Prescription medicine
Diazoxide Brand names: Vykat, Proglycem; first approved as Hyperstat
Diazoxide (Vykat) is a prescription medicine with an FDA approval on record since 1973. FDA's NDC Directory lists it from 2 generic labelers, and pharmacies paid $7.38 per mL (Diazoxide 50 mg/mL oral suspension) in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the diazoxide FDA label on DailyMed (effective March 26, 2025, Soleno Therapeutics, Inc.); the NDA 16996 record on Drugs@FDA; every diazoxide label on DailyMed.
Highlights of the record
FDA label of March 26, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageVYKAT XR is indicated for the treatment of hyperphagia in adults and pediatric patients 4 years of age and older with Prader-Willi syndrome (PWS).
Forms and strengths
- 25 mg
- 75 mg
- 150 mg
- 50 mg/ml
Film-coated tablet; suspension.
On the market
- Earliest approval on file
- January 22, 1973 Hyperstat, Schering; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 2 first December 20, 2019; 2 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 4 of which 2 under generic applications, 2 under brand applications, repackagers included
- Last listed patent
- November 12, 2035 Vykat XR tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $7.38 per mL Diazoxide 50 mg/mL oral suspension
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 1,254 through July 30, 2026
What is diazoxide used for?
From the label: indications and usageVYKAT XR is indicated for the treatment of hyperphagia in adults and pediatric patients 4 years of age and older with Prader-Willi syndrome (PWS). VYKAT XR is indicated for the treatment of hyperphagia in adults and pediatric patients 4 years of age and older with Prader-Willi syndrome (PWS).
Source: FDA drug label (VYKAT XR), Soleno Therapeutics, Inc., effective March 26, 2025 (SPL set 0e745e85-9512-e360-e063-6394a90aebf1), via openFDA; the full label on DailyMed
What does the patient leaflet for diazoxide say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about VYKAT XR?VYKAT XR may cause serious side effects, including: High blood sugar levels (hyperglycemia). Hyperglycemia is common during treatment with VYKAT XR and can also be severe. Hyperglycemia can lead to a condition called diabetic ketoacidosis (increased ketones in the blood) in some people who take VYKAT XR. Diabetic ketoacidosis is a serious condition that needs to be treated in a hospital and can be life-threatening. Your healthcare provider will: check your blood sugar levels before you start VYKAT XR, at least 1 time every week for the first 2 weeks of treatment, then at least 1 time every 4 weeks and as needed during treatment. check your blood sugar more often during the first few weeks of treatment if you have an increased chance of getting hyperglycemia. check your HbA1c, which is another measurement of blood sugar control, before starting treatment, then 1 time every 3 months and as needed during treatment. […] Tell your healthcare provider if you have trouble breathing or get any other signs or symptoms of fluid overload such as swelling of your legs, ankles, or feet, or unusual swelling anywhere in your body. […]
From the patient leaflet: How should I store VYKAT XR?Store VYKAT XR at room temperature between 68°F to 77°F (20°C to 25°C). Close the bottle tightly after each dose. Keep VYKAT XR tablets dry (protect from humidity). The bottle contains a desiccant to help keep the tablets dry. Keep the desiccant in the VYKAT XR bottle. Keep VYKAT XR and all medicines out of the reach of children.
Source: FDA drug label (VYKAT XR), Soleno Therapeutics, Inc., effective March 26, 2025 (SPL set 0e745e85-9512-e360-e063-6394a90aebf1), via openFDA; the full label on DailyMed
Is there a generic for diazoxide (Vykat)?
The FDA approved the first generic diazoxide on December 20, 2019. 2 generic applications are approved; 2 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists diazoxide from 2 labelers under a generic (ANDA) application and from 2 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists 6 patents for Vykat XR tablets: the compound patent runs to March 5, 2029, and the last listed entry to November 12, 2035. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1973 earliest approval on file
- 2019 first generic approved
- 2035 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for diazoxide (Vykat)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $7.38 per mL (Diazoxide 50 mg/mL oral suspension), up 4% from $7.09 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Diazoxide 50 mg/mL oral suspension (generic)
- Proglycem 50 mg/mL oral suspension (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Diazoxide 50 mg/mL oral suspension | Generic | $7.38 per mL | n/a | +4% |
| Proglycem 50 mg/mL oral suspension | Brand | $16.48 per mL | n/a | +7% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the diazoxide label say about other medicines?
The diazoxide label names no other medicine on this site. The labels of 7 other medicines name diazoxide. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
Other labels that name diazoxide
Source: FDA drug label (VYKAT XR), Soleno Therapeutics, Inc., effective March 26, 2025 (SPL set 0e745e85-9512-e360-e063-6394a90aebf1), via openFDA; the full label on DailyMed
What do FAERS reports show for diazoxide?
The FDA Adverse Event Reporting System holds 1,254 reports that list diazoxide among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 104 are coded as a death and 379 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Diazoxide side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other