diazoxide
Brand names: Proglycem
VYKAT XR is a medicine used to treat excessive hunger in people with Prader-Willi syndrome. It helps to control their appetite.
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.
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.
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.
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.
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 500 FDA adverse event reports.
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
Death-Related Reports
95
Hospitalization Reports
298
Top Indication
Hypoglycaemia
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | DRUG INEFFECTIVE | 128 |
| 2 | HYPOGLYCAEMIA | 97 |
| 3 | OFF LABEL USE | 66 |
| 4 | HYPERGLYCAEMIA | 45 |
| 5 | DRUG INEFFECTIVE FOR UNAPPROVED INDICATION | 38 |
| 6 | DRUG INTERACTION | 30 |
| 7 | PRODUCT USE IN UNAPPROVED INDICATION | 27 |
| 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 |
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, chloramphenic...
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.
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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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 500 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.
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