Tysabri Side Effects

Generic Name: natalizumab

Please note - some side effects for Tysabri may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Tysabri - for the Consumer

Tysabri

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 Tysabri:

Diarrhea; headache; joint pain; 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); changes in balance, eyesight, strength, or thinking; chest pain or discomfort; chills; dark urine; depression; dizziness; fast heartbeat; feeling cold; fever; flushing; muscle pain; nausea; painful menstrual periods; painful urination or changes in your amount of urine; right-sided back, stomach, or side pain; severe or persistent headache or tiredness; shortness of breath; sore throat; suicidal thoughts or attempts; swelling of the hands, ankles, or legs; tremor; vaginal discharge, itching, or odor; vomiting; yellowing of the skin or eyes.

Tysabri Side Effects - for the Professional

Tysabri

The most common adverse reactions (incidence ≥ 10%) in MS were headache, fatigue, arthralgia, urinary tract infection, lower respiratory tract infection, gastroenteritis, vaginitis, depression, pain in extremity, abdominal discomfort, diarrhea NOS, and rash; and in CD were headache, upper respiratory tract infections, nausea, and fatigue (6.1)

Side Effects by Body System

Psychiatric

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

Dermatologic

Dermatologic side effects have included rash (6% to 12%), dermatitis (5% 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.

Immunologic

Immunologic side effects have included infections, including pneumonia. Herpes (8%), tonsillitis (7%), viral infection (3% to 7%), and seasonal allergy (3%) 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.

Hypersensitivity

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.

Hypersensitivity side effects have included allergic reaction (7%), acute hypersensitivity (2% to 4%), 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.

Gastrointestinal

Gastrointestinal side effects have included nausea (17%), gastroenteritis (11%), abdominal discomfort (10% or greater), diarrhea (10%), tooth infections (9%), dyspepsia (5%), constipation (4%), toothache (4%), lower abdominal pain (4%), flatulence (3%), aphthous stomatitis (2%), cholelithiasis (0.8%), and abdominal adhesions (0.3%). At least one case of cryptosporidial gastroenteritis has been reported with prolonged use.

Hepatic

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

Genitourinary

Genitourinary side effects have included urinary tract infection (3% to 21%), vaginitis (8% to 9%), urinary urgency/frequency (9%), vaginal infections (4% to 8%), irregular menstruation and dysmenorrhea (2% to 7%), urinary incontinence (4%), amenorrhea (2%), and ovarian cyst (2%).

Nervous system

Nervous system side effects have included headache (32% to 38%), dizziness (10% or greater), vertigo (6%), tremors (1% to 3%), somnolence (2%), and syncope (2%). At least three cases of progressive multifocal leukoencephalopathy (PML) have been reported. 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.

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.

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 (15% to 17%), influenza (12%), influenza-like illness (5% to 11%), nasopharyngitis (10% or greater), sinusitis (7%), cough (3% 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.

Musculoskeletal

Musculoskeletal side effects have included arthralgia (8% to 19%), pain in extremity (16%), back pain (12%), muscle cramp (5%), and joint swelling (2%).

Local

Local side effects have included infusion related reactions including headache, nausea, dizziness, fatigue, hypersensitivity reactions, urticaria, pruritus, flushing, and rigors in 11% to 24% of patients. Infusion related anaphylactic reactions have been reported in less than 1% of patients.

Other

Other side effects have included fatigue (10% to 27%), chest discomfort (4% to 5%), rigors (3%), limb injury (3%), skin laceration (2%), and thermal burn (1%). At least one case of shakiness has also been reported.

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