GLICLAZIDE: 5,784 Adverse Event Reports & Safety Profile
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5,784
Total FAERS Reports
483 (8.4%)
Deaths Reported
3,195
Hospitalizations
5,784
As Primary/Secondary Suspect
651
Life-Threatening
178
Disabilities
First Report: 1998 · Latest Report: 20250825
What Are the Most Common GLICLAZIDE Side Effects?
#1 Most Reported
Hypoglycaemia
756 reports (13.1%)
#2 Most Reported
Nausea
596 reports (10.3%)
#3 Most Reported
Acute kidney injury
553 reports (9.6%)
All GLICLAZIDE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Hypoglycaemia | 756 | 13.1% | 67 | 483 |
| Nausea | 596 | 10.3% | 16 | 355 |
| Acute kidney injury | 553 | 9.6% | 57 | 348 |
| Drug ineffective | 507 | 8.8% | 3 | 206 |
| Fall | 415 | 7.2% | 6 | 347 |
| Dyspnoea | 400 | 6.9% | 50 | 266 |
| Vomiting | 385 | 6.7% | 9 | 293 |
| Lactic acidosis | 373 | 6.5% | 91 | 142 |
| Malaise | 360 | 6.2% | 9 | 263 |
| Hypertension | 351 | 6.1% | 1 | 158 |
| Fatigue | 338 | 5.8% | 0 | 254 |
| Diarrhoea | 337 | 5.8% | 16 | 160 |
| Cough | 335 | 5.8% | 0 | 204 |
| Diabetes mellitus inadequate control | 332 | 5.7% | 0 | 136 |
| Headache | 328 | 5.7% | 1 | 241 |
| Blood pressure increased | 302 | 5.2% | 13 | 232 |
| Rheumatoid arthritis | 296 | 5.1% | 0 | 180 |
| Pain | 295 | 5.1% | 0 | 174 |
| Off label use | 285 | 4.9% | 12 | 150 |
| Hyperkalaemia | 276 | 4.8% | 34 | 168 |
Who Reports GLICLAZIDE Side Effects? Age & Gender Data
Gender: 55.2% female, 44.8% male. Average age: 65.0 years. Most reports from: CA. View detailed demographics →
Is GLICLAZIDE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2000 | 24 | 0 | 11 |
| 2001 | 8 | 0 | 4 |
| 2003 | 8 | 1 | 7 |
| 2005 | 7 | 6 | 0 |
| 2006 | 6 | 0 | 2 |
| 2007 | 6 | 1 | 2 |
| 2008 | 4 | 0 | 2 |
| 2009 | 12 | 0 | 6 |
| 2010 | 22 | 0 | 14 |
| 2011 | 31 | 3 | 18 |
| 2012 | 80 | 6 | 54 |
| 2013 | 104 | 9 | 32 |
| 2014 | 215 | 6 | 126 |
| 2015 | 210 | 11 | 152 |
| 2016 | 218 | 46 | 152 |
| 2017 | 349 | 8 | 167 |
| 2018 | 514 | 93 | 280 |
| 2019 | 396 | 45 | 239 |
| 2020 | 264 | 28 | 164 |
| 2021 | 270 | 42 | 194 |
| 2022 | 178 | 18 | 112 |
| 2023 | 149 | 19 | 73 |
| 2024 | 102 | 1 | 78 |
| 2025 | 49 | 2 | 37 |
What Is GLICLAZIDE Used For?
| Indication | Reports |
|---|---|
| Type 2 diabetes mellitus | 1,859 |
| Product used for unknown indication | 1,832 |
| Diabetes mellitus | 1,414 |
| Blood pressure measurement | 107 |
| Blood pressure abnormal | 48 |
| Insulin-requiring type 2 diabetes mellitus | 48 |
| Blood glucose increased | 39 |
| Hyperglycaemia | 29 |
| Type 1 diabetes mellitus | 24 |
| Poisoning deliberate | 19 |
GLICLAZIDE vs Alternatives: Which Is Safer?
GLICLAZIDE vs GLIMEPIRIDE
GLICLAZIDE vs GLIMEPIRIDE\ROSIGLITAZONE
GLICLAZIDE vs GLIPIZIDE
GLICLAZIDE vs GLIVEC
GLICLAZIDE vs GLOFITAMAB
GLICLAZIDE vs GLOFITAMAB-GXBM
GLICLAZIDE vs GLUCAGON
GLICLAZIDE vs GLUCAGON\GLUCAGON\WATER
GLICLAZIDE vs GLUCARPIDASE
GLICLAZIDE vs GLUCOPHAGE
Official FDA Label for GLICLAZIDE
Official prescribing information from the FDA-approved drug label.