Lisdexamfetamine Dimesylate is a central nervous system stimulant sold in the U.S. under 3 brand and generic names, for attention deficit disorder with hyperactivity and binge drinking. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
From the FDA label for Arynta (application NDA219847). Other lisdexamfetamine dimesylate products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Indicated Population Initial Dose Titration Schedule Recommended Dose Maximum Dose ADHD (Adults and pediatric patients 6 years and older) ( 2.2 ) 30 mg every morning 10 mg or 20 mg weekly 30 mg to 70 mg per day 70 mg per day BED (Adults) ( 2.3 ) 30 mg every morning 20 mg weekly 50 mg to 70 mg per day 70 mg per day • Prior to treatment, assess for presence of cardiac disease ( 2.4 ) • Severe renal impairment: Maximum dose is 50 mg/day ( 2.5 ) • End stage renal disease (ESRD): Maximum dose is 30 mg/day ( 2.5 ) 2.1 Pretreatment Screening Prior to treating patients with ARYNTA, assess: • for the presence of cardiac disease (i.e., perform a careful history, family history of sudden death or ventricular arrhythmia, and physical exam) [see Warnings and Precautions ( 5.2 )] . • the family history and clinically evaluate patients for motor or verbal tics or Tourette's syndrome before initiating ARYNTA [see Warnings and Precautions ( 5.8 )] . 2.2 General Administration Information Take ARYNTA orally in the morning with or without food; avoid afternoon doses because of the potential for insomnia. Instruct caregivers/patients to read the ‘Instructions for Use’ for complete administration instructions. • Use the oral dosing syringe and bottle adapter provided with ARYNTA. • Ensure that the bottle adapter is firmly inserted into the bottle before first use and keep the adapter in place for…
The following adverse reactions are discussed in greater detail in other sections of the labeling: • Known hypersensitivity to amphetamine products or other ingredients of ARYNTA [see Contraindications ( 4 )] • Hypertensive Crisis When Used Concomitantly with Monoamine Oxidase Inhibitors [see Contraindications ( 4 ) and Drug Interactions ( 7.1 )] • Abuse, Misuse, and Addiction [see Boxed Warning, Warnings and Precautions ( 5.1 ), and Drug Abuse and Dependence ( 9.2 , 9.3 )] • Risks to Patients with Serious Cardiac Disease [see Warnings and Precautions ( 5.2 )] • Increased Blood Pressure and Heart Rate [see Warnings and Precautions ( 5.3 )] • Psychiatric Adverse Reactions [see Warnings and Precautions ( 5.4 )] • Long-Term Suppression of Growth in Pediatric Patients [see Warnings and Precautions ( 5.5 )] • Peripheral Vasculopathy, including Raynaud's phenomenon [see Warnings and Precautions ( 5.6 )] • Serotonin Syndrome [see Warnings and Precautions ( 5.7 )] • Motor and Verbal Tics, and Worsening of Tourette's Syndrome [see Warnings and Precautions ( 5.8 )] Most common adverse reactions (incidence ≥5% and at a rate at least twice placebo) in pediatric patients ages 6 to 17 years, and/or adults with ADHD were anorexia, anxiety, decreased appetite, decreased weight, diarrhea, dizziness, dry mouth, irritability, insomnia, nausea, upper abdominal pain, and vomiting. ( 6.1 ) Most…
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Typical price | |
|---|---|---|---|---|---|---|---|
| 1 | 72/100 | Prescription | Solution | — | — | View → | |
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Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
| Imprint | Strength | Colour | Shape | Maker |
|---|---|---|---|---|
| E0550;10mg | 10 mg | pink | capsule | — |
| E0551;20mg | 20 mg | white | capsule | — |
| E0552;30mg | 30 mg | white, orange | capsule | — |
| E0553;40mg | 40 mg | white, turquoise | capsule | — |
| E0554;50mg | 50 mg | white, blue | capsule | — |
| E0555;60mg |
From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
Lisdexamfetamine Dimesylate Capsules
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 · Oct 28, 2025
Lisdexamfetamine Dimesylate Capsules
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 · Oct 28, 2025
Lisdexamfetamine Dimesylate Capsules
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 · Oct 28, 2025
Lisdexamfetamine Dimesylate Capsules
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 · Oct 28, 2025
Lisdexamfetamine Dimesylate Capsules
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 · Oct 28, 2025
The elimination half-life of lisdexamfetamine dimesylate is less than 1 hour (parent drug). Lisdexamfetamine is an inactive prodrug: the parent's own elimination half-life is under 1 hour and it is essentially undetectable in blood by 8 hours. The clinically meaningful effect comes from its active metabolite, dextroamphetamine, which has a much longer elimination half-life of about 10 to 11 hours in healthy adults (about 8.6 to 9.5 hours in children 6 to 12).
VYVANSE- lisdexamfetamine dimesylate capsule / chewable tablet (DailyMed) ↗Half-life is how long the body takes to clear half a dose. It is not the same as how long a drug test can detect it, and it varies with age, kidney and liver function.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
ARYNTA is contraindicated in patients with: • Known hypersensitivity to amphetamine products or other ingredients of ARYNTA. Anaphylactic reactions, Stevens-Johnson Syndrome, angioedema, and urticaria have been observed in postmarketing reports [see Adverse Reactions ( 6.2 )]. • 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 )]. • Known hypersensitivity to amphetamine products or other ingredients in ARYNTA ( 4 ) • Use with monoamine oxidase (MAO) inhibitor, or within 14 days of the last MAO inhibitor dose ( 4 , 7.1 )
Acidifying and Alkalinizing Agents : Agents that alter urinary pH can alter blood levels of amphetamine. Acidifying agents decrease amphetamine blood levels, while alkalinizing agents increase amphetamine blood levels. Adjust ARYNTA dosage accordingly. ( 2.6 , 7.1 ) 7.1 Drugs Having Clinically Important Interactions with Amphetamines Table 5 Drugs Having Clinically Important Interactions with Amphetamines MAO Inhibitors (MAOI) Prevention or Management Do not administer ARYNTA during or within 14 days following the administration of MAOI [see Contraindications ( 4 )] . Mechanism and Clinical Effect(s) MAOI antidepressants slow amphetamine metabolism, increasing amphetamines effect on the release of norepinephrine and other monoamines from adrenergic nerve endings causing headaches and other signs of hypertensive crisis. Toxic neurological effects and malignant hyperpyrexia can occur, sometimes with fatal results. Serotonergic Drugs Prevention or Management Initiate with lower doses and monitor patients for signs and symptoms of serotonin syndrome, particularly during ARYNTA initiation or dosage increase. If serotonin syndrome occurs, discontinue ARYNTA and the concomitant serotonergic drug(s) [see Warnings and Precautions ( 5.7 )] . Mechanism and Clinical Effect(s) The concomitant use of lisdexamfetamine dimesylate and serotonergic drugs increases the risk of serotonin…
| 70/100 |
| Prescription |
| Capsule |
| — |
| — |
| View → |
| 3 | Not yet rated | Prescription | Capsule | — | — | View → |
| 60 mg |
| turquoise |
| capsule |
| — |
| E0556;70mg | 70 mg | blue, orange | capsule | — |
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| SZ;832 | 20 mg | yellow | capsule | — |
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| SZ;833 | 30 mg | orange | capsule | — |
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| SZ;834 | 40 mg | green | capsule | — |
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| SZ;835 | 50 mg | blue | capsule | — |
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| SZ;836 | 60 mg | blue | capsule | — |
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