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Glucophage XR (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 XR SIDE EFFECTS / ADVERSE REACTIONS

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

Possible Glucophage XR side effects / adverse reactions in 40 year old male

Reported by a consumer/non-health professional from Germany on 2011-10-20

Patient: 40 year old male weighing 89.0 kg (195.8 pounds)

Reactions: Hypersensitivity, Upper Respiratory Tract Infection, Abasia, Chromaturia, Drug Interaction

Adverse event resulted in: life threatening event

Suspect drug(s):
Glucophage XR
    Dosage: 1df:1 tabs of 500mg
    Administration route: Oral
    Indication: Metabolic Disorder
    Start date: 2011-01-01

Cefuroxime
    Dosage: stopped
    Administration route: Oral
    Indication: Respiratory Tract Infection
    Start date: 2011-01-01

Other drugs received by patient: Losartan Potassium



Possible Glucophage XR side effects / adverse reactions in 64 year old female

Reported by a consumer/non-health professional from United States on 2011-11-18

Patient: 64 year old female

Reactions: Diarrhoea

Suspect drug(s):
Glucophage XR

Other drugs received by patient: Amitriptyline HCL; Lipitor; Pantoprazole; Januvia; Gabapentin; Hyoscyamine; Oxycodone HCL and Acetaminophen; Enalapril Maleate; Levemir



Possible Glucophage XR side effects / adverse reactions in 62 year old female

Reported by a consumer/non-health professional from United States on 2011-11-18

Patient: 62 year old female

Reactions: Blood Glucose Increased

Suspect drug(s):
Glucophage XR

Other drugs received by patient: Lipitor; Synthroid; Glimepiride



See index of all Glucophage XR side effect reports >>

Drug label data at the top of this Page last updated: 2010-01-13

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