Last reviewed · How we verify
Dexedrine
At a glance
| Generic name | Dexedrine |
|---|---|
| Also known as | Dextro-amphetamine sulphate, DIN: 01924516, D-amphetamine, Adderall, Dexedrine |
| Sponsor | Centre for Addiction and Mental Health |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | FDA-approved |
Approved indications
Boxed warnings
- WARNING: ABUSE, MISUSE, AND ADDICTION DEXEDRINE 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 DEXEDRINE, can result in overdose and death [see Overdosage ] , and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection. Before prescribing DEXEDRINE, assess each patient’s risk for abuse, misuse, and addiction. Educate
Common side effects
- Headache
- Insomnia
- Dizziness
- Restlessness
- Overstimulation
- Dryness of the mouth
- Anorexia
- Weight loss
- Tremor
- Palpitations
- Tachycardia
- Elevation of blood pressure
Serious adverse events
- Psychotic episodes
- Exacerbation of motor and verbal tics
- Tourette's syndrome
- Cardiomyopathy
- Intestinal ischemia
- Rhabdomyolysis
- Dyskinesia
- Impotence
- Frequent or prolonged erections
Key clinical trials
- Efficacy and Safety of Sustained-release Dexamphetamine in Patients With Moderate to Severe Cocaine Use Disorder (PHASE2)
- A Trial to Assess How Centanafadine Interacts With Stimulants in the Body (PHASE1)
- Clinical Trial of High Dose Lisdexamfetamine and Contingency Management in MA Users (PHASE2)
- Pharmacological and Behavioral Treatment After Bariatric Surgery: Medication Change for Non-Responders (Stage 2b) (PHASE2, PHASE3)
- Clinical Trial to Investigate the Safety and Efficacy of Two Dexamfetamine Sulfate Formulations in Adults With ADHD and Moderate to Severe Depression (PHASE2)
- Vyvanse in Children Aged 6 to 12 Years (EARLY_PHASE1)
- Cognitive-Behavioral and Pharmacologic (LDX) Treatment of Binge-Eating Disorder and Obesity: Maintenance Treatment (PHASE3)
- Pharmacologic Augmentation of Targeted Cognitive Training in Schizophrenia (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Dexedrine CI brief — competitive landscape report
- Dexedrine updates RSS · CI watch RSS
- Centre for Addiction and Mental Health portfolio CI