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Gliclazide Side Effects

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.

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.

Gliclazide Side Effects Reported to FDA

The following 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.


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.
Hepatitis Fulminant
This is a report of a 85-year-old female patient (weight: NA) from FR, suffering from the following 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). The consumer presented with:
  • Hepatitis Fulminant
which developed 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.

Lactic Acidosis, Renal Failure Acute, Dehydration
This report suggests a potential Gliclazide Lactic Acidosis, Renal Failure Acute, Dehydration 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. Soon after starting Gliclazide the patient began experiencing various side effects, including:
  • Lactic Acidosis
  • Renal Failure Acute
  • Dehydration
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.

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 commencing Gliclazide (gliclazide), the patient experienced the following unwanted symptoms/side effects:
  • Hypoglycaemia
Although 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.

International Normalised Ratio Decreased
This is a report of a 72-year-old female patient (weight: NA) from GB. The patient developed the following symptoms/conditions: diabetes mellitus and was treated with Gliclazide (dosage: 80 Milligram Daily;) starting Jan 29, 2013. Concurrently used drugs:
  • Warfarin
  • Ramipril
  • Simvastatin
  • Metformin
  • Bendroflumethiazide
  • Atenolol
Soon after that, the consumer experienced the following side effects:
  • International Normalised Ratio Decreased
This opens a possibility that Gliclazide treatment could cause the above reactions, including international normalised ratio decreased, and some female subjects may be more susceptible.


Angina Pectoris, Hypoglycaemia, Abdominal Discomfort, Diarrhoea
A 62-year-old male patient (weight: NA) from HU with the following symptoms/conditions: type 2 diabetes mellitus started Gliclazide treatment (dosage: 60 Milligram Daily;) on 2013. Soon after starting Gliclazide treatment, the subject experienced various side effects, including:
  • Angina Pectoris
  • Hypoglycaemia
  • Abdominal Discomfort
  • Diarrhoea
Concurrently used drugs: NA. This finding indicates that some male patients could be more vulnerable to Gliclazide.

Hypoglycaemia, Weight Increased, Angina Pectoris
A 74-year-old female patient from HU (weight: NA) experienced symptoms, such as: type 2 diabetes mellitus and was treated with Gliclazide(dosage: 120 Mg, Daily). The treatment was initiated on NS. After that a consumer reported the following side effect(s):
  • Hypoglycaemia
  • Weight Increased
  • Angina Pectoris
Concurrently used drugs, which potentially could have contributed to side effect(s) or affected Gliclazide efficacy: NA.

International Normalised Ratio Decreased
In this report, Gliclazide was administered for the following condition: diabetes mellitus.A 72-year-old female consumer from GB (weight: NA) started Gliclazide treatment (dosage: 80 Mg, Qd) on Jan 29, 2013.Sometime after starting the treatment, the patient complained of the following side effect(s):
  • International Normalised Ratio Decreased
A possible interaction with other drugs could have contributed to this reaction:
  • Warfarin
  • Ramipril
  • Simvastatin
  • Metformin
  • Bendroflumethiazide
  • Atenolol
Establishing a causal relationship between a specific drug and consumer's side effects is complex, but it is possible that in this report Gliclazide treatment could be related to the listed above side effect(s).

Joint Swelling, Rheumatoid Arthritis, Palindromic Rheumatism
This is a report of the following Gliclazide side effect(s):
  • Joint Swelling
  • Rheumatoid Arthritis
  • Palindromic Rheumatism
A 56-year-old male patient from GB (weight: NA) presented with the following condition: NA and received a treatment with Gliclazide (dosage: 160mg Morning, 80mg Evening) starting: NS.The following concurrently used drugs could have generated interactions:
  • Metformin
  • Omeprazole
  • Ramipril
  • Sitagliptin
  • Citalopram
  • Methotrexate
  • Folic Acid
This report suggests that a Gliclazide treatment could be associated with the listed above side effect(s).

Mitral Valve Incompetence, Aortic Valve Incompetence, Fluid Retention
This Gliclazide report was submitted by a 50-year-old female consumer from IN (weight: NA). The patient was diagnosed with: type 2 diabetes mellitus and Gliclazide was administered (dosage: 160 Mg, Daily) starting: NS. The consumer developed a set of symptoms:
  • Mitral Valve Incompetence
  • Aortic Valve Incompetence
  • Fluid Retention
Other drugs used simultaneously:
  • Metformin Hydrochloride (Unk)
  • Pioglitazone (15 Mg, Daily)
  • Pioglitazone (30 Mg, Dailly)
  • Sitaglipin (100 Mg, Unk)
Those unexpected symptoms could be linked to a Gliclazide treatment, however establishing a potential drug-safety problem requires a more detailed clinical analysis.

Gastroenteritis, Incontinence, Hypotension, Fall, Constipation, Hypoglycaemia, Asthenia, Vomiting
This is a report of a possible correlation between Gliclazide use and the following symptoms/side effect(s):
  • Gastroenteritis
  • Incontinence
  • Hypotension
  • Fall
  • Constipation
  • Hypoglycaemia
  • Asthenia
  • Vomiting
which could contribute to an assessment of Gliclazide risk profile.A 65-year-old male consumer from GB (weight: NA) was suffering from type 2 diabetes mellitus and was treated with Gliclazide (dosage: 80 Mg) starting Oct 27, 2007.Other concurrent medications:
  • Metformin (2000 Mg)
  • Saxagliptin
  • Aspirin
  • Ramipril
The patient was hospitalized.

Cerebral Haematoma
A 58-year-old female patient from GB (weight: NA) presented with the following symptoms: diabetes mellitus and after a treatment with Gliclazide (dosage: Unk) experienced the following side effect(s):
  • Cerebral Haematoma
The treatment was started on May 14, 2012. Gliclazide was used in combination with the following drugs:
  • Levothyroxine (Unk)
  • Metformin (Unk)
  • Montelukast (Unk)
  • Ramipril (Unk)
  • Simvastatin (Unk)
  • Spironolactone (Unk)
  • Warfarin (Unk)
  • Victoza (1.2 Mg, Qd)
The patient was hospitalized.This report could alert potential Gliclazide consumers.

Liver Function Test Abnormal
In this report, a 69-year-old female patient from (weight: NA) was affected by a possible Gliclazide (gliclazide) side effect.The patient was diagnosed with NA. After a treatment with Gliclazide (gliclazide) (dosage: NA, start date: May 29, 2012), the patient experienced the following side effect(s):
  • Liver Function Test Abnormal
The following simultaneously used drugs could have led to this reaction:
  • Simvastatin
  • Tramadol Hcl
  • Trimethoprim
  • Alendronic Acid(alendronic Acid)
  • Gabapentin
  • Amitriptyline Hcl
  • Diazepam
  • Eplerenone
The patient was hospitalized.The findings here stress that side effects should be taken into consideration when evaluating a Gliclazide (gliclazide) treatment.

Aphasia, Cerebrovascular Accident, Metabolic Disorder, Obesity, Hypertension, Hemiparesis
This is a report of a 36-year-old female patient from UNITED KINGDOM (weight: NA), who used Gliclazide (dosage: NA) for a treatment of type 2 diabetes mellitus. After starting a treatment on NS, the patient experienced the following side effect(s):
  • Aphasia
  • Cerebrovascular Accident
  • Metabolic Disorder
  • Obesity
  • Hypertension
  • Hemiparesis
The following drugs could possibly have interacted with the Gliclazide treatment
  • Insulin
  • Rosiglitazone
  • Metformin Hcl
Taken together, these observations suggest that a Gliclazide treatment could be related to side effect(s), such as Aphasia, Cerebrovascular Accident, Metabolic Disorder, Obesity, Hypertension, Hemiparesis.

Cholelithiasis, Cholecystitis Acute
This cholelithiasis side effect was reported by a physician from FRANCE. A 68-year-old male patient (weight:NA) experienced the following symptoms/conditions: type 2 diabetes mellitus. The patient was prescribed Gliclazide (dosage: NA), which was started on Apr 04, 2010. Concurrently used drugs:
  • Aspirin Lysine
  • Janumet
  • Perindopril Arginine
  • Repaglinide
  • Metformin Pamoate
  • Januvia
When starting to take Gliclazide the consumer reported the following symptoms:
  • Cholelithiasis
  • Cholecystitis Acute
The patient was hospitalized. These side effects may potentially be related to Gliclazide.

Pancreatitis Chronic, Pancreatitis Necrotising, Pancreatic Neoplasm, Pancreatitis Acute
This is a Gliclazide side effect report of a 71-year-old male patient (weight:NA) from FRANCE, suffering from the following symptoms/conditions: type 2 diabetes mellitus, who was treated with Gliclazide (dosage:NA, start time: Jan 01, 2008), combined with:
  • Allopurinol
  • Januvia
  • Insulin Glargine
, and developed a serious reaction and a pancreatitis chronic side effect. The patient presented with:
  • Pancreatitis Chronic
  • Pancreatitis Necrotising
  • Pancreatic Neoplasm
  • Pancreatitis Acute
which developed after the beginning of treatment. The patient was hospitalized. This side effect report can indicate a possible existence of increased vulnerability to Gliclazide treatment in male patients suffering from type 2 diabetes mellitus, resulting in pancreatitis chronic.

Loss Of Consciousness, Diarrhoea, Duodenal Ulcer Haemorrhage, Faeces Discoloured, Gastrointestinal Haemorrhage, Syncope, Pallor
This report suggests a potential Gliclazide loss of consciousness side effect(s) that can have serious consequences. A 7-year-old male patient from UNITED KINGDOM (weight:NA) was diagnosed with the following health condition(s): NA and used Gliclazide (dosage: NA) starting NS. Soon after starting Gliclazide the patient began experiencing various side effects, including:
  • Loss Of Consciousness
  • Diarrhoea
  • Duodenal Ulcer Haemorrhage
  • Faeces Discoloured
  • Gastrointestinal Haemorrhage
  • Syncope
  • Pallor
Drugs used concurrently:
  • Amlodipine
  • Lisinopril
  • Pradaxa (150 Mg)
  • Aspirin
  • Metformin Hcl
  • Bisoprolol
  • Flucloxacillin
  • Metronidazole
The patient was hospitalized. Although Gliclazide demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as loss of consciousness, may still occur.

Hepatic Enzyme Increased
This hepatic enzyme increased problem was reported by a health professional from SOUTH AFRICA. A 32-year-old male patient (weight: NA) was diagnosed with the following medical condition(s): NA.On Mar 13, 2012 a consumer started treatment with Gliclazide (dosage: 80 Mg, Bid). The following drugs/medications were being taken at the same time:
  • 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)
When commencing Gliclazide, the patient experienced the following unwanted symptoms /side effects:
  • Hepatic Enzyme Increased
The patient was hospitalized. Although all drugs are carefully tested before they are licensed for use, they carry potential side effect risks. Some side effects, such as hepatic enzyme increased, may become evident only after a product is in use by the general population.

Acute Febrile Neutrophilic Dermatosis, Eosinophilia
This is a Gliclazide side effect report of a 64-year-old male patient (weight: NA) from FRANCE. The patient developed the following symptoms/conditions: NA and was treated with Gliclazide (dosage: NA) starting Feb 27, 2012. Concurrently used drugs:
  • Medrol (Unk)
  • Clarithromycin (Unk)
  • Amlodipine
  • Innovar (Unk)
  • Januvia
  • Nexium
  • Fluticasone Propionate/salmeterol
  • Levemir
Soon after that, the consumer experienced the following of symptoms:
  • Acute Febrile Neutrophilic Dermatosis
  • Eosinophilia
The patient was hospitalized. This opens a possibility that Gliclazide could cause acute febrile neutrophilic dermatosis and that some male patients may be more susceptible.

Diabetic Nephropathy
A 80-year-old male patient (weight: NA) from FRANCE with the following symptoms: NA started Gliclazide treatment (dosage: NA) on Jan 01, 2000. Soon after starting Gliclazide treatment, the consumer experienced several side effects, including:
  • Diabetic Nephropathy
. Concurrently used drugs:
  • Ramipril
  • Metformin Pamoate
This finding indicates that some patients can be more vulnerable to developing Gliclazide side effects, such as diabetic nephropathy.

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 (dosage: NA), which was started on May 16, 2012. Concurrently used drugs:
  • Xeloda
  • Metformin Hcl
  • Panadol Osteo
  • Lipitor
  • Irinotecan Hcl
.When starting to take Gliclazide the consumer reported symptoms, such as:
  • Cerebral Infarction
  • Hemiplegia
These side effects may potentially be related to Gliclazide.

Hospitalisation
This is a report of a female patient (weight: NA) from FRANCE, suffering from the following 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). The consumer presented with:
  • Hospitalisation
which developed 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.

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. Soon after starting Gliclazide the patient began experiencing various side effects, including:
  • Jaundice Cholestatic
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.

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 commencing Gliclazide, the patient experienced the following unwanted symptoms/side effects:
  • Large Intestine Perforation
Although 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.

Oedema, Oedema Peripheral, Mobility Decreased
This is a report of a 64-year-old male patient (weight: NA) from UNITED KINGDOM. The patient developed the following symptoms/conditions: NA and was treated with Gliclazide (dosage: NA) starting Mar 06, 2011. Concurrently used drugs:
  • Metformin
  • Perindopril
  • Amlodipine
  • Januvia
Soon after that, the consumer experienced the following side effects:
  • Oedema
  • Oedema Peripheral
  • Mobility Decreased
This opens a possibility that Gliclazide treatment could cause the above reactions, including oedema, and some male subjects may be more susceptible.

Cardiac Failure, Weight Decreased, Hypoglycaemia, Metastasis, Anuria, Bronchitis, Metastases To Peritoneum, Colon Cancer
A 76-year-old female patient (weight: NA) from FRANCE with the following symptoms/conditions: type 2 diabetes mellitus started Gliclazide treatment (dosage: NA) on Sep 22, 2010. Soon after starting Gliclazide treatment, the subject experienced various side effects, including:
  • Cardiac Failure
  • Weight Decreased
  • Hypoglycaemia
  • Metastasis
  • Anuria
  • Bronchitis
  • Metastases To Peritoneum
  • Colon Cancer
Concurrently used drugs:
  • Insulin Glargine
  • Insulin Glargine
  • Digoxin
  • Janumet
  • Insulin Glargine
  • Fosinopril Sodium And Hydrochlorothiazide
  • Bisoprolol Fumarate
  • Diltiazem Hydrochloride
The patient was hospitalized. This finding indicates that some female patients could be more vulnerable to Gliclazide.

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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.


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