconsciousness, Device Malfunction

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Novolog
    Dosage: sliding scale
    Start date: 2011-12-31

Novolog
    Dosage: sliding scale
    Indication: Type 1 Diabetes Mellitus
    Start date: 2007-01-01
    End date: 2011-12-30

Other drugs received by patient: Enalapril Maleate; Pravastatin; Aspirin



Possible Novolog side effects in male

Reported by a consumer/non-health professional from United States on 2012-07-24

Patient: male

Reactions: Jaundice, Weight Decreased, Deafness, Drug Withdrawal Syndrome Neonatal, Constipation, Failure To Thrive, Speech Disorder, Tethered Cord Syndrome, Type 1 Diabetes Mellitus, Gastrooesophageal Reflux Disease, Spina Bifida, Ear Infection, Meningomyelocele, Anxiety, Feeding Disorder Neonatal, Attention Deficit / Hyperactivity Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Dexamethasone
    Indication: Foetal Exposure During Pregnancy

Januvia
    Indication: Foetal Exposure During Pregnancy

Lantus
    Indication: Foetal Exposure During Pregnancy

Metformin Hydrochloride
    Indication: Foetal Exposure During Pregnancy

Novolog
    Indication: Foetal Exposure During Pregnancy

Prozac
    Indication: Foetal Exposure During Pregnancy

Seroquel
    Indication: Foetal Exposure During Pregnancy

Terbutaline
    Indication: Foetal Exposure During Pregnancy

Topamax
    Indication: Foetal Exposure During Pregnancy
    Start date: 2006-08-03
    End date: 2006-10-06

Zoloft
    Indication: Foetal Exposure During Pregnancy

Zosyn
    Indication: Foetal Exposure During Pregnancy

Other drugs received by patient: Multi-Vitamins



Possible Novolog side effects in 24 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-24

Patient: 24 year old male, weighing 54.4 kg (119.7 pounds)

Reactions: Vomiting, Nausea, Pyrexia, Blood Glucose Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Novolog



Possible Novolog side effects in

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

Patient:

Reactions: Blood Glucose Decreased, Road Traffic Accident, Device Malfunction, Incorrect Dose Administered by Device, Loss of Consciousness

Drug(s) suspected as cause:
Novolog



Possible Novolog side effects in 69 year old female

Reported by a consumer/non-health professional from United States on 2012-07-18

Patient: 69 year old female, weighing 95.7 kg (210.5 pounds)

Reactions: Dyspnoea, Incorrect Storage of Drug

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Novolog

Other drugs received by patient: Lantus; Lyrica



Possible Novolog side effects in 56 year old female

Reported by a consumer/non-health professional from United States on 2012-07-17

Patient: 56 year old female

Reactions: Retinal Detachment, Condition Aggravated

Drug(s) suspected as cause:
Lantus
    Dosage: 52-24 units twice daily based on blood sugars
    Indication: Diabetes Mellitus

Novolog
    Indication: Diabetes Mellitus



Possible Novolog side effects in male

Reported by a consumer/non-health professional from United States on 2012-07-16

Patient: male

Reactions: Renal Failure

Drug(s) suspected as cause:
Lantus
    Dosage: dose:37 unit(s)

Novolog

Solostar



Possible Novolog side effects in 65 year old female

Reported by a consumer/non-health professional from United States on 2012-07-16

Patient: 65 year old female

Reactions: Cellulitis, Accidental Overdose

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lantus
    Dosage: dose:90 unit(s)
    Indication: Type 2 Diabetes Mellitus

Novolog



Possible Novolog side effects in 39 year old male

Reported by a consumer/non-health professional from United States on 2012-07-13

Patient: 39 year old male, weighing 68.0 kg (149.7 pounds)

Reactions: Blood Glucose Decreased, Blood Glucose Fluctuation, Convulsion

Drug(s) suspected as cause:
Novolog

Other drugs received by patient: Dilantin



Possible Novolog side effects in 51 year old male

Reported by a pharmacist from United States on 2012-07-12

Patient: 51 year old male, weighing 103.0 kg (226.6 pounds)

Reactions: Dyspnoea, Pruritus, Unresponsive To Stimuli, Urticaria, Rash

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Novolog



Possible Novolog side effects in male

Reported by a individual with unspecified qualification from United States on 2012-07-09

Patient: male

Reactions: Blood Glucose Decreased, Malaise, Medication Error, Wrong Drug Administered, Drug Dispensing Error

Drug(s) suspected as cause:
Novolog

Novolog MIX 70 / 30



Possible Novolog side effects in 55 year old female

Reported by a consumer/non-health professional from United States on 2012-07-09

Patient: 55 year old female

Reactions: Coronary Artery Occlusion, Myocardial Infarction, Diabetes Mellitus Inadequate Control

Drug(s) suspected as cause:
Lantus
    Dosage: dose:70 unit(s)
    Start date: 2011-01-01

Novolog

Solostar
    Indication: Type 2 Diabetes Mellitus
    Start date: 2011-01-01

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