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),
Dyspnoea (16),
Vomiting (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 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 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 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 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 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 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 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 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 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 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
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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