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Recombivax hb

Generic Name: hepatitis B pediatric vaccine (HEP a TYE tis B pee dee AT rik VAX een)
Brand Name: Engerix-B Pediatric, Recombivax HB Pediatric/Adolescent
Physician reviewed Recombivax HB Pediatric/Adolescent patient information - includes Recombivax HB Pediatric/Adolescent description, dosage and directions.
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Drug Information:
Hepatitis B is a serious disease caused by a virus. Hepatitis B causes inflammation of the liver, vomiting, and jaundice (yellowing of the skin or eyes). Hepatitis can lead to liver cancer, cirrhosis, or death. Hepatitis B is a disease of the liver that is spread through blood or bodily fluids, sexual contact or sharing IV drug needles with an infected person, or during childbirth when a baby is born to a mother who is infected. The Recombivax HB Pediatric/Adolescent is used to help prevent this disease in children and teenagers. Learn more

Recombivax hb Side Effects

Recombivax HB Pediatric / Adolescent Side Effects

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 Pediatric / Adolescent.

For the Consumer

Applies to hepatitis b pediatric vaccine: intramuscular suspension

Warning

Hepatitis B pediatric vaccine should not be given to a child who is allergic to baker's yeast.

This vaccine will not protect against hepatitis B if your child is already infected with the virus, even if he or she does not yet show symptoms.

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

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.

Call your doctor at once if your child has:

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

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

  • unusual muscle weakness;

  • changes in behavior; or

  • severe skin reaction--fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects include:

  • diarrhea, loss of appetite;

  • feeling weak or tired;

  • mild fussiness or crying;

  • low fever; or

  • runny nose.

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

The most common adverse events were injection site reactions, headache, and fatigue.

Local

Very common (10% or more): Injection site pain (33.8%), injection site soreness (22%), injection site redness (15.6%), injection site swelling (11.7%)

Common (1% to 10%): Injection site induration

Uncommon (0.1% to 1%): Injection site ecchymosis, injection site pruritus

Postmarketing reports: Injection site reaction

Nervous system

Very common (10% or more): Headache (23.4%)

Common (1% to 10%): Dizziness, drowsiness

Uncommon (0.1% to 1%): Somnolence, tingling, paresthesia

Postmarketing reports: Encephalitis, encephalopathy, migraine, multiple sclerosis, neuritis, neuropathy including hypoesthesia, Guillain-Barre syndrome and Bell's palsy, optic neuritis, paralysis, paresis, seizures, syncope, transverse myelitis, vertigo, demyelinating disease of the central nervous system, exacerbation of multiple sclerosis

Other

Very common (10% or more): Fatigue (33.8%)

Common (1% to 10%): Fever, malaise

Uncommon (0.1% to 1%): Chills, influenza-like symptoms, sweating, achiness, sensation of warmth, lightheadedness, flushing, earache

Postmarketing reports: Tinnitus

Hypersensitivity

Apparent hypersensitivity syndrome (serum sickness-like) of delayed onset has been reported days to weeks after vaccination, including: arthralgia/arthritis (usually transient), fever, and dermatologic reactions such as urticaria, erythema multiforme, ecchymosis, and erythema nodosum.

Postmarketing reports: Allergic reaction, anaphylactoid reaction, anaphylaxis, apparent hypersensitivity syndrome

Metabolic

Common (1% to 10%): Appetite lost

Uncommon (0.1% to 1%): Anorexia

Psychiatric

Very common (10% or more): Irritability

Uncommon (0.1% to 1%): Agitation, insomnia

Respiratory

Common (1% to 10%): Pharyngitis, upper respiratory infection

Uncommon (0.1% to 1%): Upper respiratory tract illnesses, rhinitis, cough, influenza

Frequency not reported: Pharyngitis

Postmarketing reports: Apnea, bronchospasm including asthma-like symptoms

Musculoskeletal

Uncommon (0.1% to 1%): Arthralgia, back pain, myalgia, pain/stiffness in arm, shoulder, or neck

Postmarketing reports: Arthritis, muscular weakness

Gastrointestinal

Common (1% to 10%): Gastrointestinal symptoms

Uncommon (0.1% to 1%): Abdominal pain/cramps, constipation, diarrhea, nausea, vomiting

Postmarketing reports: Dyspepsia

Hematologic

Uncommon (0.1% to 1%): Lymphadenopathy

Postmarketing reports: Thrombocytopenia, increased erythrocyte sedimentation rate

Dermatologic

Uncommon (0.1% to 1%): Erythema, petechiae, pruritus, rash, sweating, urticaria

Postmarketing reports: Alopecia, angioedema, eczema, erythema multiforme including Stevens-Johnson syndrome, erythema nodosum, lichen planus, purpura

Cardiovascular

Uncommon (0.1% to 1%): Flushing, hypotension

Postmarketing reports: Palpitations, tachycardia, vasculitis, syncope

Ocular

Very rare (less than 0.01%): Uveitis

Postmarketing reports: Conjunctivitis, keratitis, visual disturbances, optic neuritis

Genitourinary

Uncommon (0.1% to 1%): Dysuria

Hepatic

Postmarketing reports: Abnormal liver function tests

Immunologic

Postmarketing reports: Herpes zoster, meningitis

Editorial References and Review

Medically reviewed by BestRx Medical Team Last updated on 1/1/2020.

Source: Drugs.com Recombivax Hb