Prescription medicine
Cladribine Brand names: Mavenclad; first approved as Leustatin
Cladribine (Mavenclad) is a prescription medicine with an FDA approval on record since 1993. FDA's NDC Directory lists it from 6 generic labelers.
- Generic listed
- Boxed warning
Check it at the source: the cladribine FDA label on DailyMed (effective May 27, 2026, EMD Serono, Inc.); the NDA 20229 record on Drugs@FDA; every cladribine label on DailyMed.
Highlights of the record
FDA label of May 27, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
MALIGNANCIES AND RISK OF TERATOGENICITY.
Malignancies Treatment with MAVENCLAD may increase the risk of malignancy. MAVENCLAD is contraindicated in patients with current malignancy. In patients with prior malignancy or with increased risk of malignancy, evaluate the benefits and risks of the use of MAVENCLAD on an individual patient basis. Follow standard cancer screening guidelines in patients treated with MAVENCLAD [see Contraindications (4) and Warnings and Precautions (5.1) ]. Risk of Teratogenicity MAVENCLAD is contraindicated for use in pregnant women and in females and males of reproductive potential who do not plan to use effective contraception because of the potential for fetal harm. Malformations and embryolethality occurred in animals. Exclude pregnancy before the start of treatment with MAVENCLAD in females of reproductive potential. Advise females and males of reproductive potential to use effective contraception during MAVENCLAD dosing and for 6 months after the last dose in each treatment course for females, and 14 weeks for males. Stop MAVENCLAD if the patient becomes pregnant [see Contraindications (4), Warnings and Precautions (5.2), and Use in Specific Populations (8.1 , 8.3) ]. WARNING: MALIGNANCIES and RISK OF TERATOGENICITY See full prescribing information for complete boxed warning. Malignancies MAVENCLAD may increase the risk of malignancy. […]
Used for
From the label: indications and usageMAVENCLAD is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include relapsing-remitting disease and active secondary progressive disease, in adults.
Forms and strengths
- 10 mg
- 1 mg/ml
Tablet; injection (solution); injection.
On the market
- Earliest approval on file
- February 26, 1993 Leustatin, Janssen Pharms; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 6 first February 28, 2000; 5 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 7 of which 6 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- September 10, 2041 Mavenclad tablets; 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)
- No recall recorded
- FAERS reports
- 9,555 through July 30, 2026
What is cladribine used for?
From the label: indications and usageMAVENCLAD is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include relapsing-remitting disease and active secondary progressive disease, in adults. Because of its safety profile, use of MAVENCLAD is generally recommended for patients who have had an inadequate response to, or are unable to tolerate, an alternate drug indicated for the treatment of MS [see Warnings and Precautions (5) ]. Limitations of Use MAVENCLAD is not recommended for use in patients with clinically isolated syndrome (CIS) because of its safety profile [see Warnings and Precautions (5) ]. […]
Conditions named in the indications of cladribine's FDA labels, with every medicine labeled for each:
From other cladribine labelsLeukemia, lymphoma and myeloma: INDICATIONS FOR USE Cladribine Injection, USP is indicated for the treatment of active Hairy Cell Leukemia as defined by clinically significant anemia, neutropenia, thrombocytopenia or disease-related symptoms.
FDA pharmacologic class: Purine Antimetabolite.
Source: FDA drug label (Mavenclad), EMD Serono, Inc., effective May 27, 2026 (SPL set 9c75e30a-a410-40f1-b653-04d532bd9144), via openFDA; the full label on DailyMed
What does the patient leaflet for cladribine say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about MAVENCLAD?MAVENCLAD can cause serious side effects, including: Risk of cancer (malignancies). Treatment with MAVENCLAD may increase your risk of developing cancer. Talk to your healthcare provider about your risk of developing cancer if you receive MAVENCLAD. You should follow your healthcare provider's instructions about screening for cancer. MAVENCLAD may cause birth defects if used during pregnancy. Females must not be pregnant when they start treatment with MAVENCLAD or become pregnant during MAVENCLAD dosing and within 6 months after the last dose of each yearly treatment course. Stop your treatment with MAVENCLAD and call your healthcare provider right away if you become pregnant during treatment with MAVENCLAD. For females who are able to become pregnant: Your healthcare provider should order a pregnancy test for you before you begin your first and second yearly treatment course of MAVENCLAD to make sure that you are not pregnant. Your healthcare provider will decide when to do the test. Use effective birth control (contraception) on the days on which you take MAVENCLAD and for at least 6 months after the last dose of each yearly treatment course. Ask your healthcare provider which contraception method is right for you. For males with female partners who are able to become pregnant: Use effective birth control (contraception) during the days on which you take MAVENCLAD and for at least 14 weeks after the last dose of each yearly treatment course. MAVENCLAD Pregnancy Safety Study For females treated with MAVENCLAD: if you become pregnant while taking MAVENCLAD or during the 6 months after your last dose. For males treated with MAVENCLAD with a female partner: if your partner becomes pregnant while you are taking MAVENCLAD or during the 14 weeks after your last dose. […]
From the patient leaflet: How should I store MAVENCLAD?MAVENCLAD comes in a child resistant package. Store MAVENCLAD at room temperature between 68°F and 77°F (20°C and 25°C). Store MAVENCLAD in the original package to protect from moisture. Ask your healthcare provider or pharmacist about how to safely throw away any unused or expired MAVENCLAD tablets and packaging. Keep MAVENCLAD and all medicines out of the reach of children.
Source: FDA drug label (Mavenclad), EMD Serono, Inc., effective May 27, 2026 (SPL set 9c75e30a-a410-40f1-b653-04d532bd9144), via openFDA; the full label on DailyMed
Is there a generic for cladribine (Mavenclad)?
The FDA approved the first generic cladribine on February 28, 2000. 6 generic applications are approved; 5 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 cladribine from 6 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 3 patents for Mavenclad tablets, the last expiring on September 10, 2041. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1993 earliest approval on file
- 2000 first generic approved
- 2041 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the cladribine label say about other medicines?
The cladribine label names 11 other medicines in its interaction, contraindication or warning sections. The labels of 1 other medicine name cladribine. 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 |
|---|---|---|
| Cilostazol | drug interactions | Prevention or Management; Avoid co-administration of potent ENT1, CNT3, or BCRP transporter inhibitors (e.g., ritonavir, eltrombopag, curcumin, cyclosporine, dilazep, nifedipine, nimodipine, cilostazol, sulindac, dipyridamole, or reserpine) during the 4 to 5 day MAVENCLAD treatment cycles. … |
| Cyclosporine | drug interactions | Prevention or Management; Avoid co-administration of potent ENT1, CNT3, or BCRP transporter inhibitors (e.g., ritonavir, eltrombopag, curcumin, cyclosporine, dilazep, nifedipine, nimodipine, cilostazol, sulindac, dipyridamole, or reserpine) during the 4 to 5 day MAVENCLAD treatment cycles. … |
| Dipyridamole | drug interactions | Prevention or Management; Avoid co-administration of potent ENT1, CNT3, or BCRP transporter inhibitors (e.g., ritonavir, eltrombopag, curcumin, cyclosporine, dilazep, nifedipine, nimodipine, cilostazol, sulindac, dipyridamole, or reserpine) during the 4 to 5 day MAVENCLAD treatment cycles. … |
| Eltrombopag | drug interactions | Prevention or Management; Avoid co-administration of potent ENT1, CNT3, or BCRP transporter inhibitors (e.g., ritonavir, eltrombopag, curcumin, cyclosporine, dilazep, nifedipine, nimodipine, cilostazol, sulindac, dipyridamole, or reserpine) during the 4 to 5 day MAVENCLAD treatment cycles. … |
| Lamivudine | drug interactions | Clinical Impact; Compounds that require intracellular phosphorylation to become active (e.g., lamivudine, zalcitabine, ribavirin, stavudine, and zidovudine) could interfere with the intracellular phosphorylation and activity of cladribine. |
| Nifedipine | drug interactions | Prevention or Management; Avoid co-administration of potent ENT1, CNT3, or BCRP transporter inhibitors (e.g., ritonavir, eltrombopag, curcumin, cyclosporine, dilazep, nifedipine, nimodipine, cilostazol, sulindac, dipyridamole, or reserpine) during the 4 to 5 day MAVENCLAD treatment cycles. … |
| Nimodipine | drug interactions | Prevention or Management; Avoid co-administration of potent ENT1, CNT3, or BCRP transporter inhibitors (e.g., ritonavir, eltrombopag, curcumin, cyclosporine, dilazep, nifedipine, nimodipine, cilostazol, sulindac, dipyridamole, or reserpine) during the 4 to 5 day MAVENCLAD treatment cycles. … |
| Ribavirin | drug interactions | Clinical Impact; Compounds that require intracellular phosphorylation to become active (e.g., lamivudine, zalcitabine, ribavirin, stavudine, and zidovudine) could interfere with the intracellular phosphorylation and activity of cladribine. |
| Ritonavir | drug interactions | Prevention or Management; Avoid co-administration of potent ENT1, CNT3, or BCRP transporter inhibitors (e.g., ritonavir, eltrombopag, curcumin, cyclosporine, dilazep, nifedipine, nimodipine, cilostazol, sulindac, dipyridamole, or reserpine) during the 4 to 5 day MAVENCLAD treatment cycles. … |
| Sulindac | drug interactions | Prevention or Management; Avoid co-administration of potent ENT1, CNT3, or BCRP transporter inhibitors (e.g., ritonavir, eltrombopag, curcumin, cyclosporine, dilazep, nifedipine, nimodipine, cilostazol, sulindac, dipyridamole, or reserpine) during the 4 to 5 day MAVENCLAD treatment cycles. … |
| Zidovudine | drug interactions | Clinical Impact; Compounds that require intracellular phosphorylation to become active (e.g., lamivudine, zalcitabine, ribavirin, stavudine, and zidovudine) could interfere with the intracellular phosphorylation and activity of cladribine. |
Other labels that name cladribine
Source: FDA drug label (Mavenclad), EMD Serono, Inc., effective May 27, 2026 (SPL set 9c75e30a-a410-40f1-b653-04d532bd9144), via openFDA; the full label on DailyMed
What do FAERS reports show for cladribine?
The FDA Adverse Event Reporting System holds 9,555 reports that list cladribine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 709 are coded as a death and 2,213 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 cladribine?
8 other medicines are given the same way (oral) and in the same FDA class as cladribine or labeled mainly for the same use (multiple sclerosis), the same class first. Multiple sclerosis lists all 23 medicines labeled for it, by any route. 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 |
|---|---|---|---|---|
| Dimethyl fumarate | Multiple sclerosis | 19 labelers | $0.467 per capsule 240 mg capsule | No current entry |
| Teriflunomide | Multiple sclerosis | 15 labelers | $0.233 per tablet 14 mg tablet | No current entry |
| Fingolimod | Multiple sclerosis | 21 labelers | $1.58 per capsule 0.5 mg capsule | No current entry |
| Dalfampridine | Multiple sclerosis | 9 labelers | $0.399 per tablet 10 mg tablet | No current entry |
| Siponimod | Multiple sclerosis | none listed | n/a | No current entry |
| Ponesimod | Multiple sclerosis | none listed | n/a | No current entry |
| Diroximel fumarate | Multiple sclerosis | none listed | n/a | No current entry |
| Monomethyl fumarate | Multiple sclerosis | none listed | n/a | No current entry |
Every medicine labeled for the same conditions as cladribine
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to cladribine
- 8 medicines for the same use
- Other purine antimetabolites
- the pharmacologic class, with prices and generics
- Cladribine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other