Prescription medicine
Cysteamine Brand names: Procysbi, Cystaran, Cystagon, Cystadrops
Cysteamine (Procysbi) is a prescription medicine with an FDA approval on record since 1994. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the cysteamine FDA label on DailyMed (effective April 30, 2025, Leadiant Biosciences, Inc.); the NDA 20392 record on Drugs@FDA; every cysteamine label on DailyMed.
Highlights of the record
FDA label of April 30, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageCYSTARAN ® is a cystine-depleting agent indicated for the treatment of corneal cystine crystal accumulation in patients with cystinosis.
Forms and strengths
- 25 mg
- 50 mg
- 75 mg
- 150 mg
- 300 mg
- 3.5 mg/ml
- 6.5 mg/ml
Solution; delayed-release granule; capsule; capsule (delayed release pellets).
On the market
- Earliest approval on file
- August 15, 1994 Cystagon, Mylan; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 4 of which 0 under generic applications, 4 under brand applications, repackagers included
- Last listed patent
- February 16, 2037 Procysbi capsules; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 3 since 2018 0 Class I among all firms' recalls; latest September 24, 2020
- FAERS reports
- 1,390 through July 30, 2026
What is cysteamine used for?
From the label: indications and usageCYSTARAN ® is a cystine-depleting agent indicated for the treatment of corneal cystine crystal accumulation in patients with cystinosis. CYSTARAN is a cystine-depleting agent indicated for the treatment of corneal cystine crystal accumulation in patients with cystinosis.
FDA pharmacologic class: Cystine Depleting Agent.
Source: FDA drug label (CYSTARAN), Leadiant Biosciences, Inc., effective April 30, 2025 (SPL set b98ee838-ed23-42a9-93b5-72579e490fba), via openFDA; the full label on DailyMed
Is there a generic for cysteamine (Procysbi)?
No generic cysteamine is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 12 patents for Procysbi capsules: the compound patent runs to January 26, 2027 (pediatric exclusivity to July 26, 2027), and the last listed entry to February 16, 2037. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1994 earliest approval on file
- 2037 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has cysteamine been recalled?
The FDA's Enforcement Report lists 3 recalls naming cysteamine since 2018: 0 Class I (the most serious), 0 Class II, 3 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| September 24, 2020 | Class III | Leadiant Biosciences, Inc. | Subpotent Drug: Product testing identified a decreased level of the active ingredient, Cysteamine HCl. |
| April 9, 2018 | Class III | LEADIANT BIOSCIENCES, INC | Subpotent drug: Out of specification for an active ingredient cysteamine hydrochloride. |
| February 14, 2018 | Class III | LEADIANT BIOSCIENCES, INC | Subpotent Drug: Out of specification for an active ingredient cysteamine hydrochloride. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the cysteamine label say about other medicines?
The cysteamine label names 3 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 |
|---|---|---|
| Benzalkonium | warnings and precautions | Contact Lens Use CYSTARAN contains benzalkonium chloride, which may be absorbed by soft contact lenses. |
| Omeprazole | drug interactions | Concomitant administration of 20 mg omeprazole did not affect the pharmacokinetics of cysteamine when PROCYSBI was administered with 240 mL of orange juice or with 240 mL of water [see Clinical Pharmacology (12.3) ]. |
| Penicillamine | contraindications | CONTRAINDICATIONS The use of PROCYSBI is contraindicated in patients with a serious hypersensitivity reaction, including anaphylaxis, to penicillamine or cysteamine. Hypersensitivity to penicillamine or cysteamine |
Source: FDA drug label (CYSTARAN), Leadiant Biosciences, Inc., effective April 30, 2025 (SPL set b98ee838-ed23-42a9-93b5-72579e490fba), via openFDA; the full label on DailyMed
What do FAERS reports show for cysteamine?
The FDA Adverse Event Reporting System holds 1,390 reports that list cysteamine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 87 are coded as a death and 375 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?
- Cysteamine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other