Dextroamphetamine saccharate
Adderall, Amphetamine / Amphetamine / Dextroamphetamine / Dextroamphetamine, Mydayis (dextroamphetamine saccharate) is a small molecule pharmaceutical. Dextroamphetamine saccharate was first approved as Adderall 10 on 1996-02-13. It is used to treat attention deficit disorder with hyperactivity and narcolepsy in the USA.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| nervous system diseases | D009422 |
| mental disorders | D001523 |
Trade Name
FDA
EMA
Combinations
Adderall, Dextroamp saccharate, amp aspartate, dextroamp amp, Mydayis (discontinued: Adderall, Dextroamp saccharate, amp aspartate, dextroamp amp, Dextroamp saccharate,amp aspartate,dextroamp amp)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Amphetamine aspartate
+
Amphetamine sulfate
+
Dextroamphetamine saccharate
+
Dextroamphetamine sulfate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| ADDERALL XR 10 | Takeda | N-021303 RX | 2001-10-11 | 1 products, RLD |
| ADDERALL XR 20 | Takeda | N-021303 RX | 2001-10-11 | 1 products, RLD |
| ADDERALL XR 30 | Takeda | N-021303 RX | 2001-10-11 | 1 products, RLD, RS |
| ADDERALL XR 25 | Takeda | N-021303 RX | 2002-05-22 | 1 products, RLD |
| ADDERALL XR 5 | Takeda | N-021303 RX | 2002-05-22 | 1 products, RLD |
| ADDERALL XR 15 | Takeda | N-021303 RX | 2002-05-22 | 1 products, RLD |
| MYDAYIS | Takeda | N-022063 RX | 2017-06-20 | 4 products, RLD, RS |
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Labels
FDA
EMA
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Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| narcolepsy | HP_0030050 | D009290 | G47.4 |
| attention deficit disorder with hyperactivity | EFO_0003888 | D001289 | F90 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
AMPHETAMINE ASPARTATE / AMPHETAMINE SULFATE / DEXTROAMPHETAMINE SACCHARATE / DEXTROAMPHETAMINE SULFATE, MYDAYIS, TAKEDA PHARMS USA | |||
| 2023-03-13 | PED | ||
ATC Codes
No data
HCPCS
No data
Clinical
Clinical Trials
109 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Attention deficit disorder with hyperactivity | D001289 | EFO_0003888 | F90 | 5 | 10 | 4 | 9 | 11 | 36 |
| Hyperkinesis | D006948 | HP_0000752 | — | 4 | 5 | 3 | 6 | 8 | 24 |
| Substance-related disorders | D019966 | EFO_0003890 | F13 | 1 | 4 | — | 1 | 4 | 9 |
| Depression | D003863 | — | F33.9 | — | 2 | — | 1 | 1 | 4 |
| Depressive disorder | D003866 | EFO_1002014 | F32.A | — | 2 | — | 1 | 1 | 4 |
| Bipolar disorder | D001714 | EFO_0000289 | F30.9 | 1 | 1 | — | 1 | — | 3 |
| Stroke | D020521 | EFO_0000712 | I63.9 | — | 2 | — | 1 | — | 3 |
| Autism spectrum disorder | D000067877 | HP_0000729 | F84.0 | — | 1 | — | 1 | — | 2 |
| Conduct disorder | D019955 | EFO_0004216 | F91 | — | — | — | 2 | — | 2 |
| Major depressive disorder | D003865 | EFO_0003761 | F22 | — | — | — | 1 | 1 | 2 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Glioma | D005910 | EFO_0000520 | — | — | — | 1 | — | — | 1 |
| Asthenia | D001247 | EFO_0007625 | R53.1 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cocaine-related disorders | D019970 | — | F14 | 8 | 8 | — | — | 4 | 20 |
| Healthy volunteers/patients | — | — | — | 6 | 1 | — | — | 3 | 10 |
| Opioid-related disorders | D009293 | EFO_0005611 | F11 | — | 2 | — | — | 2 | 4 |
| Schizophrenia | D012559 | EFO_0000692 | F20 | — | 2 | — | — | 2 | 4 |
| Narcolepsy | D009290 | HP_0030050 | G47.4 | 2 | 1 | — | — | — | 3 |
| Amphetamine-related disorders | D019969 | EFO_0004701 | F15 | 1 | 3 | — | — | — | 3 |
| Psychotic disorders | D011618 | — | F20.81 | — | 1 | — | — | 1 | 2 |
| Anhedonia | D059445 | — | R45.84 | 1 | 1 | — | — | — | 2 |
| Disorders of excessive somnolence | D006970 | — | G47.1 | — | 1 | — | — | 1 | 2 |
| Addictive behavior | D016739 | EFO_0004347 | — | — | 1 | — | — | 1 | 2 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Drug misuse | D000076064 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Tobacco use disorder | D014029 | — | F17 | — | — | — | — | 3 | 3 |
| Alcoholism | D000437 | EFO_0003829 | F10.1 | — | — | — | — | 2 | 2 |
| Hiv | D006678 | — | — | — | — | — | — | 1 | 1 |
| Hemorrhage | D006470 | MP_0001914 | R58 | — | — | — | — | 1 | 1 |
| Heart failure | D006333 | HP_0001635 | I50 | — | — | — | — | 1 | 1 |
| Hypertension | D006973 | EFO_0000537 | I10 | — | — | — | — | 1 | 1 |
| Covid-19 | D000086382 | — | — | — | — | — | — | 1 | 1 |
| Infections | D007239 | EFO_0000544 | — | — | — | — | — | 1 | 1 |
| Coronavirus infections | D018352 | EFO_0007224 | B34.2 | — | — | — | — | 1 | 1 |
| Menorrhagia | D008595 | EFO_0003945 | N92.0 | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Dextroamphetamine saccharate |
| INN | — |
| Description | (S)-amphetamine is a 1-phenylpropan-2-amine that has S configuration. It has a role as a neurotoxin, an adrenergic uptake inhibitor, a dopaminergic agent, a sympathomimetic agent, a dopamine uptake inhibitor and an adrenergic agent. It is an enantiomer of a (R)-amphetamine. |
| Classification | Small molecule |
| Drug class | — |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | C[C@H](N)Cc1ccccc1.O=C(O)[C@@H](O)[C@@H](O)[C@H](O)[C@@H](O)C(=O)O |
Identifiers
| PDB | — |
| CAS-ID | 51-64-9 |
| RxCUI | 3288 |
| ChEMBL ID | CHEMBL3989844 |
| ChEBI ID | — |
| PubChem CID | 5826 |
| DrugBank | DB01576 |
| UNII ID | — |
Target
No data
Variants
No data
Financial
Estimated US medical usage
No data
Trends
PubMed Central
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Safety
Black-box Warning
Black-box warning for: Adderall, Adderall xr, Dextroamphetamine saccharate and amphetamine aspartate and dextroamphetamine sulfate and amphetamine sulfate, Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate, Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate, Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release, Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate, Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate extended-release, Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate, Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, amphetamine sulfate, Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, amphetamine sulfate tablets,cii, Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate, Mixed salts of a single entity amphetamine product, Mixed salts of a single-entity amphetamine product, Mydayis
Adverse Events
Top Adverse Reactions
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36,919 adverse events reported
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