Common Natalizumab Side Effects


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

Headache (309)
Fatigue (264)
Multiple Sclerosis (180)
Fall (154)
Condition Aggravated (138)
Asthenia (132)
Nausea (112)
Dizziness (107)
Convulsion (98)
Urinary Tract Infection (94)
Pain (91)
Dyspnoea (89)
Infusion Related Reaction (87)
Depression (86)
Progressive Multifocal Leukoencephalopathy (79)
Back Pain (74)
Multiple Sclerosis Relapse (74)
Chest Pain (72)
Pyrexia (67)
Arthralgia (64)

➢ 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.

Natalizumab Side Effects Reported to FDA



Natalizumab Side Effect Report#9849656
Myocardial Infarction
This is a report of a 45-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: multiple sclerosis, who was treated with Natalizumab (dosage: 300 Mg Other Iv, start time:
Dec 12, 2011), combined with: NA. and developed a serious reaction and side effect(s): Myocardial Infarction after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Natalizumab treatment in male patients, resulting in Myocardial Infarction side effect. The patient was hospitalized.
Natalizumab Side Effect Report#9727845
Progressive Multifocal Leukoencephalopathy
This report suggests a potential Natalizumab Progressive Multifocal Leukoencephalopathy side effect(s) that can have serious consequences. A 43-year-old male patient (weight: NA) from HU was diagnosed with the following symptoms/conditions: multiple sclerosis,hypertension,hypercholesterolaemia and used Natalizumab (dosage: NA) starting
Jan 19, 2013. After starting Natalizumab the patient began experiencing various side effects, including: Progressive Multifocal LeukoencephalopathyAdditional drugs used concurrently:
  • Telmisartan
  • Fluvastatin
The patient was hospitalized. Although Natalizumab demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Progressive Multifocal Leukoencephalopathy, may still occur.
Natalizumab Side Effect Report#9715380
Hypotension
This Hypotension problem was reported by a physician from FR. A 55-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: secondary progressive multiple sclerosis,diabetes mellitus. On
Oct 26, 2012 this consumer started treatment with Natalizumab (dosage: NA). The following drugs were being taken at the same time:
  • Metformin
When using Natalizumab, the patient experienced the following unwanted symptoms/side effects: HypotensionThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Hypotension, may become evident only after a product is in use by the general population.
Natalizumab Side Effect Report#9670512
Cellulitis
This Cellulitis side effect was reported by a physician from US. A 56-year-old female patient (weight:NA) experienced the following symptoms/conditions: secondary progressive multiple sclerosis,neuralgia.The patient was prescribed Natalizumab (drug dosage: NA), which was initiated on 1990. Concurrently used drugs:
  • Tegretol
  • Tegretol
  • Detrol
  • Detrol
  • Tylenol
  • Tylenol
  • Topamax
  • Topamax
.After starting to take Natalizumab the consumer reported adverse symptoms, such as: CellulitisThese side effects may potentially be related to Natalizumab. The patient was hospitalized.
Natalizumab Side Effect Report#9637304
Progressive Multifocal Leukoencephalopathy, Immune Reconstitution Inflammatory Syndrome
This is a report of a 53-year-old female patient (weight: NA) from PL, suffering from the following health symptoms/conditions: multiple sclerosis, who was treated with Natalizumab (dosage: NA, start time:
Dec 03, 2013), combined with:
  • Cipronex
  • Ketonal
  • Hydroxyxine
  • Pyralginum
  • Kalipoz
  • Polprazol
and developed a serious reaction and side effect(s): Progressive Multifocal Leukoencephalopathy, Immune Reconstitution Inflammatory Syndrome after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Natalizumab treatment in female patients, resulting in Progressive Multifocal Leukoencephalopathy side effect. The patient was hospitalized.
Natalizumab Side Effect Report#9410503
Herpes Simplex Encephalitis, Convulsion, Hallucinations, Mixed
This report suggests a potential Natalizumab-tysabri- Herpes Simplex Encephalitis side effect(s) that can have serious consequences. A 40-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: multiple sclerosis and used Natalizumab-tysabri- (dosage: Infusion, 1x/month, Iv) starting NS. After starting Natalizumab-tysabri- the patient began experiencing various side effects, including: Herpes Simplex Encephalitis, Convulsion, Hallucinations, MixedAdditional drugs used concurrently: NA.The patient was hospitalized. Although Natalizumab-tysabri- demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Herpes Simplex Encephalitis, may still occur.
Natalizumab Side Effect Report#9320645
Progressive Multifocal Leukoencephalopathy, Immune Reconstitution Inflammatory Syndrome
This Progressive Multifocal Leukoencephalopathy problem was reported by a physician from CZ. A 48-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: multiple sclerosis. On
May 08, 2013 this consumer started treatment with Natalizumab (dosage: NA). The following drugs were being taken at the same time:
  • Amprilan
  • Simgal
  • Vesicare
  • Curam
When using Natalizumab, the patient experienced the following unwanted symptoms/side effects: Progressive Multifocal Leukoencephalopathy, Immune Reconstitution Inflammatory SyndromeThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Progressive Multifocal Leukoencephalopathy, may become evident only after a product is in use by the general population.
Natalizumab Side Effect Report#9304590
Polyneuropathy
This Polyneuropathy side effect was reported by a physician from IT. A 38-year-old female patient (weight:NA) experienced the following symptoms/conditions: multiple sclerosis,tremor.The patient was prescribed Natalizumab (drug dosage: NA), which was initiated on 2010. Concurrently used drugs:
  • Keppra
.After starting to take Natalizumab the consumer reported adverse symptoms, such as: PolyneuropathyThese side effects may potentially be related to Natalizumab. The patient was hospitalized.
Natalizumab Side Effect Report#9303839
Pyrexia
This is a report of a 50-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Natalizumab (dosage: Other, start time:
Jan 05, 2012), combined with: NA. and developed a serious reaction and side effect(s): Pyrexia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Natalizumab treatment in male patients, resulting in Pyrexia side effect. The patient was hospitalized.
Natalizumab Side Effect Report#9215659
Altered State Of Consciousness
This report suggests a potential Natalizumab Altered State Of Consciousness side effect(s) that can have serious consequences. A 52-year-old female patient (weight: NA) from PL was diagnosed with the following symptoms/conditions: multiple sclerosis and used Natalizumab (dosage: NA) starting
Jul 04, 2011. After starting Natalizumab the patient began experiencing various side effects, including: Altered State Of ConsciousnessAdditional drugs used concurrently:
  • Carbamazepine
The patient was hospitalized. Although Natalizumab demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Altered State Of Consciousness, may still occur.
Natalizumab Side Effect Report#9148090
Pancreatic Carcinoma
This Pancreatic Carcinoma problem was reported by a physician from US. A 45-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: secondary progressive multiple sclerosis,hypercholesterolaemia,hypertension,micturition urgency,erectile dysfunction,type 2 diabetes mellitus. On
Nov 05, 2012 this consumer started treatment with Natalizumab (dosage: NA). The following drugs were being taken at the same time:
  • Tricor
  • Lisinopril-hydrochlorothiazide
  • Vesicare
  • Cialis
  • Lantus
  • Gemfibrozil
  • Novolog Flexpen
When using Natalizumab, the patient experienced the following unwanted symptoms/side effects: Pancreatic CarcinomaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Pancreatic Carcinoma, may become evident only after a product is in use by the general population.
Natalizumab Side Effect Report#9058353
Febrile Neutropenia
This Febrile Neutropenia side effect was reported by a health professional from US. A 44-year-old male patient (weight:NA) experienced the following symptoms/conditions: multiple sclerosis.The patient was prescribed Natalizumab (drug dosage: NA), which was initiated on NS. Concurrently used drugs: NA..After starting to take Natalizumab the consumer reported adverse symptoms, such as: Febrile NeutropeniaThese side effects may potentially be related to Natalizumab. The patient was hospitalized.
Natalizumab Side Effect Report#8995107
Chills, Stridor, Pain, Dyspnoea
This is a report of a 65-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: multiple sclerosis, who was treated with Natalizumab (dosage: 300 Mg Once Iv, start time:
Nov 08, 2012), combined with: NA. and developed a serious reaction and side effect(s): Chills, Stridor, Pain, Dyspnoea after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Natalizumab treatment in male patients, resulting in Chills side effect. The patient was hospitalized.
Natalizumab Side Effect Report#8974362
Hyperhidrosis, Tremor, Muscular Weakness
This report suggests a potential Natalizumab Hyperhidrosis side effect(s) that can have serious consequences. A 47-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: multiple sclerosis and used Natalizumab (dosage: 300 Mg, Every 5 Weeks, Iv Drip) starting
Nov 06, 2012. After starting Natalizumab the patient began experiencing various side effects, including: Hyperhidrosis, Tremor, Muscular WeaknessAdditional drugs used concurrently: NA. Although Natalizumab demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Hyperhidrosis, may still occur.
Natalizumab Side Effect Report#8919992
Progressive Multifocal Leukoencephalopathy
This Progressive Multifocal Leukoencephalopathy problem was reported by a physician from BE. A 45-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Natalizumab (dosage: Df = Infusions). The following drugs were being taken at the same time:
  • Mitoxantrone
When using Natalizumab, the patient experienced the following unwanted symptoms/side effects: Progressive Multifocal LeukoencephalopathyAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Progressive Multifocal Leukoencephalopathy, may become evident only after a product is in use by the general population.
Natalizumab Side Effect Report#8918884
Progressive Multifocal Leukoencephalopathy
This Progressive Multifocal Leukoencephalopathy side effect was reported by a pharmacist from US. A female patient (weight:NA) experienced the following symptoms/conditions: crohn^s disease.The patient was prescribed Natalizumab (drug dosage: NA), which was initiated on NS. Concurrently used drugs: NA..After starting to take Natalizumab the consumer reported adverse symptoms, such as: Progressive Multifocal LeukoencephalopathyThese side effects may potentially be related to Natalizumab. The patient was hospitalized.
Natalizumab Side Effect Report#8860774
Encephalitis, Coma
This is a report of a 29-year-old male patient (weight: NA) from IT, suffering from the following health symptoms/conditions: multiple sclerosis,anxiety,depression, who was treated with Natalizumab (dosage: NA, start time:
Jan 15, 2010), combined with:
  • Bromazepam
  • Citalopram
and developed a serious reaction and side effect(s): Encephalitis, Coma after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Natalizumab treatment in male patients, resulting in Encephalitis side effect. The patient was hospitalized.
Natalizumab Side Effect Report#8860774
Coma
This report suggests a potential Natalizumab Coma side effect(s) that can have serious consequences. A 29-year-old male patient (weight: NA) from IT was diagnosed with the following symptoms/conditions: multiple sclerosis,anxiety,depression and used Natalizumab (dosage: NA) starting
Jan 15, 2010. After starting Natalizumab the patient began experiencing various side effects, including: ComaAdditional drugs used concurrently:
  • Bromazepam
  • Citalopram
The patient was hospitalized. Although Natalizumab demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Coma, may still occur.
Natalizumab Side Effect Report#8837345
Diabetes Mellitus
This Diabetes Mellitus problem was reported by a physician from FR. A 54-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: secondary progressive multiple sclerosis. On
Jul 02, 2012 this consumer started treatment with Natalizumab (dosage: NA). The following drugs were being taken at the same time: NA. When using Natalizumab, the patient experienced the following unwanted symptoms/side effects: Diabetes MellitusThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Diabetes Mellitus, may become evident only after a product is in use by the general population.
Natalizumab Side Effect Report#8837345
Insulin-requiring Type 2 Diabetes Mellitus
This Insulin-requiring Type 2 Diabetes Mellitus side effect was reported by a physician from FR. A 54-year-old female patient (weight:NA) experienced the following symptoms/conditions: secondary progressive multiple sclerosis.The patient was prescribed Natalizumab (drug dosage: NA), which was initiated on
Jul 02, 2012. Concurrently used drugs: NA..After starting to take Natalizumab the consumer reported adverse symptoms, such as: Insulin-requiring Type 2 Diabetes MellitusThese side effects may potentially be related to Natalizumab. The patient was hospitalized.
Natalizumab Side Effect Report#8791533
Progressive Multifocal Leukoencephalopathy, Jc Virus Test Positive, Muscular Weakness, Condition Aggravated, Clumsiness, Central Nervous System Lesion, Ataxia, Clostridium Test Positive
This is a report of a 57-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: multiple sclerosis, who was treated with Natalizumab (dosage: 57 Doses, start time: NS), combined with:
  • Xanax
  • Aspirin
  • Lisinopril
  • Methadone
  • Multivitamin
  • Oxycodone/acetaminophen
  • Beclofen
and developed a serious reaction and side effect(s): Progressive Multifocal Leukoencephalopathy, Jc Virus Test Positive, Muscular Weakness, Condition Aggravated, Clumsiness, Central Nervous System Lesion, Ataxia, Clostridium Test Positive after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Natalizumab treatment in female patients, resulting in Progressive Multifocal Leukoencephalopathy side effect.
Natalizumab Side Effect Report#8791417
Ataxia, Escherichia Urinary Tract Infection, Cerebellar Atrophy, Visual Impairment, Dysarthria, Progressive Multifocal Leukoencephalopathy
This report suggests a potential Natalizumab Ataxia side effect(s) that can have serious consequences. A 30-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: multiple sclerosis and used Natalizumab (dosage: NA) starting NS. After starting Natalizumab the patient began experiencing various side effects, including: Ataxia, Escherichia Urinary Tract Infection, Cerebellar Atrophy, Visual Impairment, Dysarthria, Progressive Multifocal LeukoencephalopathyAdditional drugs used concurrently:
  • Oxybutynin
Although Natalizumab demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Ataxia, may still occur.
Natalizumab Side Effect Report#8781811
Type 1 Diabetes Mellitus
This Type 1 Diabetes Mellitus problem was reported by a physician from SE. A 58-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: multiple sclerosis,gout. On 200707 this consumer started treatment with Natalizumab (dosage: NA). The following drugs were being taken at the same time:
  • Arcoxia
When using Natalizumab, the patient experienced the following unwanted symptoms/side effects: Type 1 Diabetes MellitusThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Type 1 Diabetes Mellitus, may become evident only after a product is in use by the general population.
Natalizumab Side Effect Report#8493004-3
Musculoskeletal Pain, Herpes Zoster
This Musculoskeletal Pain side effect was reported by a pharmacist from United States. A 57-year-old patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Natalizumab (drug dosage: NA), which was initiated on
Mar 23, 2012. Concurrently used drugs: NA..After starting to take Natalizumab the consumer reported adverse symptoms, such as: Musculoskeletal Pain, Herpes ZosterThese side effects may potentially be related to Natalizumab. The patient was hospitalized.
Natalizumab Side Effect Report#8492587-7
Central Nervous System Lesion, Rebound Effect, Multiple Sclerosis
This is a report of a 28-year-old male patient (weight: NA) from United States, suffering from the following health symptoms/conditions: multiple sclerosis, who was treated with Natalizumab Biogen Idec (dosage: NA, start time:
Jan 01, 2007), combined with: NA. and developed a serious reaction and side effect(s): Central Nervous System Lesion, Rebound Effect, Multiple Sclerosis after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Natalizumab Biogen Idec treatment in male patients, resulting in Central Nervous System Lesion side effect.


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The appearance of Natalizumab 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 Natalizumab Side Effects for Women?

Women Side Effects Reports
Headache 247
Fatigue 203
Multiple Sclerosis 131
Fall 123
Condition Aggravated 110
Asthenia 91
Nausea 91
Dizziness 86
Pain 75
Depression 68

What are common Natalizumab Side Effects for Men?

Men Side Effects Reports
Headache 62
Fatigue 61
Multiple Sclerosis 49
Asthenia 41
Convulsion 34
Fall 31
Condition Aggravated 28
Infusion Related Reaction 28
Urinary Tract Infection 27
Dyspnoea 24

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.

    Natalizumab 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 Natalizumab Side Effects

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    How Effective is Natalizumab for You?

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    Natalizumab Safety Alerts, Active Ingredients, Usage Information

    More About Natalizumab

    Side Effects reported to FDA: 2566

    Natalizumab safety alerts: 2012 2011 2010 2009 2008 2006 2005

    Reported deaths: 121

    Reported hospitalizations: 1156

    Tysabri (natalizumab): Drug Safety Communication - New Risk Factor for Progressive Multifocal Leukoencephalopathy (PML)

    [Posted 01/20/2012]

    AUDIENCE: Neurology, Gastroenterology

    ISSUE: FDA notified healthcare profesisonals that testing positive for anti-JC virus (JCV) antibodies has been identified as a risk factor for progressive multifocal leukoencephalopathy (PML). PML is a rare but serious brain infection associated with use of Tysabri (natalizumab) for the treatment of multiple sclerosis (MS) or Crohn's disease.

    A patient's anti-JCV antibody status may be determined using an anti-JCV antibody detection test that has been analytically and clinically validated, and has been ordered by a healthcare professional. The Stratify JCV Antibody ELISA test2 was cleared by FDA on January 20, 2012. Testing positive for anti-JCV antibodies means that a person has been exposed to JCV in the past.

    BACKGROUND: Tysabri (natalizumab) is in a class of medications called immunomodulators. It works by stopping certain cells of the immune system from causing damage to the body. Tysabri is approved for the treatment of relapsing forms of multiple sclerosis since November 2004 and for the treatment of moderately to severely active Crohn's disease since January 2008.

    RECOMMENDATION: The risks and benefits of continuing treatment with Tysabri should be carefully considered in patients who are found to be anti-JCV antibody positive and have one or more of the other known risk factors for PML. Patients with all three known risk factors have an estimated risk of PML of 11/1,000 users. See the Drug Safety Communication Data Summary section for additional information.

    Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

    • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
    • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

     

    [01/20/2012 - Drug Safety Communication - FDA]
    [01/20/2012 - News Release - FDA]

    [09/2011 - Prescribing Information]

    Previous MedWatch Alerts:
     

    [04/22/2011]
    [02/05/2010]
    [09/17/2009]
    [08/25/2008

    Latest Natalizumab clinical trials

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