November 29, 2015


Side Effects


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.

The most common solicited adverse events were injection site soreness (22%) and fatigue (14%).

In 36 clinical studies, a total of 13,495 doses of ENGERIX-B were administered to 5,071 healthy adults and children who were initially seronegative for hepatitis B markers, and healthy neonates. All subjects were monitored for 4 days post-administration. Frequency of adverse events tended to decrease with successive doses of ENGERIX-B.

Using a symptom checklist, the most frequently reported adverse events were injection site soreness (22%) and fatigue (14%). Other events are listed below. Parent or guardian completed forms for children and neonates. Neonatal checklist did not include headache, fatigue, or dizziness.

Incidence 1% to 10% of Injections

Nervous System Disorders: Dizziness, headache.

General Disorders and Administration Site Conditions: Fever ( > 37.5°C), injection site erythema, injection site induration, injection site swelling.

Incidence < 1% of Injections

Infections and Infestations: Upper respiratory tract illnesses.

Blood and Lymphatic System Disorders: Lymphadenopathy.

Metabolism and Nutrition Disorders: Anorexia.

Psychiatric Disorders: Agitation, insomnia.

Nervous System Disorders: Somnolence, tingling.

Vascular Disorders: Flushing, hypotension.

Gastrointestinal Disorders: Abdominal pain/cramps, constipation, diarrhea, nausea, vomiting.

Skin and Subcutaneous Tissue Disorders: Erythema, petechiae, pruritus, rash, sweating, urticaria.

Musculoskeletal and Connective Tissue Disorders: Arthralgia, back pain, myalgia, pain/stiffness in arm, shoulder, or neck.

General Disorders and Administration Site Conditions: Chills, influenza-like symptoms, injection site ecchymosis, injection site pain, injection site pruritus, irritability, malaise, weakness.

In a clinical trial, 416 adults with type 2 diabetes and 258 control subjects without type 2 diabetes who were seronegative for hepatitis B markers received at least one dose of ENGERIX-B. Subjects were monitored for solicited adverse events for 4 days following each vaccination. The most frequently reported solicited adverse events in the entire study population were injection site pain (reported in 39% of diabetic subjects and 45% of control subjects) and fatigue (reported in 29% of diabetic subjects and 27% of control subjects). Serious adverse events were monitored through 30 days following the last vaccination. Serious adverse events (SAEs) occurred in 3.8% of diabetic subjects and 1.6% of controls. No SAEs were deemed related to ENGERIX-B.

Postmarketing Experience

In addition to reports in clinical trials, worldwide voluntary reports of adverse events received for ENGERIX-B since market introduction (1990) are listed below. This list includes serious adverse events or events that have a suspected causal connection to components of ENGERIX-B.

Because these events are reported voluntarily from a population of unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to the vaccine.

Infections and Infestations

Herpes zoster, meningitis.

Blood and Lymphatic System Disorders


Immune System Disorders

Allergic reaction, anaphylactoid reaction, anaphylaxis. 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.

Nervous System Disorders

Encephalitis, encephalopathy, migraine, multiple sclerosis, neuritis, neuropathy including hypoesthesia, paresthesia, Guillain-Barre syndrome and Bell's palsy, optic neuritis, paralysis, paresis, seizures, syncope, transverse myelitis.

Eye Disorders

Conjunctivitis, keratitis, visual disturbances.

Ear and Labyrinth Disorders

Earache, tinnitus, vertigo.

Cardiac Disorders

Palpitations, tachycardia.

Vascular Disorders


Respiratory, Thoracic, and Mediastinal Disorders

Apnea, bronchospasm including asthma-like symptoms.

Gastrointestinal Disorders


Skin and Subcutaneous Tissue Disorders

Alopecia, angioedema, eczema, erythema multiforme including Stevens-Johnson syndrome, erythema nodosum, lichen planus, purpura.

Musculoskeletal and Connective Tissue Disorders

Arthritis, muscular weakness.

General Disorders and Administration Site Conditions

Injection site reaction.


Abnormal liver function tests.

Read the Engerix-B (hepatitis b vaccine recombinant) Side Effects Center for a complete guide to possible side effects


Concomitant Administration With Vaccines And Immune Globulin

ENGERIX-B may be administered concomitantly with immune globulin.

When concomitant administration of other vaccines or immune globulin is required, they should be given with different syringes and at different injection sites. Do not mix ENGERIX-B with any other vaccine or product in the same syringe or vial.

Interference With Laboratory Tests

Hepatitis B surface antigen (HBsAg) derived from hepatitis B vaccines has been transiently detected in blood samples following vaccination. Serum HBsAg detection may not have diagnostic value within 28 days after receipt of a hepatitis B vaccine, including ENGERIX-B.

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 11/16/2015

Side Effects

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.

Women's Health

Find out what women really need.