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Novolog MIX 70 / 30 (Insulin Aspart Protamine Suspension / 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 MIX 70 / 30 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 (69)
Death (4)
Life Threatening Events (4)

Reports by Reaction Type

Blood Glucose Increased (15)Diabetes Mellitus Inadequate Control (7)Blood Glucose Decreased (7)Pain (5)Dizziness (5)Hypoglycaemia (4)Syncope (4)Hypoglycaemic Unconsciousness (4)Medication Error (3)Cardiac Failure Congestive (3)Pneumonia (3)Hypoaesthesia (3)

Below are a few examples of reports where side effects / adverse reactions may be related to Novolog MIX 70 / 30. For a complete list or a specific selection of reports, please use the links above.

Possible Novolog MIX 70 / 30 side effects in 38 year old male

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

Patient: 38 year old male, weighing 84.0 kg (184.8 pounds)

Reactions: Diabetes Mellitus Inadequate Control

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Novolog MIX 70 / 30
    Dosage: 40 iu, qd

Novolog MIX 70 / 30
    Dosage: 48 u, qd
    Indication: Type 2 Diabetes Mellitus
    Start date: 2008-03-01

Novolog MIX 70 / 30
    Dosage: 60 iu, qd

Other drugs received by patient: Glucobay; Metformin Hydrochloride



Possible Novolog MIX 70 / 30 side effects in 38 year old male

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

Patient: 38 year old male, weighing 84.0 kg (184.8 pounds)

Reactions: Diabetes Mellitus Inadequate Control

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Novolog MIX 70 / 30
    Dosage: 48 u, qd
    Indication: Type 2 Diabetes Mellitus
    Start date: 2008-03-01

Novolog MIX 70 / 30
    Dosage: 60 iu, qd

Novolog MIX 70 / 30
    Dosage: 40 iu, qd

Other drugs received by patient: Metformin Hydrochloride; Glucobay



Possible Novolog MIX 70 / 30 side effects in 62 year old male

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

Patient: 62 year old male, weighing 74.8 kg (164.6 pounds)

Reactions: Parkinson's Disease

Drug(s) suspected as cause:
Novolog MIX 70 / 30



Possible Novolog MIX 70 / 30 side effects in 38 year old male

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

Patient: 38 year old male, weighing 84.0 kg (184.8 pounds)

Reactions: Palpitations, Diabetes Mellitus Inadequate Control

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Novolog MIX 70 / 30
    Dosage: unk

Novolog MIX 70 / 30
    Dosage: 22 u morning+ 8 u noon + 18uevening
    Indication: Type 2 Diabetes Mellitus
    Start date: 2008-03-01

Novolog MIX 70 / 30
    Dosage: unk unk, qd

Novolog MIX 70 / 30
    Dosage: 22 u morning+ 8 u noon + 18 u evening

Other drugs received by patient: Glucobay; Metformin Hydrochloride



Possible Novolog MIX 70 / 30 side effects in 65 year old male

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

Patient: 65 year old male, weighing 88.4 kg (194.6 pounds)

Reactions: Facial Bones Fracture, Dizziness, Loss of Consciousness

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Novolog MIX 70 / 30



Possible Novolog MIX 70 / 30 side effects in female

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

Patient: female

Reactions: Upper Limb Fracture, Joint Dislocation, Fall

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Novolog MIX 70 / 30



Possible Novolog MIX 70 / 30 side effects in

Reported by a individual with unspecified qualification from United States on 2012-07-17

Patient:

Reactions: Medication Error, Intercepted Drug Dispensing Error

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

Novolog MIX 70 / 30



Possible Novolog MIX 70 / 30 side effects in

Reported by a individual with unspecified qualification from United States on 2012-07-17

Patient:

Reactions: Product Label Issue, Medication Error, Drug Dispensing Error

Drug(s) suspected as cause:
Insulin Aspart Novo Rapid Penfill

Novolog MIX 70 / 30
    Dosage: novo nordisk inc.



Possible Novolog MIX 70 / 30 side effects in 67 year old male

Reported by a consumer/non-health professional from United States on 2012-07-12

Patient: 67 year old male

Reactions: Angioedema

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Activase
    Start date: 2011-11-11
    End date: 2011-11-11

Blinded: Saxagliptin
    Indication: Type 2 Diabetes Mellitus
    Start date: 2011-03-23
    End date: 2011-11-11

Metformin HCL
    Indication: Type 2 Diabetes Mellitus

Novolog MIX 70 / 30
    Indication: Type 2 Diabetes Mellitus

Placebo
    Indication: Type 2 Diabetes Mellitus
    Start date: 2011-03-23
    End date: 2011-11-11

Other drugs received by patient: Aspirin



Possible Novolog MIX 70 / 30 side effects in male

Reported by a physician from Sweden on 2012-07-10

Patient: male

Reactions: Renal Impairment, Oesophageal Stenosis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Enalapril Maleate

Novolog MIX 70 / 30
    Indication: Type 2 Diabetes Mellitus

Saxagliptin / Placebo
    Indication: Type 2 Diabetes Mellitus
    Start date: 2011-04-28

Other drugs received by patient: Calcium Antagonist; Statin NOS; Diuretics; Omeprazole; Aspirin



Possible Novolog MIX 70 / 30 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 MIX 70 / 30 side effects in 38 year old male

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

Patient: 38 year old male, weighing 84.0 kg (184.8 pounds)

Reactions: Product Counterfeit, Palpitations, Diabetes Mellitus Inadequate Control

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Novolog MIX 70 / 30
    Dosage: 22 u morning+ 8 u noon + 18 u evening

Novolog MIX 70 / 30
    Dosage: unk unk, qd

Novolog MIX 70 / 30
    Dosage: unk

Novolog MIX 70 / 30
    Dosage: 22 u morning+ 8 u noon + 18uevening
    Indication: Type 2 Diabetes Mellitus
    Start date: 2008-03-01

Other drugs received by patient: Metformin HCL; Glucobay



Possible Novolog MIX 70 / 30 side effects in 67 year old male

Reported by a consumer/non-health professional from United States on 2012-07-06

Patient: 67 year old male

Reactions: Angioedema

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Activase
    Start date: 2011-11-11
    End date: 2011-11-11

Blinded: Saxagliptin
    Indication: Type 2 Diabetes Mellitus
    Start date: 2011-03-23
    End date: 2011-11-11

Metformin HCL
    Indication: Type 2 Diabetes Mellitus

Novolog MIX 70 / 30
    Indication: Type 2 Diabetes Mellitus

Placebo
    Indication: Type 2 Diabetes Mellitus
    Start date: 2011-03-23
    End date: 2011-11-11

Other drugs received by patient: Aspirin



Possible Novolog MIX 70 / 30 side effects in 83 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-07-05

Patient: 83 year old female

Reactions: Drug Rash With Eosinophilia and Systemic Symptoms

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Amlodipine Besylate
    Dosage: unk, daily
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-07-17
    End date: 2011-08-24

Augmentin '125'
    Dosage: unk
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-07-17
    End date: 2011-07-27

Augmentin '125'
    Dosage: unk
    Administration route: Oral
    Start date: 2011-08-19
    End date: 2011-08-22

Diltiazem HCL
    Dosage: unk
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-07-17
    End date: 2011-08-24

Novolog MIX 70 / 30
    Dosage: unk
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-07-17
    End date: 2011-08-23

Repaglinide
    Dosage: unk, daily
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-07-17
    End date: 2011-07-23



Possible Novolog MIX 70 / 30 side effects in 83 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-06-29

Patient: 83 year old female

Reactions: Drug Rash With Eosinophilia and Systemic Symptoms

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Amlodipine Besylate
    Dosage: 5 mg, 1x/day
    Administration route: Oral
    Start date: 2011-07-17
    End date: 2011-08-24

Augmentin '125'
    Dosage: unk
    Administration route: Oral
    Indication: Pneumonia
    Start date: 2011-07-17
    End date: 2011-07-27

Augmentin '125'
    Dosage: unk
    Administration route: Oral
    Start date: 2011-08-19
    End date: 2011-08-22

Diltiazem HCL
    Dosage: 60 mg, unk
    Administration route: Oral
    Start date: 2011-07-17
    End date: 2011-08-24

Novolog MIX 70 / 30
    Dosage: unk
    Start date: 2011-07-17
    End date: 2011-08-23

Novonorm
    Dosage: 1 mg, unk
    Administration route: Oral
    Start date: 2011-07-17
    End date: 2011-07-23



Possible Novolog MIX 70 / 30 side effects in male

Reported by a physician from United States on 2012-06-25

Patient: male

Reactions: Intentional Drug Misuse, Diabetic Ketoacidosis, Treatment Noncompliance

Adverse event resulted in: death

Drug(s) suspected as cause:
Novolog MIX 70 / 30



Possible Novolog MIX 70 / 30 side effects in male

Reported by a consumer/non-health professional from United States on 2012-05-29

Patient: male

Reactions: Syncope, Pneumonia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Amlodipine
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Metoprolol Tartrate
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Nitroglycerin
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Novolog MIX 70 / 30
    Dosage: 16 international unit
    Indication: Type 2 Diabetes Mellitus

Placebo
    Dosage: unk
    Indication: Type 2 Diabetes Mellitus
    Start date: 2011-04-08

Ramipril
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Saxagliptin
    Dosage: unk
    Indication: Type 2 Diabetes Mellitus
    Start date: 2012-04-08

Other drugs received by patient: Aspirin; Calcium Channel Blockers



Possible Novolog MIX 70 / 30 side effects in male

Reported by a physician on 2012-05-25

Patient: male

Reactions: Syncope, Pneumonia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Amlodipine Besylate

Metoprolol

Nitroglycerin

Novolog MIX 70 / 30
    Indication: Type 2 Diabetes Mellitus

Ramipril

Saxagliptin / Placebo
    Indication: Type 2 Diabetes Mellitus
    Start date: 2011-04-08

Other drugs received by patient: Aspirin; Calcium Antagonists



Possible Novolog MIX 70 / 30 side effects in 76 year old male

Reported by a consumer/non-health professional from United States on 2012-05-24

Patient: 76 year old male, weighing 93.4 kg (205.5 pounds)

Reactions: Dehydration, Blood Glucose Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Novolog MIX 70 / 30

Other drugs received by patient: Crestor



Possible Novolog MIX 70 / 30 side effects in 77 year old female

Reported by a consumer/non-health professional from United States on 2012-05-23

Patient: 77 year old female

Reactions: Eye Haemorrhage, Injection Site Haematoma, Diabetic Retinopathy

Drug(s) suspected as cause:
Novolog MIX 70 / 30



Possible Novolog MIX 70 / 30 side effects in 56 year old male

Reported by a pharmacist from United States on 2012-05-22

Patient: 56 year old male

Reactions: Blood Glucose Decreased, Confusional State, Product Quality Issue, Hyperhidrosis, Hunger, Loss of Consciousness

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Novolog MIX 70 / 30



Possible Novolog MIX 70 / 30 side effects in 72 year old female

Reported by a consumer/non-health professional from United States on 2012-05-11

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

Reactions: Cardio-Respiratory Arrest, Pneumonia, Hypoglycaemic Coma, Cerebrovascular Accident

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Novolog MIX 70 / 30
    Dosage: 17 u, every evening

Novolog MIX 70 / 30
    Dosage: 24 u, every morning
    Indication: Type 2 Diabetes Mellitus



Possible Novolog MIX 70 / 30 side effects in male

Reported by a consumer/non-health professional from United States on 2012-04-16

Patient: male

Reactions: Osteoarthritis, Overdose, Sleep Disorder, Pain

Drug(s) suspected as cause:
Lantus
    Dosage: dose:320 unit(s)

Lantus

Novolog MIX 70 / 30



Possible Novolog MIX 70 / 30 side effects in female

Reported by a consumer/non-health professional from United States on 2012-04-12

Patient: female

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Novolog MIX 70 / 30



Possible Novolog MIX 70 / 30 side effects in male

Reported by a consumer/non-health professional from United Kingdom on 2012-04-04

Patient: male

Reactions: Syncope, Blood Glucose Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Novolog MIX 70 / 30



Possible Novolog MIX 70 / 30 side effects in female

Reported by a consumer/non-health professional from United States on 2012-04-03

Patient: female, weighing 114.8 kg (252.5 pounds)

Reactions: Oedema Peripheral, Therapeutic Response Unexpected, Abdominal Distension, Headache

Drug(s) suspected as cause:
Novolog MIX 70 / 30



Possible Novolog MIX 70 / 30 side effects in male

Reported by a consumer/non-health professional from United States on 2012-04-02

Patient: male

Reactions: Weight Increased, Hospitalisation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Novolog MIX 70 / 30



Possible Novolog MIX 70 / 30 side effects in male

Reported by a consumer/non-health professional from United States on 2012-03-27

Patient: male

Reactions: Cerebrovascular Accident

Drug(s) suspected as cause:
Novolog MIX 70 / 30



Possible Novolog MIX 70 / 30 side effects in male

Reported by a consumer/non-health professional from United States on 2012-03-20

Patient: male

Reactions: Cerebrovascular Accident

Drug(s) suspected as cause:
Novolog MIX 70 / 30



Possible Novolog MIX 70 / 30 side effects in 55 year old male

Reported by a physician from United Kingdom on 2012-03-09

Patient: 55 year old male

Reactions: Asthma

Drug(s) suspected as cause:
Novolog MIX 70 / 30

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