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Recombivax HB Dialysis Formulation Side Effects

Generic Name: hepatitis b adult vaccine

Note: This document contains side effect information about hepatitis b adult vaccine. Some of the dosage forms listed on this page may not apply to the brand name Recombivax HB Dialysis Formulation.

For the Consumer

Applies to hepatitis b adult vaccine: intramuscular solution

Other dosage forms:

Along with its needed effects, hepatitis b adult vaccine (the active ingredient contained in Recombivax HB Dialysis Formulation) 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 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

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
  • General feeling of discomfort or illness
  • headache
  • pain at the injection site
  • unusual tiredness or weakness
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]

References

1. Cerner Multum, Inc. "Australian Product Information." O 0

2. "Product Information. Engerix-B (hepatitis B vaccine)." SmithKline Beecham, Philadelphia, PA.

3. "Product Information. Recombivax HB (hepatitis B vaccine)." Merck & Company Inc, West Point, PA.

4. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

Further information

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.

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