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Tysabri Side Effects

Common Tysabri Side Effects

The most commonly reported Tysabri side effects (click to view or check a box to report):

Fatigue (11178)
Multiple Sclerosis Relapse (9081)
Headache (5926)
Fall (4880)
Gait Disturbance (4658)
Asthenia (4565)
Urinary Tract Infection (3927)
Multiple Sclerosis (3614)
Balance Disorder (3091)
Memory Impairment (2895)
Malaise (2845)
Pain In Extremity (2838)
Pain (2802)
Hypoaesthesia (2797)
Nasopharyngitis (2779)
Muscular Weakness (2643)
Nausea (2417)
Dizziness (2253)
Progressive Multifocal Leukoencephalopathy (2244)
Depression (1845)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

Tysabri Side Effects Reported to FDA

The following Tysabri reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.


The appearance of Tysabri on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.
Malaise
on Mar 12, 2014 Female from US , 53 years of age, was diagnosed with and was treated with Tysabri. Directly after, patient experienced the unwanted or unexpected Tysabri side effects: malaise. Tysabri dosage: N/A.

Vein Disorder
Patient was taking Tysabri. Patient felt the following Tysabri side effects: vein disorder on Mar 12, 2014 from US Additional patient health information: Male , 62 years of age, was diagnosed with and. Tysabri dosage: N/A.

Hypersensitivity
Adverse event was reported on Mar 12, 2014 by a Female taking Tysabri (Dosage: N/A) was diagnosed with and. Location: US , 51 years of age, After Tysabri was administered, patient encountered several Tysabri side effects: hypersensitivity.

Fall
on Mar 12, 2014 Male from US , 60 years of age, was diagnosed with and was treated with Tysabri. Directly after, patient experienced the unwanted or unexpected Tysabri side effects: fall. Tysabri dosage: N/A.


Pain, Gait Disturbance
on Mar 12, 2014 Female from US , 46 years of age, was diagnosed with and was treated with Tysabri. Patient felt the following Tysabri side effects: pain, gait disturbance. Tysabri dosage: N/A.

Malaise
Patient was taking Tysabri. After Tysabri was administered, patient encountered several Tysabri side effects: malaise on Mar 12, 2014 from US Additional patient health information: Female , 59 years of age, was diagnosed with and. Tysabri dosage: N/A.

Groin Pain, Pain In Extremity, Multiple Sclerosis Relapse
Adverse event was reported on Mar 12, 2014 by a Male taking Tysabri (Dosage: N/A) was diagnosed with and. Location: US , 31 years of age, Directly after, patient experienced the unwanted or unexpected Tysabri side effects: groin pain, pain in extremity, multiple sclerosis relapse.

Back Pain, Hypoaesthesia, Multiple Sclerosis Relapse, Headache
on Mar 12, 2014 Female from US , 21 years of age, was diagnosed with and was treated with Tysabri. Patient felt the following Tysabri side effects: back pain, hypoaesthesia, multiple sclerosis relapse, headache. Tysabri dosage: N/A.

Fatigue
on Mar 12, 2014 Female from US , 61 years of age, was diagnosed with and was treated with Tysabri. After Tysabri was administered, patient encountered several Tysabri side effects: fatigue. Tysabri dosage: N/A.

Pain In Extremity, Burning Sensation, Infusion Site Extravasation
Patient was taking Tysabri. Directly after, patient experienced the unwanted or unexpected Tysabri side effects: pain in extremity, burning sensation, infusion site extravasation on Mar 12, 2014 from US Additional patient health information: Male , 53 years of age, was diagnosed with and. Tysabri dosage: N/A.

Abnormal Sensation In Eye, Eye Disorder, Feeling Abnormal, Fatigue
Adverse event was reported on Mar 18, 2014 by a Male taking Tysabri (Dosage: N/A) was diagnosed with and. Location: US , 24 years of age, Patient felt the following Tysabri side effects: abnormal sensation in eye, eye disorder, feeling abnormal, fatigue.

Pyrexia
on Mar 12, 2014 Female from US , 30 years of age, was diagnosed with and was treated with Tysabri. After Tysabri was administered, patient encountered several Tysabri side effects: pyrexia. Tysabri dosage: N/A.

Pain
on Mar 12, 2014 Female from US , 45 years of age, was diagnosed with and was treated with Tysabri. Directly after, patient experienced the unwanted or unexpected Tysabri side effects: pain. Tysabri dosage: N/A.
Associated medications used:
  • Avonex
  • Avonex


Fatigue
Patient was taking Tysabri. Patient felt the following Tysabri side effects: fatigue on Mar 12, 2014 from US Additional patient health information: Female , 35 years of age, was diagnosed with and. Tysabri dosage: N/A.

Dizziness
Adverse event was reported on Mar 19, 2014 by a Male taking Tysabri (Dosage: N/A) was diagnosed with and. Location: US , 30 years of age, After Tysabri was administered, patient encountered several Tysabri side effects: dizziness.
Multiple concurrent drugs taken:
  • Avonex
  • Avonex


Malaise
on Mar 12, 2014 Female from US , 47 years of age, was diagnosed with and was treated with Tysabri. Directly after, patient experienced the unwanted or unexpected Tysabri side effects: malaise. Tysabri dosage: N/A.
Associated medications used:
  • Avonex


Herpes Zoster, Fatigue
on Mar 12, 2014 Female from US , 68 years of age, was diagnosed with and was treated with Tysabri. Patient felt the following Tysabri side effects: herpes zoster, fatigue. Tysabri dosage: N/A.
Multiple prescriptions taken:
  • Avonex


Depression, Skull Fracture
Patient was taking Tysabri. After Tysabri was administered, patient encountered several Tysabri side effects: depression, skull fracture on Mar 12, 2014 from US Additional patient health information: Female , 46 years of age, was diagnosed with and. Tysabri dosage: N/A.

Poor Venous Access
Adverse event was reported on Mar 12, 2014 by a Female taking Tysabri (Dosage: N/A) was diagnosed with and. Location: US , 40 years of age, Directly after, patient experienced the unwanted or unexpected Tysabri side effects: poor venous access.

Nasopharyngitis, Oropharyngeal Pain
on Mar 12, 2014 Female from US , 61 years of age, was diagnosed with and was treated with Tysabri. Patient felt the following Tysabri side effects: nasopharyngitis, oropharyngeal pain. Tysabri dosage: N/A.

Cholecystitis Acute
on Mar 20, 2014 Male from US , 64 years of age, was diagnosed with and was treated with Tysabri. After Tysabri was administered, patient encountered several Tysabri side effects: cholecystitis acute. Tysabri dosage: N/A. Patient was hospitalized.

Laceration
Patient was taking Tysabri. Directly after, patient experienced the unwanted or unexpected Tysabri side effects: laceration on Mar 11, 2014 from US Additional patient health information: Female , 38 years of age, was diagnosed with and. Tysabri dosage: N/A. Patient was hospitalized.

Malaise, Pyrexia
Adverse event was reported on Mar 11, 2014 by a Female taking Tysabri (Dosage: N/A) was diagnosed with and. Location: US , 37 years of age, Patient felt the following Tysabri side effects: malaise, pyrexia.

Pain, Sinusitis
on Mar 11, 2014 Female from US , 32 years of age, was diagnosed with and was treated with Tysabri. After Tysabri was administered, patient encountered several Tysabri side effects: pain, sinusitis. Tysabri dosage: N/A.

Confusional State, Asthenia
on Mar 11, 2014 Male from US , 51 years of age, was diagnosed with and was treated with Tysabri. Directly after, patient experienced the unwanted or unexpected Tysabri side effects: confusional state, asthenia. Tysabri dosage: N/A. Patient was hospitalized.

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Keep Track of Side Effects

Note Your Observations

It is really important to keep of your symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:

     

    Side Effects

    Scale

    Date & Time

    Other Medicine(s) or Treatment(s)

     

     

     

     

    Scale: 1 = very mild to 10 = very bad


    Track Online

  • User Sign In
  • Register to track your side effects

  • You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

    Discuss Tysabri Side Effects

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    Safety Alerts, Active Ingredients, Usage Information

    Alternative TYSABRI Names:NATALIZUM

    Active Ingredient: NATALIZUM

    Tysabri Dosage, Warnings, Usage.

    Side Effects reported to FDA: 89993

    Tysabri safety alerts: 2012 2011 2010 2009 2008 2006 2005

    Reported deaths: 2116

    Reported hospitalizations: 23926

    Latest Tysabri clinical trials