Recombivax HB Side Effects

Generic name: hepatitis b pediatric vaccine

Note: This document contains side effect information about hepatitis b pediatric vaccine. Some of the dosage forms listed on this page may not apply to the brand name Recombivax HB.

Some side effects of Recombivax HB may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to hepatitis b pediatric vaccine: intramuscular suspension

Your child should not receive a booster vaccine if he or she had a life-threatening allergic reaction after the first shot.

Keep track of any and all side effects your child has after receiving this vaccine. When the child receives a booster dose, you will need to tell the doctor if the previous shot caused any side effects.

Becoming infected with hepatitis B is much more dangerous to your child's health than receiving this vaccine. However, like any medicine, this vaccine can cause side effects but the risk of serious side effects is extremely low.

Get emergency medical help if your child has any of these signs of an allergic reaction: hives; difficulty breathing; swelling of the face, lips, tongue, or throat.

Call your doctor at once if your child has any of these serious side effects:

• fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;

• fussiness, irritability, crying for an hour or longer;

• fast or pounding heartbeats; or

• easy bruising or bleeding.

Less serious side effects include:

• redness, pain, swelling, or a lump where the shot was given;

• headache, dizziness;

• low fever;

• joint pain, body aches;

• tired feeling; or

• nausea, vomiting, stomach pain, constipation, diarrhea.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to hepatitis b pediatric vaccine: intramuscular suspension

General

Hepatitis B vaccine is generally well-tolerated. Most side effects were mild and primarily included injection site reactions and fatigue.

Respiratory

Respiratory side effects have included rhinitis, cough, pharyngitis, upper respiratory tract illness, influenza-like symptoms, and bronchospasm including asthma-like symptoms.

Other

Other side effects have included fatigue, fever, chills, flushing, lightheadedness, sweating, weakness, malaise, tinnitus, and earache.

Ocular

Ocular side effects have included optic neuritis, conjunctivitis, keratitis, and visual disturbances.

Nervous system

Nervous system side effects have included headache, dizziness, vertigo, somnolence, insomnia, irritability, agitation, migraine, syncope, paresis, neuropathy, hypoesthesia, paresthesia, convulsions, encephalitis, Guillain-Barre syndrome, radiculopathy, herpes zoster, muscle weakness, multiple sclerosis, exacerbation of multiple sclerosis, Bell's palsy, optic sclerosis, myelitis, and transverse myelitis.

Musculoskeletal

Musculoskeletal side effects have included arthritis, arthralgia, myalgia, back pain, and pain or stiffness in the arm, shoulder, or neck.

Local

Local side effects have included soreness, redness, swelling, induration, pain, pruritus, warmth, nodule formation, and ecchymosis at the injection site.

Hypersensitivity

Hypersensitivity reactions have included anaphylaxis, anaphylactoid reactions, rash, pruritus, urticaria, edema, dyspnea, chest discomfort, bronchial spasm, palpitation, hypotension, erythema multiforme, Stevens-Johnson syndrome, angioedema, arthritis, and serum sickness-like syndrome (arthralgia, arthritis, fever, urticaria, erythema multiforme, ecchymoses, and erythema nodosum).

Hepatic

Hepatic side effects have included abnormal liver function tests.

Hematologic

Hematologic side effects have included lymphadenopathy, thrombocytopenia, and increased erythrocyte sedimentation rate.

Gastrointestinal

Gastrointestinal side effects have included diarrhea, nausea, vomiting, abdominal pain, cramps, anorexia, constipation, and dyspepsia.

Dermatologic

Dermatologic side effects have included rash, urticaria, petechiae, erythema, hyperhidrosis, angioedema, eczema, herpes zoster, erythema nodosum, purpura, alopecia, and Stevens-Johnson syndrome.

Cardiovascular

Cardiovascular side effects have included syncope, hypotension, tachycardia, and palpitations.

Immunologic

Immunologic side effects including liver transplant rejection, diarrhea infections, pneumonia, and sepsis have been reported in greater than 10% of patients.

Genitourinary

Genitourinary side effects have included dysuria.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This information does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug of drug combination is safe, effective, or appropriate for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of information provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.