DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Novolin R (Insulin Human) - Product Quality Issue - Suspected Cause - Side Effect Reports

 
 



Index of reports > Cases with Product Quality Issue (8)

Below is the selection of side effect reports (a.k.a. adverse event reports) related to Novolin R (Insulin Human) where reactions include product quality issue. The selected reports were submitted to the FDA during the sample period of about a year.

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 50 year old male

Reported by a physician from China on 2012-02-16

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
    End date: 2011-12-20

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

Other drugs received by patient: Adefovir Dipivoxil KIT



Possible Novolin R side effects in 50 year old male

Reported by a physician from China on 2012-01-31

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

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

Adverse event resulted in: hospitalization

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

Reported by a health professional (non-physician/pharmacist) from China on 2011-11-16

Patient:

Reactions: Product Quality Issue, Device Failure, Malaise, Liquid Product Physical Issue, Injection Site Haemorrhage, Haemoptysis, Blood Glucose Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Novolin R
    Dosage: 14 iu in the morning and 10 iu in the afternoon.

Novolin R
    Dosage: unk
    Indication: Type 1 Diabetes Mellitus
    Start date: 2005-07-01

Novolin R
    Dosage: 12 iu in the morning and 8 iu in the afternoon.
    Start date: 2011-08-18

Other drugs received by patient: Pasiniazid



Possible Novolin R side effects in

Reported by a consumer/non-health professional from China on 2011-11-04

Patient:

Reactions: Product Quality Issue, Device Failure, Liquid Product Physical Issue, Malaise, Haemoptysis, Injection Site Haemorrhage, Blood Glucose Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Novolin R
    Dosage: unk
    Indication: Type 1 Diabetes Mellitus
    Start date: 2005-07-01

Novolin R
    Dosage: 12 iu in the morning and 8 iu in the afternoon.
    Start date: 2011-08-18

Other drugs received by patient: Pasiniazid



Possible Novolin R side effects in

Reported by a consumer/non-health professional from China on 2011-11-02

Patient:

Reactions: Product Quality Issue, Shock

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Novolin R



Possible Novolin R side effects in

Reported by a consumer/non-health professional from China on 2011-10-11

Patient:

Reactions: Product Quality Issue, Shock

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Novolin R



Possible Novolin R side effects in

Reported by a health professional (non-physician/pharmacist) from China on 2011-10-05

Patient:

Reactions: Device Failure, Product Counterfeit, Product Quality Issue, Malaise, Liquid Product Physical Issue, Haemoptysis, Injection Site Haemorrhage, Blood Glucose Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Novolin R
    Dosage: unk
    Indication: Type 1 Diabetes Mellitus
    Start date: 2005-07-01

Novolin R
    Dosage: 12 iu in the morning and 8 iu in the afternoon.
    Start date: 2011-08-18

Other drugs received by patient: Pasiniazid

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017