Recombivax HB Side Effects

Generic name: hepatitis b pediatric vaccine

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

Applies to hepatitis b pediatric vaccine: intramuscular suspension.

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.

Your child may feel faint after receiving this vaccine. Some people have had seizure like reactions after receiving this vaccine. The doctor may want your child to remain under observation for a short time after the injection.

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.

Call the doctor at once if your child has:

• breathing that stops during sleep;

• fever, chills, swollen glands.

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

• unusual muscle weakness;

• changes in behavior; or

• severe skin reaction--fever, sore throat, swelling in the face or tongue, burning in the 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 may 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 the 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.^[Ref]

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^[Ref]

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^[Ref]

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^[Ref]

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.^[Ref]

Postmarketing reports: Allergic reaction, anaphylactoid reaction, anaphylaxis, apparent hypersensitivity syndrome^[Ref]

Metabolic

Common (1% to 10%): Appetite lost

Uncommon (0.1% to 1%): Anorexia^[Ref]

Psychiatric

Very common (10% or more): Irritability

Uncommon (0.1% to 1%): Agitation, insomnia^[Ref]

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^[Ref]

Musculoskeletal

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

Postmarketing reports: Arthritis, muscular weakness^[Ref]

Gastrointestinal

Common (1% to 10%): Gastrointestinal symptoms

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

Postmarketing reports: Dyspepsia^[Ref]

Hematologic

Uncommon (0.1% to 1%): Lymphadenopathy

Postmarketing reports: Thrombocytopenia, increased erythrocyte sedimentation rate^[Ref]

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^[Ref]

Cardiovascular

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

Postmarketing reports: Palpitations, tachycardia, vasculitis, syncope^[Ref]

Ocular

Very rare (less than 0.01%): Uveitis

Postmarketing reports: Conjunctivitis, keratitis, visual disturbances, optic neuritis^[Ref]

Genitourinary

Uncommon (0.1% to 1%): Dysuria^[Ref]

Hepatic

Postmarketing reports: Abnormal liver function tests^[Ref]

Immunologic

Postmarketing reports: Herpes zoster, meningitis^[Ref]

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer