Havrix Side Effects

Please note - some side effects for Havrix may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Havrix - for the Consumer

Havrix

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Havrix:

Headache; loss of appetite; mild fever; nausea; redness, soreness, swelling, or warmth at the injection site; tiredness.

Seek medical attention right away if any of these SEVERE side effects occur when using Havrix:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); numbness or tingling of the arms or legs; seizures; shortness of breath; unusual bruising or bleeding; unusual or severe muscle weakness; yellowing of the eyes or skin.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Havrix Side Effects - for the Professional

Havrix

The most common solicited adverse events were injection-site soreness (56% of adults and 21% of children) and headache (14% of adults and less than 9% of children).

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 safety of Havrix has been evaluated in 60 clinical trials involving approximately 32,900 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.

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), induration, redness, and swelling of the injection site; 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, 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% (650/2,911) of subjects at 24 hours and decreasing to 2% (71/2,838) by 72 hours.

In a field efficacy trial, 19,037 children received the 360 EL.U. dose of Havrix. The most commonly reported adverse events by children from 2 selected schools following administration of Havrix were injection-site pain (10%, 68/719) and tenderness (8%, 58/719), following first doses of Havrix. Pain was slightly higher following the first dose of Havrix (10%) compared to the group who received the comparison vaccine ENGERIX-B® (6%) but was similar between vaccines following the second dose (6% for both groups). Likewise, tenderness was slightly higher following the first dose of Havrix (8%) compared to the group who received the comparison vaccine ENGERIX-B (5%) but was similar between vaccines following the second dose (4% for both groups). The large trial further allowed for analysis of rare adverse events, including hospitalization and death. No significant differences were found between the cohorts.

Havrix 720 EL.U./0.5 mL at 11 Months of Age and Older: In a US multicenter study, parents/guardians recorded local and general adverse events on diary cards for 4 days (Days 0 to 3) after vaccination [see Clinical Studies (14.2)]. In the 3 groups of children who received Havrix alone, safety data were available for 723 children who received 1,396 documented doses of Havrix. Additional safety data were available for 181 children who received Havrix 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 following ranges of solicited adverse event rates were observed among 3 groups of children that received their first dose of Havrix alone at between 11 and 25 months of age: Injection site pain in 15 to 21% of subjects, redness in 16 to 21% of subjects, swelling in 8% of subjects, irritability in 24 to 36% of subjects, loss of appetite in 16 to 19% of subjects, drowsiness in 15 to 17% of subjects and fever (>39.5°C) in ≤2% of subjects. Following the booster dose of Havrix, among local reactions: Pain was reported in 16 to 21% of subjects, redness in 17 to 22%, swelling in 8 to 10% of subjects. Following the booster dose of Havrix, among general events, irritability was reported in 19 to 29% of subjects, loss of appetite in 14 to 18% of subjects, drowsiness in 13 to 16% of subjects and fever (>39.5°C) in ≤1% of subjects.

Drowsiness and loss of appetite occurred at higher rates in subjects 15 to 18 months of age who received Hib conjugate vaccine and INFANRIX concomitantly with Havrix as compared to subjects 15 to 18 months of age who received Hib conjugate vaccine 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 higher rates in subjects 15 to 18 months of age who received Hib conjugate vaccine and INFANRIX concomitantly with Havrix as compared to subjects 15 to 18 months of age who received Havrix 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. Other serious adverse events reported during the course of this study with the use of Havrix alone 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 an open-label, randomized, US multicenter study, children 15 months of age received the 2-dose series of Havrix. The second dose of Havrix was given 6 to 9 months after the first dose. One group received Havrix alone (n = 122); a second group received the first dose of Havrix coadministered with INFANRIX and Hib conjugate vaccine (PRP-T) (Sanofi Pasteur SA) (n = 129); and a third group received INFANRIX and Hib conjugate vaccine coadministered and the first dose of Havrix one month later (n = 115). [See Clinical Studies (14.5).] The percentages of subjects for whom solicited local adverse events (days 0 to 3) were reported following the first dose of Havrix alone, Havrix coadministered with INFANRIX and Hib conjugate, and coadministration of INFANRIX and Hib conjugate were as follows: Pain (21%, 45%, 40%), redness (15%, 42%, 42%) and swelling (8%, 30%, 30%). The percentages of subjects for whom solicited local symptoms at the Havrix injection site were reported after the first dose of Havrix in the Havrix alone group compared to subjects who received Havrix coadministered with INFANRIX and Hib conjugate vaccine were as follows: Pain (21% versus 35%), redness (15% versus 30%), and swelling (8% versus 16%).

Solicited general adverse events (days 0 to 3) reported among children following the first dose of Havrix alone, Havrix coadministered with INFANRIX and Hib conjugate vaccine, and coadministration of INFANRIX and Hib conjugate vaccine were as follows: Irritability (33%, 43%, 34%), drowsiness (25%, 34%, 24%), loss of appetite (16%, 24%, 17%), and fever [>38.0°C] (8%, 16%, 19%).

In this trial, 14 subjects reported 24 serious adverse events, including 6 subjects in the Havrix group (status asthmaticus, asthma [2 events], failure to thrive, gastroenteritis, arthritis bacterial, developmental delay, expressive language disorder, dehydration [3 events]), 3 subjects in the group who received Havrix coadministered with INFANRIX and Hib conjugate vaccine (dehydration, gastroenteritis rotavirus, gastroenteritis, pyrexia, tachycardia), and 5 subjects in the group that received the INFANRIX and Hib conjugate vaccine followed by Havrix (bronchial hyperreactivity, respiratory distress, developmental delay, expressive language disorder, dehydration [2 events], gastroenteritis rotavirus, tonsillar hypertrophy). All events were reported as recovered or recovering by the end of the study. No fatalities occurred.

In another US multicenter study, children 15 months of age (range 14 to 16 months) received either Havrix coadministered with a US-licensed pneumococcal 7-valent conjugate vaccine (Wyeth Pharmaceuticals Inc.) followed by a second dose of Havrix 6 to 9 months later; Havrix administered alone followed by a second dose of Havrix 6 to 9 months later; or pneumococcal 7-valent conjugate vaccine administered alone followed by a first dose of Havrix one month later and a second dose of Havrix 6 to 9 months after the first [see Clinical Studies (14.5)]. 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 of Havrix 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. Reported rates of these local adverse events were similar to those 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 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 of Havrix 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. Reported rates of these general adverse events were similar to those 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 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 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 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.

Infections and Infestations: Rhinitis.

Blood and Lymphatic System Disorders: Thrombocytopenia.

Immune System Disorders: Anaphylactic reaction, anaphylactoid reaction, serum sickness–like syndrome.

Nervous System Disorders: Convulsion, dizziness, encephalopathy, Guillain-Barré syndrome, hypoesthesia, multiple sclerosis, myelitis, neuropathy, paresthesia, somnolence, syncope.

Vascular Disorders: Vasculitis.

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.

Musculoskeletal and Connective Tissue Disorders: Musculoskeletal stiffness.

General Disorders and Administration Site Conditions: Chills, influenza-like symptoms, injection site reaction, local swelling.

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Side Effects by Body System - for Healthcare Professionals

General

Hepatitis A vaccine is generally well-tolerated. Most side effects were mild, self-limiting, and of short duration (<= 24 hours).

Local

Local side effects have included pain, tenderness, warmth, induration, erythema, swelling, ecchymosis, hematoma, and injection site pruritus and/or rash.

Cardiovascular

Cardiovascular side effects have included syncope.

Dermatologic

Dermatologic side effects have included pruritus, rash, and urticaria.

Gastrointestinal

Gastrointestinal side effects have included anorexia, nausea, abdominal pain, diarrhea, dysgeusia, gastroenteritis, and vomiting.

Genitourinary

Genitourinary side effects have included menstruation disorder and isolated reports of increased urine protein.

Hematologic

Hematologic side effects have rarely included lymphadenopathy, thrombocytopenia, and eosinophilia.

Hepatic

Hepatic side effects have included isolated reports of elevated liver function tests.

Hypersensitivity

Hypersensitivity reactions have included bronchial constriction, asthma, wheezing, edema/swelling, rash, generalized erythema, urticaria, pruritus, eye irritation/itching, and dermatitis.

Musculoskeletal

Musculoskeletal side effects have included arthralgia, creatine phosphokinase elevations, myalgia, arm pain, back pain, and stiffness.

Nervous system

Nervous system side effects have included headache, hypertonic episode, insomnia, somnolence, photophobia, vertigo, Guillain-Barre syndrome, cerebellar ataxia.

Respiratory

Respiratory side effects have included pharyngitis, other upper respiratory tract infections, nasal congestion, and cough.

Other

Other side effects have included asthenia, fatigue, fever, and malaise.

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