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Metformin (Metformin Hydrochloride) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

In a U.S. double-blind clinical study of metformin in patients with type 2 diabetes, a total of 141 patients received metformin therapy (up to 2550 mg per day) and 145 patients received placebo. Adverse reactions reported in greater than 5% of the metformin patients, and that were more common in metformin- than placebo-treated patients, are listed in Table 7.

Table 7. Most Common Adverse Reactions (>5%) in a Placebo-Controlled Clinical Study of Metformin Monotherapy* 
  Adverse ReactionMetformin Monotherapy
(n=141)
Placebo
(n=145)
% of patients
* Reactions that were more common in metformin- than placebo-treated patients.
Diarrhea53.211.7
Nausea/Vomiting25.58.3
Flatulence12.15.5
Asthenia9.25.5
Indigestion7.14.1
Abdominal Discomfort6.44.8
Headache5.74.8

Diarrhea led to discontinuation of study medication in 6% of patients treated with metformin. Additionally, the following adverse reactions were reported in ≥1 to ≤5% of metformin patients and were more commonly reported with metformin than placebo: abnormal stools, hypoglycemia, myalgia, lightheaded, dyspnea, nail disorder, rash, sweating increased, taste disorder, chest discomfort, chills, flu syndrome, flushing, palpitation.

Pediatric Patients

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



REPORTS OF SUSPECTED METFORMIN SIDE EFFECTS / ADVERSE REACTIONS

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

Possible Metformin side effects / adverse reactions in 69 year old male

Reported by a physician from United Kingdom on 2011-10-27

Patient: 69 year old male

Reactions: Skin Discolouration, Skin Lesion, Rash Erythematous, Rash Macular, Naevus Flammeus

Suspect drug(s):
Metformin
    Indication: Type 2 Diabetes Mellitus

Ramipril
    Indication: Type 2 Diabetes Mellitus

Zocor
    Administration route: Oral
    Indication: Hypercholesterolaemia

Aspirin
    Indication: Type 2 Diabetes Mellitus



Possible Metformin side effects / adverse reactions in 50 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2011-10-28

Patient: 50 year old male

Reactions: Drug Level Increased, Intentional Overdose, Urine Output Decreased, Hypotension, Mental Status Changes, Lactic Acidosis, Toxicity TO Various Agents, Suicide Attempt, Anuria, Renal Failure Acute

Adverse event resulted in: hospitalization

Suspect drug(s):
Metformin HCL
    Dosage: 500 mg, bid
    Indication: Type 2 Diabetes Mellitus

Metformin
    Dosage: 52 g, unk



Possible Metformin side effects / adverse reactions in 66 year old male

Reported by a physician from Germany on 2011-11-08

Patient: 66 year old male weighing 160.0 kg (352.0 pounds)

Reactions: Bile Duct Cancer

Adverse event resulted in: death

Suspect drug(s):
Januvia
    Administration route: Oral
    Indication: Type 2 Diabetes Mellitus
    Start date: 2010-10-01
    End date: 2011-09-01

Metformin
    Administration route: Oral
    Indication: Type 2 Diabetes Mellitus
    Start date: 2009-05-01
    End date: 2011-09-01



See index of all Metformin side effect reports >>

Drug label data at the top of this Page last updated: 2007-08-16

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