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Drug side effects

diazoxide Side Effects

The reactions most often reported to the FDA for diazoxide (also sold as Proglycem), with demographics, serious outcomes, and reporting trends.

Data updated 2026-05-15

705
FAERS reports

Data from the FDA Adverse Event Reporting System (FAERS), 2004 to 2025. A FAERS report records a temporal association, not proof of cause. See our methodology for how figures are compiled and de-duplicated.

The most commonly reported side effects of diazoxide come from 705 reports to the FDA, broken down here by frequency, patient demographics, and serious outcomes.

This page analyzes 705 reports to the FDA Adverse Event Reporting System (FAERS) for diazoxide (Proglycem): the reactions reported most often, who reported them, serious outcomes such as hospitalization, and year-over-year trends. A FAERS report does not prove the drug caused the effect, and report volume tracks how widely a drug is used, not how likely an effect is for any one person. Educational information, not medical advice.

Total Reports

705

Reports Mentioning Death

95

13.5% of reports — not proof the medicine caused the death

Hospitalizations

298

42.3% of reports

Top Indication

Hypoglycaemia

Most Reported Adverse Reactions

HYPOGLYCAEMIA
97
HYPERGLYCAEMIA
45
DRUG INEFFECTIVE FOR UNAPPROVED INDICATION
38
DRUG INTERACTION
30
OEDEMA PERIPHERAL
25
DEATH
22
MALIGNANT NEOPLASM PROGRESSION
22
INSULINOMA
21
NAUSEA
21
NECROTISING COLITIS
19
OEDEMA
19
CARDIAC FAILURE
18
CONDITION AGGRAVATED
18
PULMONARY HYPERTENSION
18
THROMBOCYTOPENIA
18
VOMITING
18
WEIGHT INCREASED
18

Who Reports Side Effects

Gender Distribution

Female 338 (52%)
Male 302 (47%)
Unknown 6

Age Distribution

0-17 165 (33%)
18-44 101 (20%)
45-64 100 (20%)
65-74 67 (14%)
75+ 62 (13%)

Reporting Trend by Year

2004 2025

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
HYPOGLYCAEMIA 15
CARDIAC FAILURE 10
MALIGNANT NEOPLASM PROGRESSION 10
INSULINOMA 9
SEPSIS 8
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
HYPOGLYCAEMIA 45
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

Compare diazoxide vs acarbose →

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 hypoglycaemia with 97 submissions, followed by hyperglycaemia and drug ineffective for unapproved indication.

How to read these numbers

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.

Drugs With a Similar FAERS Report Volume

Other medications with a total FDA adverse-event report count closest to diazoxide's 705.