NUSINERSEN

N/A

9,682 FDA adverse event reports analyzed

Last updated: 2026-04-15

About NUSINERSEN

NUSINERSEN is a medication tracked in the FDA Adverse Event Reporting System (FAERS). The most commonly reported adverse reactions for NUSINERSEN include HEADACHE, POST LUMBAR PUNCTURE SYNDROME, PYREXIA, PROCEDURAL PAIN, PNEUMONIA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for NUSINERSEN.

Top Adverse Reactions

HEADACHE517 reports
POST LUMBAR PUNCTURE SYNDROME502 reports
PYREXIA389 reports
PROCEDURAL PAIN359 reports
PNEUMONIA353 reports
DEATH322 reports
VOMITING299 reports
ASTHENIA278 reports
BACK PAIN239 reports
SCOLIOSIS221 reports
FATIGUE209 reports
MALAISE168 reports
FALL166 reports
NAUSEA161 reports
NASOPHARYNGITIS155 reports
PAIN143 reports
DRUG INEFFECTIVE138 reports
RESPIRATORY FAILURE137 reports
RESPIRATORY DISORDER135 reports
MUSCULAR WEAKNESS132 reports
INFLUENZA130 reports
THERAPEUTIC RESPONSE SHORTENED126 reports
RESPIRATORY TRACT INFECTION111 reports
COVID 19110 reports
PROTEIN URINE PRESENT107 reports
DYSPNOEA102 reports
COUGH100 reports
RHINOVIRUS INFECTION100 reports
SPINAL MUSCULAR ATROPHY100 reports
OXYGEN SATURATION DECREASED95 reports
CARDIAC ARREST91 reports
PAIN IN EXTREMITY89 reports
RESPIRATORY SYNCYTIAL VIRUS INFECTION88 reports
SEIZURE88 reports
CARDIO RESPIRATORY ARREST84 reports
MOTOR DYSFUNCTION83 reports
VIRAL INFECTION81 reports
DEHYDRATION80 reports
INFECTION75 reports
DYSPHAGIA73 reports
SARS COV 2 TEST POSITIVE73 reports
INJECTION SITE PAIN72 reports
CEREBROSPINAL FLUID LEAKAGE71 reports
RESPIRATORY DISTRESS65 reports
OFF LABEL USE62 reports
POST PROCEDURAL COMPLICATION62 reports
SEPSIS61 reports
NEPHROLITHIASIS60 reports
MOBILITY DECREASED59 reports
RESPIRATORY ARREST59 reports
FEMUR FRACTURE58 reports
DIARRHOEA57 reports
ASPIRATION55 reports
WEIGHT DECREASED55 reports
ACUTE RESPIRATORY FAILURE54 reports
ASPARTATE AMINOTRANSFERASE INCREASED54 reports
PNEUMONIA ASPIRATION54 reports
URINARY TRACT INFECTION54 reports
ARTHRALGIA53 reports
GENERAL PHYSICAL HEALTH DETERIORATION52 reports
CONSTIPATION51 reports
MIGRAINE51 reports
UPPER RESPIRATORY TRACT INFECTION51 reports
DIZZINESS50 reports
ALANINE AMINOTRANSFERASE INCREASED49 reports
ATELECTASIS48 reports
PNEUMOTHORAX48 reports
ANXIETY46 reports
HYPOAESTHESIA46 reports
PROCEDURAL VOMITING46 reports
HEART RATE INCREASED45 reports
PROCEDURAL NAUSEA45 reports
INTRACRANIAL PRESSURE INCREASED44 reports
RASH43 reports
GAIT DISTURBANCE42 reports
HYPERTENSION42 reports
PROCEDURAL COMPLICATION42 reports
MUSCLE SPASMS40 reports
DECREASED APPETITE39 reports
NECK PAIN39 reports
WEIGHT INCREASED39 reports
SECRETION DISCHARGE38 reports
MATERNAL EXPOSURE DURING PREGNANCY37 reports
PLATELET COUNT DECREASED36 reports
ABDOMINAL PAIN35 reports
HEPATIC ENZYME INCREASED35 reports
THROMBOCYTOPENIA35 reports
MUSCULOSKELETAL STIFFNESS34 reports
NEURALGIA34 reports
TACHYCARDIA34 reports
PARAESTHESIA32 reports
RESPIRATORY TRACT INFECTION VIRAL31 reports
GASTROENTERITIS30 reports
GASTROINTESTINAL DISORDER29 reports
PROTEINURIA29 reports
ROAD TRAFFIC ACCIDENT29 reports
BRONCHITIS28 reports
FEELING ABNORMAL28 reports
RHINORRHOEA28 reports
TREMOR28 reports

Report Outcomes

Out of 7,291 classified reports for NUSINERSEN:

Serious 50.4%Non-Serious 49.6%

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

Female3,351 (50.7%)
Male3,259 (49.3%)

Reports by Age

Age 1217 reports
Age 3210 reports
Age 5195 reports
Age 2192 reports
Age 8187 reports
Age 4170 reports
Age 9169 reports
Age 7163 reports
Age 6155 reports
Age 10133 reports
Age 11127 reports
Age 14115 reports
Age 13114 reports
Age 12109 reports
Age 15101 reports
Age 1796 reports
Age 1886 reports
Age 1678 reports
Age 075 reports
Age 2170 reports

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

Frequently Asked Questions

How many FDA adverse event reports are associated with NUSINERSEN?

This profile reflects 9,682 FDA FAERS reports that mention NUSINERSEN. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for NUSINERSEN?

Frequently reported terms in FAERS include HEADACHE, POST LUMBAR PUNCTURE SYNDROME, PYREXIA, PROCEDURAL PAIN, PNEUMONIA, DEATH. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

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.