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Recombivax HB Dialysis Formulation Side Effects

Generic Name: hepatitis b adult vaccine

Note: This page contains side effects data for the generic drug hepatitis b adult vaccine. It is possible that some of the dosage forms included below may not apply to the brand name Recombivax HB Dialysis Formulation.

It is possible that some side effects of Recombivax HB Dialysis Formulation may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to hepatitis b adult vaccine: intramuscular suspension

As well as its needed effects, hepatitis b adult vaccine (the active ingredient contained in Recombivax HB Dialysis Formulation) may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking hepatitis b adult vaccine, check with your doctor or nurse immediately:

More common
  • Fever of 37.7 degrees C (100 degrees F) or higher
  • 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)

Some hepatitis b adult vaccine side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned 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
  • 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 suspension


The most common adverse events were injection site reactions, headache, and fatigue.[Ref]


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]


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]


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]


Common (1% to 10%): Appetite lost
Uncommon (0.1% to 1%): Anorexia[Ref]


Very common (10% or more): Irritability
Uncommon (0.1% to 1%): Agitation, insomnia[Ref]


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]


Uncommon (0.1% to 1%): Arthralgia, back pain, myalgia, pain/stiffness in arm, shoulder, or neck
Postmarketing reports: Arthritis, muscular weakness[Ref]


Common (1% to 10%): Gastrointestinal symptoms
Uncommon (0.1% to 1%): Abdominal pain/cramps, constipation, diarrhea, nausea, vomiting
Postmarketing reports: Dyspepsia[Ref]


Uncommon (0.1% to 1%): Lymphadenopathy
Postmarketing reports: Thrombocytopenia, increased erythrocyte sedimentation rate[Ref]


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]


Uncommon (0.1% to 1%): Flushing, hypotension
Postmarketing reports: Palpitations, tachycardia, vasculitis, syncope[Ref]


Very rare (less than 0.01%): Uveitis
Postmarketing reports: Conjunctivitis, keratitis, visual disturbances, optic neuritis[Ref]


Uncommon (0.1% to 1%): Dysuria[Ref]


Postmarketing reports: Abnormal liver function tests[Ref]


Postmarketing reports: Herpes zoster, meningitis[Ref]


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

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

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

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

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