← All drugs

Drug · FAERS side-effect profile with label screen

Interferon Beta-1A side effects: what 192,035 FDA adverse event reports show

Interferon Beta-1A · Rebif, Rebif Rebidose · 1,254 reaction terms · 552,508 drug–reaction co-reports · data 2026-09-14

Drug class

Interferon beta

FDA label (Established Pharmacologic Class)

Brand names

Rebif, Rebif Rebidose

openFDA label

Who reports

192,035 reports · 53% serious · 9,782 with death outcome · 80% female

openFDA FAERS counts, all years, deduplication not applied

Used for

REBIF 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. Rebif is an interferon beta indicated for the.

FDA label, Indications and Usage

What it is

REBIF (interferon beta-1a) is a purified 166 amino acid glycoprotein with a molecular weight of approximately 22,500 daltons. It is produced by recombinant DNA technology using genetically engineered Chinese Hamster Ovary cells into which the human interferon beta gene has been introduced.

FDA label, Description section

Boxed warning

None in the current label

How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation. Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)? That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.

Causality screen of the 40 strongest signals

Labeled adverse reaction 2Labeled (related wording) 7Likely indication confounding 4Reporting / coding artifact 2Lab value / disease marker 2Not in label — unassessed 23

What the badges mean

Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.

Strongest disproportionality signals

Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only (and, for the 300 most-reported drugs, adjusted for age band), and flags pairs whose reports are unusually skewed by sex or come mostly from consumers. Each row also shows the PRR against the other drugs of the same FDA class, which removes most confounding by the condition being treated, and a calibrated p-value: on validation, known non-causes average an ROR of about 2, so significance is judged against that empirical null (✓ = p < 0.05 after calibration). 1,214 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Fear of needles	108	172.1 126.9–233.4ROR 172.1 · calibrated p 3e-9 ✓	65.7 EB05 56.0 · IC025 +5.4 3/3 methods agree	Not in label — unassessed	100% consumer	not reported in cached trials
Needle fatigue	252	134.5 111.7–161.9ROR 134.7 · calibrated p 1e-8 ✓	59.8 EB05 53.9 · IC025 +5.5 3/3 methods agree	Not in label — unassessed	serious n=118 · ♀ 59% (drug 80%)	not reported in cached trials
Procedural anxiety	273	73.6 63.1–85.8ROR 73.7 · calibrated p 1e-6 ✓	43.8 EB05 39.6 · IC025 +5.1 3/3 methods agree	Not in label — unassessed	serious n=46 · 84% consumer	not reported in cached trials
Neuromyelitis optica	109	51.9 41.3–65.3ROR 52.0 · calibrated p 1e-5 ✓	35.1 EB05 29.9 · IC025 +4.6 3/3 methods agree	Not in label — unassessed	serious n=100	NCT00906399: 1/500 (0.2%) on Interferon Beta-1A (serious AE)
Drug delivery device implantation	70	49.8 37.5–66.1ROR 49.8 · calibrated p 2e-5 ✓	34.0 EB05 27.8 · IC025 +4.4 3/3 methods agree	Not in label — unassessed	serious n=67 · ♀ 0% (drug 80%) · 100% clinician	not reported in cached trials
Agraphia	185	48.4 40.7–57.6ROR 48.4 · calibrated p 2e-5 ✓	33.5 EB05 29.6 · IC025 +4.7 3/3 methods agree	Not in label — unassessed	100% consumer	not reported in cached trials
Gait spastic	101	44.5 35.3–56.2ROR 44.6 · calibrated p 3e-5 ✓	31.6 EB05 26.7 · IC025 +4.5 3/3 methods agree	Not in label — unassessed	serious n=89 · ♀ 0% (drug 80%)	not reported in cached trials
Progressive multiple sclerosis	303	37.9 33.3–43.2ROR 38.0 · calibrated p 8e-5 ✓	28.2 EB05 25.6 · IC025 +4.6 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious n=188	not reported in cached trials
General symptom	1,944	37.7 35.8–39.7ROR 38.1 · calibrated p 7e-5 ✓	28.1 EB05 27.1 · IC025 +4.7 3/3 methods agree	Labeled (related wording) related wording	serious n=384 · 80% consumer	not reported in cached trials
Loss of control of legs	957	36.3 33.7–39.0ROR 36.4 · calibrated p 9e-5 ✓	27.3 EB05 25.9 · IC025 +4.6 3/3 methods agree	Not in label — unassessed	serious n=377 · 82% consumer	not reported in cached trials
Secondary progressive multiple sclerosis	470	35.8 32.3–39.7ROR 35.9 · calibrated p 1e-4 ✓	27.0 EB05 25.0 · IC025 +4.6 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious n=232	not reported in cached trials
Multiple sclerosis relapse	15,855	32.3 31.8–32.9ROR 35.1 · calibrated p 1e-4 ✓	25.0 EB05 24.7 · IC025 +4.6 3/3 methods agree	Labeled (related wording) related wording	age-adj. PRR 22.5 · serious PRR 25.9	NCT01064401: 124/922 (13.4%) on Interferon Beta-1A (serious AE)
Relapsing-remitting multiple sclerosis	195	31.7 27.0–37.2ROR 31.7 · calibrated p 2e-4 ✓	24.6 EB05 21.8 · IC025 +4.3 3/3 methods agree	Labeled adverse reaction exact term	serious n=168 · ♀ 50% (drug 80%)	NCT01064401: 1/922 (0.1%) on Interferon Beta-1A (serious AE)
Nuclear magnetic resonance imaging abnormal	747	31.0 28.6–33.7ROR 31.1 · calibrated p 2e-4 ✓	24.2 EB05 22.8 · IC025 +4.5 3/3 methods agree	Reporting / coding artifact	serious n=234 · 74% consumer	not reported in cached trials
Lower extremity mass	128	27.9 23.0–33.9ROR 27.9 · calibrated p 4e-4 ✓	22.3 EB05 19.2 · IC025 +4.1 3/3 methods agree	Not in label — unassessed	100% consumer	not reported in cached trials
Multiple sclerosis	9,364	26.3 25.7–26.8ROR 27.5 · calibrated p 4e-4 ✓	21.3 EB05 20.9 · IC025 +4.4 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 20.6 · 71% consumer	NCT01064401: 3/922 (0.3%) on Interferon Beta-1A (serious AE)
Optic neuritis	1,679	24.5 23.2–25.8ROR 24.7 · calibrated p 7e-4 ✓	20.1 EB05 19.3 · IC025 +4.2 3/3 methods agree	Not in label — unassessed	serious PRR 18.1 · 71% consumer	NCT01064401: 1/922 (0.1%) on Interferon Beta-1A (serious AE)
Influenza like illness (flu-like illness)	13,251	20.7 20.3–21.1ROR 22.2 · calibrated p 0.001 ✓	17.5 EB05 17.3 · IC025 +4.1 3/3 methods agree	Not in label — unassessed	age-adj. PRR 16.3 · serious PRR 16.6 · 75% consumer	NCT01064401: 1/922 (0.1%) on Interferon Beta-1A (serious AE)
Primary progressive multiple sclerosis	77	20.5 16.1–26.2ROR 20.5 · calibrated p 0.002 ✓	17.3 EB05 14.3 · IC025 +3.6 3/3 methods agree	Likely indication confounding term in indications; also in warnings	–	not reported in cached trials
Neutralising antibodies positive	65	20.5 15.7–26.7ROR 20.5 · calibrated p 0.002 ✓	17.2 EB05 14.0 · IC025 +3.5 3/3 methods agree	Lab value / disease marker	100% clinician	not reported in cached trials
Central nervous system lesion	2,193	20.4 19.5–21.4ROR 20.7 · calibrated p 0.002 ✓	17.3 EB05 16.7 · IC025 +4.0 3/3 methods agree	Not in label — unassessed	serious PRR 13.4 · 75% consumer	not reported in cached trials
Frustration	553	19.5 17.8–21.3ROR 19.5 · calibrated p 0.002 ✓	16.6 EB05 15.5 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious n=76 · 89% consumer	not reported in cached trials
Exposure via direct contact	141	18.8 15.7–22.4ROR 18.8 · calibrated p 0.003 ✓	16.1 EB05 14.0 · IC025 +3.7 3/3 methods agree	Reporting / coding artifact	100% consumer	not reported in cached trials
Injection site cellulitis	268	18.5 16.2–21.0ROR 18.5 · calibrated p 0.003 ✓	15.9 EB05 14.3 · IC025 +3.7 3/3 methods agree	Labeled (related wording) related wording	serious n=230	NCT01064401: 2/919 (0.2%) on Interferon Beta-1A (serious AE)
Injection site atrophy	240	18.4 16.1–21.1ROR 18.5 · calibrated p 0.003 ✓	15.8 EB05 14.2 · IC025 +3.7 3/3 methods agree	Labeled (related wording) related wording	serious n=62 · 77% consumer	not reported in cached trials
Injection site scar	407	18.3 16.5–20.3ROR 18.3 · calibrated p 0.003 ✓	15.8 EB05 14.5 · IC025 +3.8 3/3 methods agree	Labeled (related wording) related wording	serious n=125 · 76% consumer	not reported in cached trials
Phobia	166	18.2 15.4–21.5ROR 18.2 · calibrated p 0.003 ✓	15.7 EB05 13.8 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	77% consumer	not reported in cached trials
Prolonged labour	80	16.2 12.8–20.5ROR 16.2 · calibrated p 0.006 ✓	14.1 EB05 11.7 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious n=80 · ♀ 100% (drug 80%) · 100% consumer	not reported in cached trials
Sensation of heaviness	505	16.0 14.5–17.5ROR 16.0 · calibrated p 0.005 ✓	14.0 EB05 13.0 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious n=196 · 84% consumer	not reported in cached trials
Band sensation	163	15.8 13.4–18.7ROR 15.9 · calibrated p 0.006 ✓	13.9 EB05 12.2 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious n=61 · 83% consumer	not reported in cached trials
Injection site infection	413	15.7 14.1–17.4ROR 15.7 · calibrated p 0.006 ✓	13.8 EB05 12.7 · IC025 +3.6 3/3 methods agree	Labeled (related wording) related wording	serious n=326	NCT01064401: 1/919 (0.1%) on Interferon Beta-1A (serious AE)
Peroneal nerve palsy	667	14.4 13.3–15.6ROR 14.4 · calibrated p 0.008 ✓	12.8 EB05 12.0 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious n=264 · 77% consumer	not reported in cached trials
Jc virus test positive	100	14.4 11.7–17.7ROR 14.4 · calibrated p 0.009 ✓	12.7 EB05 10.7 · IC025 +3.3 3/3 methods agree	Lab value / disease marker	100% consumer	not reported in cached trials
Trigeminal neuralgia	470	14.3 13.0–15.8ROR 14.4 · calibrated p 0.008 ✓	12.7 EB05 11.8 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious n=334	NCT01064401: 1/922 (0.1%) on Interferon Beta-1A (serious AE)
Hemianaesthesia	86	12.9 10.3–16.1ROR 12.9 · calibrated p 0.014 ✓	11.5 EB05 9.5 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious n=46 · 100% consumer	not reported in cached trials
Venous injury	96	12.4 10.0–15.3ROR 12.4 · calibrated p 0.016 ✓	11.1 EB05 9.3 · IC025 +3.1 3/3 methods agree	Labeled (related wording) related wording	♀ 100% (drug 80%) · 100% consumer	not reported in cached trials
Collapse of lung	85	12.2 9.7–15.2ROR 12.2 · calibrated p 0.017 ✓	10.8 EB05 9.0 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious n=85 · 100% consumer	not reported in cached trials
Neurogenic bladder	214	12.2 10.6–14.0ROR 12.2 · calibrated p 0.016 ✓	11.0 EB05 9.8 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious n=178	not reported in cached trials
Puncture site haemorrhage	69	11.7 9.1–15.0ROR 11.7 · calibrated p 0.020 ✓	10.4 EB05 8.4 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	100% consumer	not reported in cached trials
Injection site necrosis	196	11.5 9.9–13.3ROR 11.5 · calibrated p 0.020 ✓	10.4 EB05 9.2 · IC025 +3.1 3/3 methods agree	Labeled adverse reaction exact term	serious n=165	not reported in cached trials

Clinical concept groups

MedDRA splits one clinical problem across several terms (e.g. "neutropenia", "neutrophil count decreased", "agranulocytosis"), which dilutes term-level signals. These rows count reports with any term in a concept group (an exact union, not a sum), compared with all other drugs. Groups are hand-built and listed in the methods.

Concept	Reports	PRR 95% CI	Reading
Fall / fracture	10,983	3.23.2–3.3	signal
Depression	6,513	2.62.5–2.6	signal
Seizure	3,402	1.91.8–2.0	raised
Serious infection	10,926	1.61.5–1.6	raised
Myocardial infarction	2,686	1.41.4–1.5	raised
Stroke	2,858	1.31.2–1.3	raised
Venous thromboembolism	2,157	1.11.0–1.1	raised
Malignancy	3,514	1.01.0–1.1	no difference
Opportunistic infection	1,219	1.00.9–1.0	no difference
Hyperglycaemia / diabetes	2,969	0.90.9–1.0	lower than other drugs
Liver injury	2,585	0.90.9–1.0	lower than other drugs
Pancreatitis	589	0.80.7–0.9	lower than other drugs
Tendon disorder	257	0.70.6–0.8	lower than other drugs
Suicidality	1,524	0.70.6–0.7	lower than other drugs
Heart failure	956	0.60.5–0.6	lower than other drugs
Osteonecrosis	287	0.50.5–0.6	lower than other drugs

Trial evidence (ClinicalTrials.gov)

✓ Trial adverse-event data found on ClinicalTrials.gov

Largest completed trials with posted results that list Interferon Beta-1A as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (9 of 40 signal terms matched).

NCT01064401 — Efficacy and Safety of BIIB019 (Daclizumab High Yield Process) Versus Interferon β 1a in Participants With Rel (N=1841, PHASE3; 248 AE terms posted; arms: IFN Beta-1a 30 mcg; DAC HYP 150 mg)
NCT00906399 — Efficacy and Safety Study of Peginterferon Beta-1a in Participants With Relapsing Multiple Sclerosis (N=1516, PHASE3; 178 AE terms posted; arms: Year 1: Placebo; Year 1: Peginterferon Beta-1a Q4W; Year 1: Peginterferon Beta-1a Q2W; Year 2: Placebo Followed by Peginterfero)

Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.

Most frequently reported reactions

By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Multiple sclerosis relapse	15,855	32.3 31.8–32.9ROR 35.1 · calibrated p 1e-4 ✓	25.0 EB05 24.7 · IC025 +4.6 3/3 methods agree	Labeled (related wording) related wording	age-adj. PRR 22.5 · serious PRR 25.9	NCT01064401: 124/922 (13.4%) on Interferon Beta-1A (serious AE)
Influenza like illness (flu-like illness)	13,251	20.7 20.3–21.1ROR 22.2 · calibrated p 0.001 ✓	17.5 EB05 17.3 · IC025 +4.1 3/3 methods agree	Not in label — unassessed	age-adj. PRR 16.3 · serious PRR 16.6 · 75% consumer	NCT01064401: 1/922 (0.1%) on Interferon Beta-1A (serious AE)
Fatigue (tiredness)	11,550	1.6 1.6–1.7ROR 1.7 · calibrated p 0.752	1.6 EB05 1.6 · IC025 +0.7	Labeled adverse reaction exact term	age-adj. PRR 1.5 · serious PRR 1.3 · 78% consumer	NCT01064401: 76/922 (8.2%) on Interferon Beta-1A
Fall	10,601	3.6 3.5–3.6ROR 3.7 · calibrated p 0.435	3.5 EB05 3.4 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	age-adj. PRR 4.7 · serious PRR 3.1 · 71% consumer	NCT01064401: 2/922 (0.2%) on Interferon Beta-1A (serious AE)
Multiple sclerosis	9,364	26.3 25.7–26.8ROR 27.5 · calibrated p 4e-4 ✓	21.3 EB05 20.9 · IC025 +4.4 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 20.6 · 71% consumer	NCT01064401: 3/922 (0.3%) on Interferon Beta-1A (serious AE)
Gait disturbance	8,920	5.3 5.2–5.4ROR 5.5 · calibrated p 0.188	5.1 EB05 5.0 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	age-adj. PRR 4.7 · serious PRR 3.3 · 81% consumer	NCT00906399: 1/499 (0.2%) control (serious AE)
Headache	8,416	1.5 1.4–1.5ROR 1.5 · calibrated p 0.639	1.5 EB05 1.4 · IC025 +0.5	Labeled adverse reaction exact term	age-adj. PRR 1.3 · serious PRR 1.4 · 77% consumer	NCT01064401: 1/919 (0.1%) on Interferon Beta-1A (serious AE)
Memory impairment	7,995	6.7 6.5–6.8ROR 6.9 · calibrated p 0.102	6.3 EB05 6.2 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	age-adj. PRR 4.7 · serious PRR 3.3 · 86% consumer	not reported in cached trials
Pain	7,745	1.4 1.3–1.4ROR 1.4 · calibrated p 0.572	1.4 EB05 1.3 · IC025 +0.4	Labeled adverse reaction exact term	age-adj. PRR 1.3 · serious PRR 1.1 · 78% consumer	NCT01064401: 1/922 (0.1%) on Interferon Beta-1A (serious AE)
Injection site pain (pain where injected)	6,324	2.3 2.2–2.4ROR 2.3 · calibrated p 0.881	2.3 EB05 2.2 · IC025 +1.1 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 1.8 · serious PRR 6.2 · 78% consumer	NCT01064401: 1/922 (0.1%) on Interferon Beta-1A (serious AE)
Asthenia (weakness)	6,291	1.8 1.8–1.9ROR 1.9 · calibrated p 0.870	1.8 EB05 1.8 · IC025 +0.8	Not in label — unassessed	age-adj. PRR 1.9 · serious PRR 1.4 · 74% consumer	NCT01064401: 1/919 (0.1%) on Interferon Beta-1A (serious AE)
Hypoaesthesia (numbness)	5,558	4.2 4.1–4.3ROR 4.3 · calibrated p 0.332	4.0 EB05 4.0 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	age-adj. PRR 3.2 · serious PRR 3.4 · 75% consumer	NCT01064401: 54/922 (5.9%) on Interferon Beta-1A
Depression	5,435	2.6 2.6–2.7ROR 2.7 · calibrated p 0.738	2.6 EB05 2.5 · IC025 +1.3 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 2.1 · serious PRR 2.3	NCT01064401: 2/922 (0.2%) on Interferon Beta-1A (serious AE)
Malaise (feeling unwell)	5,103	1.3 1.2–1.3ROR 1.3 · calibrated p 0.493	1.3 EB05 1.2 · IC025 +0.3	Labeled adverse reaction exact term	age-adj. PRR 1.1 · serious PRR 0.9 · 73% consumer	not reported in cached trials
Pain in extremity	5,042	1.9 1.8–1.9ROR 1.9 · calibrated p 0.890	1.9 EB05 1.8 · IC025 +0.9	Not in label — unassessed	age-adj. PRR 1.8 · serious PRR 1.6 · 79% consumer	NCT01064401: 58/922 (6.3%) on Interferon Beta-1A

Unlabeled candidate signals

These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.

Fear of needles — n=108, PRR 172.1
Needle fatigue — n=252, PRR 134.5
Procedural anxiety — n=273, PRR 73.6
Neuromyelitis optica — n=109, PRR 51.9 (also seen in trial arm)
Drug delivery device implantation — n=70, PRR 49.8
Agraphia — n=185, PRR 48.4
Gait spastic — n=101, PRR 44.5
Loss of control of legs — n=957, PRR 36.3
Lower extremity mass — n=128, PRR 27.9
Optic neuritis — n=1,679, PRR 24.5 (also seen in trial arm)

✓ A hand-written Bradford Hill causality assessment exists for this drug: Interferon beta-1a ↔ Influenza-like illness.

Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.

Common questions

What are the most reported side effects of Interferon Beta-1A?

In FDA FAERS, the most frequently co-reported reaction terms for Interferon Beta-1A are multiple sclerosis relapse, influenza like illness, fatigue, fall, multiple sclerosis, gait disturbance. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.

Does Interferon Beta-1A have an FDA boxed warning?

No. The FDA label retrieved for Interferon Beta-1A has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Interferon Beta-1A causes these side effects?

No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.

Sources & methods

FDA label via openFDA (set ID c6fcb5d2-8fcd-44fa-a838-b84ee5f44f0f, effective 20250922; matched on openfda.generic_name.exact:"INTERFERON BETA-1A" AND openfda.product_type:"HUMAN PRESCRIPTION DRUG")
Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA count= aggregation, field patient.drug.openfda.generic_name.exact, 1,254 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction
Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
Seriousness and sex counts from openFDA count=serious, patient.patientsex, seriousnessdeath
ClinicalTrials.gov API v2 (query INTERFERON BETA-1A, results-bearing studies sorted by enrollment)

Page generated 2026-10-14. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.