Prescription medicine
Iberdomide Brand names: Zenbexus
Iberdomide (Zenbexus) is a prescription medicine with an FDA approval on record since 2026. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the iberdomide FDA label on DailyMed (effective August 13, 2026, E.R. Squibb & Sons, L.L.C.); the NDA 221075 record on Drugs@FDA; every iberdomide label on DailyMed.
Highlights of the record
FDA label of August 13, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
EMBRYO-FETAL.
TOXICITY and SERIOUS VENOUS AND ARTERIAL THROMBOEMBOLISM EMBRYO-FETAL TOXICITY ZENBEXUS is contraindicated in pregnancy. ZENBEXUS is embryo-fetal toxic in animals and can cause birth defects or embryo-fetal death in humans. In females of reproductive potential, obtain 2 negative pregnancy tests before starting ZENBEXUS treatment [ Contraindications (4), see Warnings and Precautions (5.1) and Use in Specific Populations (8.1 , 8.3) ]. Females of reproductive potential must use 2 effective forms of contraception or continuously abstain from heterosexual sex during and for 4 weeks after last dose of ZENBEXUS treatment [see Contraindications (4), Warnings and Precautions (5.1), and Use in Specific Populations (8.1 , 8.3) ]. Because of the risk of embryo-fetal toxicity, ZENBEXUS is only available through a restricted distribution program called ZENBEXUS REMS [see Warnings and Precautions (5.2) ]. Information about ZENBEXUS REMS is available at www.ZENBEXUSREMS.com or by calling the REMS Call Center at 1-888-423-5436. SERIOUS VENOUS AND ARTERIAL THROMBOEMBOLISM Increased risk of deep venous thrombosis (DVT), pulmonary embolism (PE), myocardial infarction, and stroke in patients with multiple myeloma receiving ZENBEXUS with daratumumab and hyaluronidase-fihj and dexamethasone. Anti-thrombotic prophylaxis is recommended [see Warnings and Precautions (5.3) ]. […]
Used for
From the label: indications and usageZENBEXUS is indicated, in combination with daratumumab and hyaluronidase-fihj and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least 1 prior line of therapy including a proteasome inhibitor and an immunomodulatory agent.
Forms and strengths
- 0.75 mg
- 1 mg
Capsule.
On the market
- Earliest approval on file
- August 13, 2026 Zenbexus, Bristol Myers Squibb; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 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)
- No recall recorded
- FAERS reports
- 138 through July 30, 2026
What is iberdomide used for?
From the label: indications and usageZENBEXUS is indicated, in combination with daratumumab and hyaluronidase-fihj and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least 1 prior line of therapy including a proteasome inhibitor and an immunomodulatory agent. This indication is approved under accelerated approval based on minimal residual disease (MRD)-negative complete response (CR) at any time [see Clinical Studies (14) ]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). […]
Conditions named in the indications of iberdomide's FDA labels, with every medicine labeled for each:
Source: FDA drug label (ZENBEXUS), E.R. Squibb & Sons, L.L.C., effective August 13, 2026 (SPL set 3663d9cb-3f66-48ae-bf0a-6958bc0888de), via openFDA; the full label on DailyMed
What does the patient leaflet for iberdomide 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 ZENBEXUS?ZENBEXUS can cause serious side effects, including: ZENBEXUS can harm your unborn baby, causing birth defects or death of an unborn baby. Females who can become pregnant: • Do not become pregnant during treatment with ZENBEXUS and for at least 4 weeks after your last dose of ZENBEXUS. • You must agree to stop sexual activity with a male or use two different forms of birth control (contraception) for at least 4 weeks before starting treatment with ZENBEXUS, during treatment, during any breaks (interruptions) in treatment, and for 4 weeks after your last dose of ZENBEXUS. You must use birth control even if you have a history of infertility, unless you have had a hysterectomy. • Talk to your healthcare provider about birth control methods that you can use before, during and after treatment with ZENBEXUS. • Your healthcare provider will do 2 pregnancy tests before you start treatment with ZENBEXUS. […] Tell your healthcare provider right away if you get any of the following signs and symptoms of blood clots during treatment with ZENBEXUS: ∘ swelling, pain or tenderness in your legs ∘ red or discolored skin on your leg ∘ chest pain that may spread to the arms, neck, jaw, back, or stomach area ∘ sudden shortness of breath ∘ dizziness or lightheadedness ∘ vomiting ∘ feeling sweaty ∘ sudden numbness or weakness in the face, arm, or leg, especially on one side of the body ∘ severe headache or confusion ∘ problems with vision, speech, or balance See "What are the possible side effects of ZENBEXUS?" for more information about side effects. […]
From the patient leaflet: What should I avoid while taking ZENBEXUS?Do not donate blood during treatment with ZENBEXUS and for 4 weeks after your last dose of ZENBEXUS.
From the patient leaflet: How should I store ZENBEXUS?Store ZENBEXUS at room temperature between 68°F to 77°F (20°C to 25°C). • Keep ZENBEXUS in the original bottle. The bottle contains a drying agent (desiccant) to keep the medicine dry. Keep the drying agent in the bottle. • Put the bottle cap back on tightly after each use. • Do not remove capsule from the bottle until you are ready to take ZENBEXUS. Keep ZENBEXUS and all medicines out of the reach of children.
Source: FDA drug label (ZENBEXUS), E.R. Squibb & Sons, L.L.C., effective August 13, 2026 (SPL set 3663d9cb-3f66-48ae-bf0a-6958bc0888de), via openFDA; the full label on DailyMed
Is there a generic for iberdomide (Zenbexus)?
No generic iberdomide is approved (Drugs@FDA, October 8, 2026).
- 2026 earliest approval on file
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the iberdomide label say about other medicines?
The iberdomide 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 |
|---|---|---|
| Bortezomib | warnings and precautions | In the EXCALIBER-RRMM study, at a median follow-up time of 16 months, second primary malignancies (SPM) occurred in 6.9% of patients in the IberDd arm and in 4.9% of patients in the daratumumab and hyaluronidase-fihj, bortezomib and dexamethasone (DVd) arm [see Adverse Reactions (6.1) ]. |
| Daratumumab | boxed warning | SERIOUS VENOUS AND ARTERIAL THROMBOEMBOLISM Increased risk of deep venous thrombosis (DVT), pulmonary embolism (PE), myocardial infarction, and stroke in patients with multiple myeloma receiving ZENBEXUS with daratumumab and hyaluronidase-fihj and dexamethasone. |
| Dexamethasone | boxed warning | SERIOUS VENOUS AND ARTERIAL THROMBOEMBOLISM Increased risk of deep venous thrombosis (DVT), pulmonary embolism (PE), myocardial infarction, and stroke in patients with multiple myeloma receiving ZENBEXUS with daratumumab and hyaluronidase-fihj and dexamethasone. |
Source: FDA drug label (ZENBEXUS), E.R. Squibb & Sons, L.L.C., effective August 13, 2026 (SPL set 3663d9cb-3f66-48ae-bf0a-6958bc0888de), via openFDA; the full label on DailyMed
What do FAERS reports show for iberdomide?
The FDA Adverse Event Reporting System holds 138 reports that list iberdomide among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 12 are coded as a death and 88 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.
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 iberdomide?
37 other medicines are given the same way (oral) and in the same FDA class as iberdomide or labeled mainly for the same use (leukemia, lymphoma and myeloma), the same class first. Leukemia, lymphoma and myeloma lists all 98 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 |
|---|---|---|---|---|
| Lenalidomide | Leukemia, lymphoma and myeloma | 18 labelers | n/a | No current entry |
| Dasatinib | Leukemia, lymphoma and myeloma | 14 labelers | $26.46 per tablet 100 mg tablet | No current entry |
| Pomalidomide | Leukemia, lymphoma and myeloma | 11 labelers | n/a | No current entry |
| Imatinib | Leukemia, lymphoma and myeloma | 20 labelers | $0.624 per tablet 100 mg tablet | No current entry |
| Arsenic trioxide | Leukemia, lymphoma and myeloma | none listed | n/a | A presentation being discontinued |
| Nilotinib | Leukemia, lymphoma and myeloma | 6 labelers | n/a | No current entry |
| Hydroxyurea | Leukemia, lymphoma and myeloma | 10 labelers | $0.184 per capsule 500 mg capsule | No current entry |
| Cyclophosphamide | Leukemia, lymphoma and myeloma | 4 labelers | $1.67 per capsule 50 mg capsule | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Iberdomide side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other