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Glucophage (Metformin Hydrochloride) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

In a US double-blind clinical study of GLUCOPHAGE in patients with type 2 diabetes, a total of 141 patients received GLUCOPHAGE therapy (up to 2550 mg per day) and 145 patients received placebo. Adverse reactions reported in greater than 5% of the GLUCOPHAGE patients, and that were more common in GLUCOPHAGE- than placebo-treated patients, are listed in Table 11.

Table 11: Most Common Adverse Reactions (>5.0 Percent) in a Placebo-Controlled Clinical Study of GLUCOPHAGE Monotherapy*
Adverse Reaction GLUCOPHAGE
Monotherapy
(n=141)
Placebo

(n=145)
% of Patients
* Reactions that were more common in GLUCOPHAGE- than placebo-treated patients.
Diarrhea 53.2 11.7
Nausea/Vomiting 25.5 8.3
Flatulence 12.1 5.5
Asthenia 9.2 5.5
Indigestion 7.1 4.1
Abdominal Discomfort 6.4 4.8
Headache 5.7 4.8

Diarrhea led to discontinuation of study medication in 6% of patients treated with GLUCOPHAGE. Additionally, the following adverse reactions were reported in ≥1.0% to ≤5.0% of GLUCOPHAGE patients and were more commonly reported with GLUCOPHAGE than placebo: abnormal stools, hypoglycemia, myalgia, lightheaded, dyspnea, nail disorder, rash, sweating increased, taste disorder, chest discomfort, chills, flu syndrome, flushing, palpitation.

In worldwide clinical trials over 900 patients with type 2 diabetes have been treated with GLUCOPHAGE XR in placebo- and active-controlled studies. In placebo-controlled trials, 781 patients were administered GLUCOPHAGE XR and 195 patients received placebo. Adverse reactions reported in greater than 5% of the GLUCOPHAGE XR patients, and that were more common in GLUCOPHAGE XR- than placebo-treated patients, are listed in Table 12.

Table 12: Most Common Adverse Reactions (>5.0 Percent) in Placebo-Controlled Studies of GLUCOPHAGE XR*
Adverse Reaction GLUCOPHAGE XR
(n=781)
Placebo
(n=195)
  % of Patients
* Reactions that were more common in GLUCOPHAGE XR- than placebo-treated patients.
Diarrhea 9.6 2.6
Nausea/Vomiting 6.5 1.5

Diarrhea led to discontinuation of study medication in 0.6% of patients treated with GLUCOPHAGE XR. Additionally, the following adverse reactions were reported in ≥1.0% to ≤5.0% of GLUCOPHAGE XR patients and were more commonly reported with GLUCOPHAGE XR than placebo: abdominal pain, constipation, distention abdomen, dyspepsia/heartburn, flatulence, dizziness, headache, upper respiratory infection, taste disturbance.

Pediatric Patients

In clinical trials with GLUCOPHAGE in pediatric patients with type 2 diabetes, the profile of adverse reactions was similar to that observed in adults.



REPORTS OF SUSPECTED GLUCOPHAGE SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Glucophage. The information is not vetted and should not be considered as verified clinical evidence.

Possible Glucophage side effects / adverse reactions in 81 year old female

Reported by a physician from Germany on 2011-10-03

Patient: 81 year old female

Reactions: Renal Failure, Metabolic Acidosis, Diarrhoea, Hyperkalaemia, Dehydration, General Physical Health Deterioration

Adverse event resulted in: hospitalization

Suspect drug(s):
Digoxin
    Dosage: 6 out of 7 dys for a long time,digoxine nativelle 0.25 mg tabs
    Administration route: Oral
    End date: 2011-08-22

Lansoprazole
    Dosage: lansoprazole 15 gastro resistant caps
    Administration route: Oral
    Start date: 2011-07-06
    End date: 2011-08-22

Dafalgan Codeine Tabs
    Dosage: 169 days,dafalgan codeine tabs coated tabs 2df 2 in 1 d
    Administration route: Oral
    Start date: 2011-03-16
    End date: 2011-08-22

Furosemide
    Dosage: tabs
    Administration route: Oral
    End date: 2011-08-22

Previscan
    Dosage: product strength is 20mg 1df is 0.75 units not specified
    Administration route: Oral
    End date: 2011-08-22

Monoplus Tabs 20 Mg/12.5 MG
    Dosage: product strength is 20mg/12.5 mg
    Administration route: Oral
    End date: 2011-08-22

Piascledine
    Dosage: caps
    Administration route: Oral
    End date: 2011-08-22

Loperamide HCL
    Dosage: for 48 days
    Administration route: Oral
    Start date: 2011-07-06
    End date: 2011-08-22

Zolpidem
    Administration route: Oral
    Start date: 2011-07-06
    End date: 2011-08-22

Phloroglucinol
    Dosage: for 7 days
    Administration route: Oral
    Start date: 2011-08-16
    End date: 2011-08-22

Flector
    Dosage: flector 1% gel
    Start date: 2011-06-08
    End date: 2011-08-22

Aluminum Hydroxide and Magnesium Trisilicate
    Administration route: Oral
    Start date: 2011-08-16
    End date: 2011-08-22

Onglyza
    Dosage: for 48 days
    Administration route: Oral
    Start date: 2011-07-06
    End date: 2011-08-22

Glucophage
    Dosage: for a long time
    Administration route: Oral
    End date: 2011-08-22

Crestor
    Dosage: for a long time,crestor coated tabs5mg
    Administration route: Oral
    End date: 2011-08-22

Domperidone
    Dosage: 3 to 6 times in a dy
    Administration route: Oral
    Start date: 2011-07-06
    End date: 2011-08-22

Other drugs received by patient: Levothyroxine Sodium; Metoprolol Tartrate



Possible Glucophage side effects / adverse reactions in 74 year old female

Reported by a consumer/non-health professional from United States on 2011-10-05

Patient: 74 year old female

Reactions: Head Injury, Hypoglycaemia, Loss of Consciousness

Adverse event resulted in: hospitalization

Suspect drug(s):
Blinded: Saxagliptin
    Dosage: drug interrupted on : 25-oct-2010
    Indication: Type 2 Diabetes Mellitus
    Start date: 2010-09-10

Novomix
    Dosage: insulin
    Indication: Type 2 Diabetes Mellitus
    Start date: 2010-11-10

Blinded: Placebo
    Dosage: interrupted on 25-oct-2010.
    Indication: Type 2 Diabetes Mellitus
    Start date: 2010-09-10

Glucophage
    Indication: Type 2 Diabetes Mellitus



Possible Glucophage side effects / adverse reactions in 52 year old female

Reported by a consumer/non-health professional from United States on 2011-10-05

Patient: 52 year old female

Reactions: Myalgia, Dyspnoea, Nausea, Blood Potassium Increased, Heart Rate Irregular

Adverse event resulted in: hospitalization

Suspect drug(s):
Glucophage
    Dosage: also taken on 21sep2011
    Start date: 2011-09-07

Potassium

Other drugs received by patient: Inderal; Simvastatin; Remodellin; Letairis; Levoxyl; Zaroxolyn; Zoloft; Lasix; Tadalafil; Digoxin



See index of all Glucophage side effect reports >>

Drug label data at the top of this Page last updated: 2009-02-27

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