FDA-filed SPL labeling · retrieved through openFDA

Hepatitis B Vaccine

Hepatitis B vaccine is a series of injections that protects people of all ages against hepatitis B virus infection and, because it prevents chronic hepatitis B, also helps reduce the risk of hepatitis B-related liver cancer.

Brand names Engerix-bPrehevbrioRecombivax HbRecombivaxHeplisav-b
Form 1 Routes Intramuscular; Subcutaneous · Intramuscular · Intramuscular, Subcutaneous
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

At a glance
Linked label effectiveAug 4, 2010
Earliest approval/marketing year ⓘ1986
FDA-listed product records ⓘ36
Boxed warningNone found in compared labels
How we combine label and product data →
✓No current FDA shortage listed · checked Sep 22, 2026
⭐ Hepatitis B Vaccine at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Hepatitis B vaccine is a safe and effective way to protect yourself and your family against a serious liver infection that can lead to chronic disease and liver cancer. Most people only notice minor soreness or tiredness after the shots. Completing the full series on schedule is key — talk to your pharmacist or doctor about the right schedule for your age and health situation.
How we write & review this content — our editorial policy →

📖 Hepatitis B Vaccine: Patient Information Guide

A plain-language walkthrough of Hepatitis B Vaccine — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for▾

Hepatitis B vaccine protects against hepatitis B virus (HBV) infection and its serious complications. The following groups and uses are supported by the product evidence:

  • Prevention of hepatitis B infection in people of all ages — from newborns to adults
  • Prevention of hepatitis D (delta virus infection), which cannot occur without hepatitis B
  • Infants, including those born to HBsAg-positive (hepatitis B-carrying) mothers
  • Adolescents and children who have not previously been vaccinated
  • Healthcare workers, including dentists, nurses, physicians, lab personnel, and paramedics who may be exposed to blood or body fluids
  • Patients on hemodialysis (kidney dialysis) and their contacts
  • Household members and intimate contacts of people with chronic hepatitis B
  • Individuals with chronic hepatitis C, who share similar risk factors
  • Travelers to regions where hepatitis B is common
  • People at increased risk due to sexual practices, injection drug use, or incarceration
  • Residents and staff of care facilities for people with intellectual disabilities
  • Morticians, embalmers, police, and fire department first responders
  • Engerix-B is recognized by the CDC as the first anti-cancer vaccine, because preventing chronic hepatitis B reduces the risk of hepatocellular carcinoma (primary liver cancer)
⚙️How it works▾

Hepatitis B vaccines contain a purified piece of the hepatitis B virus surface protein (HBsAg). When injected, your immune system recognizes this protein as foreign and produces antibodies against it. If you encounter the real hepatitis B virus later, those antibodies can neutralize it and prevent infection. Antibody levels of 10 mIU/mL or higher are considered protective. In hemodialysis patients, immune response may be weaker and antibody levels can decline faster, so ongoing testing is recommended.

💊How it's taken▾

Engerix-B is given as an intramuscular injection. The standard series for most people is three doses — at the start, one month later, and six months after the first dose. Some schedules use four doses, particularly for newborns of infected mothers, people recently exposed to HBV, or hemodialysis patients. Hemodialysis patients may also need periodic booster doses if their antibody levels drop below the protective threshold. Always follow the schedule your healthcare provider recommends — spacing the doses correctly is important for full protection.

  • Standard schedule: doses at months 0, 1, and 6
  • Alternate schedules exist for specific groups — your provider will choose the right one for you
  • Hemodialysis patients require additional doses and yearly antibody level testing
🤒Side effects — in detail▾

Most side effects from Engerix-B are mild and short-lived. Common reactions include:

  • Soreness at the injection site (most common, reported in about 1 in 5 people)
  • Fatigue or tiredness
  • Headache
  • Dizziness
  • Fever above 37.5°C (99.5°F)
  • Redness, swelling, or firmness at the injection site

Side effects tend to become less common with each successive dose. Serious allergic reactions are rare but require immediate medical attention — signs include difficulty breathing, swelling of the face or throat, rapid heartbeat, or dizziness.

⚠️Warnings & precautions▾
  • Latex allergy: Some Engerix-B prefilled syringes contain natural rubber latex in the tip cap or plunger. Tell your provider if you have a latex allergy — the vial form does not contain latex.
  • Premature infants: Apnea (brief pauses in breathing) has been observed after intramuscular vaccination in some premature babies. Providers will weigh the timing carefully, especially when the mother is HBsAg-positive.
  • Pre-existing infection: The vaccine cannot prevent hepatitis B in someone already infected at the time of vaccination — even if they don't have symptoms yet.
  • Incomplete protection: People who do not develop adequate antibody levels after the series may not be fully protected. Hemodialysis patients are especially likely to need monitoring and boosters.
  • No cross-protection: Engerix-B does not protect against hepatitis A, C, E, or other infections of the liver.
🔀What it interacts with▾

The FDA label for Engerix-B does not list specific drug or food interactions. One general point is worth noting for simultaneous vaccination:

  • When multiple vaccines are given at the same visit, each should be injected at a separate site with a separate syringe — this is standard practice to maintain effectiveness and minimize reactions

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

📋Before taking it▾
  • Tell your provider about any previous allergic reaction to a hepatitis B vaccine or to yeast — this is a contraindication (a reason not to use the vaccine)
  • Let your provider know if you have a latex allergy before receiving Engerix-B in a prefilled syringe
  • If you are a premature infant's caregiver, discuss the timing of vaccination with the pediatrician, especially regarding the mother's HBsAg status
  • If you are on hemodialysis, you may need a higher number of doses and regular antibody testing after completing the series
  • The vaccine may not provide full protection if you are already infected with hepatitis B but do not yet have symptoms
📡Pharmacodynamics — effects in the body▾

Hepatitis B vaccine stimulates the immune system to produce antibodies against the hepatitis B surface antigen (HBsAg). An antibody level of 10 mIU/mL or higher is recognized as protective against infection. Clinical trials with Engerix-B showed seroprotection rates of 95–98% in infants and children, and antibody titers tend to rise further with booster doses. In hemodialysis patients, the immune response is often weaker and may require more doses to achieve and maintain protective levels.

📦How to store it▾

Store refrigerated between 2° and 8°C (36° and 46°F). Do not freeze ; discard if product has been frozen.

📄 Written from Hepatitis B Vaccine’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

🩺 Pharmacist Counseling Corner

Quick, plain-English answers to the questions patients ask most about Hepatitis B Vaccine — the kind of thing our pharmacy team would talk through with you at the counter.

Who actually needs the hepatitis B vaccine — isn't it just for babies? ▾
It's recommended for everyone, not just babies. Universal vaccination of all infants and children through age 18 is recommended, but adults who weren't vaccinated as kids should get it too — especially healthcare workers, travelers to high-risk areas, people on dialysis, household contacts of someone with hepatitis B, and others at increased risk. If you're not sure whether you've been vaccinated, your doctor can check your records or do a blood test.
How many shots do I need, and how long does the series take? ▾
The standard series is three shots. You get the first one on a chosen date, the second one month later, and the third about six months after the first. Some people — like newborns of infected mothers or dialysis patients — may follow a slightly different four-dose schedule. Your doctor or pharmacist will tell you exactly which schedule is right for you. Completing the full series on time is important for the best protection.
What side effects should I expect after getting the shot? ▾
Most people just have some soreness at the injection site and maybe a little tiredness or a mild headache — these are the most common reactions and usually go away within a day or two. A low-grade fever, or some redness and swelling where the shot was given, can also happen. Side effects tend to be milder with each successive dose. Serious reactions are rare, but if you develop difficulty breathing, significant swelling of the face or throat, or feel faint shortly after the injection, get medical help right away.
I'm allergic to yeast — can I still get this vaccine? ▾
You should tell your doctor before getting any hepatitis B vaccine. A known allergy to yeast or to any component of the vaccine is a reason not to receive Engerix-B. Your healthcare provider will review your allergy history and decide whether vaccination is safe for you or whether any special precautions are needed.
Will the vaccine protect me if I was just exposed to hepatitis B? ▾
If you've recently been exposed — for example, through a needlestick or contact with an infected person — the vaccine alone may not be enough. In that situation, you'd likely need both the vaccine and an injection of hepatitis B immune globulin (HBIG), which provides immediate temporary protection while your immune system builds its own response. Talk to your doctor right away after a potential exposure — timing matters.
Does the hepatitis B vaccine protect against other types of hepatitis too? ▾
It protects against hepatitis B and, indirectly, against hepatitis D — because hepatitis D can only occur if you already have hepatitis B. But it does not protect against hepatitis A, C, or E. If you're concerned about those, ask your provider — separate vaccines or other precautions are available for hepatitis A, and there are specific treatments for hepatitis C.
When was Hepatitis B Vaccine first available? ▾
Hepatitis B Vaccine has been available in the United States since at least 1986, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Hepatitis B Vaccine? ▾
Hepatitis B Vaccine is supplied by 5 manufacturers listed in the FDA NDC Directory, including Merck Sharp & Dohme LLC, GlaxoSmithKline Biologicals SA, A-S Medication Solutions.

💬 Answers drafted from Hepatitis B Vaccine’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

🌿Drug & Supplement CheckerHepatitis B Vaccine vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Hepatitis B Vaccine NDCs & costs 🅰️Browse Drugs A–ZLook up any medication

💊 How Hepatitis B Vaccine comes

Hepatitis B Vaccine is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Injection

Into a muscle · Under the skin
Brands Engerix-b Heplisav-b Recombivax Hb
How this form is used
What it may be used for
  • Engerix-B is used to protect against infection from all known subtypes of hepatitis B virus in people of all ages, from newborns to adults
  • Engerix-B also helps prevent hepatitis D, which cannot occur without hepatitis B infection
  • Engerix-B is specifically indicated for infants born to HBsAg-positive mothers, hemodialysis patients, healthcare workers, and other high-risk groups
Important instructions
  • Engerix-B is given by intramuscular injection — into the deltoid (upper arm) in adults and older children, or the anterolateral thigh in infants and young children
  • Engerix-B should not be injected into the gluteal (buttock) region, as this can result in a lower immune response
  • Engerix-B may be given subcutaneously (under the skin) only for people at risk of bleeding with muscle injections, such as those with hemophilia — but this route may produce a lower antibody response
  • Engerix-B is given as a series of doses over several months; the exact number and timing depend on your age and health — follow your healthcare provider's schedule
Available strengths 6 strengths
5 mcg/0.5 mL 10 mcg/0.5 mL 10 mcg/mL 20 mcg/0.5 mL 20 mcg/mL 40 mcg/mL
36 FDA-listed product records ⓘ

📊 Hepatitis B Vaccine across the U.S. market

How Hepatitis B Vaccine appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

1
Dose forms ⓘ
5
Manufacturers
3
Brand names
36
FDA-listed product records ⓘ
1986
First marketed ⓘ
Merck Sharp & Dohme LLC42%
GlaxoSmithKline Biologicals SA22%
A-S Medication Solutions19%
Bamboo US BidCo LLC8%
Dynavax Technologies Corporation8%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

📈 How widely Hepatitis B Vaccine is used

A general measure of how commonly Hepatitis B Vaccine is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q3 2025 – Q1 2026, summed across every form and brand of the drug.

Think of this as a proxy for how widely Hepatitis B Vaccine is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

33
Medicaid prescriptions filled (Q3 2025 – Q1 2026)
$734 gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Hepatitis B Vaccine prescribed? Of the 1,596 medications we measure, Hepatitis B Vaccine ranks #1,557 by Medicaid prescriptions — more than 2% of them.

Where Hepatitis B Vaccine ranks among the drugs we measure · Q3 2025 – Q1 2026 · neighbors ±5
Total prescriptions — #1,557 of 1,596
#1,552 Larotrectinib 38 Rx #1,553 Vitamin A 38 Rx #1,554 Diphenhydramine / Ibup... 36 Rx #1,555 Amoxapine 35 Rx #1,556 Mecasermin Injection 35 Rx #1,557 Hepatitis B Vaccine 33 Rx #1,558 Retifanlimab-dlwr Inje... 33 Rx #1,559 Chloramphenicol Inject... 32 Rx #1,560 Loncastuximab Tesirine... 32 Rx #1,561 Calcitonin Salmon Inje... 31 Rx #1,562 Emapalumab-lzsg Inject... 29 Rx

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Hepatitis B Vaccine, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 1 of 19 listed Hepatitis B Vaccine NDCs with Medicaid activity.

🔍 Compare Hepatitis B Vaccine products

A representative set of FDA-listed product records for Hepatitis B Vaccine — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 36 of 36 products — FDA National Drug Code Directory. See every product, package size and price: browse all 36 Hepatitis B Vaccine NDCs →

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Hepatitis B Vaccine RxCUI 797752 3 dose forms · 12 strengths
  1. Dose form (SCDF) Injectable Suspension RxCUI 798420 In current FDA listings
    Clinical drug / strength (SCD) 0.005 MG/ML RxCUI 830237
  2. Dose form (SCDF) Injection RxCUI 1657681 In current FDA listings
    Clinical drug / strength (SCD) 0.5 ML hepatitis B surface antigen vaccine 0.01 MG/ML RxCUI 1658154 0.5 ML hepatitis B surface antigen vaccine 0.02 MG/ML RxCUI 1658142 0.5 ML hepatitis B surface antigen vaccine 0.04 MG/ML RxCUI 1994347 1 ML hepatitis B surface antigen vaccine 0.01 MG/ML RxCUI 1658149 1 ML hepatitis B surface antigen vaccine 0.02 MG/ML RxCUI 1658156 1 ML hepatitis B surface antigen vaccine 0.04 MG/ML RxCUI 830261
  3. Dose form (SCDF) Prefilled Syringe RxCUI 798425 No current FDA listing
    Clinical drug / strength (SCD) 0.5 ML hepatitis B surface antigen vaccine 0.01 MG/ML RxCUI 830252 0.5 ML hepatitis B surface antigen vaccine 0.02 MG/ML RxCUI 798429 0.5 ML hepatitis B surface antigen vaccine 0.04 MG/ML RxCUI 2050057 1 ML hepatitis B surface antigen vaccine 0.01 MG/ML RxCUI 830243 1 ML hepatitis B surface antigen vaccine 0.02 MG/ML RxCUI 798426

Look up RxCUI 797752 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

🏷️ Sold under these brand names

Engerix-b Prehevbrio Recombivax Hb Recombivax Heplisav-b

🏭 Manufacturers & labelers

Merck Sharp & Dohme LLC 15 GlaxoSmithKline Biologicals SA 8 A-S Medication Solutions 7 Bamboo US BidCo LLC 3 Dynavax Technologies Corporation 3

RxNorm drug class

Hepatitis B Vaccine belongs to the Inactivated Hepatitis B Virus Vaccine class.

Pharmacologic class Inactivated Hepatitis B Virus Vaccine

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

🔬 Where this comes from

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Aug 4, 2010
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Hepatitis B Vaccine.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Hepatitis B Vaccine after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
1
NDC products indexed
36
Distinct labelers/manufacturers represented
5
Linked representative label ⓘ
GlaxoSmithKline Biologicals SA
Linked label effective
Aug 4, 2010
Composite sections available
15
Linked SPL Set ID
2ec65f7e-4aa2-4b41-b578-885ea59d6e9d
Linked SPL Document ID
1e70e010-b946-4dff-b5c8-ab712eeddd75
Open the linked representative label on DailyMed ↗

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. GlaxoSmithKline Biologicals SA is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.