Interferon Beta-1b: uses, dosing, side effects & brands
Interferon Beta-1b is a medicine sold in the U.S. under one brand, for multiple sclerosis, brain neoplasms and renal cell carcinoma. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Treats
- Multiple Sclerosis, Brain Neoplasms and Renal Cell Carcinoma
- Available as
- Kit
- Sold as
- Betaseron
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
How interferon beta-1b is dosed
From the FDA label for Betaseron (application BLA103471). Other interferon beta-1b products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
For subcutaneous use only ( 2.1 ) • The recommended dose is 0.25 mg every other day. Generally, start at 0.0625 mg (0.25 mL) every other day, and increase over a six-week period to 0.25 mg (1 mL) every other day. ( 2.1 ) • Reconstitute lyophilized powder with supplied diluent ( 2.2 ) 2.1 Dosing Information The recommended starting dose is 0.0625 mg (0.25 mL) subcutaneously every other day, with dose increases over a six-week period to the recommended dose of 0.25 mg (1 mL) every other day (see Table 1 ). Table 1: Schedule for Dose Titration BETASERON Dose Dosed every other day, subcutaneously Percentage of recommended dose Volume Weeks 1-2 0.0625 mg 25% 0.25 mL Weeks 3-4 0.125 mg 50% 0.5 mL Weeks 5-6 0.1875 mg 75% 0.75 mL Week 7 and thereafter 0.25 mg 100% 1 mL If a dose of BETASERON is missed, then it should be taken as soon as the patient remembers or is able to take it. The patient should not take BETASERON on two consecutive days. The next injection should be taken about 48 hours (two days) after that dose. If the patient accidentally takes more than their prescribed dose, or takes it on two consecutive days, they should be instructed to call their healthcare provider immediately. 2.2 Reconstitution of the Lyophilized Powder (a) Prior to reconstitution, verify that the vial containing lyophilized BETASERON is not cracked or damaged. Do not use cracked or damaged vials. (b)…
Interferon Beta-1b side effects
The following serious adverse reactions are discussed in more details in other sections of labeling: • Hepatic Injury [see Warnings and Precautions ( 5.1 )] • Anaphylaxis and Other Allergic Reactions [see Warnings and Precautions ( 5.2 )] • Depression and Suicide [see Warnings and Precautions ( 5.3 )] • Congestive Heart Failure [see Warnings and Precautions ( 5.4 )] • Injection Site Reactions Including Necrosis [see Warnings and Precautions ( 5.5 )] • Leukopenia [see Warnings and Precautions ( 5.6 )] • Thrombotic Microangiopathy [see Warnings and Precautions ( 5.7 )] • Pulmonary Arterial Hypertension [see Warnings and Precautions ( 5.8 )] • Flu-like Symptom Complex [see Warnings and Precautions ( 5.9 )] • Seizures [see Warnings and Precautions ( 5.10 )] • Drug Induced Lupus Erythematosus [see Warnings and Precautions ( 5.11 )] In controlled clinical trials, the most common adverse reactions (at least 5% more frequent on BETASERON than on placebo) were: injection site reaction, lymphopenia, flu-like symptoms, myalgia, leukopenia, neutropenia, increased liver enzymes, headache, hypertonia, pain, rash, insomnia, abdominal pain, and asthenia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Bayer HealthCare Pharmaceuticals at 1-888-842-2937 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely…
Who shouldn’t take interferon beta-1b
BETASERON is contraindicated in patients with a history of hypersensitivity to natural or recombinant interferon beta, Albumin (Human), or any other component of the formulation. History of hypersensitivity to natural or recombinant interferon beta, albumin or mannitol ( 4 )
Every interferon beta-1b product we track (1)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
Only one: Betaseron.
What people report to the FDA about interferon beta-1b
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 1,724 reports naming interferon beta-1b, and the FDA flagged 91% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- multiple sclerosis relapse207 reports
- multiple sclerosis104 reports
- fatigue99 reports
- pyrexia96 reports
- influenza like illness90 reports
- headache86 reports
- injection site reaction82 reports
- gait disturbance74 reports
Read these as a signal, not a rate. A report does not mean interferon beta-1b caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved July 25, 2026.
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Frequently asked questions
What is interferon beta-1b?
Betaseron (Interferon Beta-1b) is a medication used to treat Multiple Sclerosis, Brain Neoplasms, Renal Cell Carcinoma, Cryoglobulinemia.
Can you take interferon beta-1b with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run interferon beta-1b against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What forms does interferon beta-1b come in?
Across the brands we track, interferon beta-1b is currently marketed as kit, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic interferon beta-1b?
We do not currently list a generic-labelled interferon beta-1b product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.
Cite this page
- APA
- pharmaranks. (2026, July 24). Interferon Beta-1b: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/interferon-beta-1b
- MLA
- “Interferon Beta-1b: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/interferon-beta-1b.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for interferon beta-1b on DailyMed (NIH) ↗.