Prescription medicine
Interferon beta 1b Brand names: Betaseron
Interferon beta 1b (Betaseron) is a prescription medicine with an FDA approval on record since 1993. No generic is listed; pharmacies paid $725.97 per kit (Betaseron 0.3 mg kit) in the October 7, 2026 NADAC survey.
- No generic listed
Check it at the source: the interferon beta 1b FDA label on DailyMed (effective March 3, 2026, Bayer HealthCare Pharmaceuticals Inc.); the BLA 103471 record on Drugs@FDA; every interferon beta 1b label on DailyMed.
Highlights of the record
FDA label of March 3, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageBETASERON is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
Forms and strengths
Kit.
On the market
- Earliest approval on file
- July 23, 1993 Betaseron, Bayer Healthcare Pharms; Drugs@FDA’s file, where older or withdrawn approvals can be missing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)
- $725.97 per kit Betaseron 0.3 mg kit
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 19,060 through July 30, 2026
What is interferon beta 1b used for?
From the label: indications and usageBETASERON is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. BETASERON is an interferon beta indicated for the treatment of relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
Conditions named in the indications of interferon beta 1b's FDA labels, with every medicine labeled for each:
Source: FDA drug label (Betaseron), Bayer HealthCare Pharmaceuticals Inc., effective March 3, 2026 (SPL set 66311f74-0472-4fa3-848a-06002ca0def5), via openFDA; the full label on DailyMed
What does the patient leaflet for interferon beta 1b 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 BETASERON?BETASERON can cause serious side effects, including: • liver problems including liver failure. Symptoms of liver problems may include: • yellowing of your eyes • itchy skin • nausea or vomiting • feeling very tired • flu-like symptoms • bruising easily or bleeding problems Your healthcare provider will do blood tests to check for these problems while you take BETASERON. • serious allergic reactions. Serious allergic reactions can happen quickly and may happen after your first dose of BETASERON or after you have taken BETASERON many times. Symptoms may include difficulty breathing or swallowing, swelling of the mouth or tongue, rash, itching, or skin bumps. • depression or suicidal thoughts. Call your healthcare provider right away if you have any of the following symptoms, especially if they are new, worse, or worry you: • thoughts about suicide or dying • new or worse depression • new or worse anxiety • trouble sleeping (insomnia) • acting aggressive, being angry, or violent • acting on dangerous impulses • hallucinations • other unusual changes in behavior or mood
From the patient leaflet: How should I store BETASERON?Before mixing, store BETASERON between 36°F to 86°F (2°C to 30°C). • After mixing, you can refrigerate BETASERON for up to 3 hours before using. Your BETASERON must be used within 3 hours of mixing even if refrigerated. • Do not freeze. Keep BETASERON and all medicines out of the reach of children.
Source: FDA drug label (Betaseron), Bayer HealthCare Pharmaceuticals Inc., effective March 3, 2026 (SPL set 66311f74-0472-4fa3-848a-06002ca0def5), via openFDA; the full label on DailyMed
Is there a generic for interferon beta 1b (Betaseron)?
No generic interferon beta 1b is approved (Drugs@FDA, October 8, 2026).
- 1993 earliest approval on file
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for interferon beta 1b (Betaseron)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $725.97 per kit (Betaseron 0.3 mg kit), up 5% from $691.37 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Betaseron 0.3 mg kit (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Betaseron 0.3 mg kit | Brand | $725.97 per kit | n/a | +5% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What do FAERS reports show for interferon beta 1b?
The FDA Adverse Event Reporting System holds 19,060 reports that list interferon beta 1b among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,337 are coded as a death and 4,226 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 rose sharply in 2016 (1,393, against a median of 400 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Interferon beta 1b side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other