Penicillamine
Penicillamine is a copper-binding (chelating) medicine used to treat Wilson’s disease, cystinuria, and severe, active rheumatoid arthritis that has not responded to conventional therapy.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 12 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Penicillamine is a chelating drug (it grabs onto copper so it leaves the body, and turns cystine into a form that dissolves easily in urine) for Wilson's disease, cystinuria and severe rheumatoid arthritis that has failed conventional therapy, an older standby on the market since about 1970 and available generically. Many find it hard to tolerate, and the common complaints are rash and itching, stomach upset and a dulled sense of taste. Its boxed warning says it should never be used casually, because serious blood and kidney problems can appear at any time, so keep every blood and urine test and report fever, bruising or blood in urine promptly.
Clinical pearls
- Take it an hour before or two hours after meals, and an hour apart from milk or other medicines.
- Keep antacids and iron or zinc products at least an hour away from your dose, because they cut its absorption.
- Ask about a daily vitamin B6 (pyridoxine) supplement, since penicillamine raises your body's need for it.
- For Wilson's or cystinuria, never pause it on your own, since a few days off can trigger sensitivity reactions on restarting.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Penicillamine should never be used casually. It can cause serious toxicity, so your doctor must know its risks and dosing well and supervise you closely the whole time you take it.
You have a role too: report promptly any symptom that might suggest a problem with the medicine.
Patient information guide A plain-language walkthrough of Penicillamine, written from its FDA label.
What Penicillamine is used for
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Penicillamine is approved for these uses across its capsule and tablet products (Aagylur, Cuprimine, Depen and generic penicillamine):
- Wilson’s disease, an inherited disorder of copper buildup that can damage the liver, brain, kidneys and eyes
- Cystinuria, which causes cystine to build up in urine
- Severe, active rheumatoid arthritis in people who did not respond to an adequate trial of conventional therapy
The labels note it is not of value in ankylosing spondylitis.
How Penicillamine works
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Penicillamine is a chelating agent. It binds copper so the body can remove it, which helps in Wilson’s disease. In cystinuria, it reacts with cystine to form a substance that dissolves much more easily and is passed in the urine.
Its effect in rheumatoid arthritis is not understood, but it appears to suppress disease activity. It lowers rheumatoid factor without significantly lowering overall immunoglobulin levels.
Penicillamine dosage
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Penicillamine is taken by mouth as a capsule or tablet. Take it on an empty stomach, at least one hour before meals or two hours after, and at least one hour apart from any other drug, food or milk.
- Your prescriber may add a daily vitamin B6 (pyridoxine) supplement.
- In Wilson’s disease, your dose is guided by urine and blood copper tests.
- In rheumatoid arthritis, benefit may not show for two or three months.
- For Wilson’s disease and cystinuria, treatment should usually continue daily without breaks.
Follow your prescriber and label directions for your dose.
Dosing details from the FDA-approved label
From the Penicillamine prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Wilson's Disease
- A dose between 0.75 and 1.5 g that results in an initial 24-hour cupriuresis of over 2 mg should be continued for about three months (in the absence of any drug reaction)
- Patients who cannot tolerate as much as 1 g/day initially: start with 250 mg/day and increase gradually to the requisite amount
- Maximum: It is seldom necessary to exceed a dosage of 2 g/day
- Given on an empty stomach, at least one hour before meals or two hours after meals, and at least one hour apart from any other drug, food, or milk; may require daily pyridoxine supplement
- Cystinuria (adults)
- Usual dosage 2 g/day, with a range of 1 to 4 g/day, divided into four doses
- If four equal doses are not feasible, give the larger portion at bedtime
- Initiating with 250 mg/day and increasing gradually to the requisite amount
- Retain the bedtime dose if dose is reduced; drink copiously, about a pint of fluid at bedtime and another pint once during the night; dosage individualized to limit cystine excretion to 100-200 mg/day (no history of stones) or below 100 mg/day (stone formation and/or pain)
- Cystinuria (pediatric patients)
- Dosage can be based on 30 mg/kg/day, total daily amount divided into four doses
- If four equal doses are not feasible, give the larger portion at bedtime
- Dose based on weight (30 mg/kg/day); retain the bedtime dose if dosage is reduced
- Rheumatoid Arthritis - Initial Therapy
- Single daily dose of 125 mg or 250 mg, thereafter increased at one to three month intervals by 125 mg or 250 mg/day as patient response and tolerance indicate
- If no improvement after two to three months at 500-750 mg/day, increases of 250 mg/day at two to three month intervals may be continued until satisfactory remission or signs of toxicity
- Discontinue i
- Onset of response is typically delayed (two or three months); if treatment interrupted, reintroduce cautiously starting with a lower dosage and increasing slowly
- Rheumatoid Arthritis - Maintenance Therapy
- Individualized
- Many patients respond to a dosage within the 500-750 mg/day range, some need less
- If incomplete suppression after the first six to nine months, daily dosage may be increased by 125 mg or 250 mg/day at three-month intervals
- Maximum: It is unusual to employ a dosage in excess of 1 g/day, but up to 1.5 g/day has sometimes been required
- Changes in maintenance dosage may not be reflected clinically or in erythrocyte sedimentation rate for two to three months after each adjustment
Read the label’s full dosing text
DOSAGE AND ADMINISTRATION In all patients receiving penicillamine, it is important that penicillamine capsules, USP be given on an empty stomach, at least one hour before meals or two hours after meals, and at least one hour apart from any other drug, food, or milk. Because penicillamine increases the requirement for pyridoxine, patients may require a daily supplement of pyridoxine (see PRECAUTIONS ). Wilson's Disease - Optimal dosage can be determined by measurement of urinary copper excretion and the determination of free copper in the serum. The urine must be collected in copper-free glassware, and should be quantitatively analyzed for copper before and soon after initiation of therapy with penicillamine capsules, USP. Determination of 24-hour urinary copper excretion is of greatest value in the first week of therapy with penicillamine. In the absence of any drug reaction, a dose between 0.75 and 1.5 g that results in an initial 24-hour cupriuresis of over 2 mg should be continued for about three months, by which time the most reliable method of monitoring maintenance treatment is the determination of free copper in the serum. This equals the difference between quantitatively determined total copper and ceruloplasmin-copper. Adequately treated patients will usually have less than 10 mcg free copper/dL of serum. It is seldom necessary to exceed a dosage of 2 g/day. If the patient is intolerant to therapy with penicillamine capsules, USP, alternative treatment is trientine hydrochloride. In patients who cannot tolerate as much as 1 g/day initially, initiating dosage with 250 mg/day, and increasing gradually to the requisite amount, gives closer control of the effects of the drug and may help to reduce the incidence of adverse reactions. Cystinuria - It is recommended that penicillamine capsules, USP be used along with conventional therapy. By reducing urinary cystine, it decreases crystalluria and stone formation. In some instances, it has been reported to decrease the size of, and even to dissolve, stones already formed. The usual dosage of penicillamine capsules, USP in the treatment of cystinuria is 2 g/day for adults, with a range of 1 to 4 g/day. For pediatric patients, dosage can be based on 30 mg/kg/day. The total daily amount should be divided into four doses. If four equal doses are not feasible, give the larger portion at bedtime.
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Penicillamine side effects
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Penicillamine has a high rate of side effects. Common ones include:
Common side effects
- Rash and itching
- Nausea, vomiting, poor appetite, stomach pain or occasional diarrhea
- Loss or dulling of taste
- Mouth sores
- Protein in the urine
When to get medical help
- Fever, sore throat, chills, bruising or bleeding, which can signal a drop in white blood cells or platelets
- Blood or protein in the urine, which can signal kidney damage
- Coughing up blood, new shortness of breath, unexplained cough or wheezing
- Drooping eyelids, double vision or new muscle weakness, which can be early signs of myasthenia (a muscle weakness disorder)
- Blistering skin or mouth sores, which may be pemphigus (a blistering skin disease)
- Any symptom that could suggest toxicity, so report it promptly
- Missed periods or other signs of pregnancy
Serious reactions involve blood cells, kidneys, lungs, muscles and skin. Call your doctor right away for fever, sore throat, bruising, bleeding, blood in urine, new cough or breathing trouble, or muscle weakness.
Penicillamine warnings and precautions
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- Boxed warning: Penicillamine should never be used casually. You need close physician supervision throughout treatment.
- Blood problems: Low white blood cells and platelets can occur. Fatalities from aplastic anemia, agranulocytosis and thrombocytopenia have been reported.
- Kidney problems: Protein or blood in the urine may signal serious kidney damage.
- Lungs: Goodpasture’s syndrome and obliterative bronchiolitis have been reported rarely.
- Muscle and skin: Myasthenia and pemphigus can occur.
- Liver: Liver function tests are recommended during therapy.
- Pregnancy: It can cause fetal harm.
Penicillamine interactions
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The label focuses on substances that interfere with absorption.
- Food and milk: take penicillamine apart from them, because they reduce absorption.
- Antacids: they reduce absorption.
- Iron- or zinc-containing products: they bind penicillamine and reduce absorption.
- Any other drug: take at least one hour apart.
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Penicillamine
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- Do not use during pregnancy unless treating Wilson’s disease or certain cystinuria cases; discuss with your prescriber.
- Do not breastfeed while taking it.
- Do not restart if you ever had penicillamine-related aplastic anemia or agranulocytosis.
- Rheumatoid arthritis patients with kidney insufficiency should not take it.
- Women who could become pregnant should report missed periods promptly.
What Penicillamine does in the body
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Penicillamine promotes excretion of copper in Wilson’s disease and lowers excess cystine excretion in cystinuria. It also interferes with collagen cross-links. In rheumatoid arthritis, it markedly lowers IgM rheumatoid factor without significantly lowering absolute levels of serum immunoglobulins.
How your body processes Penicillamine
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Penicillamine is absorbed rapidly but incompletely (40% to 70%), and the amount varies a lot between people. Food, antacids and iron reduce absorption. Blood levels peak 1 to 3 hours after a dose.
A small fraction is metabolized in the liver. It is mainly cleared by the kidneys. After long-term treatment stops, a slow elimination phase lasts 4 to 6 days.
How to store Penicillamine
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Dispense in a tight container as defined in the USP using a child-resistant closure.
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Penicillamine
26 supplements and herbal products have documented interactions with Penicillamine in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 3
- Moderate · 13
- Minor · 10
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Nutrient depletion considerations
Penicillamine has been associated with lower levels of 5 nutrients in the clinical literature. This does not mean a deficiency will occur — it means these may be worth discussing with your pharmacist or healthcare provider, especially with long-term use.
- Higher significance · 2
- Moderate · 2
- Unrated · 1
Educational information from a licensed clinical database (Natural Medicines) — not medical advice. Do not start or stop medications or supplements without professional guidance.
Penicillamine: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Penicillamine — the kind of thing our pharmacy team would talk through with you at the counter.
What is penicillamine used for?
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How should I take it?
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Why do I need so many blood and urine tests?
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What side effects should I call about?
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Can I take it if I’m pregnant or breastfeeding?
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Can I stop it if I feel better?
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Is Penicillamine available over the counter?
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When was Penicillamine first available?
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Who makes Penicillamine?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Penicillamine on HelloPharmacist
Penicillamine forms and strengths (how it comes)
Penicillamine is available in 2 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Penicillamine inactive ingredients by manufacturer.
Capsule
How this form is used
- Aagylur capsules are indicated for Wilson’s disease, cystinuria, and severe, active rheumatoid arthritis after conventional therapy has failed.
- Cuprimine capsules are indicated for Wilson’s disease, cystinuria, and severe, active rheumatoid arthritis after conventional therapy has failed.
- Penicillamine capsules are indicated for Wilson’s disease, cystinuria, and severe, active rheumatoid arthritis after conventional therapy has failed.
- Aagylur should be taken on an empty stomach, one hour before or two hours after meals, and one hour apart from other drugs, food or milk.
- Cuprimine should be taken on an empty stomach, one hour before or two hours after meals, and one hour apart from other drugs, food or milk.
- Penicillamine capsules should be taken on an empty stomach, one hour before or two hours after meals, and one hour apart from other drugs, food or milk.
Tablet
How this form is used
- Depen tablets are indicated for Wilson’s disease, cystinuria, and severe, active rheumatoid arthritis after conventional therapy has failed.
- Penicillamine tablets are indicated for Wilson’s disease, cystinuria, and severe, active rheumatoid arthritis after conventional therapy has failed.
- Depen should be taken on an empty stomach, one hour before or two hours after meals, and one hour apart from other drugs, food or milk.
- Penicillamine tablets should be taken on an empty stomach, one hour before or two hours after meals, and one hour apart from other drugs, food or milk.
Penicillamine on the U.S. market: products, makers and brands
How Penicillamine appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
11 companies list 12 Penicillamine product records with the FDA, mostly as capsule, tablet; the earliest marketing or approval year on record is 1970. Brand names on the directory include Cupramine, Depen, Cuprimine and 1 more; the rest are generics.
FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
Also listed with the FDA, not a patient dose form: Powder (10) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
How widely Penicillamine is used (Medicaid data)
A general measure of how commonly Penicillamine is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Penicillamine is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Penicillamine prescribed? Of the 1,601 medications we measure, Penicillamine ranks #1,505 by Medicaid prescriptions — more than 6% of them.
Utilization by Penicillamine product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
penicillamine 250 MG Oral Tablet Most dispensed
Summed across the 2 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 198071
penicillamine 250 MG Oral Capsule
Summed across the 1 of 14 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 198070
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Penicillamine, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 3 of 17 listed Penicillamine NDCs with Medicaid activity.
Compare Penicillamine products
A representative set of FDA-listed product records for Penicillamine — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Capsule | ||||
| 250 mg | Oral | Actavis Pharma, Inc. | ANDA | View NDC → |
| 250 mg | Oral | Bausch Health US, LLC | NDA | View NDC → |
| 250 mg | Oral | Breckenridge Pharmaceutical, Inc. | ANDA | View NDC → |
| 250 mg | Oral | Cycle Pharmaceuticals Ltd. | ANDA | View NDC → |
| 250 mg | Oral | Dr. Reddy's Laboratories Inc. | ANDA | View NDC → |
| 250 mg | Oral | Endo USA, Inc. | ANDA | View NDC → |
| 250 mg | Oral | Granules Pharmaceuticals Inc. | ANDA | View NDC → |
| 250 mg | Oral | Navinta LLC | ANDA | View NDC → |
| 250 mg | Oral | Proficient Rx LP | ANDA | View NDC → |
| 💊Tablet | ||||
| 250 mg | Oral | Endo USA, Inc. | ANDA | View NDC → |
| 250 mg | Oral | Lupin Pharmaceuticals, Inc. | ANDA | View NDC → |
| 250 mg | Oral | Viatris Specialty LLC | NDA | View NDC → |
Showing 12 of 12 products — FDA National Drug Code Directory. See every product, package size and price: browse all 12 Penicillamine NDCs →
Penicillamine side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Penicillamine — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Penicillamine in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Penicillamine FDA approval history
How Penicillamine went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Penicillamine recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list one Penicillamine recall since July 2021. It is no longer listed as ongoing. A recall names specific lots from one company, so check the lot number on your own bottle rather than assuming every product is affected; your pharmacist can check whether your supply came from an affected lot.
- Penicillamine Tablets USP 250 mg, 100-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 Manufactured by: Lupin Limited, Nagpur-441 108, India, NDC# 70748-153-01 Lots: Lot # M200498, Exp. June 2024 FDA record D-0148-2024 →
Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 7975 2 dose forms · 5 strengths
-
Dose form (SCDF) Oral Capsule RxCUI 373257In current FDA listings -
Dose form (SCDF) Oral Tablet RxCUI 373258In current FDA listings
Look up RxCUI 7975 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Penicillamine supply and shortage status
Whether Penicillamine is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
Penicillamine brand names
Penicillamine is sold under 4 brand names in the FDA directory — Cupramine, Depen, Cuprimine, Aagylur. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Penicillamine: manufacturers and labelers
11 companies list Penicillamine products with the FDA. By number of product records, the largest are Endo USA, Inc., Actavis Pharma, Inc., Bausch Health US, LLC. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Penicillamine drug class (RxNorm)
Penicillamine belongs to the Antirheumatic Agent class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Penicillamine page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Bausch Health US, LLC is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →