Engerix-B Side Effects

Generic name: hepatitis b adult vaccine

Medically reviewed by Drugs.com. Last updated on May 9, 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 suspension.

Other dosage forms:

• intramuscular solution, 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:

More common

• fever of 37.7 degrees C (100 degrees F) or higher

Rare

• aches or pain in the joints, fever, or skin rash or welts (may occur days or weeks after receiving the vaccine)
• blurred vision or other vision changes
• confusion
• difficulty with breathing or swallowing
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• hives
• itching, especially of the feet or hands
• muscle weakness
• numbness or tingling of the arms and legs
• reddening of the skin, especially around the ears
• sweating
• swelling of the eyes, face, or inside of the nose
• unusual tiredness or weakness (sudden and severe)

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

• dizziness
• headache
• soreness at the injection site

Less common

• hard lump, redness, swelling, pain, itching, purple spot, tenderness, or warmth at the injection site
• unusual tiredness or weakness

Rare

• aches or pain in the muscles
• agitation
• back pain or stiffness or pain in neck or shoulder
• chills
• constipation
• diarrhea
• difficulty with moving
• feeling of warmth
• general feeling of discomfort or illness
• headache (mild), sore throat, runny nose, or fever (mild)
• increased sweating
• itching
• lack of appetite or decreased appetite
• nausea or vomiting
• redness of the face, neck, arms, and occasionally, upper chest
• sleepiness or unusual drowsiness
• sleeplessness
• stomach cramps or pain
• sudden redness of skin
• swelling of glands in the armpit or neck
• trouble with sleeping
• unable to sleep
• welts
• weight loss

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

• 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.

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

Medical Disclaimer