Prescription medicine
Penicillamine Brand names: Depen, Cuprimine, Aagylur
Penicillamine (Depen) is a prescription medicine with an FDA approval on record since 1970. FDA's NDC Directory lists it from 9 generic labelers.
- Generic listed
- Boxed warning
Check it at the source: the penicillamine FDA label on DailyMed (effective January 26, 2026, Bausch Health US, LLC); the NDA 19853 record on Drugs@FDA; every penicillamine label on DailyMed.
Highlights of the record
FDA label of January 26, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Physicians planning to use penicillamine should thoroughly familiarize themselves with its toxicity, special dosage considerations, and therapeutic benefits. Penicillamine should never be used casually. Each patient should remain constantly under the close supervision of the physician. Patients should be warned to report promptly any symptoms suggesting toxicity.
Used for
From the label: indications and usageCUPRIMINE is indicated in the treatment of Wilson’s disease, cystinuria, and in patients with severe, active rheumatoid arthritis who have failed to respond to an adequate trial of conventional therapy.
Forms and strengths
- 250 mg
Capsule; tablet; gelatin-coated capsule; film-coated tablet.
On the market
- Earliest approval on file
- December 4, 1970 Cuprimine, Valeant Pharms Intl; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 12 first May 7, 2019; 9 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 11 of which 9 under generic applications, 2 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)
- 1 since 2023 0 Class I among all firms' recalls; latest November 22, 2023
- FAERS reports
- 922 through July 30, 2026
What is penicillamine used for?
From the label: indications and usageCUPRIMINE is indicated in the treatment of Wilson’s disease, cystinuria, and in patients with severe, active rheumatoid arthritis who have failed to respond to an adequate trial of conventional therapy. Available evidence suggests that CUPRIMINE is not of value in ankylosing spondylitis. Wilson’s Disease Wilson’s disease (hepatolenticular degeneration) occurs in individuals who have inherited an autosomal-recessive defect that leads to an accumulation of copper far in excess of metabolic requirements. […]
Conditions named in the indications of penicillamine's FDA labels, with every medicine labeled for each:
From other penicillamine labelsRheumatoid arthritis: INDICATIONS CUPRIMINE is indicated in the treatment of Wilson’s disease, cystinuria, and in patients with severe, active rheumatoid arthritis who have failed to respond to an adequate trial of conventional therapy.
FDA pharmacologic class: Antirheumatic Agent.
Source: FDA drug label (Cuprimine), NDA019853 (Valeant Pharms Intl), as published by Bausch Health US, LLC, effective January 26, 2026 (SPL set 80e736d3-2017-4d68-94b4-38255c3c59c6), via openFDA; the full label on DailyMed
Is there a generic for penicillamine (Depen)?
The FDA approved the first generic penicillamine on May 7, 2019. 12 generic applications are approved; 9 of them carry 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 penicillamine from 9 labelers under a generic (ANDA) application and from 2 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1970 earliest approval on file
- 2019 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has penicillamine been recalled?
The FDA's Enforcement Report lists 1 recall naming penicillamine since 2023: 0 Class I (the most serious), 1 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| November 22, 2023 | Class II | Lupin Pharmaceuticals Inc. | Failed Dissolution Specifications |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the penicillamine label say about other medicines?
The penicillamine label names no other medicine on this site. The labels of 7 other medicines name penicillamine. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
Other labels that name penicillamine
Source: FDA drug label (Cuprimine), NDA019853 (Valeant Pharms Intl), as published by Bausch Health US, LLC, effective January 26, 2026 (SPL set 80e736d3-2017-4d68-94b4-38255c3c59c6), via openFDA; the full label on DailyMed
What do FAERS reports show for penicillamine?
The FDA Adverse Event Reporting System holds 922 reports that list penicillamine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 90 are coded as a death and 245 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 penicillamine?
9 other medicines are given the same way (oral) and in the same FDA class as penicillamine or labeled mainly for the same use (rheumatoid arthritis), the same class first. Rheumatoid arthritis lists all 46 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 |
|---|---|---|---|---|
| Hydroxychloroquine | Rheumatoid arthritis | 28 labelers | $0.149 per tablet 200 mg tablet | A presentation being discontinued |
| Leflunomide | Rheumatoid arthritis | 16 labelers | $0.324 per tablet 10 mg tablet | A presentation being discontinued |
| Indomethacin | Rheumatoid arthritis | 25 labelers | $0.210 per capsule 75 mg capsule | No current entry |
| Tofacitinib | Rheumatoid arthritis | 24 labelers | $0.573 per tablet 5 mg tablet | No current entry |
| Methotrexate | Rheumatoid arthritis | 25 labelers | $0.158 per tablet 2.5 mg tablet | In shortage |
| Baricitinib | Rheumatoid arthritis | none listed | $92.54 per tablet 2 mg tablet | No current entry |
| Flurbiprofen | Rheumatoid arthritis | 3 labelers | $3.17 per tablet 100 mg tablet | No current entry |
| Upadacitinib | Rheumatoid arthritis | none listed | $229.31 per tablet 15 mg tablet | No current entry |
Every medicine labeled for the same conditions as penicillamine
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to penicillamine
- 9 medicines for the same use
- Other antirheumatic agents
- the pharmacologic class, with prices and generics
- Penicillamine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other