Recombivax

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 in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Recombivax in Detail - Patient Information: Side Effects

You should not receive a booster vaccine if you had a life-threatening allergic reaction after the first shot.

Keep track of any and all side effects you have after receiving this vaccine. When you receive a booster dose, you will need to tell the doctor if the previous shots caused any side effects.

Becoming infected with hepatitis B is much more dangerous to your health than receiving the vaccine to protect against it. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;
  • fussiness, irritability, crying for an hour or longer;
  • fast or pounding heartbeats; or
  • easy bruising or bleeding.

Less serious side effects include:

  • redness, pain, swelling, or a lump where the shot was given;
  • headache, dizziness;
  • low fever;
  • joint pain, body aches;
  • tired feeling; or
  • nausea, vomiting, stomach pain, constipation, diarrhea.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Recombivax (Hepatitis B Vaccine (Recombinant)) »

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

RECOMBIVAX (hepatitis b vaccine (recombinant)) HB and RECOMBIVAX (hepatitis b vaccine (recombinant)) HB Dialysis Formulation are generally well-tolerated. No adverse experiences were reported during clinical trials which could be related to changes in the titers of antibodies to yeast. As with any vaccine, there is the possibility that broad use of the vaccine could reveal adverse reactions not observed in clinical trials.

In three clinical studies, 434 doses of RECOMBIVAX (hepatitis b vaccine (recombinant)) 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 complaints 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.10

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

In a group of studies, 3258 doses of RECOMBIVAX (hepatitis b vaccine (recombinant)) HB, 10 mcg, were administered to 1252 healthy adults who were monitored for 5 days after each dose. Injection site reactions and systemic complaints 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

LOCAL REACTION (INJECTION SITE)

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

BODY AS A WHOLE

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

DIGESTIVE SYSTEM

Nausea; and diarrhea

RESPIRATORY SYSTEM

Pharyngitis; and upper respiratory infection

Incidence Less Than 1% of Injections

BODY AS A WHOLE

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

DIGESTIVE SYSTEM

Vomiting; abdominal pains/cramps; dyspepsia; and diminished appetite

RESPIRATORY SYSTEM

Rhinitis; influenza; and cough

NERVOUS SYSTEM

Vertigo/dizziness; and paresthesia

INTEGUMENTARY SYSTEM

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

MUSCULOSKELETAL SYSTEM

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

HEMIC/LYMPHATIC SYSTEM

Lymphadenopathy

PSYCHIATRIC/BEHAVIORAL

Insomnia/disturbed sleep

SPECIAL SENSES

Earache

UROGENITAL SYSTEM

Dysuria

CARDIOVASCULAR SYSTEM

Hypotension

Marketed Experience

The following additional adverse reactions have been reported with use of the marketed vaccine. In many instances, the relationship to the vaccine was unclear.

Hypersensitivity

Anaphylaxis and symptoms of immediate hypersensitivity reactions including rash, pruritus, urticaria, edema, angioedema, dyspnea, chest discomfort, bronchial spasm, palpitation, or symptoms consistent with a hypotensive episode 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).

Digestive System

Elevation of liver enzymes; constipation

Nervous System

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

Integumentary System

Stevens-Johnson Syndrome; alopecia; petechiae; eczema

Musculoskeletal System

Arthritis

Pain in extremity

Hematologic

Increased erythrocyte sedimentation rate; thrombocytopenia

Immune System

Systemic lupus erythematosus (SLE); lupus-like syndrome; vasculitis; polyarteritis nodosa

Psychiatric/Behavioral

Irritability; agitation; somnolence

Special Senses

Optic neuritis; tinnitus; conjunctivitis; visual disturbances

Cardiovascular System

Syncope; tachycardia.

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

Patients, parents and guardians should be instructed to report any serious adverse reactions to their healthcare provider, who in turn should report such events to the U.S. Department of Health and Human Services through the Vaccine Adverse Event Reporting System (VAERS), 1-800-822-7967.31

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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