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Tysabri Side Effects

PatientsVille

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.

Tysabri Side Effects Reported to FDA



Tysabri Side Effect Report#9998407
Malaise
This is a report of a 53-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: multiple sclerosis, who was treated with Tysabri (dosage: NA, start time:
Jun 01, 1996), combined with: NA. and developed a serious reaction and side effect(s): Malaise after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Tysabri treatment in female patients, resulting in Malaise side effect.
Tysabri Side Effect Report#9998406
Vein Disorder
This report suggests a potential Tysabri Vein Disorder side effect(s) that can have serious consequences. A 62-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: multiple sclerosis and used Tysabri (dosage: NA) starting
Jan 13, 2014. After starting Tysabri the patient began experiencing various side effects, including: Vein DisorderAdditional drugs used concurrently: NA. Although Tysabri demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Vein Disorder, may still occur.
Tysabri Side Effect Report#9998402
Hypersensitivity
This Hypersensitivity problem was reported by a consumer or non-health professional from US. A 51-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: multiple sclerosis. On
Sep 06, 2013 this consumer started treatment with Tysabri (dosage: NA). The following drugs were being taken at the same time: NA. When using Tysabri, the patient experienced the following unwanted symptoms/side effects: HypersensitivityAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Hypersensitivity, may become evident only after a product is in use by the general population.
Tysabri Side Effect Report#9998401
Fall
This Fall side effect was reported by a health professional from US. A 60-year-old male patient (weight:NA) experienced the following symptoms/conditions: multiple sclerosis.The patient was prescribed Tysabri (drug dosage: NA), which was initiated on
May 09, 2011. Concurrently used drugs: NA..After starting to take Tysabri the consumer reported adverse symptoms, such as: FallThese side effects may potentially be related to Tysabri.
Tysabri Side Effect Report#9998400
Pain, Gait Disturbance
This is a report of a 46-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: multiple sclerosis, who was treated with Tysabri (dosage: NA, start time:
Mar 28, 2013), combined with: NA. and developed a serious reaction and side effect(s): Pain, Gait Disturbance after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Tysabri treatment in female patients, resulting in Pain side effect.
Tysabri Side Effect Report#9998398
Malaise
This report suggests a potential Tysabri Malaise side effect(s) that can have serious consequences. A 59-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: multiple sclerosis and used Tysabri (dosage: NA) starting
May 15, 2007. After starting Tysabri the patient began experiencing various side effects, including: MalaiseAdditional drugs used concurrently: NA. Although Tysabri demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Malaise, may still occur.
Tysabri Side Effect Report#9998397
Groin Pain, Pain In Extremity, Multiple Sclerosis Relapse
This Groin Pain problem was reported by a consumer or non-health professional from US. A 31-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: multiple sclerosis. On
Oct 03, 2013 this consumer started treatment with Tysabri (dosage: NA). The following drugs were being taken at the same time: NA. When using Tysabri, the patient experienced the following unwanted symptoms/side effects: Groin Pain, Pain In Extremity, Multiple Sclerosis RelapseAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Groin Pain, may become evident only after a product is in use by the general population.
Tysabri Side Effect Report#9998396
Back Pain, Hypoaesthesia, Multiple Sclerosis Relapse, Headache
This Back Pain side effect was reported by a consumer or non-health professional from US. A 21-year-old female patient (weight:NA) experienced the following symptoms/conditions: multiple sclerosis.The patient was prescribed Tysabri (drug dosage: NA), which was initiated on
Aug 09, 2012. Concurrently used drugs: NA..After starting to take Tysabri the consumer reported adverse symptoms, such as: Back Pain, Hypoaesthesia, Multiple Sclerosis Relapse, HeadacheThese side effects may potentially be related to Tysabri.
Tysabri Side Effect Report#9998395
Fatigue
This is a report of a 61-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: multiple sclerosis, who was treated with Tysabri (dosage: NA, start time:
Sep 09, 2013), combined with: NA. and developed a serious reaction and side effect(s): Fatigue after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Tysabri treatment in female patients, resulting in Fatigue side effect.
Tysabri Side Effect Report#9998394
Pain In Extremity, Burning Sensation, Infusion Site Extravasation
This report suggests a potential Tysabri Pain In Extremity side effect(s) that can have serious consequences. A 53-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: multiple sclerosis and used Tysabri (dosage: NA) starting
Jul 08, 2011. After starting Tysabri the patient began experiencing various side effects, including: Pain In Extremity, Burning Sensation, Infusion Site ExtravasationAdditional drugs used concurrently: NA. Although Tysabri demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Pain In Extremity, may still occur.
Tysabri Side Effect Report#9998393
Abnormal Sensation In Eye, Eye Disorder, Feeling Abnormal, Fatigue
This Abnormal Sensation In Eye problem was reported by a consumer or non-health professional from US. A 24-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: multiple sclerosis. On
Oct 04, 2012 this consumer started treatment with Tysabri (dosage: NA). The following drugs were being taken at the same time: NA. When using Tysabri, the patient experienced the following unwanted symptoms/side effects: Abnormal Sensation In Eye, Eye Disorder, Feeling Abnormal, FatigueAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Abnormal Sensation In Eye, may become evident only after a product is in use by the general population.
Tysabri Side Effect Report#9998392
Pyrexia
This Pyrexia side effect was reported by a consumer or non-health professional from US. A 30-year-old female patient (weight:NA) experienced the following symptoms/conditions: multiple sclerosis.The patient was prescribed Tysabri (drug dosage: NA), which was initiated on
May 31, 2011. Concurrently used drugs: NA..After starting to take Tysabri the consumer reported adverse symptoms, such as: PyrexiaThese side effects may potentially be related to Tysabri.
Tysabri Side Effect Report#9998390
Pain
This is a report of a 45-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: multiple sclerosis, who was treated with Tysabri (dosage: NA, start time:
Oct 01, 2011), combined with:
  • Avonex
  • Avonex
and developed a serious reaction and side effect(s): Pain after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Tysabri treatment in female patients, resulting in Pain side effect.
Tysabri Side Effect Report#9998388
Fatigue
This report suggests a potential Tysabri Fatigue side effect(s) that can have serious consequences. A 35-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: multiple sclerosis and used Tysabri (dosage: NA) starting
May 02, 2013. After starting Tysabri the patient began experiencing various side effects, including: FatigueAdditional drugs used concurrently: NA. Although Tysabri demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Fatigue, may still occur.
Tysabri Side Effect Report#9998383
Dizziness
This Dizziness problem was reported by a consumer or non-health professional from US. A 30-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: multiple sclerosis. On
May 01, 2011 this consumer started treatment with Tysabri (dosage: NA). The following drugs were being taken at the same time:
  • Avonex
  • Avonex
When using Tysabri, the patient experienced the following unwanted symptoms/side effects: DizzinessAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Dizziness, may become evident only after a product is in use by the general population.
Tysabri Side Effect Report#9998375
Malaise
This Malaise side effect was reported by a health professional from US. A 47-year-old female patient (weight:NA) experienced the following symptoms/conditions: multiple sclerosis.The patient was prescribed Tysabri (drug dosage: NA), which was initiated on
Jul 21, 2011. Concurrently used drugs:
  • Avonex
.After starting to take Tysabri the consumer reported adverse symptoms, such as: MalaiseThese side effects may potentially be related to Tysabri.
Tysabri Side Effect Report#9998374
Herpes Zoster, Fatigue
This is a report of a 68-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: multiple sclerosis, who was treated with Tysabri (dosage: NA, start time:
Sep 02, 2008), combined with:
  • Avonex
and developed a serious reaction and side effect(s): Herpes Zoster, Fatigue after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Tysabri treatment in female patients, resulting in Herpes Zoster side effect.
Tysabri Side Effect Report#9998371
Depression, Skull Fracture
This report suggests a potential Tysabri Depression side effect(s) that can have serious consequences. A 46-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: multiple sclerosis and used Tysabri (dosage: NA) starting
Nov 06, 2013. After starting Tysabri the patient began experiencing various side effects, including: Depression, Skull FractureAdditional drugs used concurrently: NA. Although Tysabri demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Depression, may still occur.
Tysabri Side Effect Report#9998368
Poor Venous Access
This Poor Venous Access problem was reported by a health professional from US. A 40-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: multiple sclerosis. On
Oct 24, 2013 this consumer started treatment with Tysabri (dosage: NA). The following drugs were being taken at the same time: NA. When using Tysabri, the patient experienced the following unwanted symptoms/side effects: Poor Venous AccessAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Poor Venous Access, may become evident only after a product is in use by the general population.
Tysabri Side Effect Report#9998367
Nasopharyngitis, Oropharyngeal Pain
This Nasopharyngitis side effect was reported by a consumer or non-health professional from US. A 61-year-old female patient (weight:NA) experienced the following symptoms/conditions: multiple sclerosis.The patient was prescribed Tysabri (drug dosage: NA), which was initiated on
Oct 29, 2012. Concurrently used drugs: NA..After starting to take Tysabri the consumer reported adverse symptoms, such as: Nasopharyngitis, Oropharyngeal PainThese side effects may potentially be related to Tysabri.
Tysabri Side Effect Report#9998358
Cholecystitis Acute
This is a report of a 64-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: crohn^s disease, who was treated with Tysabri (dosage: NA, start time:
Jan 13, 2009), combined with: NA. and developed a serious reaction and side effect(s): Cholecystitis Acute after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Tysabri treatment in male patients, resulting in Cholecystitis Acute side effect. The patient was hospitalized.
Tysabri Side Effect Report#9994538
Laceration
This report suggests a potential Tysabri Laceration side effect(s) that can have serious consequences. A 38-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: multiple sclerosis and used Tysabri (dosage: NA) starting
Nov 04, 2011. After starting Tysabri the patient began experiencing various side effects, including: LacerationAdditional drugs used concurrently: NA.The patient was hospitalized. Although Tysabri demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Laceration, may still occur.
Tysabri Side Effect Report#9994537
Malaise, Pyrexia
This Malaise problem was reported by a health professional from US. A 37-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: multiple sclerosis. On
Feb 15, 2008 this consumer started treatment with Tysabri (dosage: NA). The following drugs were being taken at the same time: NA. When using Tysabri, the patient experienced the following unwanted symptoms/side effects: Malaise, PyrexiaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Malaise, may become evident only after a product is in use by the general population.
Tysabri Side Effect Report#9994535
Pain, Sinusitis
This Pain side effect was reported by a consumer or non-health professional from US. A 32-year-old female patient (weight:NA) experienced the following symptoms/conditions: multiple sclerosis.The patient was prescribed Tysabri (drug dosage: NA), which was initiated on
Jan 16, 2012. Concurrently used drugs: NA..After starting to take Tysabri the consumer reported adverse symptoms, such as: Pain, SinusitisThese side effects may potentially be related to Tysabri.
Tysabri Side Effect Report#9994533
Confusional State, Asthenia
This is a report of a 51-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: multiple sclerosis, who was treated with Tysabri (dosage: NA, start time:
Nov 11, 2009), combined with: NA. and developed a serious reaction and side effect(s): Confusional State, Asthenia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Tysabri treatment in male patients, resulting in Confusional State side effect. The patient was hospitalized.

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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.


What are common Tysabri Side Effects for Women?

Women Side EffectsReports
Fatigue 8891
Multiple Sclerosis Relapse 7087
Headache 4916
Fall 3783
Asthenia 3400
Gait Disturbance 3349
Urinary Tract Infection 3148
Multiple Sclerosis 2599
Pain 2305
Pain In Extremity 2292

What are common Tysabri Side Effects for Men?

Men Side EffectsReports
Fatigue 2273
Multiple Sclerosis Relapse 1982
Gait Disturbance 1307
Asthenia 1162
Fall 1096
Multiple Sclerosis 1014
Headache 1002
Balance Disorder 838
Urinary Tract Infection 777
Muscular Weakness 756

Track Your Side Effects

Note Your Observations

It is really important to keep track of your health 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

    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.

    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.

    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.

    Discuss Tysabri Side Effects

    Did You Have a Tysabri Side Effect?

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    How Effective is Tysabri for You?

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    Tysabri Safety Alerts, Active Ingredients, Usage Information

    NDC59075-730
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NameTYSABRI
    Namenatalizumab
    Dosage FormINJECTION
    RouteINTRAVENOUS
    On market since20041123
    LabelerElan Pharmaceuticals, Inc.
    Active Ingredient(s)NATALIZUMAB
    Strength(s)300
    Unit(s)mg/15mL
    Pharma ClassIntegrin Receptor Antagonist [EPC],Integrin Receptor Antagonists [MoA]

    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