Prescription medicine
Rasagiline Brand names: Azilect
Rasagiline (Azilect) is a prescription medicine with an FDA approval on record since 2006. FDA's NDC Directory lists it from 14 generic labelers, and pharmacies paid $0.521 per rasagiline mesylate 0.5 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the rasagiline FDA label on DailyMed (effective June 30, 2020, Teva Pharmaceuticals USA, Inc.); the NDA 21641 record on Drugs@FDA; every rasagiline label on DailyMed.
Highlights of the record
FDA label of June 30, 2020; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageRasagiline tablets are indicated for the treatment of Parkinson’s disease (PD).
Forms and strengths
- 0.5 mg
- 1 mg
Tablet.
On the market
- Earliest approval on file
- May 16, 2006 Azilect, Teva; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 12 first July 1, 2013; 10 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 16 of which 14 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- August 27, 2027 Azilect tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.521 per tablet Rasagiline mesylate 0.5 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 3 since 2013 0 Class I among all firms' recalls; latest August 2, 2023
- FAERS reports
- 11,067 through July 30, 2026
What is rasagiline used for?
From the label: indications and usageRasagiline tablets are indicated for the treatment of Parkinson’s disease (PD). Rasagiline, a monoamine oxidase (MAO)-B inhibitor (MAOI), is indicated for the treatment of Parkinson’s disease
Conditions named in the indications of rasagiline's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Monoamine Oxidase Inhibitor.
Source: FDA drug label (Rasagiline), Teva Pharmaceuticals USA, Inc., effective June 30, 2020 (SPL set e802c83c-e581-4a11-b83d-1df47120078d), via openFDA; the full label on DailyMed
Is there a generic for rasagiline (Azilect)?
The FDA approved the first generic rasagiline on July 1, 2013. 12 generic applications are approved; 10 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 1 tentative approval: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists rasagiline from 14 labelers 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.
The Orange Book lists 2 patents for Azilect tablets: the compound patent runs to August 27, 2027. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2006 earliest approval on file
- 2013 first generic approved
- 2027 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for rasagiline (Azilect)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.521 per Rasagiline mesylate 0.5 mg tablet, down 46% from $0.959 on October 8, 2025. The survey records the price, not the reason for a change; large moves often follow a new generic or a list-price change. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Rasagiline mesylate 0.5 mg tablet (generic)
- Azilect 0.5 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Rasagiline mesylate 0.5 mg tablet | Generic | $0.521 per tablet | $15.63 | -46% |
| Rasagiline mesylate 1 mg tablet | Generic | $0.926 per tablet | $27.77 | -8% |
| Azilect 0.5 mg tablet | Brand | $44.05 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $1,321.39 | +9% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has rasagiline been recalled?
The FDA's Enforcement Report lists 3 recalls naming rasagiline since 2013: 0 Class I (the most serious), 3 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| August 2, 2023 | Class II | Aurobindo Pharma USA Inc. | Failed dissolution specifications - results obtained were below spec average. |
| December 28, 2022 | Class II | Ascend Laboratories, LLC | Presence of Foreign Substance- A complaint was received of black spots/shiny metallic speck on the tablets. |
| July 2, 2013 | Class II | Aidapak Services, LLC | Labeling:Label Mixup; RASAGILINE MESYLATE, Tablet, 0.5 mg may be potentially mislabeled as OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 40985022921, Pedigree … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the rasagiline label say about other medicines?
The rasagiline label names 13 other medicines in its interaction, contraindication or warning sections. The labels of 6 other medicines name rasagiline. 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 |
|---|---|---|
| Ciprofloxacin | drug interactions | Rasagiline plasma concentrations may increase up to 2 fold in patients using concomitant ciprofloxacin and other CYP1A2 inhibitors. |
| Cyclobenzaprine | contraindications | Rasagiline is contraindicated for use with St. John’s wort and with cyclobenzaprine. |
| Dextromethorphan | contraindications | Rasagiline is contraindicated for use with dextromethorphan because of risk of episode of psychosis or bizarre behavior. |
| Fluoxetine | warnings and precautions | Because of the long half-lives of certain antidepressants (e.g., fluoxetine and its active metabolite), at least five weeks (perhaps longer, especially if fluoxetine has been prescribed chronically and/or at higher doses) should elapse between discontinuation of fluoxetine and initiation of rasagiline [see Drug … |
| Fluvoxamine | warnings and precautions | Rasagiline clinical trials did not allow concomitant use of fluoxetine or fluvoxamine with rasagiline, and the potential drug interaction between rasagiline and antidepressants has not been studied systematically. |
| Levodopa | warnings and precautions | Decreasing the levodopa dose may lessen or eliminate this side effect ( 5.7 ) May cause hallucinations and psychotic-like behavior ( 5.8 ) May cause impulse control/compulsive behaviors ( 5.9 ) May cause withdrawal-emergent hyperpyrexia and confusion |
| Meperidine | contraindications | CONTRAINDICATIONS Rasagiline is contraindicated for use with meperidine, tramadol, methadone, propoxyphene, and MAO inhibitors (MAOIs), including other selective MAO-B inhibitors, because of risk of serotonin syndrome [see Warnings and Precautions ( 5.2 )]. |
| Methadone | contraindications | CONTRAINDICATIONS Rasagiline is contraindicated for use with meperidine, tramadol, methadone, propoxyphene, and MAO inhibitors (MAOIs), including other selective MAO-B inhibitors, because of risk of serotonin syndrome [see Warnings and Precautions ( 5.2 )]. |
| Metoclopramide | drug interactions | It is possible that dopamine antagonists, such as antipsychotics or metoclopramide, could diminish the effectiveness of rasagiline. |
| Phenelzine | warnings and precautions | … antidepressants, tetracyclic antidepressants, triazolopyridine antidepressants) and a nonselective MAOI (e.g., phenelzine, tranylcypromine) or selective MAO-B inhibitors, such as selegiline (Eldepryl) and rasagiline. |
| Selegiline | warnings and precautions | … antidepressants) and a nonselective MAOI (e.g., phenelzine, tranylcypromine) or selective MAO-B inhibitors, such as selegiline (Eldepryl) and rasagiline. |
| Tramadol | contraindications | CONTRAINDICATIONS Rasagiline is contraindicated for use with meperidine, tramadol, methadone, propoxyphene, and MAO inhibitors (MAOIs), including other selective MAO-B inhibitors, because of risk of serotonin syndrome [see Warnings and Precautions ( 5.2 )]. |
| Tranylcypromine | warnings and precautions | … tetracyclic antidepressants, triazolopyridine antidepressants) and a nonselective MAOI (e.g., phenelzine, tranylcypromine) or selective MAO-B inhibitors, such as selegiline (Eldepryl) and rasagiline. |
Other labels that name rasagiline
Source: FDA drug label (Rasagiline), Teva Pharmaceuticals USA, Inc., effective June 30, 2020 (SPL set e802c83c-e581-4a11-b83d-1df47120078d), via openFDA; the full label on DailyMed
What do FAERS reports show for rasagiline?
The FDA Adverse Event Reporting System holds 11,067 reports that list rasagiline among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,236 are coded as a death and 3,592 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 else is labeled for the same conditions as rasagiline?
13 other medicines are given the same way (oral) and in the same FDA class as rasagiline or labeled mainly for the same use (parkinson's disease), the same class first. Parkinson's disease lists all 19 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Selegiline | Parkinson's disease | 11 labelers | $0.756 per capsule 5 mg capsule | No current entry |
| Ropinirole | Parkinson's disease | 27 labelers | $0.046 per tablet 0.25 mg tablet | No current entry |
| Pramipexole | Parkinson's disease | 22 labelers | $0.0452 per tablet 0.25 mg tablet | No current entry |
| Carbidopa and levodopa | Parkinson's disease | 33 labelers | $0.0759 per tablet 25-100 tablet | No current entry |
| Benztropine | Parkinson's disease | 19 labelers | $0.0753 per tablet 1 mg tablet | A presentation being discontinued |
| Carbidopa and entacapone and levodopa | Parkinson's disease | 4 labelers | $0.695 per tablet 25-100-200 mg tablet | No current entry |
| Trihexyphenidyl | Parkinson's disease | 8 labelers | $0.0884 per tablet 2 mg tablet | No current entry |
| Entacapone | Parkinson's disease | 11 labelers | $0.325 per tablet 200 mg tablet | No current entry |
Every medicine labeled for the same conditions as rasagiline
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does rasagiline compare with medicines for the same use?
1 side-by-side page set rasagiline beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to rasagiline
- 13 medicines for the same use
- Other MAO inhibitors
- the pharmacologic class, with prices and generics
- Rasagiline side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other