Recombivax

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 Recombivax (hepatitis b vaccine (recombinant)) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

There are no known drug interactions. (See INDICATIONS AND USAGE, Use with Other Vaccines.)

Read the Recombivax Drug Interactions Center for a complete guide to possible interactions

Last reviewed on RxList: 9/2/2008
This monograph has been modified to include the generic and brand name in many instances.

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