> Trialight public data. Index of pages: https://trialight.com/llms.txt
> Web page: https://trialight.com/data/asset/atomoxetine-hydrochloride-ec642fa5-6de5-4361-a5d5-ba620d2a4aef
> Record changed: 2026-10-13

# Atomoxetine hydrochloride

Highest phase reached

Approved

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1702)

Drug type

Small molecule

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1702)

First approval year

2002

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1702)

## Development status

**First approval year**

2002

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1702)

**Listing at source**

Listed

**Highest phase reached**

Approved

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1702)

## Names and chemistry

**Drug type**

Small molecule

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1702)

**Drug name**

Atomoxetine hydrochloride

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1702)

**Molecular weight**

291.82

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1702)

**Structure (SMILES)**

CNCC\[C@@H\](Oc1ccccc1C)c1ccccc1.Cl

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1702)

### Brand names (4)

- atomoxetine hydrochloride
- Atomoxetine hydrochloride
- strattera
- Strattera

### Other names (43)

- (r)-(-)-tomoxetine hydrochloride
- atomoxetin strattera
- Atomoxetine (as hydrochloride)
- atomoxetine as hydrochloride
- atomoxetine hcl
- Atomoxetine hcl
- Atomoxetine HCL \[VANDF\]
- atomoxetine hcl vandf
- atomoxetine hydrochloride
- Atomoxetine hydrochloride
- Atomoxetine hydrochloride \[EP MONOGRAPH\]
- Atomoxetine hydrochloride \[JAN\]
- Atomoxetine hydrochloride \[MART.\]
- Atomoxetine hydrochloride \[MI\]
- Atomoxetine hydrochloride \[ORANGE BOOK\]
- Atomoxetine hydrochloride \[USAN\]
- Atomoxetine hydrochloride \[USP MONOGRAPH\]
- Atomoxetine hydrochloride \[USP-RS\]
- Atomoxetine hydrochloride \[WHO-DD\]
- atomoxetine hydrochloride ep monograph
- atomoxetine hydrochloride jan
- atomoxetine hydrochloride mart
- atomoxetine hydrochloride mi
- atomoxetine hydrochloride orange book
- atomoxetine hydrochloride usan

And 18 more, listed on the interactive page.

## Identifiers

**CAS registry numbers**

- 82248-59-7

**ChEMBL ID**

CHEMBL1702

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1702)

**InChIKey**

LUCXVPAZUDVVBT-UNTBIKODSA-N

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1702)

**RxNorm IDs (RxCUI)**

- 353103

**FDA ingredient codes (UNII)**

- 57WVB6I2W0

### PubChem compound IDs (3)

- 54840
- 11426336
- 45108252

## Regulatory information

### United States

**Applicant**

LILLY

**Approval date**

26 Nov 2002

**Application number**

NDA021411

### Other regulatory facts

**Patents**

0

**Designations**

1

**First in class**

No

**Fast track**

No

**Breakthrough designation**

No

**Orphan designation**

No

**Priority review**

No

**Orphan exclusivity**

No

**Accelerated approval**

No

**Availability**

Prescription only

**Boxed warning**

Yes

## Pharmacology

### Drug classification

**Pharmacology name**

atomoxetine

**Type**

Synthetic organic

**Drug name stem**

\-oxetine

#### Administration routes

- Oral

### Mechanisms of action (3)

- **Action type**  
Inhibitor

**Target**  
DAT

**Gene symbol**  
DAT
- **Action type**  
Inhibitor

**Target**  
SERT

**Gene symbol**  
SERT
- **Mechanism**  
Norepinephrine transporter inhibitor

**Action type**  
Inhibitor

**Target**  
Sodium-dependent noradrenaline transporter

**Protein identifier**  
P23975

### Open Targets mechanisms

- **Mechanism**  
Norepinephrine transporter inhibitor

**Action type**  
Inhibitor

**Target**  
Sodium-dependent noradrenaline transporter

### Investigated indications (5)

- **Condition**  
Attention Deficit Disorder with Hyperactivity

**Highest recorded phase**  
4

**Condition identifier**  
EFO:0003888

**Subject identifier**  
D001289
- **Condition**  
Sleep Apnea, Obstructive

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0003918

**Subject identifier**  
D020181
- **Condition**  
Attention Deficit and Disruptive Behavior Disorders

**Highest recorded phase**  
3

**Condition identifier**  
HP:0010865

**Subject identifier**  
D019958
- **Condition**  
Syncope, Vasovagal

**Highest recorded phase**  
3

**Condition identifier**  
HP:0012668

**Subject identifier**  
D019462
- **Condition**  
Alzheimer Disease

**Highest recorded phase**  
2

**Condition identifier**  
MONDO:0004975

**Subject identifier**  
D000544

### Open Targets indications (9)

- **Condition identifier**  
EFO\_0003888
- **Condition identifier**  
EFO\_0003918

**Highest recorded phase**  
2
- **Condition identifier**  
HP\_0010865

**Highest recorded phase**  
3
- **Condition identifier**  
HP\_0012668

**Highest recorded phase**  
3
- **Condition identifier**  
MONDO\_0004975
- **Condition identifier**  
MONDO\_0004975

**Highest recorded phase**  
4
- **Condition identifier**  
MONDO\_0007739
- **Condition identifier**  
MONDO\_0007739

**Highest recorded phase**  
4
- **Condition identifier**  
MONDO\_0007743

**Highest recorded phase**  
4

### Warnings (2)

- **Warning**  
Black Box Warning
- **Warning**  
Black Box Warning

**Effect**  
cardiotoxicity

### Open Targets warnings (2)

- **Warning**  
Black Box Warning

**Country**  
United States
- **Warning**  
Black Box Warning

**Effect**  
cardiotoxicity

**Country**  
United States

### Reported adverse events (46)

- **Event**  
abnormal behaviour

**Reports**  
222

**Reporting signal score**

401.665
- **Event**  
aggression

**Reports**  
318

**Reporting signal score**

611.011
- **Event**  
agitation

**Reports**  
187

**Reporting signal score**

188.274
- **Event**  
alanine aminotransferase increased

**Reports**  
175

**Reporting signal score**

142.275
- **Event**  
anger

**Reports**  
132

**Reporting signal score**

239.905
- **Event**  
anorexia

**Reports**  
58

**Reporting signal score**

83.1282
- **Event**  
anxiety

**Reports**  
217

**Reporting signal score**

107.693
- **Event**  
aspartate aminotransferase increased

**Reports**  
158

**Reporting signal score**

130.307
- **Event**  
attention deficit/hyperactivity disorder

**Reports**  
39

**Reporting signal score**

94.4847
- **Event**  
blood alkaline phosphatase increased

**Reports**  
78

**Reporting signal score**

70.7765
- **Event**  
convulsion

**Reports**  
146

**Reporting signal score**

114.865
- **Event**  
crying

**Reports**  
120

**Reporting signal score**

204.535
- **Event**  
decreased eye contact

**Reports**  
24

**Reporting signal score**

101.005
- **Event**  
depressed mood

**Reports**  
94

**Reporting signal score**

103.12
- **Event**  
depression

**Reports**  
211

**Reporting signal score**

102.804
- **Event**  
diarrhoea

**Reports**  
41

**Reporting signal score**

106.252
- **Event**  
disturbance in attention

**Reports**  
113

**Reporting signal score**

134.002
- **Event**  
drug screen positive

**Reports**  
53

**Reporting signal score**

111.776
- **Event**  
dystonia

**Reports**  
60

**Reporting signal score**

75.0851
- **Event**  
educational problem

**Reports**  
28

**Reporting signal score**

88.714
- **Event**  
ejaculation disorder

**Reports**  
39

**Reporting signal score**

120.033
- **Event**  
electrocardiogram qt corrected interval prolonged

**Reports**  
29

**Reporting signal score**

84.5358
- **Event**  
grand mal convulsion

**Reports**  
59

**Reporting signal score**

83.5108
- **Event**  
hallucination, auditory

**Reports**  
63

**Reporting signal score**

88.1533
- **Event**  
heart rate increased

**Reports**  
138

**Reporting signal score**

129.823

And 21 more, listed on the interactive page.

### Trial references (30)

- NCT00190736  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00190736)
- NCT00190775  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00190775)
- NCT00190879  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00190879)
- NCT00190931  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00190931)
- NCT00191386  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00191386)
- NCT00191659  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00191659)
- NCT00191698  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00191698)
- NCT00191945  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00191945)
- NCT00216918  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00216918)
- NCT00218322  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00218322)
- NCT00485407  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00485407)
- NCT00485459  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00485459)
- NCT00485550  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00485550)
- NCT00485628  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00485628)
- NCT00485849  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00485849)
- NCT00485875  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00485875)
- NCT00486083  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00486083)
- NCT00486122  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00486122)
- NCT00506727  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00506727)
- NCT00510276  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00510276)
- NCT00557960  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00557960)
- NCT00568685  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00568685)
- NCT00700427  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00700427)
- NCT01106430  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01106430)
- NCT01244490  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01244490)

And 5 more, listed on the interactive page.

## Dosing

**Dose**

0.5 mg/kg/day to 1.2 mg/kg/day, up to 100 mg/day

**Route**

Oral

**How often**

Once daily or twice daily

### Conditions of use (2)

- Take with or without food
- Use supplied syringe and bottle adapter

## Chemical properties

**Hydrogen bond acceptors**

2

**Hydrogen bond donors**

1

**Polar surface area**

21.26

**Calculated partition coefficient (ALogP)**

3.72

**Prodrug**

No

**Chirality**

Single enantiomer

**Inorganic**

No

**Rule-of-five violations**

0

**Rotatable bonds**

6

**Heavy atoms**

20

**Molecular formula**

C17H22ClNO

**Monoisotopic mass**

291.1389920

**Natural product**

No

## National Drug Codes

- 0002-3227
- 0002-3228
- 0002-3229
- 0002-3238
- 0002-3239
- 0002-3250
- 0002-3251
- 0093-3542
- 0093-3543
- 0093-3544
- 0093-3545
- 0093-3546
- 0093-3547
- 0093-3548
- 0904-6908
- 16714-755
- 16714-756
- 16714-757
- 16714-758
- 16714-759
- 16714-760
- 16714-761
- 30698-456
- 31722-714
- 31722-715

And 112 more, listed on the interactive page.

## Evidence counts

**Recorded assays**

1,014

**Active assays**

32

### Active assay types (4)

- Confirmatory
- Other
- Screening
- Summary

## Pharmacologic actions

- Adrenergic Uptake Inhibitors  
Source: [id.nlm.nih.gov](https://id.nlm.nih.gov/mesh/D018759.html)

## Related records

### Trials (185)

- A Bioequivalence (BE) Study in Healthy Subjects
- A Clinical Trial to Examine Effects of Atomoxetine in the Treatment of Negative Symptoms in Patients With Schizophrenia
- A Combination of Two Currently Approved Drugs to Enhance the Treatment of Schizophrenia
- A Comparative Effectiveness Study of Positive Airway Pressure (PAP) Therapy, Dental Device, and Atomoxetine-Oxybutynin for Treatment of Obstructive Sleep Apnea in Adults
- A Dose Response Effect of Atomoxetine to the Acute Effects of Alcohol
- A Dose-Ranging Study of the Efficacy of ABT-894 in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)
- A Drug Treatment for Cocaine Users Who Are Also on Methadone Maintenance Treatment
- A Functional Outcomes Study With Atomoxetine-Hydrochloride and Placebo in Adults With Attention-Deficit/Hyperactivity Disorder
- A Long Term Follow-Up Study for Asian Adult Patients With Attention Deficit Hyperactivity Disorder
- A Long Term Study of a Medication for Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)
- A Novel Pharmacological Therapy for Obstructive Sleep Apnea
- A Randomized, Double-Blind Comparison of Placebo and Atomoxetine Hydrochloride Given Once a Day in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)
- A Safety and Efficacy Study of ABT-089 in Children With Attention-Deficit/Hyperactivity Disorder (ADHD)
- A Study Comparing the Effect of Atomoxetine Versus Other Standard Care Therapy on the Long Term Functioning in Attention-Deficit/Hyperactivity Disorder (ADHD) Children and Adolescents
- A Study for Patients With Attention-Deficit/Hyperactivity Disorder Treated With Atomoxetine
- A Study in Attention Deficit Hyperactivity Disorder in Children and Adolescents
- A Study of Atomoxetine for Attention Deficit and Hyperactive/Impulsive Behaviour Problems in Children With ASD
- A Study of Label Compliance for Attention Deficit/Hyperactivity Disorder (ADHD) Medications in Japan
- A Study of TAK-503 in Children and Teenagers With Attention Deficit Hyperactivity Disorder (ADHD)
- A Study on Suicidality, Psychosis or Substance Abuse With Methylphenidate, Atomoxetine, Amphetamine/Dextroamphetamine or Lisdexamfetamine

### Approved for (1)

- Attention deficit-hyperactivity disorder

### In development for (3)

- [Alzheimer disease](https://trialight.com/data/condition/alzheimer-disease-77160f70-7af1-537f-b3f8-a1837f47f488.md) Phase 2
- [Obstructive sleep apnea syndrome](https://trialight.com/data/condition/obstructive-sleep-apnea-syndrome-02928491-a2d7-50f4-a4b7-30b79e6771ff.md) Phase 2
- Oppositional defiant disorder Phase 3

### Other linked conditions (1)

- [Huntington disease](https://trialight.com/data/condition/huntington-disease-fe2d46ec-080a-5259-a901-cad1d6e07061.md)

### Targets (1)

- [SLC6A2](https://trialight.com/data/target/slc6a2-e24825e0-4238-596c-a718-6dd7ff85f000.md) Norepinephrine transporter inhibitor

---

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