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Galvus Side Effects

Common Galvus Side Effects


The most commonly reported Galvus side effects (click to view or check a box to report):

Blood Glucose Increased (54)
Malaise (24)
Dizziness (18)
Fall (17)
Blood Pressure Increased (17)
Diarrhoea (16)
Fatigue (16)
Nausea (16)
Vomiting (16)
Pneumonia (15)
Hyperglycaemia (15)
Asthenia (14)
Feeling Abnormal (13)
Diabetes Mellitus Inadequate Control (13)
Hypertension (13)
Weight Decreased (13)
Hypoglycaemia (12)
Glycosylated Haemoglobin Increased (12)
Headache (12)
Abdominal Pain Upper (11)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

Galvus Side Effects Reported to FDA

The following Galvus reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.


The appearance of Galvus on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.
Hydrocephalus, Dementia Alzheimer^s Type, Parkinson^s Disease, Blood Cholesterol Increased, Thyroid Disorder, Gait Disturbance, Screaming, Speech Disorder, Mood Altered
This is a report of a male patient (weight: NA) from COUNTRY NOT SPECIFIED, suffering from the following symptoms/conditions: diabetes mellitus, who was treated with Galvus Met (dosage: 2 Df, (metf 850 Mg/ Vild 50 Mg) Daily, start time: NS), combined with:
  • Metformin (850 Mg, Daily)
  • Atenolol (2 Df, (25 Mg) Daily)
  • Lexapro (1 Df (15mg), Daily)
  • Diamicron (1 Df (60mg), Daily)
and developed a serious reaction and side effect(s). The consumer presented with:
  • Hydrocephalus
  • Dementia Alzheimer^s Type
  • Parkinson^s Disease
  • Blood Cholesterol Increased
  • Thyroid Disorder
  • Gait Disturbance
  • Screaming
  • Speech Disorder
  • Mood Altered
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Galvus Met treatment in male patients, resulting in hydrocephalus side effect.

Cerebral Ischaemia, Poor Peripheral Circulation, Gait Disturbance, Sensation Of Heaviness, Dyskinesia, Paraesthesia, Nausea, Anxiety
This report suggests a potential Galvus Met Cerebral Ischaemia, Poor Peripheral Circulation, Gait Disturbance, Sensation Of Heaviness, Dyskinesia, Paraesthesia, Nausea, Anxiety side effect(s) that can have serious consequences. A female patient (weight: NA) from BR was diagnosed with the following symptoms/conditions: diabetes mellitus,hypertension and used Galvus Met (dosage: 1 Df(1000mg Metf/50 Mg Vild), Bid (1 Tablet In Morn And 1 Tablet At Night )) starting NS. Soon after starting Galvus Met the patient began experiencing various side effects, including:
  • Cerebral Ischaemia
  • Poor Peripheral Circulation
  • Gait Disturbance
  • Sensation Of Heaviness
  • Dyskinesia
  • Paraesthesia
  • Nausea
  • Anxiety
Drugs used concurrently:
  • Rasilez Amlo (1 Df (300mg Alis/5 Mg Amlo), Daily)
  • Atenolol
Although Galvus Met demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as cerebral ischaemia, may still occur.

Fall, Upper Limb Fracture, Pain
This Fall, Upper Limb Fracture, Pain problem was reported by a consumer or non-health professional from COUNTRY NOT SPECIFIED. A 68-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: diabetes mellitus. On 2013 this consumer started treatment with Galvus Met (dosage: 1 Df (850 Of Met And 50 Of Vilda), Qd). The following drugs were being taken at the same time: NA. When commencing Galvus Met, the patient experienced the following unwanted symptoms/side effects:
  • Fall
  • Upper Limb Fracture
  • Pain
Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as fall, may become evident only after a product is in use by the general population.

Blood Glucose Increased
This is a report of a 73-year-old female patient (weight: NA) from COUNTRY NOT SPECIFIED. The patient developed the following symptoms/conditions: diabetes mellitus and was treated with Galvus (dosage: 1 Df (50 Mg), Daily) starting NS. Concurrently used drugs:
  • Metformin
  • Enalapril
Soon after that, the consumer experienced the following side effects:
  • Blood Glucose Increased
This opens a possibility that Galvus treatment could cause the above reactions, including blood glucose increased, and some female subjects may be more susceptible.


Cataract, Corneal Decompensation, Eye Pain
A female patient (weight: NA) from COUNTRY NOT SPECIFIED with the following symptoms/conditions: diabetes mellitus,hypertension,thyroid disorder started Galvus Met treatment (dosage: 1 Df (850/50 Mg), Daily) on NS. Soon after starting Galvus Met treatment, the subject experienced various side effects, including:
  • Cataract
  • Corneal Decompensation
  • Eye Pain
Concurrently used drugs:
  • Diovan (320 Mg, Daily)
  • Synthroid (1 Df, Daily)
This finding indicates that some female patients could be more vulnerable to Galvus Met.

Urticaria, Pruritus
A 66-year-old male patient from COUNTRY NOT SPECIFIED (weight: NA) experienced symptoms, such as: diabetes mellitus,hypertension and was treated with Galvus Met(dosage: 2 Df (850/50 Mg), Per Day). The treatment was initiated on 201308. After that a consumer reported the following side effect(s):
  • Urticaria
  • Pruritus
Concurrently used drugs, which potentially could have contributed to side effect(s) or affected Galvus Met efficacy:
  • Diovan (160 Mg, Daily)
  • Glucaminol (100 Mg , Per Day (1 Of 100 Mg Or 2 Of 50 Mg))
  • Euglucon (5 Mg, Per Day)
  • Secotex (1 Df, Per Day)
  • Secotex



In this report, Galvus was administered for the following condition: diabetes mellitus,hypertension.A 79-year-old female consumer from COUNTRY NOT SPECIFIED (weight: NA) started Galvus treatment (dosage: 1 Df, (50mg Vilda), Daily) on NS.Sometime after starting the treatment, the patient complained of the following side effect(s):
    A possible interaction with other drugs could have contributed to this reaction:
    • Diovan (320 Mg, Unk)
    • Co-diovan
    Establishing a causal relationship between a specific drug and consumer's side effects is complex, but it is possible that in this report Galvus treatment could be related to the listed above side effect(s).

    Blood Cholesterol Abnormal, Hypertension, Blood Glucose Increased
    This is a report of the following Galvus Met side effect(s):
    • Blood Cholesterol Abnormal
    • Hypertension
    • Blood Glucose Increased
    A 60-year-old male patient from COUNTRY NOT SPECIFIED (weight: NA) presented with the following condition: diabetes mellitus,hypertension and received a treatment with Galvus Met (dosage: 0.5 Df (1000mg Metf/ 50mg Vild), Tid) starting: Sep 19, 2013.The following concurrently used drugs could have generated interactions:
    • Exforge (0.5 Df (320mg Vals/ 5mg Amlo), Unk, In The Morning)
    • Competact (1 Ukn, In The Evening)
    • Pioglitazona (1 Ukn, In The Evening)
    • Metformin (850 Mg, Unk)
    • Redevant (7 Ukn, Daily)
    • Aspirina (0.5 Ukn, In The Evening)
    This report suggests that a Galvus Met treatment could be associated with the listed above side effect(s).

    Diabetes Mellitus, Nasal Dryness, Wound, Pain, Abdominal Rigidity, Limb Discomfort
    This Galvus Met report was submitted by a 56-year-old female consumer from COUNTRY NOT SPECIFIED (weight: NA). The patient was diagnosed with: diabetes mellitus and Galvus Met was administered (dosage: 1 Df (1000 Mg Vild/50mg Metf), Unk) starting: NS. The consumer developed a set of symptoms:
    • Diabetes Mellitus
    • Nasal Dryness
    • Wound
    • Pain
    • Abdominal Rigidity
    • Limb Discomfort
    Other drugs used simultaneously: NA.Those unexpected symptoms could be linked to a Galvus Met treatment, however establishing a potential drug-safety problem requires a more detailed clinical analysis.

    Infarction, Hypertension, Muscular Weakness, Blood Cholesterol Increased
    This is a report of a possible correlation between Galvus Met use and the following symptoms/side effect(s):
    • Infarction
    • Hypertension
    • Muscular Weakness
    • Blood Cholesterol Increased
    which could contribute to an assessment of Galvus Met risk profile.A 69-year-old female consumer from COUNTRY NOT SPECIFIED (weight: NA) was suffering from blood glucose abnormal,hypertension and was treated with Galvus Met (dosage: 1 Df (850/50 Mg), Daily) starting NS.Other concurrent medications:
    • Diovan (160 Unk, Unk)
    • Diovan (320 Mg, Daily)
    • Glifage (1 Df, Daily)
    • Aas (100 Mg, Daily)
    • Selozok (50 Mg, Daily)
    The patient was hospitalized.

    Intervertebral Disc Protrusion, Gait Disturbance, Dysstasia, Ear Discomfort, Pain In Extremity, Abdominal Discomfort
    A 71-year-old female patient from COUNTRY NOT SPECIFIED (weight: NA) presented with the following symptoms: diabetes mellitus,hypertension and after a treatment with Galvus Met (dosage: 1 Df( 850 Mg Metf And 50 Mg Vilda), Daily) experienced the following side effect(s):
    • Intervertebral Disc Protrusion
    • Gait Disturbance
    • Dysstasia
    • Ear Discomfort
    • Pain In Extremity
    • Abdominal Discomfort
    The treatment was started on Nov 12, 2011. Galvus Met was used in combination with the following drugs:
    • Co-diovan (2 Df, (vals 160 Mg, Hydr 12.5 Mg) Daily)
    This report could alert potential Galvus Met consumers.

    Blood Glucose Increased, Hypoglycaemia, Nerve Compression, Intervertebral Disc Protrusion, Burning Sensation, Dry Mouth, Thyroid Disorder, Spinal Pain, Visual Impairment
    In this report, a 65-year-old female patient from BR (weight: NA) was affected by a possible Galvus Met side effect.The patient was diagnosed with diabetes mellitus. After a treatment with Galvus Met (dosage: 1 Df (850/50 Mg), Bid, start date: 1986), the patient experienced the following side effect(s):
    • Blood Glucose Increased
    • Hypoglycaemia
    • Nerve Compression
    • Intervertebral Disc Protrusion
    • Burning Sensation
    • Dry Mouth
    • Thyroid Disorder
    • Spinal Pain
    • Visual Impairment
    The following simultaneously used drugs could have led to this reaction: NA.The findings here stress that side effects should be taken into consideration when evaluating a Galvus Met treatment.

    Renal Disorder
    This is a report of a 75-year-old male patient from COUNTRY NOT SPECIFIED (weight: NA), who used Galvus (dosage: 50 Mg, Unk) for a treatment of diabetes mellitus. After starting a treatment on NS, the patient experienced the following side effect(s):
    • Renal Disorder
    The following drugs could possibly have interacted with the Galvus treatment
    • Rasilez Hct (300 Mg, Unk)
    • Exforge (320/10 Mg, Unk)
    • Aclasta (5 Mg, Unk)
    Taken together, these observations suggest that a Galvus treatment could be related to side effect(s), such as Renal Disorder.

    Blood Glucose Increased, Fatigue, Vision Blurred, Hyperphagia, Polyuria, Polydipsia, Hypoaesthesia, Dry Mouth, Dry Skin
    This blood glucose increased side effect was reported by a consumer or non-health professional from COUNTRY NOT SPECIFIED. A 53-year-old female patient (weight:NA) experienced the following symptoms/conditions: diabetes mellitus,hypertension. The patient was prescribed Galvus Met (dosage: 2 Df (1000mg Met, 50mg Vilda), Daily), which was started on 201201. Concurrently used drugs:
    • Diovan (1 Df (80mg), Daily)
    • Amaryl (1 Ukn, Daily)
    • Omega-3 Fatty Acids (3 Ukn, Daily)
    • Biotone (3 Ukn, At Night)
    When starting to take Galvus Met the consumer reported the following symptoms:
    • Blood Glucose Increased
    • Fatigue
    • Vision Blurred
    • Hyperphagia
    • Polyuria
    • Polydipsia
    • Hypoaesthesia
    • Dry Mouth
    • Dry Skin
    These side effects may potentially be related to Galvus Met.

    Cataract, Eyelid Ptosis, Rectal Polyp, Haematochezia, Breast Oedema, Eyelid Oedema, Eye Colour Change, Pollakiuria, Visual Impairment
    This is a Galvus Met side effect report of a 60-year-old female patient (weight:NA) from COUNTRY NOT SPECIFIED, suffering from the following symptoms/conditions: diabetes mellitus,hypertension,prophylaxis, who was treated with Galvus Met (dosage:1 Df (850/50mg), Tid (1 In Breakfast, 1 At Lunch And 1 At Afternoon Snack Or Dinner), start time: NS), combined with:
    • Diovan Amlo Fix (1 Df (320/5mg), Qd (in Morning))
    • Calcium + Vitamin D /01483701/ (500 Mg, Qd (at Lunch))
    • Linseed Oil (1 Df, Daily)
    , and developed a serious reaction and a cataract side effect. The patient presented with:
    • Cataract
    • Eyelid Ptosis
    • Rectal Polyp
    • Haematochezia
    • Breast Oedema
    • Eyelid Oedema
    • Eye Colour Change
    • Pollakiuria
    • Visual Impairment
    which developed after the beginning of treatment. This side effect report can indicate a possible existence of increased vulnerability to Galvus Met treatment in female patients suffering from diabetes mellitus,hypertension,prophylaxis, resulting in cataract.


    This report suggests a potential Galvus death side effect(s) that can have serious consequences. A 84-year-old female patient from COUNTRY NOT SPECIFIED (weight:NA) was diagnosed with the following health condition(s): diabetes mellitus,hypertension and used Galvus (dosage: 1 Ukn (1000mg), Daily) starting Jan 15, 2013. Soon after starting Galvus the patient began experiencing various side effects, including:
      Drugs used concurrently:
      • Diovan Amlo Fix (1 Ukn (160/5mg), Daily)
      Although Galvus demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as death, may still occur.

      Hypertension, Renal Disorder, Fatigue, Blood Glucose Decreased, Blood Urea Increased, Blood Creatinine Increased, Blood Potassium Decreased
      This hypertension problem was reported by a consumer or non-health professional from COUNTRY NOT SPECIFIED. A 52-year-old female patient (weight: NA) was diagnosed with the following medical condition(s): diabetes mellitus.On 200809 a consumer started treatment with Galvus Met (dosage: 1 Df(850/50 Mg), Bid). The following drugs/medications were being taken at the same time: NA. When commencing Galvus Met, the patient experienced the following unwanted symptoms /side effects:
      • Hypertension
      • Renal Disorder
      • Fatigue
      • Blood Glucose Decreased
      • Blood Urea Increased
      • Blood Creatinine Increased
      • Blood Potassium Decreased
      Although all drugs are carefully tested before they are licensed for use, they carry potential side effect risks. Some side effects, such as hypertension, may become evident only after a product is in use by the general population.

      Liver Disorder, Visual Acuity Reduced, Diabetes Mellitus, Diabetes Mellitus Inadequate Control, Blood Glucose Abnormal
      This is a Galvus Met side effect report of a female patient (weight: NA) from COUNTRY NOT SPECIFIED. The patient developed the following symptoms/conditions: diabetes mellitus management and was treated with Galvus Met (dosage: 2 Df (850/50mg), Daily) starting Sep 04, 2013. Concurrently used drugs: NA. Soon after that, the consumer experienced the following of symptoms:
      • Liver Disorder
      • Visual Acuity Reduced
      • Diabetes Mellitus
      • Diabetes Mellitus Inadequate Control
      • Blood Glucose Abnormal
      This opens a possibility that Galvus Met could cause liver disorder and that some female patients may be more susceptible.

      Convulsion, Agitation, Confusional State, Dyspraxia, Pneumonia, Pulmonary Sepsis, Blood Pressure Decreased, White Blood Cell Count Increased, Pyrexia
      A male patient (weight: NA) from BR with the following symptoms: diabetes mellitus started Galvus Met treatment (dosage: 2 Df,(500mg Met, 50mg Vilda) Qd) on NS. Soon after starting Galvus Met treatment, the consumer experienced several side effects, including:
      • Convulsion
      • Agitation
      • Confusional State
      • Dyspraxia
      • Pneumonia
      • Pulmonary Sepsis
      • Blood Pressure Decreased
      • White Blood Cell Count Increased
      • Pyrexia
      . Concurrently used drugs:
      • Levofloxacin
      The patient was hospitalized. This finding indicates that some patients can be more vulnerable to developing Galvus Met side effects, such as convulsion.

      Pneumonia, Loss Of Consciousness
      This pneumonia side effect was reported by a consumer or non-health professional from COUNTRY NOT SPECIFIED. A 87-year-old female patient (weight:NA) experienced the following symptoms/conditions: diabetes mellitus,blood pressure abnormal.The patient was prescribed Galvus Met (dosage: 1 Df, (850mg Met, 50mg Vilda), Daily), which was started on NS. Concurrently used drugs:
      • Exforge (1 Df, (320mg Vals, 5mg Amlo), Daily)
      .When starting to take Galvus Met the consumer reported symptoms, such as:
      • Pneumonia
      • Loss Of Consciousness
      These side effects may potentially be related to Galvus Met. The patient was hospitalized.

      Infarction, Coronary Artery Occlusion, Weight Decreased, Headache, Nausea, Dizziness
      This is a report of a 74-year-old female patient (weight: NA) from BR, suffering from the following symptoms/conditions: diabetes mellitus,cardiac disorder, who was treated with Galvus Met (dosage: 2 Df, (850 Mg Metf/ 50 Mg Vilda) Daily, start time: 2013), combined with:
      • Diovan (1 Df, (320 Mg) Daily)
      • Ancoron (1 Df, (200 Mg)daily)
      • Selozok (1 Df, (50 Mg) Daily)
      • Plavix (1 Df, (75 Mg) Daily)
      • Simvastatin (1 Df, (40 Mg) Daily)
      • Pantoprazole (1 Df, (40 Mg) Daily)
      • Aspirina Prevent (1 Df, (100 Mg) Daily)
      and developed a serious reaction and side effect(s). The consumer presented with:
      • Infarction
      • Coronary Artery Occlusion
      • Weight Decreased
      • Headache
      • Nausea
      • Dizziness
      which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Galvus Met treatment in female patients, resulting in infarction side effect.

      Infarction, Malaise, Balance Disorder, Dizziness, Migraine, Nausea
      This report suggests a potential Galvus Met Infarction, Malaise, Balance Disorder, Dizziness, Migraine, Nausea side effect(s) that can have serious consequences. A 74-year-old female patient (weight: NA) from COUNTRY NOT SPECIFIED was diagnosed with the following symptoms/conditions: diabetes mellitus,tachycardia,off label use,hypertension,arterial occlusive disease and used Galvus Met (dosage: 1 Df (850/50 Mg), Bid (one In The Morning And One At Night)) starting 2013. Soon after starting Galvus Met the patient began experiencing various side effects, including:
      • Infarction
      • Malaise
      • Balance Disorder
      • Dizziness
      • Migraine
      • Nausea
      Drugs used concurrently:
      • Diovan (320 Mg, Daily)
      • Diovan
      • Ancoron (200 Mg, Daily)
      • Ancoron
      The patient was hospitalized. Although Galvus Met demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as infarction, may still occur.

      Blood Glucose Increased, Arrhythmia, Chest Discomfort, Dry Mouth, Fatigue
      This Blood Glucose Increased, Arrhythmia, Chest Discomfort, Dry Mouth, Fatigue problem was reported by a consumer or non-health professional from COUNTRY NOT SPECIFIED. A 60-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: diabetes mellitus. On 2012 this consumer started treatment with Galvus Met (dosage: 1 Df, (500 Mg Metf/ 50 Mg Vilda/ Daily). The following drugs were being taken at the same time: NA. When commencing Galvus Met, the patient experienced the following unwanted symptoms/side effects:
      • Blood Glucose Increased
      • Arrhythmia
      • Chest Discomfort
      • Dry Mouth
      • Fatigue
      The patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as blood glucose increased, may become evident only after a product is in use by the general population.

      Pneumonia, Influenza
      This is a report of a 70-year-old male patient (weight: NA) from BR. The patient developed the following symptoms/conditions: NA and was treated with Galvus (dosage: 50 Mg, Unk) starting Apr 17, 2013. Concurrently used drugs:
      • Diovan Hct (1 Df (80mg Vals/ 12.5mg Hydr), Unk)
      • Diovan Hct
      • Influenza A (h1n1) (Unk Ukn, Unk)
      Soon after that, the consumer experienced the following side effects:
      • Pneumonia
      • Influenza
      This opens a possibility that Galvus treatment could cause the above reactions, including pneumonia, and some male subjects may be more susceptible.

      Gastritis, Vomiting, Hypertension, Blood Pressure Increased, Malaise, Blood Glucose Increased, Diarrhoea, Gastroenteritis Radiation, Blood Cholesterol Increased
      A 72-year-old female patient (weight: NA) from COUNTRY NOT SPECIFIED with the following symptoms/conditions: blood glucose abnormal started Galvus treatment (dosage: 50 Mg, Unk) on 2003. Soon after starting Galvus treatment, the subject experienced various side effects, including:
      • Gastritis
      • Vomiting
      • Hypertension
      • Blood Pressure Increased
      • Malaise
      • Blood Glucose Increased
      • Diarrhoea
      • Gastroenteritis Radiation
      • Blood Cholesterol Increased
      Concurrently used drugs: NA.The patient was hospitalized. This finding indicates that some female patients could be more vulnerable to Galvus.

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      Keep Track of Side Effects

      Note Your Observations

      It is really important to keep of your symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

      Why Your Notes are Important

      Your notes could be helpful in several ways:

    • You can use them to remind you of details that may alert your health care professional(s) to a problem
    • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

    • Log Form

      You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

      Medicine Name and Dosage:
      Side Effects Scale Date & Time Other Medicine(s) or Treatment(s)
      Scale: 1 = very mild to 10 = very bad

      You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


      Discuss Galvus Side Effects

      Did You Have a Galvus Side Effect?

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      Yes, Moderate
      Yes, Minor
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      How Effective is Galvus for You?

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      Effective
      Somewhat Effective
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