Prescription medication · Potassium Channel Opener (Hyperinsulinism)
diazoxide
Also sold as Proglycem. VYKAT XR treats hyperphagia (excessive hunger) in people aged 4 years and older who have Prader-Willi syndrome (PWS).
Data updated 2026-05-15
- 705
- FDA reportsRarely reported
- 3
- InteractionsFew interactions
- 50% less
- Generic vs brandBig savings
- $14.10
- Brand price (NADAC)
What the data shows
diazoxide (Proglycem) is a prescription Potassium Channel Opener (Hyperinsulinism), among the least-reported drugs the FDA tracks (705 FDA reports), whose generic runs roughly half the brand price or less (50% less).
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
diazoxide (Proglycem) is a prescription Potassium Channel Opener (Hyperinsulinism). VYKAT XR treats hyperphagia (excessive hunger) in people aged 4 years and older who have Prader-Willi syndrome (PWS).
VYKAT XR is a medicine used to treat excessive hunger in people with Prader-Willi syndrome. It helps to control their appetite.
Verify with FDA → · CMS NADAC pricing →
Drug Pricing (NADAC)
Brand Price
$14.10/unit
Generic Price
$7.10/unit
Generic Savings
50%
Generic Available
Yes (2 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
VYKAT XR treats hyperphagia (excessive hunger) in people aged 4 years and older who have Prader-Willi syndrome (PWS).
Common side effects
Increased hair growth, Swelling, High blood sugar
Key warnings
VYKAT XR can cause high blood sugar, sometimes leading to a serious condition called diabetic ketoacidosis.
The sections below are summarized in plain English from diazoxide's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
VYKAT XR contains diazoxide choline. It is thought to work by affecting how insulin is released in the body. This helps to reduce hunger.
How to Take It
Take VYKAT XR once a day by mouth. You can take it with or without food. Swallow the tablets whole; do not crush, split, or chew them. Your doctor will determine the right dose for you based on your weight.
This is a plain-language summary of diazoxide's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
Pregnancy & Breastfeeding
It is not known if VYKAT XR can harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant. It is also not known if VYKAT XR passes into breast milk. Talk to your doctor about the best way to feed your baby if you are taking this medicine.
This is a plain-language summary of diazoxide's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.
Missed Dose
If you miss a dose of VYKAT XR, take it as soon as you remember. If you miss doses for 7 days or more, talk to your doctor about how to restart the medicine.
This is a plain-language summary of diazoxide's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
Storage
Store VYKAT XR at room temperature (68°F to 77°F) in a tightly closed container, away from humidity. Keep the desiccant in the bottle.
Side Effects (from patient reports)
Based on 705 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for diazoxide, by number of reports
- Low blood sugar
Low blood sugar
97 reports
- High blood sugar
High blood sugar
45 reports
- The medicine is not working for a condition it's not approved for 38
The medicine is not working for a condition it's not approved for
38 reports
- The medicine is interacting with another medicine 30
The medicine is interacting with another medicine
30 reports
- Swelling in the arms or legs 25
Swelling in the arms or legs
25 reports
- Death 22
Death
22 reports
- Cancer getting worse 22
Cancer getting worse
22 reports
- Tumor in the pancreas that makes insulin 21
Tumor in the pancreas that makes insulin
21 reports
- Feeling sick to your stomach 21
Feeling sick to your stomach
21 reports
- Severe inflammation of the colon 19
Severe inflammation of the colon
19 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for diazoxide each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where diazoxide sits
diazoxide has more FDA adverse-event reports than 4% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is diazoxide; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 705 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2004–2025.
Total Reports
705
Reports Mentioning Death
95
13.5% of reports — not proof of cause
Hospitalization Reports
298
Top Indication
Hypoglycaemia
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 2 | HYPOGLYCAEMIA | 97 |
| 4 | HYPERGLYCAEMIA | 45 |
| 5 | DRUG INEFFECTIVE FOR UNAPPROVED INDICATION | 38 |
| 6 | DRUG INTERACTION | 30 |
| 8 | OEDEMA PERIPHERAL | 25 |
| 9 | DEATH | 22 |
| 10 | MALIGNANT NEOPLASM PROGRESSION | 22 |
| 11 | INSULINOMA | 21 |
| 12 | NAUSEA | 21 |
| 13 | NECROTISING COLITIS | 19 |
| 14 | OEDEMA | 19 |
| 15 | CARDIAC FAILURE | 18 |
| 16 | CONDITION AGGRAVATED | 18 |
| 17 | PULMONARY HYPERTENSION | 18 |
| 18 | THROMBOCYTOPENIA | 18 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
VYKAT XR can cause high blood sugar, sometimes leading to a serious condition called diabetic ketoacidosis. Watch for signs like excessive thirst, frequent urination, and increased appetite with weight loss. This medicine can also cause fluid overload. Tell your doctor if you notice swelling or other signs of fluid retention.
Known Drug Interactions
Highly protein-bound drugs include diazepam, diazoxide, and lidocaine. 7.3 Other Highly Protein-Bound Drugs Raloxifene hydrochloride should be used with caution with certain other highly protein-bound drugs such as diazepam, diazoxide, and lidocaine.
Mechanism: These drugs compete for the same binding spots on proteins in your bloodstream. This competition can change how much of each drug is active in your body at one time.
What to do: Use this combination with caution. Your healthcare provider may need to monitor your response to these medications more frequently.
The following are examples of medications that may reduce the glucose-lowering effect of sulfonylureas including glimepiride, leading to worsening glycemic control: danazol, glucagon, somatropin, protease inhibitors, atypical antipsychotic medications (e.g., olanzapine and clozapine), barbiturates, diazoxide, laxatives, rifampin, thiazides and other diuretics, corticosteroids, phenothiazines, thyroid hormones, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics (e.g., epinephrine, albuterol, terbutaline), and isoniazid.
Mechanism: Diazoxide can cause blood sugar to rise, which prevents glimepiride from working as well as it should.
What to do: Your doctor may need to check your blood sugar more frequently and might change your dose.
Table 1: Drugs That Affect Phenytoin Concentrations Interacting Agent Examples Drugs that may increase phenytoin serum levels Antiepileptic drugs Ethosuximide, felbamate, oxcarbazepine, methsuximide, topiramate Azoles Fluconazole, ketoconazole, itraconazole, miconazole, voriconazole Antineoplastic agents Capecitabine, fluorouracil Antidepressants Fluoxetine, fluvoxamine, sertraline Gastric acid reducing agents H 2 antagonists (cimetidine), omeprazole Sulfonamides Sulfamethizole, sulfaphenazole, sulfadiazine, sulfamethoxazole trimethoprim Other Acute alcohol intake, amiodarone,...
Mechanism: Diazoxide can lower the amount of phenytoin in your blood, which might make your seizure medicine work less effectively.
What to do: Your doctor should monitor your phenytoin blood levels and may need to increase your dose.
This is a plain-language summary of interactions documented in FDA labeling, not individualized advice. Ask a pharmacist or prescriber before combining medications.
Common Questions
Can I split the VYKAT XR tablets?
What should I do if my blood sugar gets too high?
How often will my blood sugar be checked?
Can I take VYKAT XR with other medicines?
What are the signs of fluid overload?
How long will I need to take VYKAT XR?
What should I do if I have side effects?
Can VYKAT XR cure Prader-Willi syndrome?
Is it okay to stop taking VYKAT XR if I feel better?
Are there any foods I should avoid while taking VYKAT XR?
What are the common side effects of diazoxide?
Does diazoxide interact with other medications?
What drug class is diazoxide?
Is there a generic version of diazoxide?
Is diazoxide safe during pregnancy?
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canagliflozin
Invokana
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colesevelam
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What the FDA Data Shows for diazoxide
The FDA label for diazoxide (sold under brand names such as Proglycem) classifies it as a prescription-only medication in the Potassium Channel Opener (Hyperinsulinism) class. VYKAT XR treats hyperphagia (excessive hunger) in people aged 4 years and older who have Prader-Willi syndrome (PWS). Official labeling lists 8 commonly reported side effects, including Increased hair growth, Swelling, High blood sugar.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 705 voluntary reports. The database also lists 3 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated moderate severity. NADAC pricing from CMS shows a generic unit cost of $7.10 versus $14.10 for the brand - a 50% generic savings.
Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice, always consult a licensed healthcare provider before starting, stopping, or changing any medication.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.
Last updated: March 26, 2025
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages