Natalizumab Side Effects

Brand Names: Tysabri

Please note - some side effects for Natalizumab may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Natalizumab - for the Consumer

Natalizumab

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Natalizumab:

Diarrhea; headache; indigestion; joint pain; mild stomach discomfort; muscle cramps; pain in the arms or legs; tiredness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); anxiety; changes in balance, eyesight, memory, strength, or thinking; chest pain or discomfort; clumsiness; confusion; depression; dizziness; fainting; fast heartbeat; feeling cold; fever, chills, cough, or persistent sore throat; flushing; muscle pain; nausea; painful menstrual periods; painful urination or changes in the amount of urine; personality changes; severe or persistent headache or tiredness; severe or persistent stomach or back pain; shortness of breath or wheezing; suicidal thoughts or attempts; swelling of the hands, ankles, or legs; symptoms of liver problems (eg, dark urine; pale stools; right-sided stomach pain; unusual loss of appetite, nausea, vomiting, or weakness; yellowing of the skin or eyes); tremor; vaginal discharge, itching, or odor.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Side Effects by Body System - for Healthcare Professionals

Nervous system

One patient, a 46-year-old female, developed PML after she received 37 doses of natalizumab over 33 months. The other patient received 28 doses of natalizumab before developing PML and remains severely disabled.

In postmarketing experience, one MS patient who received natalizumab developed herpes encephalitis and died; a second MS patient developed herpes meningitis and recovered with appropriate treatment.

Nervous system side effects have included headache (up to 38%), dizziness (10% or greater), vertigo (6%), tremors (up to 3%), somnolence (2%), and syncope (2%). At least three cases of progressive multifocal leukoencephalopathy (PML) have been reported. Herpes infections of the central nervous system have been reported during postmarketing experience and have included herpes simplex virus (HSV) encephalitis, HSV meningitis, and herpes zoster virus meningitis. PML has also been reported during postmarketing experience.

Respiratory

Respiratory side effects have included opportunistic infections. These have included pneumocystis carinii pneumonia, pulmonary mycobacterium avium intracellulare, bronchopulmonary aspergillosis, and Burkholderia cepacia. Upper respiratory tract infection (22%), lower respiratory tract infection (up to 17%), influenza (12%), influenza-like illness (up to 11%), nasopharyngitis (10% or greater), sinusitis (7%), cough (up to 7%), and pharyngolaryngeal pain (6%) have been reported. At least one patient who had been administered natalizumab (3 mg per kg) experienced bronchospasm that rapidly responded to antihistamines and corticosteroids.

Psychiatric

Psychiatric side effects have included depression (19%), including suicidal ideation or attempt.

Gastrointestinal

Gastrointestinal side effects have included nausea (17%), gastroenteritis (11%), abdominal discomfort (11%), diarrhea (10%), tooth infections (9%), dyspepsia (5%), constipation (4%), toothache (4%), lower abdominal pain (4%), flatulence (3%), aphthous stomatitis (2%), intestinal obstruction or stenosis (2%), cholelithiasis (1%), and abdominal adhesions (0.3%). At least one case of cryptosporidial gastroenteritis has been reported with prolonged use.

Immunologic

Immunologic side effects have included immunosuppression/infections, including pneumonias and urinary tract infections (including serious cases), gastroenteritis, vaginal infections, tooth infections, tonsillitis, and herpes infections. Herpes (8%), tonsillitis (7%), and viral infection (up to 7%) have been reported. Antibodies to natalizumab were detected in approximately 9% of patients at least once during treatment with persistent antibody-positivity in 6% of patients.

Development of antibodies to natalizumab occurred by week 12 in most of the patients (82%) who became persistently antibody-positive. The presence of anti-natalizumab antibodies was correlated with a reduction in serum natalizumab levels. Persistent antibody-positivity to natalizumab was associated with a substantial decrease in the effectiveness of the drug.

Other

Other side effects have included fatigue (up to 27%), peripheral edema (up to 6%), chest discomfort (up to 5%), rigors (3%), limb injury (3%), skin laceration (2%), and thermal burn (1%). At least one case of shakiness has also been reported.

Local

Local side effects have included infusion related reactions including headache, nausea, dizziness, fatigue, hypersensitivity reactions, urticaria, pruritus, flushing, and rigors in up to 24% of patients. Infusion related anaphylactic reactions have been reported in less than 1% of patients.

Genitourinary

Genitourinary side effects have included urinary tract infection (up to 21%), vaginitis (up to 10%), urinary urgency/frequency (9%), vaginal infections (up to 8%), dysmenorrhea (up to 6%), irregular menstruation (5%), urinary incontinence (4%), amenorrhea (2%), and ovarian cyst (2%).

Musculoskeletal

Musculoskeletal side effects have included arthralgia (up to 19%), pain in extremity (16%), back pain (12%), muscle cramp (5%), and joint swelling (2%).

Dermatologic

Dermatologic side effects have included rash (up to 12%), dermatitis (up to 7%), pruritus (4%), perianal abscess (2% or greater), urticaria (1%), dry skin (1%), and night sweats (1%). At least of case of serum sickness-like illness has also been reported.

Hypersensitivity

Hypersensitivity side effects have included allergic reaction (7%), acute hypersensitivity (up to 4%), seasonal allergy (3%), and anaphylaxis/anaphylactoid reactions. An infusion-related reaction has been reported to occur within 2 hours of the start of an infusion. At least 2 cases of allergic dermatitis have also been reported.

Patients experiencing hypersensitivity reactions recovered with treatment and/or discontinuation of the infusion. Patients who developed antibodies to natalizumab were more likely to have an infusion-related reaction.

Hepatic

Hepatic side effects have included abnormal liver function tests (5%).

Metabolic

Metabolic side effects have included weight decreased and increased in 2% of patients.

Cardiovascular

Cardiovascular side effects have included pericarditis.

Ocular

Ocular side effects have included at least one case of ocular toxoplasmosis reactivation.

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