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Rash (83)
Weight Gain (61)
Swelling Of Feet (46)
Liver Enzyme (35)
Dizziness (34)
Skin Rash (33)
Depression (32)
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Galvus Side Effects and Adverse Effects reported to US Food and Drug Administration (FDA)

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Showing 1-25 of 139 

Stomatitis, Oropharyngeal Swelling, Laryngeal Oedema, Hypersensitivity, Lip Swelling (7470257-1)
on May 04, 2011 Female from ISRAEL , 80 years of age, was diagnosed with
  • diabetes mellitus
and was treated with Galvus. Directly after, patient experienced the unwanted or unexpected Galvus side effects: stomatitis, oropharyngeal swelling, laryngeal oedema, hypersensitivity, lip swelling. Galvus dosage: N/A.
Associated medications used:
  • Sulfonamides, Urea Derivatives
  • Altace (Unk)
  • Aspirin
  • Hmg Coa Reductase Inhibitors
  • Analgesics
Patient was hospitalized.

Visual Acuity Reduced (7383104-3)
Patient was taking Galvus. Patient felt the following Galvus side effects: visual acuity reduced on Mar 22, 2011 from FRANCE Additional patient health information: Male , 56 years of age, was diagnosed with
  • diabetes mellitus
  • liver transplant
and. Galvus dosage: Unk.
Multiple prescriptions taken:
  • Cellcept (Unk)
  • Prograf (Unk)
  • Plavix (Unk)
  • Lucentis (Unk)
  • Tacrolimus (Unk)


Tremor, Cataract, Dizziness, Eye Disorder, Hyperhidrosis, Vision Blurred, Blood Glucose Fluctuation (7380479-6)
Adverse event was reported on Mar 18, 2011 by a Female taking Galvus (Dosage: N/A) . Location: BRAZIL , 65 years of age, weighting 209.4 lb, After Galvus was administered, patient encountered several Galvus side effects: tremor, cataract, dizziness, eye disorder, hyperhidrosis, vision blurred, blood glucose fluctuation.
Multiple concurrent drugs taken:
  • Lantus
  • Cymbalta
  • Losartan Potassium
  • Atorvastatin Calcium
  • Cilostazol
  • Novorapid
  • Puran T4
  • Pioglitazone


Paralysis, Cerebrovascular Accident (7277650-0)
on Feb 01, 2011 Male from BRAZIL , 73 years of age, weighting 187.4 lb, was diagnosed with
  • type 2 diabetes mellitus
  • tremor
and was treated with Galvus. Directly after, patient experienced the unwanted or unexpected Galvus side effects: paralysis, cerebrovascular accident. Galvus dosage: N/A.
Associated medications used:
  • Niar
  • Lipidil
  • Lantus
  • Autopen 24
  • Proscar
  • Primidone
  • Atacand
  • Atenolol
Patient was hospitalized.


Pancreatitis Acute (7273753-5)
on Jan 21, 2011 Male from DENMARK , 41 years of age, was diagnosed with
  • type 2 diabetes mellitus
and was treated with Galvus. Patient felt the following Galvus side effects: pancreatitis acute. Galvus dosage: 50 Mg, Bid.
Multiple prescriptions taken:
  • Metformin (1000 Mg, Bid)
  • Simvastatin (40 Mg, Qd)
Patient was hospitalized.

Pancreatitis Acute (7273752-3)
Patient was taking Galvus. After Galvus was administered, patient encountered several Galvus side effects: pancreatitis acute on Jan 21, 2011 from DENMARK Additional patient health information: Male , 41 years of age, was diagnosed with
  • type 2 diabetes mellitus
  • dyslipidaemia
and. Galvus dosage: 50 Mg, Bid.
Multiple concurrent drugs taken:
  • Simvastatin (40 Mg, Qd)
  • Metformin (1000 Mg, Bid)
Patient was hospitalized.

Blood Glucose Increased, Decreased Appetite, Dry Mouth, Dry Skin, Gastric Ulcer Haemorrhage, Insomnia, Lacrimation Increased, Muscular Weakness, Nervousness (7201323-3)
Adverse event was reported on Dec 16, 2010 by a Female taking Galvus (Dosage: (50 Mg), 2 Df, Qd) was diagnosed with
  • diabetes mellitus
  • hypertension
and. Location: MEXICO , 82 years of age, Directly after, patient experienced the unwanted or unexpected Galvus side effects: blood glucose increased, decreased appetite, dry mouth, dry skin, gastric ulcer haemorrhage, insomnia, lacrimation increased, muscular weakness, nervousness.
Associated medications used:
  • Co-diovan (1 Df, Qd)
  • Forteo
  • Bivcant
  • Padiet
  • Concor (Unk)
  • Tranxene
  • Pantoprazole
  • Pariet
Patient was hospitalized.

Diabetes Mellitus Inadequate Control (7033742-2)
on Sep 21, 2010 Male from BRAZIL , 68 years of age, was treated with Galvus. Patient felt the following Galvus side effects: diabetes mellitus inadequate control. Galvus dosage: 50 Mg.
Multiple prescriptions taken:
  • Diovan Amlo (80/5 Mg)
  • Actos (30 Mg Mid)
  • Glucobay (100 Mg, Bid)
  • Nph Insulin (15 Iu Night)
  • Omeprazole (20 Mg)
  • Simvastatin (20 Mg)


Fall, Joint Injury (7014533-5)
on Aug 03, 2010 Female from MEXICO , 64 years of age, was diagnosed with
  • diabetes mellitus
  • hypersensitivity
and was treated with Galvus Met. After Galvus was administered, patient encountered several Galvus side effects: fall, joint injury. Galvus Met dosage: 2 Tablet ( 50/500mg) Per Day.
Multiple concurrent drugs taken:
  • Carbamazepine
  • Amaryl
  • Dabex
  • Sintral
  • Caret (Unk)
  • Daflon (diosmin)
  • Dextropropoxyphene (Unk)
  • Evista


Abdominal Pain Upper, Asthenia, Fatigue, Feeling Abnormal, Feeling Cold, Nausea, Retching, Salivary Hypersecretion (6941998-7)
Patient was taking Galvus Met. Directly after, patient experienced the unwanted or unexpected Galvus side effects: abdominal pain upper, asthenia, fatigue, feeling abnormal, feeling cold, nausea, retching, salivary hypersecretion on Aug 24, 2010 from BRAZIL Additional patient health information: Female , weighting 136.7 lb, was diagnosed with
  • diabetes mellitus
and. Galvus Met dosage: 1 Df, Bid (in The Morning And Evening).
Associated medications used:
  • Enalapril (10 Mg)
  • Enalapril (1 Df, Bid (in The Morning And Night))
  • Atenolol (1 Df, Bid (in The Morning And Evening))
  • Monocordil (1 Df, Bid (in The Morning And Night))
  • Hydrochlorothiazide (1 Tablet (25 Mg) Daily)
  • Ranitidine (1 Df, Bid (in The Morning And Night))
  • Aspirin (1 Tablet (100 Mg) Daily)
  • Simvastatin (1 Tablet (20 Mg) At Night)


Dehydration, Fatigue, Malaise, Palpitations, Tachycardia, Tremor (6941994-X)
Adverse event was reported on Aug 18, 2010 by a Male taking Galvus Met (Dosage: 1700/100 Mg Daily (850/50mg Twice Daily)) was diagnosed with
  • type 2 diabetes mellitus
and. Location: MALAYSIA , 64 years of age, Patient felt the following Galvus side effects: dehydration, fatigue, malaise, palpitations, tachycardia, tremor.
Multiple prescriptions taken:
  • Enalapril (10 Mg, Daily)
  • Felodipine (5 Mg, Daily)


Gallbladder Disorder, Gallbladder Operation (6936995-1)
on Aug 09, 2010 Female from MEXICO , weighting 132.3 lb, was diagnosed with
  • diabetes mellitus
  • hypertension
and was treated with Galvus. After Galvus was administered, patient encountered several Galvus side effects: gallbladder disorder, gallbladder operation. Galvus dosage: 1 Tablet, Unk.
Multiple concurrent drugs taken:
  • Diovan Hct (1/2 Tablet (160/12.5 Mg ) Per Day)
Patient was hospitalized.

Fall, Joint Injury (6931062-5)
on Aug 03, 2010 Female from MEXICO , 64 years of age, was diagnosed with
  • diabetes mellitus
  • hypersensitivity
and was treated with Galvus Met. Directly after, patient experienced the unwanted or unexpected Galvus side effects: fall, joint injury. Galvus Met dosage: 2 Tablet ( 50/500mg) Per Day.
Associated medications used:
  • Carbamazepine
  • Amaryl
  • Dabex
  • Sintral
  • Caret (Unk)
  • Daflon (diosmin)
  • Dextropropoxyphene (Unk)
  • Evista


Cataract, Cataract Operation (6879976-9)
Patient was taking Galvus. Patient felt the following Galvus side effects: cataract, cataract operation on Jul 16, 2010 from MEXICO Additional patient health information: Female , 54 years of age, was diagnosed with
  • diabetes mellitus
  • hypertension
  • eye disorder
and. Galvus dosage: 50 Mg, 1 Tablet Per Day.
Multiple prescriptions taken:
  • Diovan Hct (Half Tablet Per Day)
  • Vigamox (Unk)
  • Prefrin (Unk)
  • Miracil
Patient was hospitalized.

Gallbladder Operation (6800912-5)
Adverse event was reported on Jun 16, 2010 by a Male taking Galvus Met (Dosage: 2 Tablets ( 50/500 Mg ) Per Day) was diagnosed with
  • diabetes mellitus
  • hypertension
and. Location: MEXICO , 58 years of age, After Galvus was administered, patient encountered several Galvus side effects: gallbladder operation.
Multiple concurrent drugs taken:
  • Exforge (1 Tablet)
  • Dolac
  • Levofloxacin (Unk)
Patient was hospitalized.

Blood Glucose Increased, Gastric Ulcer Perforation (6782166-1)
on Jun 10, 2010 Female from MEXICO , 82 years of age, was diagnosed with
  • diabetes mellitus
  • hypertension
and was treated with Galvus. Directly after, patient experienced the unwanted or unexpected Galvus side effects: blood glucose increased, gastric ulcer perforation. Galvus dosage: (50 Mg), 2 Df, Qd.
Associated medications used:
  • Diovan Hct (1 Df, Qd)
  • Forteo
  • Bivcant
  • Padiet
Patient was hospitalized.

Decreased Appetite, Fatigue, Myalgia, Nausea, Urinary Tract Infection (6670758-X)
on Mar 29, 2010 Female from BRAZIL , weighting 163.1 lb, was diagnosed with
  • type 2 diabetes mellitus
  • hypertension
and was treated with Galvus Met. Patient felt the following Galvus side effects: decreased appetite, fatigue, myalgia, nausea, urinary tract infection. Galvus Met dosage: 1 Df, Bid.
Multiple prescriptions taken:
  • Losartan Potassium (1 Tablet In The Morning)
  • Aas Infantil (1 Tablet At Lunch)


Dehydration, Fatigue, Malaise, Palpitations, Tachycardia, Tremor (6637938-0)
Patient was taking Galvus Met. After Galvus was administered, patient encountered several Galvus side effects: dehydration, fatigue, malaise, palpitations, tachycardia, tremor on Mar 08, 2010 from MALAYSIA Additional patient health information: Male , 64 years of age, was diagnosed with
  • type 2 diabetes mellitus
and. Galvus Met dosage: 1700/100 Mg Daily (850/50mg Twice Daily).
Multiple concurrent drugs taken:
  • Enalapril Maleate (10 Mg, Daily)
  • Felodipine (5 Mg, Daily)


Blood Glucose Increased, Diarrhoea, Glycosylated Haemoglobin Increased, Hypersensitivity, Nausea, Rash Papular (6637912-4)
Adverse event was reported on Mar 05, 2010 by a Male taking Galvus Met (Dosage: 1 Tablet In Morning And Night) . Location: BRAZIL , 50 years of age, Directly after, patient experienced the unwanted or unexpected Galvus side effects: blood glucose increased, diarrhoea, glycosylated haemoglobin increased, hypersensitivity, nausea, rash papular.
Associated medications used:
  • Insulin (Bid)


Abdominal Distension, Blood Bilirubin Increased, Discomfort, Fatigue, Hepatitis, Malaise, Ocular Icterus (6634013-6)
on Mar 04, 2010 Male from MEXICO , 56 years of age, was diagnosed with
  • diabetes mellitus
and was treated with Galvus Met. Patient felt the following Galvus side effects: abdominal distension, blood bilirubin increased, discomfort, fatigue, hepatitis, malaise, ocular icterus. Galvus Met dosage: 2 Tablets Daily.
Multiple prescriptions taken:
  • Aprovel
  • Levemir
  • Salofalk
  • Espaven Enzimatico


Hyperglycaemia (6623848-1)
on Mar 01, 2010 Female from BRAZIL , 63 years of age, weighting 187.4 lb, was diagnosed with
  • type 2 diabetes mellitus
and was treated with Galvus Met. After Galvus was administered, patient encountered several Galvus side effects: hyperglycaemia. Galvus Met dosage: 1 Df, Bid (lunch And Dinner).
Multiple concurrent drugs taken:
  • Insulin (30 Ui In The Morning, 28 Ui In The Evening And 10 Ui At Night)
  • Insulin (30 Ui In The Morning, 25 Ui In The Evening And 25 Ui At Night)


Malaise, Tachycardia, Tremor (6609869-3)
Patient was taking Galvus Met. Directly after, patient experienced the unwanted or unexpected Galvus side effects: malaise, tachycardia, tremor on Feb 19, 2010 from MALAYSIA Additional patient health information: Male , 64 years of age, was diagnosed with
  • type 2 diabetes mellitus
and. Galvus Met dosage: 1700/100mg Daily (850/50mg Twice Daily).
Associated medications used:
  • Enalapril Maleate (10 Mg, Daily)
  • Felodipine (5 Mg, Daily)


Hyperglycaemia (6603064-X)
Adverse event was reported on Feb 19, 2010 by a Female taking Galvus Met (Dosage: 1 Df, Bid (lunch And Dinner)) was diagnosed with
  • type 2 diabetes mellitus
and. Location: BRAZIL , 63 years of age, weighting 187.4 lb, Patient felt the following Galvus side effects: hyperglycaemia.
Multiple prescriptions taken:
  • Insulin (30 Ui In The Morning, 28 Ui In The Evening And 10 Ui At Night)
  • Insulin (30 Ui In The Morning, 25 Ui In The Evening And 25 Ui At Night)


Abdominal Pain, Lipase Increased, Weight Decreased (6588736-8)
on Feb 09, 2010 Male from BRAZIL , 54 years of age, weighting 253.5 lb, was diagnosed with
  • diabetes mellitus
and was treated with Galvus Met. After Galvus was administered, patient encountered several Galvus side effects: abdominal pain, lipase increased, weight decreased. Galvus Met dosage: 2 Tablets Daily.
Multiple concurrent drugs taken:
  • Novolin N (Unk)
  • Sibutramine (Unk)
  • Ciprofibrate
Patient was hospitalized.

Hyperglycaemia, Toe Amputation (6581064-6)
on Feb 03, 2010 Male from BRAZIL , 67 years of age, weighting 165.3 lb, was diagnosed with
  • diabetes mellitus
and was treated with Galvus Met. Directly after, patient experienced the unwanted or unexpected Galvus side effects: hyperglycaemia, toe amputation. Galvus Met dosage: 1 Df, Bid. Patient was hospitalized.

Showing 1-25 of 139 

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Most drugs have a large list of nonsevere or mild adverse effects which do not rule out continued usage. These effects depend on individual sensitivity, and can include nausea, dizziness, diarrhea, malaise, vomiting, headache, dermatitis, dry mouth, etc. Check commonly reported side effects . These can be considered a form of pseudo-allergic reaction, as not all users experience these effects; many users experience none at all.

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.

Galvus Information

More About Galvus

Side Effects reported to FDA: 139. View Galvus Adverse Reports

Galvus safety alerts: No

Reported deaths: 9

Reported hospitalizations: 20

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