Havrix Side Effects

Please note - some side effects for Havrix 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 Havrix - for the Consumer

Havrix

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 Havrix:

Headache; loss of appetite; mild fever; nausea; redness, soreness, swelling, or warmth at the injection site; tiredness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); numbness or tingling of the arms or legs; seizures; shortness of breath; unusual bruising or bleeding; unusual or severe muscle weakness; yellowing of the eyes or skin.

Havrix Side Effects - for the Professional

Havrix

 

The most common solicited adverse events were injection-site soreness (56% of adults and 21% of children) and headache (14% of adults and less than 9% of children). (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or VAERS at 1-800-822-7967 or www.vaers.hhs.gov.

Side Effects by Body System

General

Hepatitis A vaccine is generally well-tolerated. Most side effects were mild, self-limiting, and of short duration (<= 24 hours).

Local

Local side effects have included pain, tenderness, warmth, induration, erythema, swelling, ecchymosis, hematoma, and injection site pruritus and/or rash.

Cardiovascular

Cardiovascular side effects have included syncope.

Dermatologic

Dermatologic side effects have included pruritus, rash, and urticaria.

Gastrointestinal

Gastrointestinal side effects have included anorexia, nausea, abdominal pain, diarrhea, dysgeusia, gastroenteritis, and vomiting.

Genitourinary

Genitourinary side effects have included menstruation disorder and isolated reports of increased urine protein.

Hematologic

Hematologic side effects have rarely included lymphadenopathy, thrombocytopenia, and eosinophilia.

Hepatic

Hepatic side effects have included isolated reports of elevated liver function tests.

Hypersensitivity

Hypersensitivity reactions have included bronchial constriction, asthma, wheezing, edema/swelling, rash, generalized erythema, urticaria, pruritus, eye irritation/itching, and dermatitis.

Musculoskeletal

Musculoskeletal side effects have included arthralgia, creatine phosphokinase elevations, myalgia, arm pain, back pain, and stiffness.

Nervous system

Nervous system side effects have included headache, hypertonic episode, insomnia, somnolence, photophobia, vertigo, Guillain-Barre syndrome, cerebellar ataxia.

Respiratory

Respiratory side effects have included pharyngitis, other upper respiratory tract infections, nasal congestion, and cough.

Other

Other side effects have included asthenia, fatigue, fever, and malaise.

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