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
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