Engerix-B Side Effects

Generic name: hepatitis b adult vaccine

Medically reviewed by Drugs.com. Last updated on Dec 15, 2024.

Note: This document provides detailed information about Engerix-B Side Effects associated with hepatitis b adult vaccine. Some dosage forms listed on this page may not apply specifically to the brand name Engerix-B.

Applies to hepatitis b adult vaccine: intramuscular solution, intramuscular suspension.

Other dosage forms:

• intramuscular suspension

Common 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 side effects

• 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 side effects

• fever
• redness or swelling at the injection site

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 side effects

• 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

For healthcare professionals

Applies to hepatitis b adult vaccine: intramuscular solution, intramuscular suspension.

General adverse events

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

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

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]

Frequently asked questions

• What is the difference between Heplisav-B and Engerix-B?

Further information

Engerix-B side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer