Note: This document contains side effect information about hepatitis b adult vaccine. Some dosage forms listed on this page may not apply to the brand name Engerix-B.
Applies to hepatitis b adult vaccine: intramuscular solution, intramuscular suspension. Other dosage forms:
- intramuscular suspension
Serious side effects of Engerix-B
Along with its needed effects, hepatitis b adult vaccine (the active ingredient contained in Engerix-B) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur while taking hepatitis b adult vaccine:
Rare
- Chest pain or discomfort
- inability to move the arms and legs
- nausea
- pain or discomfort in the arms, jaw, back, or neck
- sudden numbness and weakness in the arms and legs
- sweating
- vomiting
Incidence not known
- Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- chest tightness
- cough
- difficulty swallowing
- dizziness
- fast heartbeat
- hives, itching, skin rash
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- stomach pain
- trouble breathing
- unusual tiredness or weakness
Other side effects of Engerix-B
Some side effects of hepatitis b adult vaccine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.
Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Difficulty in moving
- general feeling of discomfort or illness
- headache
- joint pain
- muscle aches, cramps, pains, or stiffness
- pain or tenderness at the injection site
- swollen joints
Less common
- Fever
- redness or swelling at the injection site
For Healthcare Professionals
Applies to hepatitis b adult vaccine: intramuscular solution, 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]
