Prescription medicine
Pomalidomide Brand names: Pomalyst
Pomalidomide (Pomalyst) is a prescription medicine with an FDA approval on record since 2013. FDA's NDC Directory lists it from 11 generic labelers.
- Generic listed
- Boxed warning
Check it at the source: the pomalidomide FDA label on DailyMed (effective February 26, 2025, Celgene Corporation); the NDA 204026 record on Drugs@FDA; every pomalidomide label on DailyMed.
Highlights of the record
FDA label of February 26, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
EMBRYO-FETAL.
TOXICITY and VENOUS AND ARTERIAL THROMBOEMBOLISM WARNING: EMBRYO-FETAL TOXICITY and VENOUS AND ARTERIAL THROMBOEMBOLISM See full prescribing information for complete boxed warning EMBRYO-FETAL TOXICITY
POMALYST is contraindicated in pregnancy. POMALYST is a thalidomide analogue. Thalidomide is a known human teratogen that causes severe life-threatening birth defects ( 4 , 5.1 , 8.1 ).
For females of reproductive potential: Exclude pregnancy before start of treatment. Prevent pregnancy during treatment by the use of 2 reliable methods of contraception ( 5.1 , 8.3 ). POMALYST is available only through a restricted program called PS-Pomalidomide REMS ( 5.2 ). VENOUS AND ARTERIAL THROMBOEMBOLISM
Deep venous thrombosis (DVT), pulmonary embolism (PE), myocardial infarction, and stroke occur in patients with multiple myeloma treated with POMALYST. Antithrombotic prophylaxis is recommended ( 5.3 ). Embryo-Fetal Toxicity
POMALYST is contraindicated in pregnancy. POMALYST is a thalidomide analogue. Thalidomide is a known human teratogen that causes severe birth defects or embryo-fetal death. In females of reproductive potential, obtain 2 negative pregnancy tests before starting POMALYST treatment. […]
Used for
From the label: indications and usagePOMALYST is a thalidomide analogue indicated for the treatment of adult patients:
in combination with dexamethasone, for patients with multiple myeloma (MM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy ( 1.1 ).
Forms and strengths
- 1 mg
- 2 mg
- 3 mg
- 4 mg
Capsule.
On the market
- Earliest approval on file
- February 8, 2013 Pomalyst, Bristol; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 11 first October 30, 2020; 10 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 12 of which 11 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- December 21, 2031 Pomalyst 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)
- No recall recorded
- FAERS reports
- 102,194 through July 30, 2026
What is pomalidomide used for?
From the label: indications and usagePOMALYST is a thalidomide analogue indicated for the treatment of adult patients:
in combination with dexamethasone, for patients with multiple myeloma (MM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy ( 1.1 ).
with AIDS-related Kaposi sarcoma (KS) after failure of highly active antiretroviral therapy (HAART) or in patients with KS who are HIV-negative. This indication is approved under accelerated approval based on overall response rate. […]
Conditions named in the indications of pomalidomide's FDA labels, with every medicine labeled for each:
From other pomalidomide labelsLeukemia, lymphoma and myeloma: Multiple Myeloma POMALYST, in combination with dexamethasone, is indicated for adult patients with multiple myeloma (MM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated …
FDA pharmacologic class: Thalidomide Analog.
Source: FDA drug label (Pomalyst), NDA204026 (Bristol), as published by Celgene Corporation, effective February 26, 2025 (SPL set 2b25ef01-5c9e-11e1-b86c-0800200c9a66), via openFDA; the full label on DailyMed
What does the patient leaflet for pomalidomide 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 POMALYST?Before you begin taking POMALYST, you must read and agree to all of the instructions in PS-Pomalidomide REMS. For more information, call 1-888-423-5436 or go to www.PS-PomalidomideREMS.com. Before prescribing POMALYST, your healthcare provider will explain PS-Pomalidomide REMS to you and have you sign the Patient-Physician Agreement Form. POMALYST can cause serious side effects including: • Possible birth defects (deformed babies) or death of an unborn baby. Females who are pregnant or who plan to become pregnant must not take POMALYST. POMALYST is similar to the medicine thalidomide (THALOMID). We know thalidomide can cause severe life-threatening birth defects. POMALYST has not been tested in pregnant females. POMALYST has harmed unborn animals in animal testing. Females must not get pregnant: ∘ For at least 4 weeks before starting POMALYST ∘ While taking POMALYST ∘ During any breaks (interruptions) in your treatment with POMALYST ∘ For at least 4 weeks after stopping POMALYST Females who can become pregnant: ∘ Will have pregnancy tests weekly for 4 weeks, then every 4 weeks if your menstrual cycle is regular, or every 2 weeks if your menstrual cycle is irregular. If you miss your period or have unusual bleeding, you will need to have a pregnancy test and receive counseling. ∘ Must agree to use two acceptable forms of birth control at the same time, for at least 4 weeks before, while taking, during any breaks (interruptions) in your treatment, and for at least 4 weeks after stopping POMALYST. ∘ Talk with your healthcare provider to find out about options for acceptable forms of birth control that you may use to prevent pregnancy before, during, and after treatment with POMALYST. […]
From the patient leaflet: What should I avoid while taking POMALYST?See "What is the most important information I should know about POMALYST?" • Females: Do not get pregnant and do not breastfeed while taking POMALYST . • Males: Do not donate sperm. • Do not share POMALYST with other people. It may cause birth defects and other serious problems. • Do not donate blood while you take POMALYST, during any breaks (interruptions) in your treatment, and for 4 weeks after stopping POMALYST. If someone who is pregnant gets your donated blood, her baby may be exposed to POMALYST and may be born with birth defects. • POMALYST can cause dizziness and confusion. Avoid taking other medicines that may cause dizziness and confusion during treatment with POMALYST. Avoid situations that require you to be alert until you know how POMALYST affects you.
From the patient leaflet: How should I store POMALYST?Store POMALYST at room temperature between 68°F to 77°F (20°C to 25°C). • Return any unused POMALYST to PS-Pomalidomide REMS by calling 1-888-423-5346 or your healthcare provider. Keep POMALYST and all medicines out of the reach of children.
Source: FDA drug label (Pomalyst), NDA204026 (Bristol), as published by Celgene Corporation, effective February 26, 2025 (SPL set 2b25ef01-5c9e-11e1-b86c-0800200c9a66), via openFDA; the full label on DailyMed
Is there a generic for pomalidomide (Pomalyst)?
The FDA approved the first generic pomalidomide on October 30, 2020. 11 generic applications are approved; 10 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 pomalidomide from 11 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 Pomalyst capsules: the compound patent runs to June 21, 2031 (pediatric exclusivity to December 21, 2031). A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2013 earliest approval on file
- 2020 first generic approved
- 2031 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the pomalidomide label say about other medicines?
The pomalidomide label names 5 other medicines in its interaction, contraindication or warning sections. The labels of 5 other medicines name pomalidomide. 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 |
|---|---|---|
| Ciprofloxacin | drug interactions | Avoid co-administration of strong CYP1A2 inhibitors (e.g. ciprofloxacin and fluvoxamine). |
| Dexamethasone | warnings and precautions | Increased Mortality: Observed in patients with MM when pembrolizumab was added to dexamethasone and a thalidomide analogue ( 5.4 ). |
| Fluvoxamine | drug interactions | Drugs That Affect Pomalidomide Plasma Concentrations CYP1A2 inhibitors: In healthy subjects, co-administration of fluvoxamine, a strong CYP1A2 inhibitor, increased C max and AUC of pomalidomide by 24% and 125% respectively [see Clinical Pharmacology (12.3) ]. |
| Pembrolizumab | warnings and precautions | Increased Mortality: Observed in patients with MM when pembrolizumab was added to dexamethasone and a thalidomide analogue ( 5.4 ). |
| Thalidomide | boxed warning | Thalidomide is a known human teratogen that causes severe life-threatening birth defects ( 4 , 5.1 , 8.1 ). |
Other labels that name pomalidomide
Source: FDA drug label (Pomalyst), NDA204026 (Bristol), as published by Celgene Corporation, effective February 26, 2025 (SPL set 2b25ef01-5c9e-11e1-b86c-0800200c9a66), via openFDA; the full label on DailyMed
What do FAERS reports show for pomalidomide?
The FDA Adverse Event Reporting System holds 102,194 reports that list pomalidomide among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 14,025 are coded as a death and 27,241 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 pomalidomide?
37 other medicines are given the same way (oral) and in the same FDA class as pomalidomide 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 |
| 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 |
| Bosutinib | Leukemia, lymphoma and myeloma | 3 labelers | n/a | No current entry |
Every medicine labeled for the same conditions as pomalidomide
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does pomalidomide compare with medicines for the same use?
1 side-by-side page set pomalidomide beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to pomalidomide
- 37 medicines for the same use
- Other thalidomide analogs
- the pharmacologic class, with prices and generics
- Pomalidomide side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other