Engerix-B Side Effects

Generic name: hepatitis b adult vaccine

Medically reviewed by Drugs.com. Last updated on Mar 24, 2025.

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

Precautions

It is important that your doctor check your progress to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

This vaccine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you have a rash, itching, a fast heartbeat, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after receiving the vaccine.

Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results..

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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:

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:

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]

See also:

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