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

• intramuscular suspension

Serious side effects

Along with its needed effects, hepatitis b adult vaccine 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

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]