Prescription medicine
Lisdexamfetamine Brand names: Vyvanse, Arynta
Lisdexamfetamine (Vyvanse) is a prescription medicine with an FDA approval on record since 2007. FDA's NDC Directory lists it from 19 generic labelers, and pharmacies paid $2.44 per lisdexamfetamine 20 mg capsule in the October 7, 2026 NADAC survey.
- Generic listed
- In shortage
- Boxed warning
- DEA Schedule II
Check it at the source: the lisdexamfetamine FDA label on DailyMed (effective April 30, 2026, Takeda Pharmaceuticals America, Inc.); the NDA 21977 record on Drugs@FDA; every lisdexamfetamine label on DailyMed.
Highlights of the record
FDA label of April 30, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
ABUSE, MISUSE, AND ADDICTION.
VYVANSE has a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including VYVANSE, can result in overdose and death [see Overdosage (10) ], and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection. Before prescribing VYVANSE, assess each patient's risk for abuse, misuse, and addiction. Educate patients and their families about these risks, proper storage of the drug, and proper disposal of any unused drug. Throughout VYVANSE treatment, reassess each patient's risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction [see Warnings and Precautions (5.1), Drug Abuse and Dependence (9.2) ]. WARNING: ABUSE, MISUSE, AND ADDICTION See full prescribing information for complete boxed warning. VYVANSE has a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including VYVANSE, can result in overdose and death ( 5.1 , 9.2 , 10 ): Before prescribing VYVANSE, assess each patient's risk for abuse, misuse, and addiction. Educate patients and their families about these risks, proper storage of the drug, and proper disposal of any unused drug. […]
Used for
From the label: indications and usageVYVANSE ® is indicated for the treatment of: Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1) ].
Forms and strengths
- 10 mg
- 20 mg
- 30 mg
- 40 mg
- 50 mg
- 60 mg
- 70 mg
- 10 mg/ml
Capsule; chewable tablet; solution.
On the market
- Earliest approval on file
- February 23, 2007 Vyvanse, Takeda Pharms Usa; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 22 first August 25, 2023; 22 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 21 of which 19 under generic applications, 2 under brand applications, repackagers included
- Last listed patent
- August 30, 2040 Arynta oral solution; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $2.44 per capsule Lisdexamfetamine 20 mg capsule
- Shortage (FDA)
- 34 of 108 presentations limited or unavailable updated October 6, 2026
- Recalls by its makers (FDA)
- 11 since 2016 0 Class I among all firms' recalls; latest October 28, 2025
- FAERS reports
- 34,602 through July 30, 2026
What is lisdexamfetamine used for?
From the label: indications and usageVYVANSE ® is indicated for the treatment of: Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1) ]. Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2) ]. […]
Conditions named in the indications of lisdexamfetamine's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Central Nervous System Stimulant.
Source: FDA drug label (Vyvanse), Takeda Pharmaceuticals America, Inc., effective April 30, 2026 (SPL set 704e4378-ca83-445c-8b45-3cfa51c1ecad), via openFDA; the full label on DailyMed
What does the patient leaflet for lisdexamfetamine 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 VYVANSE?VYVANSE may cause serious side effects, including: Abuse, misuse, and addiction. VYVANSE has a high chance for abuse and misuse and may lead to substance use problems, including addiction. Misuse and abuse of VYVANSE, other amphetamine containing medicines, and methylphenidate containing medicines, can lead to overdose and death. The risk of overdose and death is increased with higher doses of VYVANSE or when it is used in ways that are not approved, such as snorting or injection. Your healthcare provider should check you or your child's risk for abuse, misuse, and addiction before starting treatment with VYVANSE and will monitor you or your child during treatment. VYVANSE may lead to physical dependence after prolonged use, even if taken as directed by your healthcare provider. Do not give VYVANSE to anyone else. See " What is VYVANSE? " for more information. Keep VYVANSE in a safe place and properly dispose of any unused medicine. See " How should I store VYVANSE? " for more information. Tell your healthcare provider if you or your child have ever abused or been dependent on alcohol, prescription medicines, or street drugs. Risks for people with serious heart disease. Sudden death has happened in people who have heart defects or other serious heart disease. Your healthcare provider should check you or your child carefully for heart problems before starting treatment with VYVANSE. Tell your healthcare provider if you or your child have any heart problems, heart disease, or heart defects. Call your healthcare provider right away or go to the nearest hospital emergency room right away if you or your child have any signs of heart problems such as chest pain, shortness of breath, or fainting during treatment with VYVANSE. Increased blood pressure and heart rate. […]
From the patient leaflet: How should I store VYVANSE?Store VYVANSE in a safe place (like a locked cabinet) at room temperature between 68°F to 77°F (20°C to 25°C). Keep the container tightly closed and protect VYVANSE from light. Dispose of remaining, unused, or expired VYVANSE by a medicine take-back program at a U.S. Drug Enforcement Administration (DEA) authorized collection site. If no take-back program or DEA authorized collector is available, mix VYVANSE with an undesirable, nontoxic substance such as dirt, cat litter, or used coffee grounds to make it less appealing to children and pets. Place the mixture in a container such as a sealed plastic bag and throw away VYVANSE in the household trash. Visit www.fda.gov/drugdisposal for additional information on disposal of unused medicines. Keep VYVANSE and all medicines out of the reach of children.
Source: FDA drug label (Vyvanse), Takeda Pharmaceuticals America, Inc., effective April 30, 2026 (SPL set 704e4378-ca83-445c-8b45-3cfa51c1ecad), via openFDA; the full label on DailyMed
Is there a generic for lisdexamfetamine (Vyvanse)?
The FDA approved the first generic lisdexamfetamine on August 25, 2023. 22 generic applications are approved; 22 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 lisdexamfetamine from 19 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 no patent for Vyvanse capsules; a patent listed only for Arynta oral solution runs to August 30, 2040. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2007 earliest approval on file
- 2023 first generic approved
- 2040 last listed patent
- 2023 to now in shortage
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for lisdexamfetamine (Vyvanse)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $2.44 per Lisdexamfetamine 20 mg capsule, down 32% from $3.57 on October 8, 2025. The survey records the price, not the reason for a change; large moves often follow a new generic or a list-price change. 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.
- Lisdexamfetamine 20 mg capsule (generic)
- Vyvanse 30 mg capsule (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Lisdexamfetamine 10 mg capsule | Generic | $2.62 per capsule | $78.72 | -19% |
| Lisdexamfetamine 10 mg tablet chewable | Generic | $3.74 per tablet | $112.15 | -44% |
| Lisdexamfetamine 20 mg capsule | Generic | $2.44 per capsule | $73.11 | -32% |
| Lisdexamfetamine 20 mg tablet chewable | Generic | $4.34 per tablet | $130.14 | -35% |
| Lisdexamfetamine 30 mg capsule | Generic | $2.70 per capsule | $81.03 | -23% |
| Lisdexamfetamine 30 mg tablet chewable | Generic | $3.29 per tablet | $98.74 | -55% |
| Lisdexamfetamine 40 mg capsule | Generic | $2.60 per capsule | $78.04 | -26% |
| Lisdexamfetamine 40 mg tablet chewable | Generic | $3.98 per tablet | $119.42 | -38% |
| Lisdexamfetamine 50 mg capsule | Generic | $2.64 per capsule | $79.19 | -26% |
| Lisdexamfetamine 50 mg tablet chewable | Generic | $3.65 per tablet | $109.46 | -40% |
| Lisdexamfetamine 60 mg capsule | Generic | $2.67 per capsule | $80.19 | -21% |
| Lisdexamfetamine 60 mg tablet chewable | Generic | $3.65 per tablet | $109.38 | -37% |
| Lisdexamfetamine 70 mg capsule | Generic | $2.68 per capsule | $80.26 | -20% |
| Vyvanse 10 mg capsule | Brand | $12.35 per capsule | $370.48 | -0.1% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Is lisdexamfetamine in shortage?
The FDA Drug Shortage Database lists 34 of 108 lisdexamfetamine presentations as limited or unavailable (updated October 6, 2026); the first entry was posted on July 14, 2023. 74 more presentations are on the list as available.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Lisdexamfetamine Dimesylate, Capsule, 10 mg (NDC 0054-0660-25) | Hikma Pharmaceuticals USA, Inc. | Current | May 12, 2026 |
| Lisdexamfetamine Dimesylate, Capsule, 10 mg (NDC 0378-6854-77) | Mylan Pharmaceuticals Inc., a Viatris Company | Current | October 5, 2026 |
| Lisdexamfetamine Dimesylate, Capsule, 10 mg (NDC 0406-5111-01) | SpecGx LLC | Current | August 20, 2026 |
| Lisdexamfetamine Dimesylate, Capsule, 10 mg (NDC 0480-3565-01) | Teva Pharmaceuticals USA, Inc. | Current | October 1, 2026 |
| Lisdexamfetamine Dimesylate, Capsule, 10 mg (NDC 0527-4661-37) | Lannett Company, Inc. | Current | October 1, 2026 |
| Lisdexamfetamine Dimesylate, Capsule, 10 mg (NDC 42858-161-01) | Rhodes Pharmaceuticals L.P. | Current | June 24, 2026 |
| Lisdexamfetamine Dimesylate, Capsule, 10 mg (NDC 43547-602-10) | Solco Healthcare US, LLC | Current | June 29, 2026 |
| Lisdexamfetamine Dimesylate, Capsule, 10 mg (NDC 47781-562-01) | Alvogen | Current | October 2, 2026 |
Every lisdexamfetamine presentation in the FDA shortage database
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
Has lisdexamfetamine been recalled?
The FDA's Enforcement Report lists 11 recalls naming lisdexamfetamine since 2016: 0 Class I (the most serious), 10 Class II, 1 Class III; 8 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| October 28, 2025 | Class II | SUN PHARMACEUTICAL INDUSTRIES INC | Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25°C … |
| August 11, 2025 | Class II | Lannett Company Inc. | Labeling: Label Mix-up. A bottle labeled as Lisdexamphetamine Dimesylate Capsules 40mg, contained Lisdexamphetamine Dimesylate Capsules 30mg. |
| June 16, 2025 | Class II | SUN PHARMACEUTICAL INDUSTRIES INC | Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 9 month long term stability station (25°C … |
| October 25, 2024 | Class II | Lannett Company Inc. | Failed Content Uniformity Specifications: Product failed to meet the action limits for stratified content uniformity. |
| September 2, 2016 | Class III | Shire | Presence of Foreign Tablets/Capsules |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the lisdexamfetamine label say about other medicines?
The lisdexamfetamine label names 8 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Amphetamine | contraindications | CONTRAINDICATIONS VYVANSE is contraindicated in patients with: Known hypersensitivity to amphetamine products or other ingredients of VYVANSE. |
| Buspirone | warnings and precautions | … reuptake inhibitors (SNRIs), triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, and St. John's Wort [see Drug Interactions (7.1) ]. |
| Dextroamphetamine | drug interactions | Clinical Impact; The concomitant use of VYVANSE and CYP2D6 inhibitors may increase the exposure of dextroamphetamine, the active metabolite of VYVANSE compared to the use of the drug alone and increase the risk of serotonin syndrome. |
| Fentanyl | warnings and precautions | … inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, and St. John's Wort [see Drug Interactions (7.1) ]. |
| Linezolid | contraindications | Patients taking monoamine oxidase inhibitors (MAOIs), or within 14 days of stopping MAOIs (including MAOIs such as linezolid or intravenous methylene blue), because of an increased risk of hypertensive crisis [see Warnings and Precautions (5.7) and Drug Interactions (7.1) ]. |
| Lithium | warnings and precautions | … (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, and St. John's Wort [see Drug Interactions (7.1) ]. |
| Methylene blue | contraindications | Patients taking monoamine oxidase inhibitors (MAOIs), or within 14 days of stopping MAOIs (including MAOIs such as linezolid or intravenous methylene blue), because of an increased risk of hypertensive crisis [see Warnings and Precautions (5.7) and Drug Interactions (7.1) ]. |
| Tramadol | warnings and precautions | … serotonin norepinephrine reuptake inhibitors (SNRIs), triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, and St. John's Wort [see Drug Interactions (7.1) ]. |
Source: FDA drug label (Vyvanse), Takeda Pharmaceuticals America, Inc., effective April 30, 2026 (SPL set 704e4378-ca83-445c-8b45-3cfa51c1ecad), via openFDA; the full label on DailyMed
What do FAERS reports show for lisdexamfetamine?
The FDA Adverse Event Reporting System holds 34,602 reports that list lisdexamfetamine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 470 are coded as a death and 4,332 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 else is labeled for the same conditions as lisdexamfetamine?
10 other medicines are given the same way (oral) and in the same FDA class as lisdexamfetamine or labeled mainly for the same use (ADHD), the same class first. ADHD lists all 12 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Methylphenidate | ADHD | 31 labelers | $0.158 per tablet 10 mg tablet | In shortage |
| Amphetamine and dextroamphetamine | ADHD | 25 labelers | $0.233 per tablet 10 mg tablet | In shortage |
| Dexmethylphenidate | ADHD | 13 labelers | $1.45 per capsule 10 mg capsule | No current entry |
| Amphetamine | ADHD | 13 labelers | $0.449 per tablet 10 mg tablet | No current entry |
| Dextroamphetamine | ADHD | 14 labelers | $0.373 per tablet 10 mg tablet | No current entry |
| Dexmethylphenidate and serdexmethylphenidate | ADHD | none listed | $14.40 per capsule 26.1 mg-5.2 mg capsule | No current entry |
| Methamphetamine | ADHD | 3 labelers | $5.10 per tablet 5 mg tablet | No current entry |
| Atomoxetine | ADHD | 20 labelers | $0.442 per capsule 40 mg capsule | No current entry |
Every medicine labeled for the same conditions as lisdexamfetamine
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does lisdexamfetamine compare with medicines for the same use?
6 side-by-side pages set lisdexamfetamine beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to lisdexamfetamine
- 10 medicines for the same use
- Other stimulants
- the pharmacologic class, with prices and generics
- Lisdexamfetamine side effects
- the label's list beside FAERS reports
- Lisdexamfetamine shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other