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Gliclazide Side Effects

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Common Gliclazide Side Effects


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

Hypoglycaemia (20)
Diarrhoea (15)
Renal Failure Acute (12)
Vomiting (9)
Blood Glucose Increased (8)
Lactic Acidosis (8)
Pancreatic Carcinoma (7)
Breast Pain (6)
Abdominal Pain Upper (6)
Breast Enlargement (6)
Dyspnoea (6)
Liver Function Test Abnormal (6)
Pancreatitis (6)
Gynaecomastia (5)
Fall (5)
Hypotension (5)
Oedema Peripheral (5)
Weight Decreased (5)
Jaundice (4)
Hypothermia (4)

➢ 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.

Gliclazide Side Effects Reported to FDA



Gliclazide Side Effect Report#9823262
Hepatitis Fulminant
This is a report of a 85-year-old female patient (weight: NA) from FR, suffering from the following health symptoms/conditions: NA, who was treated with Gliclazide (dosage: 30 Mg, Daily, start time:
Aug 25, 2013), combined with:
  • Metformin Hydrochloride (1 Df, Daily)
and developed a serious reaction and side effect(s): Hepatitis Fulminant after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Gliclazide treatment in female patients, resulting in Hepatitis Fulminant side effect.
Gliclazide Side Effect Report#9795262
Lactic Acidosis, Renal Failure Acute, Dehydration
This report suggests a potential Gliclazide Lactic Acidosis side effect(s) that can have serious consequences. A 86-year-old female patient (weight: NA) from CN was diagnosed with the following symptoms/conditions: type 2 diabetes mellitus and used Gliclazide (dosage: Modified-release Formulation) starting NS. After starting Gliclazide the patient began experiencing various side effects, including: Lactic Acidosis, Renal Failure Acute, DehydrationAdditional drugs used concurrently:
  • Metformin Hydrochloride
  • Polyethylene Glycol
The patient was hospitalized. Although Gliclazide demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Lactic Acidosis, may still occur.
Gliclazide Side Effect Report#9696049
Hypoglycaemia
This Hypoglycaemia problem was reported by a consumer or non-health professional from IT. A 84-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: type 2 diabetes mellitus. On
Oct 10, 2013 this consumer started treatment with Gliclazide (gliclazide) (dosage: NA). The following drugs were being taken at the same time:
  • Clarithromycin (clarithromycin)
  • Nebivolol (nebivolol) ?
  • Lercanidipine (lercanidipine) ?
  • Enalapril
  • Glyceryl Trinitrate (glyceryl Trinitrate)
  • Paracetamol (paracetamol)?
  • Cardioaspirin (acetylsalicylic Acid)
  • Amoxicillin (amoxicillin)
When using Gliclazide (gliclazide), the patient experienced the following unwanted symptoms/side effects: HypoglycaemiaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Hypoglycaemia, may become evident only after a product is in use by the general population.
Gliclazide Side Effect Report#9664101
International Normalised Ratio Decreased
This International Normalised Ratio Decreased side effect was reported by a pharmacist from GB. A 72-year-old female patient (weight:NA) experienced the following symptoms/conditions: diabetes mellitus.The patient was prescribed Gliclazide (drug dosage: 80 Milligram Daily;), which was initiated on
Jan 29, 2013. Concurrently used drugs:
  • Warfarin
  • Ramipril
  • Simvastatin
  • Metformin
  • Bendroflumethiazide
  • Atenolol
.After starting to take Gliclazide the consumer reported adverse symptoms, such as: International Normalised Ratio DecreasedThese side effects may potentially be related to Gliclazide.
Gliclazide Side Effect Report#9657775
Angina Pectoris, Hypoglycaemia, Abdominal Discomfort, Diarrhoea
This is a report of a 62-year-old male patient (weight: NA) from HU, suffering from the following health symptoms/conditions: type 2 diabetes mellitus, who was treated with Gliclazide (dosage: 60 Milligram Daily;, start time: 2013), combined with: NA. and developed a serious reaction and side effect(s): Angina Pectoris, Hypoglycaemia, Abdominal Discomfort, Diarrhoea after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Gliclazide treatment in male patients, resulting in Angina Pectoris side effect.
Gliclazide Side Effect Report#9629990
Hypoglycaemia, Weight Increased, Angina Pectoris
This report suggests a potential Gliclazide Hypoglycaemia side effect(s) that can have serious consequences. A 74-year-old female patient (weight: NA) from HU was diagnosed with the following symptoms/conditions: type 2 diabetes mellitus and used Gliclazide (dosage: 120 Mg, Daily) starting NS. After starting Gliclazide the patient began experiencing various side effects, including: Hypoglycaemia, Weight Increased, Angina PectorisAdditional drugs used concurrently: NA. Although Gliclazide demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Hypoglycaemia, may still occur.
Gliclazide Side Effect Report#9373588
International Normalised Ratio Decreased
This International Normalised Ratio Decreased problem was reported by a health professional from GB. A 72-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: diabetes mellitus. On
Jan 29, 2013 this consumer started treatment with Gliclazide (dosage: 80 Mg, Qd). The following drugs were being taken at the same time:
  • Warfarin
  • Ramipril
  • Simvastatin
  • Metformin
  • Bendroflumethiazide
  • Atenolol
When using Gliclazide, the patient experienced the following unwanted symptoms/side effects: International Normalised Ratio DecreasedAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as International Normalised Ratio Decreased, may become evident only after a product is in use by the general population.
Gliclazide Side Effect Report#9057806
Joint Swelling, Rheumatoid Arthritis, Palindromic Rheumatism
This Joint Swelling side effect was reported by a pharmacist from GB. A 56-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Gliclazide (drug dosage: 160mg Morning, 80mg Evening), which was initiated on NS. Concurrently used drugs:
  • Metformin
  • Omeprazole
  • Ramipril
  • Sitagliptin
  • Citalopram
  • Methotrexate
  • Folic Acid
.After starting to take Gliclazide the consumer reported adverse symptoms, such as: Joint Swelling, Rheumatoid Arthritis, Palindromic RheumatismThese side effects may potentially be related to Gliclazide.
Gliclazide Side Effect Report#8828073
Mitral Valve Incompetence, Aortic Valve Incompetence, Fluid Retention
This is a report of a 50-year-old female patient (weight: NA) from IN, suffering from the following health symptoms/conditions: type 2 diabetes mellitus, who was treated with Gliclazide (dosage: 160 Mg, Daily, start time: NS), combined with:
  • Metformin Hydrochloride (Unk)
  • Pioglitazone (15 Mg, Daily)
  • Pioglitazone (30 Mg, Dailly)
  • Sitaglipin (100 Mg, Unk)
and developed a serious reaction and side effect(s): Mitral Valve Incompetence, Aortic Valve Incompetence, Fluid Retention after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Gliclazide treatment in female patients, resulting in Mitral Valve Incompetence side effect.
Gliclazide Side Effect Report#8764374
Gastroenteritis, Incontinence, Hypotension, Fall, Constipation, Hypoglycaemia, Asthenia, Vomiting
This report suggests a potential Gliclazide Gastroenteritis side effect(s) that can have serious consequences. A 65-year-old male patient (weight: NA) from GB was diagnosed with the following symptoms/conditions: type 2 diabetes mellitus and used Gliclazide (dosage: 80 Mg) starting
Oct 27, 2007. After starting Gliclazide the patient began experiencing various side effects, including: Gastroenteritis, Incontinence, Hypotension, Fall, Constipation, Hypoglycaemia, Asthenia, VomitingAdditional drugs used concurrently:
  • Metformin (2000 Mg)
  • Saxagliptin
  • Aspirin
  • Ramipril
The patient was hospitalized. Although Gliclazide demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Gastroenteritis, may still occur.
Gliclazide Side Effect Report#8762120
Cerebral Haematoma
This Cerebral Haematoma problem was reported by a health professional from GB. A 58-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: diabetes mellitus. On
May 14, 2012 this consumer started treatment with Gliclazide (dosage: Unk). The following drugs were being taken at the same time:
  • Levothyroxine (Unk)
  • Metformin (Unk)
  • Montelukast (Unk)
  • Ramipril (Unk)
  • Simvastatin (Unk)
  • Spironolactone (Unk)
  • Warfarin (Unk)
  • Victoza (1.2 Mg, Qd)
When using Gliclazide, the patient experienced the following unwanted symptoms/side effects: Cerebral HaematomaThe 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 Cerebral Haematoma, may become evident only after a product is in use by the general population.
Gliclazide Side Effect Report#8474730-9
Liver Function Test Abnormal
This Liver Function Test Abnormal side effect was reported by a health professional from . A 69-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Gliclazide (gliclazide) (drug dosage: NA), which was initiated on
May 29, 2012. Concurrently used drugs:
  • Simvastatin
  • Tramadol Hcl
  • Trimethoprim
  • Alendronic Acid(alendronic Acid)
  • Gabapentin
  • Amitriptyline Hcl
  • Diazepam
  • Eplerenone
.After starting to take Gliclazide (gliclazide) the consumer reported adverse symptoms, such as: Liver Function Test AbnormalThese side effects may potentially be related to Gliclazide (gliclazide). The patient was hospitalized.
Gliclazide Side Effect Report#8472755-0
Aphasia, Cerebrovascular Accident, Metabolic Disorder, Obesity, Hypertension, Hemiparesis
This is a report of a 36-year-old female patient (weight: NA) from United Kingdom, suffering from the following health symptoms/conditions: type 2 diabetes mellitus, who was treated with Gliclazide (dosage: NA, start time: NS), combined with:
  • Insulin
  • Rosiglitazone
  • Metformin Hcl
and developed a serious reaction and side effect(s): Aphasia, Cerebrovascular Accident, Metabolic Disorder, Obesity, Hypertension, Hemiparesis after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Gliclazide treatment in female patients, resulting in Aphasia side effect.
Gliclazide Side Effect Report#8469776-0
Cholelithiasis, Cholecystitis Acute
This report suggests a potential Gliclazide Cholelithiasis side effect(s) that can have serious consequences. A 68-year-old male patient (weight: NA) from France was diagnosed with the following symptoms/conditions: type 2 diabetes mellitus and used Gliclazide (dosage: NA) starting
Apr 04, 2010. After starting Gliclazide the patient began experiencing various side effects, including: Cholelithiasis, Cholecystitis AcuteAdditional drugs used concurrently:
  • Aspirin Lysine
  • Janumet
  • Perindopril Arginine
  • Repaglinide
  • Metformin Pamoate
  • Januvia
The patient was hospitalized. Although Gliclazide demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Cholelithiasis, may still occur.
Gliclazide Side Effect Report#8457429-4
Pancreatitis Chronic, Pancreatitis Necrotising, Pancreatic Neoplasm, Pancreatitis Acute
This Pancreatitis Chronic problem was reported by a physician from France. A 71-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: type 2 diabetes mellitus. On
Jan 01, 2008 this consumer started treatment with Gliclazide (dosage: NA). The following drugs were being taken at the same time:
  • Allopurinol
  • Januvia
  • Insulin Glargine
When using Gliclazide, the patient experienced the following unwanted symptoms/side effects: Pancreatitis Chronic, Pancreatitis Necrotising, Pancreatic Neoplasm, Pancreatitis AcuteThe 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 Pancreatitis Chronic, may become evident only after a product is in use by the general population.
Gliclazide Side Effect Report#8457292-1
Loss Of Consciousness, Diarrhoea, Duodenal Ulcer Haemorrhage, Faeces Discoloured, Gastrointestinal Haemorrhage, Syncope, Pallor
This Loss Of Consciousness side effect was reported by a health professional from United Kingdom. A 7-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Gliclazide (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Amlodipine
  • Lisinopril
  • Pradaxa (150 Mg)
  • Aspirin
  • Metformin Hcl
  • Bisoprolol
  • Flucloxacillin
  • Metronidazole
.After starting to take Gliclazide the consumer reported adverse symptoms, such as: Loss Of Consciousness, Diarrhoea, Duodenal Ulcer Haemorrhage, Faeces Discoloured, Gastrointestinal Haemorrhage, Syncope, PallorThese side effects may potentially be related to Gliclazide. The patient was hospitalized.
Gliclazide Side Effect Report#8450807-9
Hepatic Enzyme Increased
This is a report of a 32-year-old male patient (weight: NA) from South Africa, suffering from the following health symptoms/conditions: NA, who was treated with Gliclazide (dosage: 80 Mg, Bid, start time:
Mar 13, 2012), combined with:
  • Moxifloxacin (Unk)
  • Moxifloxacin (400 Mg, Qd)
  • Ethionamide (750 Mg, Qd)
  • Kanamycin (1 G, Qd)
  • Metformin Hcl (1 G, Bid)
  • Ethambutol Hydrochloride (12 G, Qd)
  • Tropicamide (8 Gtt, Unk)
  • Metformin Hcl (500 Mg, Bid)
and developed a serious reaction and side effect(s): Hepatic Enzyme Increased after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Gliclazide treatment in male patients, resulting in Hepatic Enzyme Increased side effect. The patient was hospitalized.
Gliclazide Side Effect Report#8448740-1
Acute Febrile Neutrophilic Dermatosis, Eosinophilia
This report suggests a potential Gliclazide Acute Febrile Neutrophilic Dermatosis side effect(s) that can have serious consequences. A 64-year-old male patient (weight: NA) from France was diagnosed with the following symptoms/conditions: NA and used Gliclazide (dosage: NA) starting
Feb 27, 2012. After starting Gliclazide the patient began experiencing various side effects, including: Acute Febrile Neutrophilic Dermatosis, EosinophiliaAdditional drugs used concurrently:
  • Medrol (Unk)
  • Clarithromycin (Unk)
  • Amlodipine
  • Innovar (Unk)
  • Januvia
  • Nexium
  • Fluticasone Propionate/salmeterol
  • Levemir
The patient was hospitalized. Although Gliclazide demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Acute Febrile Neutrophilic Dermatosis, may still occur.
Gliclazide Side Effect Report#8448665-1
Diabetic Nephropathy
This Diabetic Nephropathy problem was reported by a physician from France. A 80-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Jan 01, 2000 this consumer started treatment with Gliclazide (dosage: NA). The following drugs were being taken at the same time:
  • Ramipril
  • Metformin Pamoate
When using Gliclazide, the patient experienced the following unwanted symptoms/side effects: Diabetic NephropathyAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Diabetic Nephropathy, may become evident only after a product is in use by the general population.
Gliclazide Side Effect Report#8433023-6
Cerebral Infarction, Hemiplegia
This Cerebral Infarction side effect was reported by a physician from Australia. A male patient (weight:NA) experienced the following symptoms/conditions: diabetes mellitus,colon cancer metastatic.The patient was prescribed Gliclazide (drug dosage: NA), which was initiated on
May 16, 2012. Concurrently used drugs:
  • Xeloda
  • Metformin Hcl
  • Panadol Osteo
  • Lipitor
  • Irinotecan Hcl
.After starting to take Gliclazide the consumer reported adverse symptoms, such as: Cerebral Infarction, HemiplegiaThese side effects may potentially be related to Gliclazide.
Gliclazide Side Effect Report#8422768-X
Hospitalisation
This is a report of a female patient (weight: NA) from France, suffering from the following health symptoms/conditions: type 2 diabetes mellitus, who was treated with Gliclazide (dosage: NA, start time:
Dec 14, 2009), combined with:
  • Acarbose
  • Januvia
  • Metformin Hcl
and developed a serious reaction and side effect(s): Hospitalisation after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Gliclazide treatment in female patients, resulting in Hospitalisation side effect. The patient was hospitalized.
Gliclazide Side Effect Report#8414687-X
Jaundice Cholestatic
This report suggests a potential Gliclazide Jaundice Cholestatic side effect(s) that can have serious consequences. A 62-year-old male patient (weight: NA) from United Kingdom was diagnosed with the following symptoms/conditions: NA and used Gliclazide (dosage: NA) starting
Mar 19, 2012. After starting Gliclazide the patient began experiencing various side effects, including: Jaundice CholestaticAdditional drugs used concurrently:
  • Levothyroxine Sodium
  • Tadalafil
  • Bendroflumethiazide
  • Metformin
  • Tramadol Hydrochloride
  • Amlodipine
  • Acetaminophen
  • Losartan Potassium
The patient was hospitalized. Although Gliclazide demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Jaundice Cholestatic, may still occur.
Gliclazide Side Effect Report#8397129-2
Large Intestine Perforation
This Large Intestine Perforation problem was reported by a consumer or non-health professional from Canada. A female patient (weight: NA) was diagnosed with the following symptoms/conditions: diabetes mellitus. On
Jun 22, 2010 this consumer started treatment with Gliclazide (dosage: NA). The following drugs were being taken at the same time:
  • Calcium Carbonate
  • Pantoprazole
  • Mabthera (Day 1 And Day 15)
  • Cephalexin
  • Latanoprost
  • Lyrica
  • Prednisone Tab
  • Brimonidine Tartrate
When using Gliclazide, the patient experienced the following unwanted symptoms/side effects: Large Intestine PerforationAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Large Intestine Perforation, may become evident only after a product is in use by the general population.
Gliclazide Side Effect Report#8396353-2
Oedema, Oedema Peripheral, Mobility Decreased
This Oedema side effect was reported by a health professional from United Kingdom. A 64-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Gliclazide (drug dosage: NA), which was initiated on
Mar 06, 2011. Concurrently used drugs:
  • Metformin
  • Perindopril
  • Amlodipine
  • Januvia
.After starting to take Gliclazide the consumer reported adverse symptoms, such as: Oedema, Oedema Peripheral, Mobility DecreasedThese side effects may potentially be related to Gliclazide.
Gliclazide Side Effect Report#8388658-6
Cardiac Failure, Weight Decreased, Hypoglycaemia, Metastasis, Anuria, Bronchitis, Metastases To Peritoneum, Colon Cancer
This is a report of a 76-year-old female patient (weight: NA) from France, suffering from the following health symptoms/conditions: type 2 diabetes mellitus, who was treated with Gliclazide (dosage: NA, start time:
Sep 22, 2010), combined with:
  • Insulin Glargine
  • Insulin Glargine
  • Digoxin
  • Janumet
  • Insulin Glargine
  • Fosinopril Sodium And Hydrochlorothiazide
  • Bisoprolol Fumarate
  • Diltiazem Hydrochloride
and developed a serious reaction and side effect(s): Cardiac Failure, Weight Decreased, Hypoglycaemia, Metastasis, Anuria, Bronchitis, Metastases To Peritoneum, Colon Cancer after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Gliclazide treatment in female patients, resulting in Cardiac Failure side effect. The patient was hospitalized.


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The appearance of Gliclazide 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.

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Note Your Observations

It is really important to keep track of your health 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

    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.

    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.

    Gliclazide 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.

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