Recombivax HB Side Effects
Generic Name: hepatitis b pediatric vaccine
Note: This page contains side effects data for the generic drug hepatitis b pediatric vaccine. It is possible that some of the dosage forms included below may not apply to the brand name Recombivax HB.
Common side effects of Recombivax HB include: fatigue, tenderness at injection site, and pain at injection site. Other side effects include: pruritus, fever, dizziness, headache, vertigo, swelling at injection site, induration at injection site, erythema, ecchymoses, and inflammation at injection site. See below for a comprehensive list of adverse effects.
For the Consumer
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.
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
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
The most common adverse events were injection site reactions, headache, and fatigue.[Ref]
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]
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]
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]
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]
Common (1% to 10%): Appetite lost
Uncommon (0.1% to 1%): Anorexia[Ref]
Very common (10% or more): Irritability
Uncommon (0.1% to 1%): Agitation, insomnia[Ref]
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]
Uncommon (0.1% to 1%): Arthralgia, back pain, myalgia, pain/stiffness in arm, shoulder, or neck
Postmarketing reports: Arthritis, muscular weakness[Ref]
Common (1% to 10%): Gastrointestinal symptoms
Uncommon (0.1% to 1%): Abdominal pain/cramps, constipation, diarrhea, nausea, vomiting
Postmarketing reports: Dyspepsia[Ref]
Uncommon (0.1% to 1%): Lymphadenopathy
Postmarketing reports: Thrombocytopenia, increased erythrocyte sedimentation rate[Ref]
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]
Uncommon (0.1% to 1%): Flushing, hypotension
Postmarketing reports: Palpitations, tachycardia, vasculitis, syncope[Ref]
Very rare (less than 0.01%): Uveitis
Postmarketing reports: Conjunctivitis, keratitis, visual disturbances, optic neuritis[Ref]
Uncommon (0.1% to 1%): Dysuria[Ref]
Postmarketing reports: Abnormal liver function tests[Ref]
Postmarketing reports: Herpes zoster, meningitis[Ref]
1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
2. Cerner Multum, Inc. "Australian Product Information." O 0
3. "Product Information. Engerix-B Pediatric (hepatitis B pediatric vaccine)." GlaxoSmithKline, Research Triangle Park, NC.
4. "Product Information. Recombivax HB Pediatric/Adolescent (hepatitis B pediatric vaccine)." Merck & Company Inc, West Point, PA.
It is possible that some side effects of Recombivax HB may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.
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