lisdexamfetamine
Brand names: Vyvanse
Lisdexamfetamine (Vyvanse) is a stimulant medicine. It can help improve focus and reduce impulsive behavior.
Drug Shortage Alert
lisdexamfetamine is currently listed as in shortage by the FDA. Affected manufacturer: Rhodes Pharmaceuticals L.P.. Status: Available.
View all drug shortages →Drug Pricing (NADAC)
Brand Price
$12.38/unit
Generic Price
$4.93/unit
Generic Savings
60%
Generic Available
Yes (21 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
This medicine treats Attention Deficit Hyperactivity Disorder (ADHD) in adults and kids 6 years and older.
Common side effects
Anorexia, Anxiety, Decreased appetite
Key warnings
This medicine has a high risk for abuse, misuse, and addiction.
How It Works
Lisdexamfetamine affects chemicals in your brain. These chemicals help control hyperactivity and impulses. It can also help reduce binge eating.
How to Take It
Take this medicine by mouth in the morning, with or without food. Do not take it in the afternoon, as it may cause trouble sleeping. You can swallow the capsule whole, or open it and mix the contents with yogurt, water, or orange juice. Take the mixture right away and do not store it for later.
Pregnancy & Breastfeeding
This medicine may harm your unborn baby. Tell your doctor if you are pregnant or plan to become pregnant. Breastfeeding is not recommended while taking this medicine.
Missed Dose
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular schedule.
Storage
Store this medicine at room temperature, away from light and moisture.
Side Effects (from patient reports)
Based on 5,614 FDA adverse event reports.
FDA Adverse Event Report Analysis
Detailed analysis of 5,840 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2007–2025.
Total Reports
5,840
Death-Related Reports
208
Hospitalization Reports
1,746
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | INTENTIONAL OVERDOSE | 1,068 |
| 2 | INTENTIONAL SELF-INJURY | 1,009 |
| 3 | DRUG INEFFECTIVE | 904 |
| 4 | PRODUCT AVAILABILITY ISSUE | 487 |
| 5 | FATIGUE | 402 |
| 6 | HEADACHE | 377 |
| 7 | ANXIETY | 357 |
| 8 | INABILITY TO AFFORD MEDICATION | 348 |
| 9 | PRODUCT SUBSTITUTION ISSUE | 344 |
| 10 | OFF LABEL USE | 318 |
| 11 | DEPRESSION | 303 |
| 12 | CONDITION AGGRAVATED | 268 |
| 13 | INSOMNIA | 248 |
| 14 | PRODUCT USE ISSUE | 244 |
| 15 | INSURANCE ISSUE | 230 |
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
This medicine has a high risk for abuse, misuse, and addiction. Misusing it can lead to overdose and death. Your doctor will check your risk before and during treatment. Store this medicine safely and do not share it with anyone.
Known Drug Interactions
7.2 Drugs Having No Clinically Important Interactions with Lisdexamfetamine Dimesylate Capsules From a pharmacokinetic perspective, no dose adjustment of lisdexamfetamine dimesylate capsules is necessary when lisdexamfetamine dimesylate capsules is co-administered with guanfacine, venlafaxine, or omeprazole. From a pharmacokinetic perspective, no dose adjustment for drugs that are substrates of CYP1A2 (e.g., theophylline, duloxetine, melatonin), CYP2D6 (e.g., atomoxetine, desipramine, venlafaxine), CYP2C19 (e.g., omeprazole, lansoprazole, clobazam), and CYP3A4 (e.g., midazolam, pimozide, si...
Mechanism: These two drugs do not significantly change how the body breaks each other down. They can be processed by the body at the same time without causing major problems.
What to do: No dose changes are needed when taking these medicines together. You can continue taking them as prescribed.
From a pharmacokinetic perspective, no dose adjustment for drugs that are substrates of CYP1A2 (e.g., theophylline, duloxetine, melatonin), CYP2D6 (e.g., atomoxetine, desipramine, venlafaxine), CYP2C19 (e.g., omeprazole, lansoprazole, clobazam), and CYP3A4 (e.g., midazolam, pimozide, simvastatin) is necessary when VYVANSE is co-administered [see Clinical Pharmacology (12.3) ] .
Mechanism: Lisdexamfetamine does not interfere with the way your body processes this cholesterol medicine. Both drugs can work normally without affecting each other's levels.
What to do: You do not need to change your dose of either medication. It is safe to take them together as directed by your doctor.
From a pharmacokinetic perspective, no dose adjustment for drugs that are substrates of CYP1A2 (e.g., theophylline, duloxetine, melatonin), CYP2D6 (e.g., atomoxetine, desipramine, venlafaxine), CYP2C19 (e.g., omeprazole, lansoprazole, clobazam), and CYP3A4 (e.g., midazolam, pimozide, simvastatin) is necessary when VYVANSE is co-administered [see Clinical Pharmacology (12.3) ] .
Mechanism: This ADHD medicine does not change how your body breaks down this antidepressant. They do not have a significant chemical interaction in the liver.
What to do: No dose adjustments are required for this combination. Continue taking your medications as scheduled.
7.2 Drugs Having No Clinically Important Interactions with Lisdexamfetamine Dimesylate Capsules From a pharmacokinetic perspective, no dose adjustment of lisdexamfetamine dimesylate capsules is necessary when lisdexamfetamine dimesylate capsules is co-administered with guanfacine, venlafaxine, or omeprazole. In addition, no dose adjustment of guanfacine or venlafaxine is needed when lisdexamfetamine dimesylate capsules is co-administered [see Clinical Pharmacology (12.3) ] . From a pharmacokinetic perspective, no dose adjustment for drugs that are substrates of CYP1A2 (e.g., theophylline, d...
Mechanism: Lisdexamfetamine does not change how the body breaks down venlafaxine through liver enzymes.
What to do: No dose changes are needed when taking these two medications together.
From a pharmacokinetic perspective, no dose adjustment for drugs that are substrates of CYP1A2 (e.g., theophylline, duloxetine, melatonin), CYP2D6 (e.g., atomoxetine, desipramine, venlafaxine), CYP2C19 (e.g., omeprazole, lansoprazole, clobazam), and CYP3A4 (e.g., midazolam, pimozide, simvastatin) is necessary when VYVANSE is co-administered [see Clinical Pharmacology (12.3) ] .
Mechanism: Lisdexamfetamine does not affect the specific liver enzyme that processes atomoxetine.
What to do: You can take these medications together without needing to adjust your dosage.
Common Questions
Can I take this medicine if I have heart problems?
Will this medicine affect my growth?
Can I take this with other medicines?
What should I do if I feel agitated or have new psychotic symptoms?
Can this medicine cause tics?
What if I have kidney problems?
Can I drive while taking this medicine?
How often will my doctor check my blood pressure and heart rate?
What if I think I'm having a serious side effect?
Can I stop taking this medicine suddenly?
What are the common side effects of lisdexamfetamine?
Does lisdexamfetamine interact with other medications?
What drug class is lisdexamfetamine?
Is there a generic version of lisdexamfetamine?
Is lisdexamfetamine safe during pregnancy?
Has lisdexamfetamine been recalled?
Is lisdexamfetamine currently in shortage?
Active Recalls
Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.
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, 60%RH) for Lisdexamfetamine dimesylate capsules.
SUN PHARMACEUTICAL INDUSTRIES INC
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What the FDA Data Shows for lisdexamfetamine
The FDA label for lisdexamfetamine (sold under brand names such as Vyvanse) classifies it as a prescription-only medication in the CNS Stimulant class. This medicine treats Attention Deficit Hyperactivity Disorder (ADHD) in adults and kids 6 years and older. Official labeling lists 15 commonly reported side effects, including Anorexia, Anxiety, Decreased appetite.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 5,614 voluntary reports. The database also lists 14 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated minor severity. NADAC pricing from CMS shows a generic unit cost of $4.93 versus $12.38 for the brand — a 60% 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 (currently 2 recall records on file), 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). Shortage status: FDA Drug Shortages Database.
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: November 3, 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