INTERFERON BETA 1A

72/100 · Elevated

Manufactured by Biogen Inc.

Multiple Sclerosis Treatment: Common Adverse Events and Safety Concerns

322,666 FDA adverse event reports analyzed

Last updated: 2026-05-12

About INTERFERON BETA 1A

INTERFERON BETA 1A is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Biogen Inc.. Based on analysis of 322,666 FDA adverse event reports, INTERFERON BETA 1A has a safety score of 72 out of 100. This score indicates a relatively favorable safety profile, with fewer or less severe adverse events compared to many other tracked medications. The most commonly reported adverse reactions for INTERFERON BETA 1A include MULTIPLE SCLEROSIS RELAPSE, INFLUENZA LIKE ILLNESS, FATIGUE, FALL, MULTIPLE SCLEROSIS. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for INTERFERON BETA 1A.

AI Safety Analysis

Interferon Beta-1a has a safety concern score of 72 out of 100, placing it in the elevated concern category based on analysis of FDA adverse event data. The FDA has received approximately 322,666 adverse event reports for this medication, which is primarily manufactured by Biogen Inc..

The most commonly reported adverse events include Multiple Sclerosis Relapse, Influenza Like Illness, Fatigue. Of classified reports, 53.1% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Fatigue and falls are among the most common adverse events reported.

Serious adverse events, such as death and myocardial infarction, are concerning. Infections, including pneumonia and urinary tract infections, are frequently reported. Drug ineffectiveness and multiple sclerosis relapse are significant issues. Psychiatric symptoms like depression and anxiety are also commonly reported.

Patients taking Interferon Beta-1a should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Interferon beta-1a can interact with other drugs, and patients should be monitored for potential drug interactions. Warnings include the risk of serious adverse events such as death and myocardial infarction. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.

Safety Score: 72/100

Interferon Beta-1a received a safety concern score of 72/100 (elevated concern). This is based on a 53.1% serious event ratio across 191,325 classified reports. The score accounts for 322,666 total adverse event reports and 100 distinct reaction types. This elevated score indicates a notable proportion of serious adverse events and warrants careful monitoring.

Top Adverse Reactions

MULTIPLE SCLEROSIS RELAPSE15,800 reports
INFLUENZA LIKE ILLNESS13,239 reports
FATIGUE11,525 reports
FALL10,576 reports
MULTIPLE SCLEROSIS9,305 reports
GAIT DISTURBANCE8,898 reports
HEADACHE8,405 reports
MEMORY IMPAIRMENT7,977 reports
PAIN7,724 reports
INJECTION SITE PAIN6,310 reports
ASTHENIA6,288 reports
HYPOAESTHESIA5,550 reports
DEPRESSION5,427 reports
MALAISE5,091 reports
PAIN IN EXTREMITY5,031 reports
PYREXIA5,001 reports
DEATH4,976 reports
DRUG INEFFECTIVE4,956 reports
BALANCE DISORDER4,888 reports
URINARY TRACT INFECTION4,697 reports
ANXIETY4,465 reports
NAUSEA4,454 reports
DIZZINESS4,251 reports
MUSCULAR WEAKNESS4,081 reports
PNEUMONIA3,863 reports
INJECTION SITE ERYTHEMA3,782 reports
MOBILITY DECREASED3,692 reports
TREMOR3,649 reports
FEELING ABNORMAL3,484 reports
CHILLS3,447 reports
MUSCLE SPASMS3,364 reports
STRESS3,281 reports
VOMITING3,255 reports
HYPERTENSION3,139 reports
BACK PAIN3,031 reports
INJECTION SITE HAEMORRHAGE3,002 reports
INSOMNIA2,963 reports
PARAESTHESIA2,832 reports
NASOPHARYNGITIS2,831 reports
ARTHRALGIA2,748 reports
VISUAL IMPAIRMENT2,719 reports
DIARRHOEA2,695 reports
DRUG DOSE OMISSION2,651 reports
COGNITIVE DISORDER2,631 reports
INJECTION SITE BRUISING2,578 reports
INFLUENZA2,531 reports
WEIGHT DECREASED2,500 reports
DYSPNOEA2,468 reports
MYOCARDIAL INFARCTION2,460 reports
CONDITION AGGRAVATED2,431 reports
CEREBROVASCULAR ACCIDENT2,418 reports
ABASIA2,329 reports
CONFUSIONAL STATE2,322 reports
CONVULSION2,308 reports
CONTUSION2,239 reports
CENTRAL NERVOUS SYSTEM LESION2,191 reports
INJECTION SITE REACTION1,956 reports
GENERAL SYMPTOM1,944 reports
LOSS OF CONSCIOUSNESS1,835 reports
MYALGIA1,809 reports
VISION BLURRED1,769 reports
MIGRAINE1,754 reports
DIABETES MELLITUS1,713 reports
DEHYDRATION1,690 reports
OPTIC NEURITIS1,672 reports
AMNESIA1,635 reports
CHEST PAIN1,624 reports
MATERNAL EXPOSURE DURING PREGNANCY1,605 reports
MUSCULOSKELETAL DISORDER1,601 reports
MUSCULOSKELETAL STIFFNESS1,595 reports
ADVERSE DRUG REACTION1,578 reports
PRURITUS1,528 reports
BREAST CANCER1,465 reports
SPEECH DISORDER1,442 reports
HYPERSENSITIVITY1,417 reports
WEIGHT INCREASED1,382 reports
RASH1,331 reports
COORDINATION ABNORMAL1,304 reports
ARTHRITIS1,291 reports
DRUG INTOLERANCE1,289 reports
ABDOMINAL PAIN UPPER1,283 reports
ALOPECIA1,259 reports
URINARY INCONTINENCE1,250 reports
INTERVERTEBRAL DISC PROTRUSION1,235 reports
COUGH1,232 reports
CYSTITIS1,217 reports
INJECTION SITE MASS1,213 reports
CONSTIPATION1,212 reports
THROMBOSIS1,205 reports
ROAD TRAFFIC ACCIDENT1,200 reports
BURNING SENSATION1,194 reports
HEPATIC ENZYME INCREASED1,171 reports
FLUSHING1,168 reports
INFECTION1,160 reports
HYPERHIDROSIS1,154 reports
BLOOD PRESSURE INCREASED1,116 reports
NERVOUSNESS1,113 reports
ABORTION SPONTANEOUS1,109 reports
OEDEMA PERIPHERAL1,103 reports
SOMNOLENCE1,094 reports

Key Safety Signals

  • Falls and gait disturbance
  • Serious adverse events like death and myocardial infarction
  • Infections, particularly pneumonia and urinary tract infections
  • Drug ineffectiveness and relapse in multiple sclerosis
  • Psychiatric symptoms including depression and anxiety

Patient Demographics

Adverse event reports by sex: Female: 150,178, Male: 38,044, Unknown: 467. The most frequently reported age groups are age 52 (3,528 reports), age 53 (3,453 reports), age 50 (3,393 reports). These demographics reflect reporting patterns and may not represent the full patient population.

Report Outcomes

Out of 191,325 classified reports for INTERFERON BETA 1A:

  • Serious: 101,664 reports (53.1%) — includes hospitalization, disability, life-threatening events, or death
  • Non-Serious: 89,661 reports (46.9%)
Serious 53.1%Non-Serious 46.9%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Female150,178 (79.6%)
Male38,044 (20.2%)
Unknown467 (0.2%)

Reports by Age

Age 523,528 reports
Age 533,453 reports
Age 503,393 reports
Age 513,376 reports
Age 493,343 reports
Age 483,323 reports
Age 563,298 reports
Age 543,267 reports
Age 473,260 reports
Age 573,228 reports
Age 553,184 reports
Age 463,077 reports
Age 593,035 reports
Age 583,034 reports
Age 452,987 reports
Age 602,925 reports
Age 442,838 reports
Age 432,728 reports
Age 422,680 reports
Age 612,660 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Drug Interactions & Warnings

Interferon beta-1a can interact with other drugs, and patients should be monitored for potential drug interactions. Warnings include the risk of serious adverse events such as death and myocardial infarction.

What You Should Know

If you are taking Interferon Beta-1a, here are important things to know. The most commonly reported side effects include multiple sclerosis relapse, influenza like illness, fatigue, fall, multiple sclerosis. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Monitor for signs of serious adverse events such as falls, infections, and psychiatric symptoms. Discuss potential drug interactions with your healthcare provider. If you experience a serious adverse reaction, seek emergency medical attention immediately or call 911. You can report side effects to the FDA's MedWatch program at 1-800-FDA-1088.

Regulatory Context

Regulatory oversight is ongoing, with a focus on monitoring serious adverse events and ensuring patient safety. Patients should report any adverse events to their healthcare provider and the FDA.

Frequently Asked Questions

How many adverse event reports has the FDA received for Interferon Beta-1a?

The FDA has received approximately 322,666 adverse event reports associated with Interferon Beta-1a. These reports come from healthcare professionals, consumers, and manufacturers through the FDA Adverse Event Reporting System (FAERS). Note that the number of reports does not directly indicate the frequency of side effects, as adverse events are voluntarily reported and may be underrepresented.

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

The most frequently reported adverse events for Interferon Beta-1a include Multiple Sclerosis Relapse, Influenza Like Illness, Fatigue, Fall, Multiple Sclerosis. By volume, the top reported reactions are: Multiple Sclerosis Relapse (15,800 reports), Influenza Like Illness (13,239 reports), Fatigue (11,525 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Interferon Beta-1a.

What percentage of Interferon Beta-1a adverse event reports are serious?

Out of 191,325 classified reports, 101,664 (53.1%) were classified as serious and 89,661 as non-serious. The FDA classifies an event as "serious" if it results in death, hospitalization, disability, or other medically significant outcomes. A higher serious-event ratio warrants closer attention but does not necessarily mean the drug is unsafe.

Who reports adverse events for Interferon Beta-1a (by sex)?

Adverse event reports for Interferon Beta-1a break down by patient sex as follows: Female: 150,178, Male: 38,044, Unknown: 467. This distribution reflects reporting patterns rather than actual risk differences between groups. Reporting rates can be influenced by prescribing patterns, disease demographics, and reporting behavior.

What age groups report the most side effects for Interferon Beta-1a?

The most frequently reported age groups for Interferon Beta-1a adverse events are: age 52: 3,528 reports, age 53: 3,453 reports, age 50: 3,393 reports, age 51: 3,376 reports, age 49: 3,343 reports. Age-related reporting patterns can reflect both the demographics of the patient population and potential age-related susceptibility to certain side effects.

Who manufactures Interferon Beta-1a?

The primary manufacturer associated with Interferon Beta-1a adverse event reports is Biogen Inc.. Multiple manufacturers may produce generic versions of this drug. The manufacturer listed reflects the most frequently reported brand in FDA adverse event data.

What other side effects have been reported for Interferon Beta-1a?

Beyond the most common reactions, other reported adverse events for Interferon Beta-1a include: Gait Disturbance, Headache, Memory Impairment, Pain, Injection Site Pain. Less common side effects can still be clinically significant. Patients should report any unusual symptoms to their healthcare provider.

How do I report a side effect from Interferon Beta-1a?

You can report adverse events from Interferon Beta-1a to the FDA through their MedWatch program at www.fda.gov/medwatch, by calling 1-800-FDA-1088, or by completing Form FDA 3500. Healthcare professionals, consumers, and manufacturers can all submit reports. Reporting helps the FDA monitor drug safety after approval.

What is Interferon Beta-1a's safety score and what does it mean?

Interferon Beta-1a has a safety concern score of 72 out of 100 (elevated concern). This score is calculated from the ratio of serious to non-serious adverse events, the diversity of reported reactions, and the overall volume of reports relative to usage. Fatigue and falls are among the most common adverse events reported.

What are the key safety signals for Interferon Beta-1a?

Key safety signals identified in Interferon Beta-1a's adverse event data include: Falls and gait disturbance. Serious adverse events like death and myocardial infarction. Infections, particularly pneumonia and urinary tract infections. Drug ineffectiveness and relapse in multiple sclerosis. Psychiatric symptoms including depression and anxiety. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.

Does Interferon Beta-1a interact with other drugs?

Interferon beta-1a can interact with other drugs, and patients should be monitored for potential drug interactions. Warnings include the risk of serious adverse events such as death and myocardial infarction. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Interferon Beta-1a.

What should patients know before taking Interferon Beta-1a?

Monitor for signs of serious adverse events such as falls, infections, and psychiatric symptoms. Discuss potential drug interactions with your healthcare provider.

Are Interferon Beta-1a side effects well-documented?

Interferon Beta-1a has 322,666 adverse event reports on file with the FDA. Serious adverse events, such as death and myocardial infarction, are concerning. The volume of reports for Interferon Beta-1a reflects both the drug's usage level and the vigilance of the reporting community.

What is the FDA's position on Interferon Beta-1a?

Regulatory oversight is ongoing, with a focus on monitoring serious adverse events and ensuring patient safety. Patients should report any adverse events to their healthcare provider and the FDA. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.

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Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.