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Nusinersen Side Effects

For the Consumer

Applies to nusinersen: intrathecal solution

Along with its needed effects, nusinersen may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking nusinersen:

More common
  • Agitation
  • black, tarry stools
  • bleeding gums
  • blood in the urine or stools
  • body aches or pain
  • chills
  • coma
  • confusion
  • cough
  • decreased urine output
  • depression
  • difficulty with breathing
  • dizziness
  • ear congestion
  • fever
  • headache
  • irritability
  • lethargy
  • loss of voice
  • muscle twitching
  • nausea
  • pinpoint red spots on the skin
  • rapid weight gain
  • runny or stuffy nose
  • seizures
  • sneezing
  • sore throat
  • stupor
  • swelling of the face, ankles, or hands
  • unusual bleeding or bruising
  • unusual tiredness or weakness

Some side effects of nusinersen may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Back pain
  • difficulty having a bowel movement (stool)
  • teething
Less common
  • Change in hearing
  • ear drainage
  • earache or pain in the ear

For Healthcare Professionals

Applies to nusinersen: intrathecal solution

Respiratory

Very common (10% or more): Lower respiratory tract infection (i.e., pneumonia, bronchiolitis, pneumonia viral, respiratory syncytial virus bronchiolitis, lower respiratory tract infection, pneumonia bacterial, bronchitis, bronchitis viral, pneumonia moraxella, pneumonia parainfluenzae viral, lower respiratory tract infection viral, lung infection, pneumonia influenza, pneumonia pseudomonal, pneumonia respiratory syncytial viral) (43%), upper respiratory tract infection (i.e., upper respiratory tract infection, nasopharyngitis, rhinitis, pharyngitis, tracheitis) (39%)
Common (1% to 10%): Upper respiratory tract congestion, aspiration[Ref]

Renal

Frequency not reported: Renal toxicity (including potentially fatal glomerulonephritis), elevated urine protein[Ref]

Other

Common (1% to 10%): Ear infection
Frequency not reported: Growth retardation in infants[Ref]

Dermatologic

Frequency not reported: Rash[Ref]

Nervous system

Very common (10% or more): Headache (50%)[Ref]

Musculoskeletal

Very common (10% or more): Back pain (41%)[Ref]

Metabolic

Frequency not reported: Hyponatremia[Ref]

Hematologic

Frequency not reported: Coagulation abnormalities, thrombocytopenia[Ref]

Gastrointestinal

Very common (10% or more): Constipation (30%), teething (14%)[Ref]

References

1. "Product Information. Spinraza (nusinersen)." Biogen Idec Inc, Cambridge, MA.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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