diazoxide Side Effects
Also known as: Proglycem
Analysis of 705 adverse event reports submitted to the FDA from 2004 to 2025.
Total Reports
705
Death-Related
95
13.5% of reports
Hospitalizations
298
42.3% of reports
Top Indication
Hypoglycaemia
Most Reported Adverse Reactions
Who Reports Side Effects
Gender Distribution
Age Distribution
Reporting Trend by Year
Reactions in Death Reports
Top reactions reported in 95 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| DEATH | 22 |
| DRUG INEFFECTIVE | 15 |
| HYPOGLYCAEMIA | 15 |
| CARDIAC FAILURE | 10 |
| MALIGNANT NEOPLASM PROGRESSION | 10 |
| INSULINOMA | 9 |
| SEPSIS | 8 |
| OFF LABEL USE | 6 |
| HYPERGLYCAEMIA | 5 |
| NECROTISING COLITIS | 5 |
| RENAL FAILURE | 5 |
| HYPOGLYCAEMIC SEIZURE | 4 |
| HYPOTENSION | 4 |
| HYPOXIA | 4 |
| MULTI-ORGAN FAILURE | 4 |
| NEUTROPENIA | 4 |
| ASTHENIA | 3 |
| CARDIO-RESPIRATORY ARREST | 3 |
| CONDITION AGGRAVATED | 3 |
| DISEASE PROGRESSION | 3 |
Reactions in Hospitalization Reports
Top reactions in 298 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| DRUG INEFFECTIVE | 53 |
| HYPOGLYCAEMIA | 45 |
| OFF LABEL USE | 25 |
| HYPERGLYCAEMIA | 21 |
| OEDEMA PERIPHERAL | 21 |
| DRUG INEFFECTIVE FOR UNAPPROVED INDICATION | 18 |
| PULMONARY HYPERTENSION | 15 |
| DRUG INTERACTION | 14 |
| CARDIAC FAILURE CONGESTIVE | 13 |
| HYPERGLYCAEMIC HYPEROSMOLAR NONKETOTIC SYNDROME | 13 |
| MALIGNANT NEOPLASM PROGRESSION | 12 |
| OEDEMA | 12 |
| PNEUMONIA | 12 |
| PYREXIA | 12 |
| THROMBOCYTOPENIA | 12 |
| NAUSEA | 11 |
| WEIGHT DECREASED | 11 |
| WEIGHT INCREASED | 11 |
| FALL | 10 |
| INSULINOMA | 10 |
Nearby — Related Medications
What the FAERS Data Reveals About diazoxide Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 705 voluntary reports linked to diazoxide and its brand equivalents (Proglycem), spanning 2004 through 2025. Of those, 95 (13.5%) listed death as an outcome and 298 (42.3%) involved hospitalization. The most common indication reported alongside adverse events was Hypoglycaemia.
Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 52% were female and 47% male; age distribution skews toward 0-17, with 165 reports in that bracket. The single most reported reaction is drug ineffective with 128 submissions, followed by hypoglycaemia and off label use.
FAERS is a signal-detection tool, not a scorecard. Reports are voluntary, and a single case may list multiple suspect drugs, so numbers above should not be read as incidence rates or per-patient risk. Widely prescribed drugs naturally accumulate more reports than niche therapies even when individual risk is low. These aggregates are useful for spotting patterns that merit further pharmacovigilance, not for choosing between medications. This page is for educational reference only and is not medical advice — speak with a licensed clinician about any side-effect concerns.
Read our methodology — how this data is sourced, computed, and verified.