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Natalizumab Side Effects

The most commonly reported side effects of natalizumab include multiple sclerosis relapse, fatigue, and fatigue, based on 179,695 FDA adverse event reports from 2004 to 2025. 2.3% of reports found the drug to be ineffective.

Natalizumab side effects

Percentages show how often each reaction appears relative to total reports for natalizumab.

1
Multiple Sclerosis Relapse6.2%11,127
2
Fatigue6.1%10,909
3
Fatigue4.8%8,600
4
Multiple Sclerosis3.8%6,851
5
Gait Disturbance3.2%5,780
6
Multiple Sclerosis Relapse3.2%5,694
7
Memory Impairment3.1%5,573
8
Headache3.1%5,482
9
Malaise2.9%5,209
10
Fall2.7%4,782
11
Asthenia2.5%4,528
12
Headache2.5%4,455
13
Drug Ineffective2.3%4,187
14
Pain2.1%3,850
15
Urinary Tract Infection2.1%3,722

These are voluntary reports and do not establish that natalizumab caused these reactions.

Report severity

31.2%Serious56,101 reports
19.2%Hospitalizations34,459 reports
2.8%Fatal5,045 reports

Seriousness is determined by the reporter, not by OpenClaim.

Natalizumab drug interactions

Other drugs that appear in adverse event reports alongside natalizumab. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Dalfampridine1.9%3,326
2
Interferon1.5%2,702
3
Dimethyl1.5%2,690
4
Ocrelizumab0.4%741
5
Fingolimod0.4%695
6
Glatiramer-acetate0.2%360
7
Rituximab0.2%280
8
Teriflunomide0.2%280
9
Methylprednisolone0.1%209
10
Alemtuzumab0.1%208
11
Tizanidine-hydrochloride<0.1%149
12
Peginterferon<0.1%143
13
Baclofen<0.1%125
14
Daclizumab<0.1%115
15
Ofatumumab<0.1%112

Taken alongside

1
Interferon11.7%20,974
2
Baclofen2.1%3,802
3
Ergocalciferol1.8%3,311
4
Gabapentin1.5%2,741
5
Acetaminophen1.3%2,372
6
Dalfampridine1.2%2,139
7
Pregabalin0.7%1,232
8
Levothyroxine-sodium0.7%1,195
9
Glatiramer-acetate0.7%1,182
10
Duloxetine-hydrochloride0.7%1,177
11
Aspirin0.6%1,101
12
Modafinil0.6%1,098
13
Ibuprofen0.6%1,083
14
Clonazepam0.6%1,013
15
Cyanocobalamin0.5%964

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports natalizumab side effects

75.8% of natalizumab adverse event reports involve female patients and 22.6% involve male patients. The largest age group is adult at 94%. These figures reflect who reports side effects, not underlying risk.

Sex

Female75.8%
Male22.6%
Unknown1.7%

Age group

< 20.5%
2–11<0.1%
12–170.4%
18–6493.9%
65+5.2%

What is natalizumab used for

Conditions and purposes for which patients were taking natalizumab when the adverse event was reported.

Accidental ExposureAccidental Exposure To ProductAcute Disseminated EncephalomyelitisAcute Graft Versus Host DiseaseAmnesiaAtaxiaAcute Graft Versus Host DiseaseAdverse Drug ReactionAdverse ReactionAnkylosing SpondylitisAutoimmune DisorderAutoinflammatory DiseaseBlood DisorderBone Marrow Conditioning RegimenBone Marrow Failure

Showing 15 of 154 indications

Natalizumab brand names and reporting trend

Natalizumab is sold under brand names including Tysabri, Tyruko.

Brand names

Tysabri3,037
Tyruko1

Quarterly reports (20042025)

20052010201520202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking natalizumab with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.