Recombivax

Recombivax Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Recombivax [hepatitis b vaccine (recombinant)] is a vaccine used to help prevent the disease Hepatitis B. It is a viral vaccine. Common side effects include pain/soreness/redness/swelling at the injection site, fever, headache, tiredness, sore throat, nausea, diarrhea, loss of appetite, and dizziness.

The dose of Recombivax is a vaccination regimen of 3 doses of vaccine given according to the following schedule: First dose: at elected date; Second dose: 1 month later; Third dose: 6 months after the first dose. Adolescents 11 to 15 years may follow a 2 dose regimen. Recombivax may interact with other recent vaccines, steroid medicines, medications to treat psoriasis, rheumatoid arthritis, or other autoimmune disorders, or medicines to treat or prevent organ transplant rejection. Tell your doctor all medications you use. During pregnancy, Recombivax should be used only when prescribed. It is unknown whether this drug passes into breast milk. Consult your doctor before breast-feeding.

Our Recombivax [hepatitis b vaccine (recombinant)] Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Recombivax Overview - Patient Information: Side Effects

SIDE EFFECTS: Pain/soreness/redness/swelling at the injection site, fever, headache, tiredness, sore throat, nausea, diarrhea, loss of appetite, and dizziness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Infrequently, temporary symptoms such as fainting/dizziness/lightheadedness, vision changes, numbness/tingling, or seizure-like movements have happened after vaccine injections. Tell your health care provider right away if you have any of these symptoms soon after receiving an injection. Sitting or lying down may relieve symptoms.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US, you may report side effects to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967. In Canada, you may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Recombivax (Hepatitis B Vaccine (Recombinant))»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Recombivax FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

In healthy infants and children (up to 10 years of age), the most frequently reported systemic adverse reactions ( > 1% injections), in decreasing order of frequency, were irritability, fever, diarrhea, fatigue/weakness, diminished appetite, and rhinitis. In healthy adults, injection site reactions and systemic adverse reactions were reported following 17% and 15% of the injections, respectively.

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a vaccine cannot be directly compared to rates in the clinical trials of another vaccine and may not reflect the rates observed in practice.

In three clinical studies, 434 doses of RECOMBIVAX HB, 5 mcg, were administered to 147 healthy infants and children (up to 10 years of age) who were monitored for 5 days after each dose. Injection site reactions and systemic adverse reactions were reported following 0.2% and 10.4% of the injections, respectively. The most frequently reported systemic adverse reactions ( > 1% injections), in decreasing order of frequency, were irritability, fever ( ≥ 101°F oral equivalent), diarrhea, fatigue/weakness, diminished appetite, and rhinitis.

In a study that compared the three-dose regimen (5 mcg) with the two-dose regimen (10 mcg) of RECOMBIVAX HB in adolescents, the overall frequency of adverse reactions was generally similar.

In a group of studies, 3258 doses of RECOMBIVAX HB, 10 mcg, were administered to 1252 healthy adults who were monitored for 5 days after each dose. Injection site reactions and systemic adverse reactions were reported following 17% and 15% of the injections, respectively. The following adverse reactions were reported:

Incidence Equal To or Greater Than 1% of Injections

General Disorders And Administration Site Conditions

Injection site reactions consisting principally of soreness, and including pain, tenderness, pruritus, erythema, ecchymosis, swelling, warmth, nodule formation.

The most frequent systemic complaints include fatigue/weakness; headache; fever ( ≥ 100°F); malaise.

Gastrointestinal Disorders

Nausea; diarrhea

Respiratory, Thoracic And Mediastinal Disorders

Pharyngitis; upper respiratory infection

Incidence Less Than 1% of Injections

General Disorders And Administration Site Conditions

Sweating; achiness; sensation of warmth; lightheadedness; chills; flushing

Gastrointestinal Disorders

Vomiting; abdominal pains/cramps; dyspepsia; diminished appetite

Respiratory, Thoracic And Mediastinal Disorders

Rhinitis; influenza; cough

Nervous System Disorders

Vertigo/dizziness; paresthesia

Skin And Subcutaneous Tissue Disorders

Pruritus; rash (non-specified); angioedema; urticaria

Musculoskeletal And Connective Tissue Disorders

Arthralgia including monoarticular; myalgia; back pain; neck pain; shoulder pain; neck stiffness

Blood And Lymphatic Disorders

Lymphadenopathy

Psychiatric Disorders

Insomnia/disturbed sleep

Ear And Labyrinth Disorders

Earache

Renal And Urinary Disorders

Dysuria

Cardiac Disorders

Hypotension

Post-Marketing Experience

The following additional adverse reactions have been reported with use of the marketed vaccine. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to a vaccine exposure.

Immune System Disorders

Hypersensitivity reactions including anaphylactic/anaphylactoid reactions, bronchospasm, and urticaria have been reported within the first few hours after vaccination. An 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, ecchymoses and erythema nodosum [see WARNINGS AND PRECAUTIONS]. Autoimmune diseases including systemic lupus erythematosus (SLE), lupus-like syndrome, vasculitis, and polyarteritis nodosa have also been reported.

Gastrointestinal Disorders

Elevation of liver enzymes; constipation

Nervous System Disorders

Guillain-Barré syndrome; multiple sclerosis; exacerbation of multiple sclerosis; myelitis including transverse myelitis; seizure; febrile seizure; peripheral neuropathy including Bell's Palsy; radiculopathy; herpes zoster; migraine; muscle weakness; hypesthesia; encephalitis

Skin and Subcutaneous Disorders

Stevens-Johnson syndrome; alopecia; petechiae; eczema

Musculoskeletal and Connective Tissue Disorders

Arthritis

Pain in extremity

Blood and Lymphatic System Disorders

Increased erythrocyte sedimentation rate; thrombocytopenia

Psychiatric Disorders

Irritability; agitation; somnolence

Eye Disorders

Optic neuritis; tinnitus; conjunctivitis; visual disturbances; uveitis

Cardiac Disorders

Syncope; tachycardia

The following adverse reaction has been reported with another Hepatitis B Vaccine (Recombinant) but not with RECOMBIVAX HB: keratitis.

Read the entire FDA prescribing information for Recombivax (Hepatitis B Vaccine (Recombinant)) »

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Recombivax - User Reviews

Recombivax User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Recombivax sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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