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Spinraza Side Effects

Generic Name: nusinersen

Note: This document contains side effect information about nusinersen. Some of the dosage forms listed on this page may not apply to the brand name Spinraza.

For the Consumer

Applies to nusinersen: intrathecal solution

Along with its needed effects, nusinersen (the active ingredient contained in Spinraza) 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.

Some side effects of Spinraza may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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