> Trialight public data. Index of pages: https://trialight.com/llms.txt
> Web page: https://trialight.com/data/asset/atomoxetine-1775a289-8363-4e6f-be94-6b2bd2db4995
> Record changed: 2026-11-04

# Atomoxetine

Highest phase reached

Approved

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL641)

Drug type

Small molecule

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL641)

First approval year

2002

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL641)

## Development status

**First approval year**

2002

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL641)

**Listing at source**

Listed

**Highest phase reached**

Approved

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL641)

## Names and chemistry

**Drug type**

Small molecule

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL641)

**Drug name**

Atomoxetine

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL641)

**Molecular weight**

255.36

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL641)

**Structure (SMILES)**

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

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL641)

### Brand names (8)

- atomoxetine component of ad 109
- atomoxetine component of ad 313
- Atomoxetine component of ad-109
- Atomoxetine component of ad-313
- atomoxetine component of ad109
- Atomoxetine component of ad109
- atomoxetine component of ad313
- Atomoxetine component of ad313

### Other names (22)

- ad 109 component atomoxetine
- ad 313 component atomoxetine
- AD-109 COMPONENT ATOMOXETINE
- AD-313 COMPONENT ATOMOXETINE
- ad109 component atomoxetine
- AD109 COMPONENT ATOMOXETINE
- ad313 component atomoxetine
- AD313 COMPONENT ATOMOXETINE
- atomoxetina
- Atomoxetina
- atomoxetine
- Atomoxetine
- ATOMOXETINE \[HSDB\]
- atomoxetine \[INN\]
- ATOMOXETINE \[MI\]
- ATOMOXETINE \[VANDF\]
- Atomoxetine \[WHO-DD\]
- atomoxetine hsdb
- atomoxetine inn
- atomoxetine mi
- atomoxetine vandf
- atomoxetine who dd

## Identifiers

**ATC classification codes**

- N06BA09

Sources for recorded values

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL641)

**CAS registry numbers**

- 83015-26-3

**ChEMBL ID**

CHEMBL641

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL641)

**InChIKey**

VHGCDTVCOLNTBX-QGZVFWFLSA-N

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL641)

**PubChem compound IDs**

- 54841

**FDA ingredient codes (UNII)**

- ASW034S0B8

### RxNorm IDs (RxCUI) (2)

- 38400
- 353103

## Regulatory information

### United States

**Applicant**

LILLY

**Approval date**

26 Nov 2002

**Application number**

NDA021411

### Other regulatory facts

**First in class**

No

**Orphan designation**

No

**Availability**

Prescription only

**Boxed warning**

Yes

## Approval status

**United States (FDA)**

Approved

## Pharmacology

### Drug classification

**Pharmacology name**

atomoxetine

**Type**

Synthetic organic

**Drug name stem**

\-oxetine

**Approval recorded by Guide to Pharmacology**

Yes

#### Administration routes

- Oral

### Mechanisms of action (3)

- **Action**  
Inhibition

**Action type**  
Inhibitor

**Target**  
NET

**Gene symbol**  
SLC6A2

**Protein identifier**  
P23975

**Median affinity**

8.69

**Affinity units**  
pKd

**Primary target**  
Yes
- **Action**  
Inhibition

**Action type**  
Inhibitor

**Target**  
SERT

**Gene symbol**  
SLC6A4

**Protein identifier**  
P31645

**Median affinity**

8.05

**Affinity units**  
pKd
- **Action**  
Inhibition

**Action type**  
Inhibitor

**Target**  
DAT

**Gene symbol**  
SLC6A3

**Protein identifier**  
Q01959

**Median affinity**

5.97

**Affinity units**  
pKd

### Open Targets mechanisms

- **Mechanism**  
Norepinephrine transporter inhibitor

**Action type**  
Inhibitor

**Target**  
Sodium-dependent noradrenaline transporter

### DrugCentral mechanisms

- **Action type**  
Inhibitor

**Gene symbol**  
SLC6A2

**Protein identifier**  
P23975

**Organism**  
Homo sapiens

**Target development level**  
Clinical

### Investigated indications (22)

- **Condition**  
Cocaine-Related Disorders

**Highest recorded phase**  
1

**Condition identifier**  
EFO:0002610

**Subject identifier**  
D019970
- **Condition**  
Autistic Disorder

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0003758

**Subject identifier**  
D001321
- **Condition**  
Tobacco Use Disorder

**Highest recorded phase**  
1

**Condition identifier**  
EFO:0003768

**Subject identifier**  
D014029
- **Condition**  
Sleep Apnea Syndromes

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0003877

**Subject identifier**  
D012891
- **Condition**  
Attention Deficit Disorder with Hyperactivity

**Highest recorded phase**  
4

**Condition identifier**  
EFO:0003888

**Subject identifier**  
D001289
- **Condition**  
Substance-Related Disorders

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0003890

**Subject identifier**  
D019966
- **Condition**  
Sleep Apnea, Obstructive

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0003918

**Subject identifier**  
D020181
- **Condition**  
Amphetamine-Related Disorders

**Highest recorded phase**  
1

**Condition identifier**  
EFO:0004701

**Subject identifier**  
D019969
- **Condition**  
Tourette Syndrome

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0004895

**Subject identifier**  
D005879
- **Condition**  
Hypotension, Orthostatic

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0005252

**Subject identifier**  
D007024
- **Condition**  
Opioid-Related Disorders

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0005611

**Subject identifier**  
D009293
- **Condition**  
Marijuana Abuse

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0007191

**Subject identifier**  
D002189
- **Condition**  
Orthostatic Intolerance

**Highest recorded phase**  
1

**Condition identifier**  
EFO:1000645

**Subject identifier**  
D054971
- **Condition**  
Phobia, Social

**Highest recorded phase**  
2

**Condition identifier**  
EFO:1001917

**Subject identifier**  
D000072861
- **Condition**  
Syncope, Vasovagal

**Highest recorded phase**  
2

**Condition identifier**  
HP:0012668

**Subject identifier**  
D019462
- **Condition**  
Cognitive Dysfunction

**Highest recorded phase**  
2

**Condition identifier**  
HP:0100543

**Subject identifier**  
D060825
- **Condition**  
Substance-Related Disorders

**Highest recorded phase**  
2

**Condition identifier**  
MONDO:0002491

**Subject identifier**  
D019966
- **Condition**  
Neoplasms

**Highest recorded phase**  
3

**Condition identifier**  
MONDO:0004992

**Subject identifier**  
D009369
- **Condition**  
Schizophrenia

**Highest recorded phase**  
3

**Condition identifier**  
MONDO:0005090

**Subject identifier**  
D012559
- **Condition**  
Diabetes Mellitus, Type 1

**Highest recorded phase**

0.5

**Condition identifier**  
MONDO:0005147

**Subject identifier**  
D003922
- **Condition**  
Parkinson Disease

**Highest recorded phase**

0.5

**Condition identifier**  
MONDO:0005180

**Subject identifier**  
D010300
- **Condition**  
Alcoholism

**Highest recorded phase**  
2

**Condition identifier**  
MONDO:0007079

**Subject identifier**  
D000437

### Open Targets indications (62)

- **Condition identifier**  
EFO\_0001072

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_0001074
- **Condition identifier**  
EFO\_0002610

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_0003758

**Highest recorded phase**  
3
- **Condition identifier**  
EFO\_0003768
- **Condition identifier**  
EFO\_0003877

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_0003888
- **Condition identifier**  
EFO\_0003890

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_0003918

**Highest recorded phase**  
3
- **Condition identifier**  
EFO\_0004701
- **Condition identifier**  
EFO\_0004895

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_0005252

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_0005611

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_0007191

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_0803536

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_1000645

**Highest recorded phase**  
1
- **Condition identifier**  
EFO\_1001917
- **Condition identifier**  
HP\_0000752
- **Condition identifier**  
HP\_0000822

**Highest recorded phase**  
2
- **Condition identifier**  
HP\_0001288

**Highest recorded phase**  
1
- **Condition identifier**  
HP\_0001297

**Highest recorded phase**  
2
- **Condition identifier**  
HP\_0001513

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

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

**Highest recorded phase**  
2
- **Condition identifier**  
HP\_0025267

**Highest recorded phase**  
1

And 37 more, listed on the interactive page.

### Open Targets warnings (2)

- **Warning**  
Black Box Warning

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

**Effect**  
cardiotoxicity

**Country**  
United States

### Reported adverse events (93)

- **Event**  
abnormal loss of weight

**Reports**  
3

**Reporting signal score**

6.60814
- **Event**  
affect lability

**Reports**  
13

**Reporting signal score**

37.0287
- **Event**  
aggression

**Reports**  
44

**Reporting signal score**

122.812
- **Event**  
agitation

**Reports**  
14

**Reporting signal score**

16.8366
- **Event**  
anger

**Reports**  
12

**Reporting signal score**

26.9543
- **Event**  
anti-ganglioside antibody positive

**Reports**  
1

**Reporting signal score**

7.86879
- **Event**  
anxiety

**Reports**  
41

**Reporting signal score**

61.4022
- **Event**  
bacterial infection

**Reports**  
10

**Reporting signal score**

24.9075
- **Event**  
bipolar i disorder

**Reports**  
3

**Reporting signal score**

9.51023
- **Event**  
blepharospasm

**Reports**  
5

**Reporting signal score**

15.761
- **Event**  
bruxism

**Reports**  
22

**Reporting signal score**

96.9143
- **Event**  
choreoathetosis

**Reports**  
15

**Reporting signal score**

78.349
- **Event**  
circulatory collapse

**Reports**  
5

**Reporting signal score**

8.19073
- **Event**  
coma

**Reports**  
7

**Reporting signal score**

6.94941
- **Event**  
congenital anomaly

**Reports**  
5

**Reporting signal score**

12.458
- **Event**  
coordination abnormal

**Reports**  
21

**Reporting signal score**

70.8373
- **Event**  
crying

**Reports**  
30

**Reporting signal score**

94.2454
- **Event**  
decreased appetite

**Reports**  
24

**Reporting signal score**

25.2802
- **Event**  
decreased eye contact

**Reports**  
21

**Reporting signal score**

145.631
- **Event**  
depressed mood

**Reports**  
28

**Reporting signal score**

73.9423
- **Event**  
depression

**Reports**  
28

**Reporting signal score**

32.4755
- **Event**  
disturbance in attention

**Reports**  
6

**Reporting signal score**

6.50891
- **Event**  
drooling

**Reports**  
4

**Reporting signal score**

9.47805
- **Event**  
drug intolerance

**Reports**  
10

**Reporting signal score**

6.52832
- **Event**  
dyskinesia

**Reports**  
26

**Reporting signal score**

67.0837

And 68 more, listed on the interactive page.

### Trial references (81)

- NCT00089869  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00089869)
- NCT00216281  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00216281)
- NCT00167297  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00167297)
- NCT00174226  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00174226)
- NCT00181740  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00181740)
- NCT00181766  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00181766)
- NCT00181948  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00181948)
- NCT00183391  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00183391)
- NCT00190684  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00190684)
- NCT00191035  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00191035)
- NCT00191295  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00191295)
- NCT00191516  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00191516)
- NCT00191542  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00191542)
- NCT00191633  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00191633)
- NCT00191737  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00191737)
- NCT00191880  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00191880)
- NCT00254462  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00254462)
- NCT00299234  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00299234)
- NCT00320528  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00320528)
- NCT00356070  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00356070)
- NCT00386581  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00386581)
- NCT00429091  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00429091)
- NCT00447278  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00447278)
- NCT00471354  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00471354)
- NCT00528697  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00528697)

And 56 more, listed on the interactive page.

## Dosing

**Dose**

0.5 mg/kg increasing to 1.2 mg/kg

**Route**

Oral

**How often**

Once daily or divided doses in the morning and late afternoon/early evening

### Conditions of use (5)

- Discontinue without tapering
- Do not exceed 1.4 mg/kg or 100 mg in children up to 70 kg
- Initiate after minimum 3 days
- Initiate at 40 mg and increase to 80 mg in over 70 kg or adults
- May be taken with or without food

## Chemical properties

**Hydrogen bond acceptors**

2

**Hydrogen bond donors**

1

**Polar surface area**

21.26

**Calculated partition coefficient (ALogP)**

3.72

**Calculated partition coefficient (XLogP)**

3.7

**Prodrug**

No

**Chirality**

Single enantiomer

**Inorganic**

No

**Rule-of-five violations**

0

**Rotatable bonds**

6

**Heavy atoms**

19

**Molecular formula**

C17H21NO

**Monoisotopic mass**

255.162314293

**Natural product**

Yes

## Evidence counts

**Recorded assays**

362

**Active assays**

75

### Active assay types (2)

- Confirmatory
- Other

## Pharmacologic actions

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

## Biological measurements

These details could not be displayed.

## Related records

### Trials (148)

- 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 Gene by Medication Interaction to the Acute Effects of Alcohol
- A Long Term Follow-Up Study for Asian Adult Patients With Attention Deficit Hyperactivity Disorder
- A Novel Pharmacological Therapy for Obstructive Sleep Apnea
- 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 Label Compliance for Attention Deficit/Hyperactivity Disorder (ADHD) Medications in Japan
- A Study on Suicidality, Psychosis or Substance Abuse With Methylphenidate, Atomoxetine, Amphetamine/Dextroamphetamine or Lisdexamfetamine
- A Study to Evaluate 3 Different Doses of JNJ-31001074 in the Treatment of Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)
- A Study to Examine the Progression of Attention-Deficit Hyperactivity Disorder (ADHD) Drug Treatment and to Analyze Associated Factors
- ADHD Medication and Predictors of Treatment Outcome
- Agonist Replacement Therapy for Cocaine Dependence
- An Evaluation of Treatments for Sustained Clinical Response (18 Months) in Symptomatic Alzheimer's Disease

### Approved for (1)

- Attention deficit-hyperactivity disorder

### In development for (33)

- [Alcohol abuse](https://trialight.com/data/condition/alcohol-abuse-de2eaa0d-f882-51b6-befd-e62533fe8ee1.md) Phase 2
- Alcohol dependence Phase 2
- Attention deficit hyperactivity disorder, inattentive type Phase 2
- Autism Phase 3
- Autism spectrum disorder Phase 3
- [Cancer](https://trialight.com/data/condition/cancer-703b1dfc-4812-50eb-83f4-d7a205d16bdb.md) Phase 3
- Cannabis dependence Phase 2
- Cocaine abuse Phase 2
- Cocaine dependence Phase 1
- Drug dependence Phase 2
- [Huntington disease](https://trialight.com/data/condition/huntington-disease-fe2d46ec-080a-5259-a901-cad1d6e07061.md) Phase 2
- [Hypertensive disorder](https://trialight.com/data/condition/hypertensive-disorder-6d786557-b9e8-5afc-80f3-89a1995f9da5.md) Phase 2
- Methamphetamine dependence Phase 1
- [Multiple sclerosis](https://trialight.com/data/condition/multiple-sclerosis-62806c95-fe1b-529e-bd16-95cb92d15375.md) Phase 2
- Nicotine dependence Phase 1
- [Obesity disorder](https://trialight.com/data/condition/obesity-disorder-f3b57dc0-68ac-555c-8f13-0d81e595d9cb.md) Phase 2
- Obesity-hypoventilation syndrome Phase 2
- [Obstructive sleep apnea syndrome](https://trialight.com/data/condition/obstructive-sleep-apnea-syndrome-02928491-a2d7-50f4-a4b7-30b79e6771ff.md) Phase 2
- [Opiate dependence](https://trialight.com/data/condition/opiate-dependence-75d4615b-1445-5bca-8b05-ae8266043d82.md) Phase 2
- Oppositional defiant disorder Phase 3

### Other linked conditions (6)

- Anorexia nervosa
- [Chronic obstructive pulmonary disease](https://trialight.com/data/condition/chronic-obstructive-pulmonary-disease-8e23f74b-95b9-5920-a241-c0278555234f.md)
- [Depressive disorder](https://trialight.com/data/condition/depressive-disorder-7618feda-3f90-5521-94e1-99f7100e8324.md)
- [Major depressive disorder](https://trialight.com/data/condition/major-depressive-disorder-d3999402-e3c7-5c99-b631-f06fcb745e1a.md)
- Morbid obesity
- Schizoaffective disorder

### Targets (3)

- [SLC6A2](https://trialight.com/data/target/slc6a2-e24825e0-4238-596c-a718-6dd7ff85f000.md) Norepinephrine transporter inhibitor
- [SLC6A3](https://trialight.com/data/target/slc6a3-f602f09f-d39b-5692-b299-89c357c6d2ac.md)
- [SLC6A4](https://trialight.com/data/target/slc6a4-84e5ed20-84c3-553b-a5e4-897663516251.md)

---

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