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Glucovance (Glyburide / Metformin) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Glucovance (Glyburide / Metformin) 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 (27)
Death (2)
Life Threatening Events (2)
Disability (1)

Reports by Reaction Type

Hepatic Cirrhosis (5)Lactic Acidosis (3)Myalgia (3)Blood Glucose Increased (3)Disseminated Intravascular Coagulation (2)Coma (2)Multi-Organ Failure (2)Pyelonephritis (2)Renal Failure Acute (2)Hepatic Fibrosis (2)Incorrect Dose Administered (2)Toxicity To Various Agents (2)

Possible Glucovance side effects in 86 year old female

Reported by a consumer/non-health professional from Germany on 2012-08-10

Patient: 86 year old female

Reactions: Incorrect Dose Administered, Pollakiuria, Cerebrovascular Accident

Drug(s) suspected as cause:
Glucovance

Other drugs received by patient: Atenolol; Aspirin; Vicog



Possible Glucovance side effects in 59 year old male

Reported by a consumer/non-health professional from United States on 2012-08-03

Patient: 59 year old male, weighing 81.0 kg (178.2 pounds)

Reactions: Photosensitivity Reaction, Dyspepsia, Feeling Hot

Drug(s) suspected as cause:
Avapro
    Administration route: Oral
    Indication: Hypertension
    Start date: 2003-05-28

Lipitor

Lantus
    Dosage: 1 dosage form= 54 units also on 64units

Glucovance
    Dosage: 1 dosage form= 2.5/500mg.
    Administration route: Oral
    Indication: Diabetes Mellitus
    Start date: 2003-05-28

Aspirin

Protonix

Metformin HCL

Lovastatin
    Dosage: 2tab in night

Other drugs received by patient: Loratadine; Lyrica; Naproxen



Possible Glucovance side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-03

Patient: male, weighing 63.0 kg (138.6 pounds)

Reactions: Blood Glucose Increased

Drug(s) suspected as cause:
Glucovance



Possible Glucovance side effects in 65 year old female

Reported by a consumer/non-health professional from United States on 2012-08-03

Patient: 65 year old female, weighing 66.0 kg (145.2 pounds)

Reactions: Protein Urine Present, Hypoaesthesia Oral, Abnormal Sensation in Eye, DRY Eye

Drug(s) suspected as cause:
Glucovance



Possible Glucovance side effects in 71 year old female

Reported by a consumer/non-health professional from France on 2012-08-03

Patient: 71 year old female

Reactions: Blood Glucose Increased

Drug(s) suspected as cause:
Glucovance

Lantus
    Dosage: 1df:10 units inj solution 100 in/ml
    Indication: Diabetes Mellitus
    Start date: 2011-11-01

Byetta



Possible Glucovance side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-03

Patient: female

Reactions: Abdominal Pain, Diarrhoea

Drug(s) suspected as cause:
Glucovance



Possible Glucovance side effects in 69 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-07-27

Patient: 69 year old female

Reactions: Metabolic Acidosis, Pneumonia Aspiration, Hypothermia, Incorrect Dose Administered, Disseminated Intravascular Coagulation, Coma, Continuous Haemodiafiltration, Lactic Acidosis, Toxicity To Various Agents, Multi-Organ Failure, Shock, Renal Failure Acute

Adverse event resulted in: death

Drug(s) suspected as cause:
Glucovance
    Dosage: 60 tablets
    Indication: Product Used FOR Unknown Indication

Alprazolam
    Dosage: 0.50 mg, 60 tabs
    Indication: Product Used FOR Unknown Indication

Tercian (Cyamemazine)
    Dosage: 25 mg, 60 tabs
    Indication: Product Used FOR Unknown Indication

Lithium Carbonate
    Dosage: 400 mg, 60 tabs
    Indication: Product Used FOR Unknown Indication

Metfformin Hydrochloride
    Dosage: 30 gm
    Indication: Product Used FOR Unknown Indication

Effexor
    Dosage: 75 mg, 30 tablets
    Indication: Product Used FOR Unknown Indication



Possible Glucovance side effects in 69 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-07-23

Patient: 69 year old female

Reactions: Hypotension, Disseminated Intravascular Coagulation, Coma, Lactic Acidosis, Toxicity To Various Agents, Multi-Organ Failure, Hypoxia, Bradycardia, Shock, Renal Failure Acute

Adverse event resulted in: death

Drug(s) suspected as cause:
Alprazolam
    Dosage: 0.50 mg, 60 tabs

Tercian
    Dosage: 25 mg, 60 tabs

Lithium Carbonate
    Dosage: 400 mg, 60 tabs

Glucovance
    Dosage: 60 tablets

Metformin HCL
    Dosage: 30 g, unk

Effexor
    Dosage: 75 mg, 30 tablets



Possible Glucovance side effects in female

Reported by a consumer/non-health professional from United States on 2012-06-29

Patient: female

Reactions: Nausea, Flatulence, Cystitis Noninfective, Ulcer, Abdominal Pain Upper, Hepatomegaly, Product Taste Abnormal, Bladder Disorder, Calculus Urinary, Blood Glucose Increased, Eye Pruritus

Drug(s) suspected as cause:
Glucovance

Other drugs received by patient: Multi-Vitamin; Vitamin D; Vitamin B-12



Possible Glucovance side effects in 79 year old female

Reported by a consumer/non-health professional from United States on 2012-06-15

Patient: 79 year old female, weighing 78.0 kg (171.6 pounds)

Reactions: White Blood Cell Count Decreased, Hypersensitivity, Feeling Abnormal, Blood Glucose Abnormal

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Glucovance



Possible Glucovance side effects in 71 year old female

Reported by a physician from United States on 2012-05-25

Patient: 71 year old female, weighing 74.4 kg (163.7 pounds)

Reactions: Hypoglycaemia, Mental Status Changes, Hypertension

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Glucovance

Pazopanib
    Dosage: 800mg per day
    Administration route: Oral
    Indication: Uterine Cancer
    Start date: 2011-12-16

Other drugs received by patient: Imodium; Ambien; Diovan HCT



Possible Glucovance side effects in

Reported by a consumer/non-health professional from United States on 2012-04-17

Patient:

Reactions: Incorrect Storage of Drug

Drug(s) suspected as cause:
Avapro

Plavix

Reyataz

Hydrea

Avalide

Sustiva

Sprycel

Zerit

Coumadin

Videx

Glucovance

Onglyza

Azactam
    Dosage: powdered vial

Abilify

Kombiglyze XR

Kenalog-40



Possible Glucovance side effects in 67 year old male

Reported by a consumer/non-health professional from Ecuador on 2012-03-16

Patient: 67 year old male, weighing 54.5 kg (119.9 pounds)

Reactions: Myalgia

Drug(s) suspected as cause:
Amaryl
    Dosage: half at morning and half at night
    Administration route: Oral

Amaryl
    Dosage: half at morning and half at night
    Administration route: Oral
    Start date: 2010-01-01

Glucovance
    Dosage: one at morning and one at night
    Administration route: Oral
    Start date: 2010-01-01



Possible Glucovance side effects in 75 year old male

Reported by a pharmacist from United States on 2012-03-09

Patient: 75 year old male

Reactions: Myalgia, Drug Intolerance, Asthenia, LOW Density Lipoprotein Increased

Drug(s) suspected as cause:
Lipitor
    Dosage: 80 mg, per day

Glucovance
    Dosage: unk
    Indication: Diabetes Mellitus

Lipitor
    Dosage: unk
    Indication: Blood Cholesterol

Lipitor
    Dosage: 40 per day, one 80 mg every other night

Lipitor
    Dosage: 60 mg per day



Possible Glucovance side effects in 36 year old male

Reported by a consumer/non-health professional from United States on 2012-02-24

Patient: 36 year old male

Reactions: Pancreatitis, Lactic Acidosis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Metformin HCL
    Administration route: Oral

Glucovance

Other drugs received by patient: Insulin



Possible Glucovance side effects in 67 year old male

Reported by a consumer/non-health professional from Kazakhstan on 2012-01-30

Patient: 67 year old male, weighing 54.5 kg (119.9 pounds)

Reactions: Myalgia

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Amaryl
    Dosage: half at morning and half at night
    Administration route: Oral

Glucovance
    Dosage: one at morning and one at night
    Administration route: Oral
    Start date: 2010-01-01

Amaryl
    Dosage: half at morning and half at night
    Administration route: Oral
    Start date: 2010-01-01



Possible Glucovance side effects in male

Reported by a physician from Germany on 2012-01-13

Patient: male

Reactions: Gastrointestinal Disorder, Haemolytic Anaemia

Adverse event resulted in: life threatening event, disablity

Drug(s) suspected as cause:
Loperamide
    Administration route: Oral

Glucovance
    Administration route: Oral

Zocor

Other drugs received by patient: Repaglinide; Glyburide



Possible Glucovance side effects in 80 year old female

Reported by a physician from France on 2012-01-11

Patient: 80 year old female

Reactions: Hepatic Fibrosis

Drug(s) suspected as cause:
Methotrexate
    Dosage: for more than 10 years
    Administration route: Oral
    End date: 2011-09-15

Arthrotec
    Dosage: artotec 75 mg/0.2 mg 1df=1film-coated tablet
    Administration route: Oral
    End date: 2011-09-15

Irbesartan and Hydrochlorothiazide
    Dosage: film coated tabs for more than 3 years 1df:1 tablet
    Administration route: Oral
    End date: 2011-09-15

Glucovance
    Dosage: 1df=1 tabs film coated tabs more than 3 years
    Administration route: Oral
    End date: 2011-09-15

Lorazepam
    Dosage: in the evng
    Administration route: Oral

Omeprazole
    Dosage: mopral 10 mg 1df:1tablet enteric coated tablet more than 3 years
    Administration route: Oral

Acetaminophen
    Dosage: doliprane 500mg
    Administration route: Oral



Possible Glucovance side effects in female

Reported by a physician from France on 2012-01-11

Patient: female

Reactions: Hepatic Fibrosis

Drug(s) suspected as cause:
Glucovance
    Administration route: Oral
    End date: 2011-09-15

Irbesartan and Hydrochlorothiazide
    Administration route: Oral
    End date: 2011-09-15

Lorazepam
    Administration route: Oral

Methotrexate
    Dosage: 10 to 15 mg per week for around 10 years - estimated total dose received: more than 3 grams
    Administration route: Oral
    End date: 2011-09-15

Acetaminophen
    Administration route: Oral

Omeprazole
    Dosage: 10 mg, daily, treatment started for more than 3 years
    Administration route: Oral

Arthrotec
    Administration route: Oral
    End date: 2011-09-15



Possible Glucovance side effects in 80 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-01-10

Patient: 80 year old female

Reactions: Hepatic Cirrhosis, Pyelonephritis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Methotrexate Sodium
    Dosage: 12.5 mg, weekly
    Administration route: Oral
    End date: 2011-09-15

Arthrotec
    Dosage: 75/0.2mg, 2x/day
    Administration route: Oral
    End date: 2011-09-15

Irbesartan and Hydrochlorothiazide
    Dosage: 300mg/25mg, 1 dfx/1 day
    Administration route: Oral
    End date: 2011-09-15

Omeprazole
    Dosage: 10 mg, 1x/day
    Administration route: Oral

Acetaminophen
    Dosage: 1 g, 3x/day
    Administration route: Oral

Glucovance
    Dosage: 500mg/5mg, 1dfx/3day
    Administration route: Oral
    End date: 2011-09-15

Lorazepam
    Dosage: 1 mg, 1x/day
    Administration route: Oral



Possible Glucovance side effects in 80 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2011-12-29

Patient: 80 year old female

Reactions: Hepatic Cirrhosis, Pyelonephritis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lorazepam
    Dosage: 1 mg, 1x/day
    Administration route: Oral

Acetaminophen
    Dosage: 1 g, 3x/day
    Administration route: Oral

Irbesartan and Hydrochlorothiazide
    Dosage: 300mg/25mg, 1 dfx/1 day
    Administration route: Oral
    End date: 2011-09-15

Glucovance
    Dosage: 500mg/5mg, 1dfx/3day
    Administration route: Oral
    End date: 2011-09-15

Methotrexate Sodium
    Dosage: 12.5 mg, weekly
    Administration route: Oral
    End date: 2011-09-15

Arthrotec
    Dosage: 75/0.2mg, 2x/day
    Administration route: Oral
    End date: 2011-09-15

Omeprazole
    Dosage: 10 mg, 1x/day
    Administration route: Oral



Possible Glucovance side effects in 80 year old female

Reported by a physician from France on 2011-12-23

Patient: 80 year old female

Reactions: Hepatic Cirrhosis

Drug(s) suspected as cause:
Omeprazole
    Dosage: mopral 10 mg 1df:1tablet enteric coated tablet more than 3 years
    Administration route: Oral

Arthrotec
    Dosage: artotec 75 mg/0.2 mg 1df=1film-coated tablet
    Administration route: Oral
    End date: 2011-09-15

Methotrexate
    Dosage: for more than 10 years
    Administration route: Oral
    End date: 2011-09-15

Irbesartan and Hydrochlorothiazide
    Dosage: film coated tabs for more than 3 years 1df:1 tablet
    Administration route: Oral
    End date: 2011-09-15

Lorazepam
    Dosage: in the evng
    Administration route: Oral

Glucovance
    Dosage: 1df=1 tabs film coated tabs more than 3 years
    Administration route: Oral
    End date: 2011-09-15

Acetaminophen
    Dosage: doliprane 500mg
    Administration route: Oral



Possible Glucovance side effects in female

Reported by a physician from France on 2011-12-22

Patient: female

Reactions: Hepatic Cirrhosis

Drug(s) suspected as cause:
Omeprazole
    Administration route: Oral

Methotrexate
    Dosage: 10 to 15 mg per week for around 10 years
    Administration route: Oral
    End date: 2011-09-15

Irbesartan and Hydrochlorothiazide
    Administration route: Oral
    End date: 2011-09-15

Lorazepam
    Administration route: Oral

Acetaminophen
    Administration route: Oral

Glucovance
    Administration route: Oral
    End date: 2011-09-15

Arthrotec
    Administration route: Oral
    End date: 2011-09-15



Possible Glucovance side effects in 80 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2011-12-16

Patient: 80 year old female

Reactions: Hepatic Cirrhosis

Drug(s) suspected as cause:
Omeprazole
    Dosage: 10 mg, 1x/day
    Administration route: Oral

Arthrotec
    Dosage: 75 mg, 2x/day
    Administration route: Oral
    End date: 2011-09-15

Irbesartan and Hydrochlorothiazide
    Dosage: 300mg/25mg, 1 dfx/1 day
    Administration route: Oral
    End date: 2011-09-15

Glucovance
    Dosage: 500mg/5mg, 1dfx/3day
    Administration route: Oral
    End date: 2011-09-15

Acetaminophen
    Dosage: 1 g, 3x/day
    Administration route: Oral

Lorazepam
    Dosage: 1 mg, 1x/day
    Administration route: Oral

Methotrexate
    Dosage: 12.5 mg, weekly
    Administration route: Oral



Possible Glucovance side effects in

Reported by a consumer/non-health professional from United States on 2011-11-30

Patient:

Reactions: Surgery

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Glucovance



Possible Glucovance side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2011-11-23

Patient: male, weighing 79.8 kg (175.6 pounds)

Reactions: Malaise

Drug(s) suspected as cause:
Glucovance
    Dosage: 5mg
    Indication: Diabetes Mellitus
    Start date: 2004-01-01

Metformin HCL
    Dosage: 500



Possible Glucovance side effects in 82 year old

Reported by a health professional (non-physician/pharmacist) from France on 2011-10-03

Patient: 82 year old

Reactions: Pancreatitis Chronic

Drug(s) suspected as cause:
Januvia
    Administration route: Oral
    Indication: Type 2 Diabetes Mellitus
    Start date: 2010-04-22
    End date: 2011-05-18

Tramadol HCL
    Administration route: Oral
    Start date: 2010-06-03
    End date: 2011-04-03

Glucovance
    Administration route: Oral
    End date: 2011-04-12

Zestoretic
    Administration route: Oral
    End date: 2011-04-11

Aspirin
    Administration route: Oral
    End date: 2011-04-03

Pantoprazole Sodium
    Administration route: Oral
    End date: 2011-04-12

Levothyroxine Sodium
    Administration route: Oral

Modopar
    Administration route: Oral

Other drugs received by patient: Glucophage; Nexium; Zestril; Lovenox; Alfuzosin HCL; Indapamide; Atarax; Amaryl; Bactrim; Prozac

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