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Havrix

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Havrix

Havrix

Havrix Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Havrix (hepatitis a vaccine, inactivated) is used to help prevent the Hepatitis A disease in adults. It is recommended for adults who have risk factors for getting Hepatitis A, including: being a homosexual male; having chronic liver disease; using intravenous (IV) drugs; receiving treatment for hemophilia or other bleeding disorders; working in a research laboratory or around animals (especially monkeys) where you may be exposed to the hepatitis A virus; or being in an area where there has been an outbreak of hepatitis A. It is a vaccine. Common side effects include pain/redness/swelling at the injection site, fever, tiredness, headache, nausea, and loss of appetite.

Primary immunization for adults consists of a single 1-mL dose of Havrix and a 1-mL booster dose administered anytime between 6 and 12 months later. Havrix may interact with drugs or treatments that can weaken the immune system, such as steroids, 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, and all other vaccines you recently received. During pregnancy, Havrix should be used only when prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

Our Havrix (hepatitis a vaccine) 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.

Havrix in Detail - Patient Information: Side Effects

You should not receive a booster vaccine if you have ever 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 A 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.

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

  • high fever;
  • fast or uneven heartbeats; or
  • behavior changes.

Less serious side effects include:

  • low fever;
  • headache;
  • dizziness, tired feeling;
  • nausea, vomiting, stomach pain, diarrhea, loss of appetite;
  • joint pain;
  • sore throat; or
  • swelling, redness, or a hard lump where the shot was given.

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 vaccine side effects to the US Department of Health and Human Services at 1-800-822-7967.

Read the entire detailed patient monograph for Havrix (Hepatitis A Vaccine, Inactivated) »

What is Patient Information Overview?

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

Havrix Overview - Patient Information: Side Effects

SIDE EFFECTS: Pain/redness/swelling at the injection site, fever, tiredness, headache, nausea, and loss of appetite 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. Report all side effects to your doctor before you receive the next injection.

Tell your doctor immediately if this rare but serious side effect occurs: seizures.

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 Havrix (Hepatitis A Vaccine, Inactivated)»

What is Prescribing information?

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

Havrix FDA Prescribing Information: Side Effects
(Adverse Reactions)

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. As with any vaccine, there is the possibility that broad use of HAVRIX (hepatitis a vaccine, inactivated) could reveal adverse reactions not observed in clinical trials.

The safety of HAVRIX (hepatitis a vaccine, inactivated) has been evaluated in clinical trials involving approximately 32,500 individuals receiving doses ranging from 360 EL.U. to 1440 EL.U.

The frequency of solicited adverse events tended to decrease with successive doses of HAVRIX (hepatitis a vaccine, inactivated) .

Of solicited adverse events in clinical trials, the most frequently reported by volunteers was injection-site soreness (56% of adults and 21% of children); however, less than 0.5% of soreness was reported as severe. Headache was reported by 14% of adults and less than 9% of children. Other solicited and unsolicited events occurring during clinical trials are listed below.

Incidence 1% to 10% of Injections:Metabolism and nutrition disorders: Anorexia.

Gastrointestinal disorders: Nausea.

General disorders and administration site conditions: Fatigue, fever ( > 37.5°C), injection site induration, injection site redness, injection site swelling, malaise.

Incidence < 1% of Injections: Infections and infestations: Pharyngitis, upper respiratory tract infections.

Blood and lymphatic system disorders: Lymphadenopathy.

Psychiatric disorders: Insomnia.

Nervous system disorders: Dysgeusia, hypertonia.

Eye disorders: Photophobia.

Ear and labyrinth disorders: Vertigo.

Gastrointestinal disorders: Abdominal pain, diarrhea, vomiting.

Skin and subcutaneous tissue disorders: Pruritus, rash, urticaria.

Musculoskeletal and connective tissue disorders: Arthralgia, myalgia.

General disorders and administration site conditions: Injection site hematoma.

Investigations:Creatine phosphokinase increased.

Outbreak Setting and a Field Efficacy Trial: Safety data were obtained from 2 additional sources in which large populations were vaccinated. In an outbreak setting in which 4,930 individuals were immunized with a single dose of either 720 EL.U. or 1440 EL.U. of HAVRIX (hepatitis a vaccine, inactivated) , no serious adverse events due to vaccination were reported. Overall, less than 10% of vaccinees reported solicited general adverse events following the vaccine. The most common solicited local adverse reaction was pain at the injection site, reported in 22.3% of subjects at 24 hours and decreasing to 2.4% by 72 hours.

In a field efficacy trial, 19,037 children received the 360 EL.U. dose of HAVRIX (hepatitis a vaccine, inactivated) . The most commonly reported adverse events following administration of HAVRIX (hepatitis a vaccine, inactivated) were injection-site pain (9.5%) and tenderness (8.1%), which were reported following first doses of HAVRIX (hepatitis a vaccine, inactivated) . Other adverse events were infrequent and comparable to the control vaccine ENGERIX-B® [Hepatitis B Vaccine (Recombinant)]. Additionally, no serious adverse events due to the vaccine were reported. The large trial further allowed for analysis of rare adverse events, including hospitalization and death. No significant differences were found between the cohorts.

HAVRIX (hepatitis a vaccine, inactivated) 720 EL.U./0.5 mL at 11 Months of Age and Older: In a multicenter study, parents/guardians recorded local and general symptoms on diary cards for 4 days (Days 0 to 3) after vaccination [see Clinical Studies]. In the 3 groups of children who received HAVRIX (hepatitis a vaccine, inactivated) alone, safety data were available for 723 children who received 1,396 documented doses of HAVRIX (hepatitis a vaccine, inactivated) . Additional safety data were available for 181 children who received HAVRIX (hepatitis a vaccine, inactivated) coadministered with INFANRIX® (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed) (DTaP) and Haemophilus influenzae type b (Hib) conjugate vaccine (tetanus toxoid conjugate) (PRP-T) (Sanofi Pasteur SA).

The frequencies of solicited local and general events following receipt of HAVRIX (hepatitis a vaccine, inactivated) were monitored during the 4-day observation period. The following ranges of solicited adverse event rates were observed among 3 groups of children that received their first dose of HAVRIX (hepatitis a vaccine, inactivated) alone at between 11 and 25 months of age: Injection site pain in 15-21% of subjects, redness in 16-21% of subjects, swelling in 8% of subjects, irritability in 24-36% of subjects, loss of appetite in 16-19% of subjects, drowsiness in 15-17% of subjects and fever > 39.5° C in ≤ 2% of subjects. Following the booster dose of HAVRIX (hepatitis a vaccine, inactivated) , among local reactions: Pain was reported in 16-21% of subjects, redness in 17-22%, swelling in 8-10% of subjects. Following the booster dose of HAVRIX (hepatitis a vaccine, inactivated) , among general events, irritability was reported in 19-29% of subjects, loss of appetite in 14-18% of subjects, drowsiness in 13-16% of subjects and fever > 39.5° C in ≤ 1% of subjects.

Drowsiness and loss of appetite occurred at statistically significantly higher rates in subjects 15 to 18 months of age who received Hib conjugate vaccine (PRP-T) (Sanofi Pasteur SA) and INFANRIX concomitantly with HAVRIX (hepatitis a vaccine, inactivated) as compared to subjects 15 to 18 months of age who received Hib conjugate vaccine (PRP-T) and INFANRIX (drowsiness 34% and 22% and loss of appetite 29% and 19%, respectively). With the exception of fever ( > 39.5° C), the solicited general symptoms occurred at statistically significantly higher rates in subjects 15 to 18 months of age who received Hib conjugate vaccine (PRP-T) and INFANRIX concomitantly with HAVRIX (hepatitis a vaccine, inactivated) as compared to subjects 15 to 18 months of age who received HAVRIX (hepatitis a vaccine, inactivated) alone (irritability 46% and 30%, drowsiness 34% and 17%, and loss of appetite 29% and 17%, respectively).

A febrile seizure was reported in an 18-month-old subject 2 days after receiving the first dose of HAVRIX (hepatitis a vaccine, inactivated) . Other serious adverse events reported during the course of this study included a single case each of hepatitis 5 months post dose 1, insulin-dependent diabetes 4 months post dose 1, and Kawasaki's disease 3½ months post dose 1. The association of these events with vaccination is unknown.

In a US multicenter study, children 15 months of age (range 14 to 16 months) received either HAVRIX (hepatitis a vaccine, inactivated) coadministered with a US-licensed pneumococcal 7-valent conjugate vaccine (Wyeth Pharmaceuticals Inc.) followed by a second dose of HAVRIX (hepatitis a vaccine, inactivated) 6 to 9 months later; HAVRIX (hepatitis a vaccine, inactivated) administered alone followed by a second dose of HAVRIX (hepatitis a vaccine, inactivated) 6 to 9 months later; or pneumococcal 7-valent conjugate vaccine administered alone followed by a first dose of HAVRIX (hepatitis a vaccine, inactivated) one month later and a second dose of HAVRIX 6 to 9 months after the first[see Clinical Studies]. Parents/guardians recorded local and general symptoms on diary cards for 4 days (Days 0 to 3) after vaccination.

Solicited local adverse events were reported as follows among children who received the first dose HAVRIX (hepatitis a vaccine, inactivated) coadministered with pneumococcal 7-valent conjugate vaccine: Pain was reported in 36% of subjects, redness in 41% of subjects, and swelling in 29% of subjects. The reported rates of these local adverse events were similar to those reported in children who received the first dose of pneumococcal 7-valent conjugate vaccine alone (44%, 46%, and 27%, respectively). Among children who received the first dose of HAVRIX (hepatitis a vaccine, inactivated) alone, pain was reported in 28% of subjects, redness in 22% of subjects, and swelling in 7% of subjects.

Solicited general adverse events were reported as follows among children who received the first dose HAVRIX (hepatitis a vaccine, inactivated) coadministered with pneumococcal 7-valent conjugate vaccine: Irritability was reported in 35% of subjects, drowsiness in 26% of subjects, loss of appetite in 25% of subjects, and fever in 14% of subjects. The reported rates of these general adverse events were similar to those reported in children who received the first dose of pneumococcal 7-valent conjugate vaccine alone (41%, 32%, 25%, and 16%, respectively). Among children who received the first dose of HAVRIX (hepatitis a vaccine, inactivated) alone, irritability was reported in 35% of subjects, drowsiness in 29% of subjects, loss of appetite in 26% of subjects, and fever in 9% of subjects.

Postmarketing Experience

In addition to reports in clinical trials, worldwide voluntary reports of adverse events received for HAVRIX (hepatitis a vaccine, inactivated) since market introduction of this vaccine are listed below. This list includes serious adverse events or events which have a suspected causal connection to components of HAVRIX (hepatitis a vaccine, inactivated) or other vaccines or drugs. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to the vaccine.

Blood and lymphatic system disorders: Thrombocytopenia.

Immune system disorders: Anaphylactic reaction, anaphylactoid reaction.

Nervous system disorders: Convulsion, dizziness, encephalopathy, Guillain-Barré syndrome, multiple sclerosis, myelitis, neuropathy, paresthesia, somnolence, syncope.

Respiratory, thoracic, and mediastinal disorders: Dyspnea.

Hepatobiliary disorders: Hepatitis, jaundice.

Skin and subcutaneous tissue disorders: Angioedema, erythema multiforme, hyperhidrosis.

Congenital, familial and genetic disorders: Congenital anomaly.

General disorders and administration site conditions: Local swelling.

Read the entire FDA prescribing information for Havrix (Hepatitis A Vaccine, Inactivated) »

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Havrix - User Reviews

Havrix 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 Havrix 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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