Prescription medicine
Ioflupane i 123 Brand names: Datscan
Ioflupane i 123 (Datscan) is a prescription medicine with an FDA approval on record since 2011. FDA's NDC Directory lists it from 1 generic labeler.
- Generic listed
Check it at the source: the ioflupane i 123 FDA label on DailyMed (effective April 24, 2026, Medi-Physics Inc. dba GE Healthcare.); the NDA 22454 record on Drugs@FDA; every ioflupane i 123 label on DailyMed.
Highlights of the record
FDA label of April 24, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageDATSCAN is indicated as an adjunct to other diagnostic evaluations for striatal dopamine transporter visualization using single photon emission computed tomography (SPECT) brain imaging in adult patients with: suspected Parkinsonian syndromes (PS) or suspected dementia with Lewy bodies (DLB).
Forms and strengths
Injection (solution).
On the market
- Earliest approval on file
- January 14, 2011 Datscan, Ge Hlthcare Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 1 first March 30, 2022; 1 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 2 of which 1 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 532 through July 30, 2026
What is ioflupane i 123 used for?
From the label: indications and usageDATSCAN is indicated as an adjunct to other diagnostic evaluations for striatal dopamine transporter visualization using single photon emission computed tomography (SPECT) brain imaging in adult patients with: suspected Parkinsonian syndromes (PS) or suspected dementia with Lewy bodies (DLB). DATSCAN is a radioactive diagnostic agent indicated as an adjunct to other diagnostic evaluations for striatal dopamine transporter visualization using single photon emission computed tomography (SPECT) brain imaging in adult patients with: suspected Parkinsonian syndromes (PS) or suspected dementia with Lewy bodies (DLB).
FDA pharmacologic class: Radioactive Diagnostic Agent.
Source: FDA drug label (DaTscan), NDA022454 (Ge Hlthcare Inc), as published by Medi-Physics Inc. dba GE Healthcare., effective April 24, 2026 (SPL set ef7804d7-c691-495b-8aaf-5bc54fd5d9f6), via openFDA; the full label on DailyMed
Is there a generic for ioflupane i 123 (Datscan)?
The FDA approved the first generic ioflupane i 123 on March 30, 2022. 1 generic application is approved; 1 of it carries a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists ioflupane i 123 from 1 labeler under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 2011 earliest approval on file
- 2022 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the ioflupane i 123 label say about other medicines?
The ioflupane i 123 label names 17 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Amoxapine | drug interactions | Amoxapine, amphetamine, armodafinil, benztropine, bupropion, buspirone, cocaine, mazindol, methamphetamine, methylphenidate, modafinil norephedrine, phentermine, selegiline, sertraline, citalopram, paroxetine, venlafaxine, and desvenlafaxine may impact DATSCAN image interpretation. |
| Amphetamine | drug interactions | Amoxapine, amphetamine, armodafinil, benztropine, bupropion, buspirone, cocaine, mazindol, methamphetamine, methylphenidate, modafinil norephedrine, phentermine, selegiline, sertraline, citalopram, paroxetine, venlafaxine, and desvenlafaxine may impact DATSCAN image interpretation. |
| Armodafinil | drug interactions | Amoxapine, amphetamine, armodafinil, benztropine, bupropion, buspirone, cocaine, mazindol, methamphetamine, methylphenidate, modafinil norephedrine, phentermine, selegiline, sertraline, citalopram, paroxetine, venlafaxine, and desvenlafaxine may impact DATSCAN image interpretation. |
| Benztropine | drug interactions | Amoxapine, amphetamine, armodafinil, benztropine, bupropion, buspirone, cocaine, mazindol, methamphetamine, methylphenidate, modafinil norephedrine, phentermine, selegiline, sertraline, citalopram, paroxetine, venlafaxine, and desvenlafaxine may impact DATSCAN image interpretation. |
| Bupropion | drug interactions | Amoxapine, amphetamine, armodafinil, benztropine, bupropion, buspirone, cocaine, mazindol, methamphetamine, methylphenidate, modafinil norephedrine, phentermine, selegiline, sertraline, citalopram, paroxetine, venlafaxine, and desvenlafaxine may impact DATSCAN image interpretation. |
| Buspirone | drug interactions | Amoxapine, amphetamine, armodafinil, benztropine, bupropion, buspirone, cocaine, mazindol, methamphetamine, methylphenidate, modafinil norephedrine, phentermine, selegiline, sertraline, citalopram, paroxetine, venlafaxine, and desvenlafaxine may impact DATSCAN image interpretation. |
| Citalopram | drug interactions | Selective serotonin reuptake inhibitors (paroxetine and citalopram) may increase or decrease ioflupane binding to the dopamine transporter. |
| Cocaine | drug interactions | Amoxapine, amphetamine, armodafinil, benztropine, bupropion, buspirone, cocaine, mazindol, methamphetamine, methylphenidate, modafinil norephedrine, phentermine, selegiline, sertraline, citalopram, paroxetine, venlafaxine, and desvenlafaxine may impact DATSCAN image interpretation. |
| Desvenlafaxine | drug interactions | In patients taking venlafaxine or desvenlafaxine prior to DATSCAN administration, there have been cases of altered DATSCAN uptake that impacted image interpretation. |
| Methamphetamine | drug interactions | Amoxapine, amphetamine, armodafinil, benztropine, bupropion, buspirone, cocaine, mazindol, methamphetamine, methylphenidate, modafinil norephedrine, phentermine, selegiline, sertraline, citalopram, paroxetine, venlafaxine, and desvenlafaxine may impact DATSCAN image interpretation. |
| Methylphenidate | drug interactions | Amoxapine, amphetamine, armodafinil, benztropine, bupropion, buspirone, cocaine, mazindol, methamphetamine, methylphenidate, modafinil norephedrine, phentermine, selegiline, sertraline, citalopram, paroxetine, venlafaxine, and desvenlafaxine may impact DATSCAN image interpretation. |
| Modafinil | drug interactions | Amoxapine, amphetamine, armodafinil, benztropine, bupropion, buspirone, cocaine, mazindol, methamphetamine, methylphenidate, modafinil norephedrine, phentermine, selegiline, sertraline, citalopram, paroxetine, venlafaxine, and desvenlafaxine may impact DATSCAN image interpretation. |
| Paroxetine | drug interactions | Selective serotonin reuptake inhibitors (paroxetine and citalopram) may increase or decrease ioflupane binding to the dopamine transporter. |
| Phentermine | drug interactions | Amoxapine, amphetamine, armodafinil, benztropine, bupropion, buspirone, cocaine, mazindol, methamphetamine, methylphenidate, modafinil norephedrine, phentermine, selegiline, sertraline, citalopram, paroxetine, venlafaxine, and desvenlafaxine may impact DATSCAN image interpretation. |
Every other medicine the ioflupane i 123 label names
| Medicine named | Section | What the label says |
|---|---|---|
| Selegiline | drug interactions | … methamphetamine, methylphenidate, modafinil norephedrine, phentermine, selegiline, sertraline, citalopram, paroxetine, venlafaxine, and desvenlafaxine may impact DATSCAN image interpretation. |
| Sertraline | drug interactions | … methylphenidate, modafinil norephedrine, phentermine, selegiline, sertraline, citalopram, paroxetine, venlafaxine, and desvenlafaxine may impact DATSCAN image interpretation. |
| Venlafaxine | drug interactions | In patients taking venlafaxine or desvenlafaxine prior to DATSCAN administration, there have been cases of altered DATSCAN uptake that impacted image interpretation. |
Source: FDA drug label (DaTscan), NDA022454 (Ge Hlthcare Inc), as published by Medi-Physics Inc. dba GE Healthcare., effective April 24, 2026 (SPL set ef7804d7-c691-495b-8aaf-5bc54fd5d9f6), via openFDA; the full label on DailyMed
What do FAERS reports show for ioflupane i 123?
The FDA Adverse Event Reporting System holds 532 reports that list ioflupane i 123 among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 7 are coded as a death and 17 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other radioactive diagnostic agents
- the pharmacologic class, with prices and generics
- Ioflupane i 123 side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other