Fluarix Side Effects

Generic Name: influenza virus vaccine inactivated,influenza virus vaccine live intranasal

Please note - some side effects for Fluarix 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 Fluarix - for the Consumer

Fluarix

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 Fluarix:

Diarrhea; drowsiness; fatigue; general body discomfort; headache; irritability; loss of appetite; mild fever; mild pain, redness, swelling, or tenderness at the injection site; muscle aches.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); decreased movement of the face muscles; decreased movement or sensation in the arm or shoulder; muscle weakness; numbness or tingling of the hands or feet; severe or persistent headache or fever; vision changes; vomiting.

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.

Top

Fluarix Side Effects - for the Professional

Fluarix

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. There is the possibility that broad use of Fluarix could reveal adverse reactions not observed in clinical trials.

Adults: In adults, the most common local adverse reactions and general adverse events observed with Fluarix were pain and redness at the injection site, muscle aches, fatigue, and headache.

Fluarix has been administered to 10,317 adults 18 to 64 years of age and 606 subjects ≥65 years of age in 4 clinical trials.

One of the 4 clinical trials was a randomized, double-blind, placebo-controlled study that evaluated a total of 952 subjects: Fluarix (N = 760) and placebo (N = 192). The population was 18 to 64 years of age (mean 39.1), 54% were female and 80% were white. Solicited events were collected for 4 days (day of vaccination and the next 3 days) (Table 1). Unsolicited events that occurred within 21 days of vaccination (day 0-20) were recorded using diary cards supplemented by spontaneous reports and a medical history as reported by subjects.

Table 1. Percentage of Subjects With Solicited Local Adverse Reactions or General Adverse Events Within 4 Daysa of Vaccination (Total Vaccinated Cohort)

	Fluarix N = 760 %	Placebo N = 192 %
Local Adverse Reactions
Pain	55	12
Redness	18	10
Swelling	9	6
General Adverse Events
Muscle aches	23	12
Fatigue	20	18
Headache	19	21
Arthralgia	6	6
Shivering	3	3
Fever (≥100.4°F)	2	2

Total vaccinated cohort for safety included all vaccinated subjects for whom safety data were available.

a 4 days included day of vaccination and the subsequent 3 days.

Unsolicited adverse events that occurred in ≥1% of recipients of Fluarix and at a rate greater than placebo included upper respiratory tract infection (3.9% versus 2.6%), nasopharyngitis (2.5% versus 1.6%), nasal congestion (2.2% versus 2.1%), diarrhea (1.6% versus 0%), influenza-like illness (1.6% versus 0.5%), vomiting (1.4% versus 0%), and dysmenorrhea (1.3% versus 1.0%).

A randomized, single-blind, active-controlled US study evaluated subjects randomized to receive Fluarix (N = 917) or FLUZONE (N = 910), a US-licensed trivalent, inactivated influenza virus vaccine (Sanofi Pasteur SA) stratified by age: 18 to 64 years and ≥65 years of age. In the overall population, 59% of subjects were female and 91% were white. Solicited events were collected using diary cards for 4 days (day of vaccination and the next 3 days) (Table 2). Unsolicited events that occurred within 21 days of vaccination (day 0-20) were recorded using diary cards.

Table 2. Percentage of Subjects With Solicited Local Adverse Reactions or General Adverse Events Within 4 Daysa of Vaccination With Fluarix or Comparator Influenza Vaccine by Age Group (Total Vaccinated Cohort)

	18-64 Years of Age		≥65 Years of Age
	Fluarix N = 315 %	Comparator Influenza Vaccine N = 314 %	Fluarix N = 601-602 %	Comparator Influenza Vaccine N = 596 %
Local Adverse Reactions
Pain	48	53	19	18
Redness	13	16	11	13
Swelling	9	11	6	9
General Adverse Events
Fatigue	21	18	9	10
Headache	20	21	8	8
Muscle aches	16	13	7	7
Arthralgia	9	9	6	5
Shivering	3	5	2	2
Fever (≥99.5°F)	3	1	2	1

Total vaccinated cohort for safety included all vaccinated subjects for whom safety data were available.

a 4 days included day of vaccination and the subsequent 3 days.

Unsolicited adverse events that occurred in ≥1% of all recipients of Fluarix or the comparator influenza vaccine in the 21-day post-vaccination period included headache (2.8% versus 2.3%), back pain (1.5% versus 0.4%), pain in extremity (1.2% versus 0.7%), pharyngolaryngeal pain (1.2% versus 0.9%), cough (1.1% versus 0.9%), fatigue (1.1% versus 0.7%), nasopharyngitis (1.0% versus 1.3%), nausea (0.4% versus 1.0%), arthralgia (0.3% versus 1.0%), and injection site pruritus (0.2% versus 1.0%).

A double-blind, placebo-controlled study in subjects 18 to 64 years of age randomized (2:1) to receive Fluarix (N = 5,103) or placebo (N = 2,549) was conducted to evaluate the efficacy of Fluarix. In the total population, 60% were female and 99.9% were white. In a subset (Fluarix [N = 305] and placebo [N = 155]), unsolicited events that occurred within 21 days of vaccination (day 0-20) were recorded on diary cards. The percentage of subjects reporting at least one unsolicited event was similar among the groups (24.3% for Fluarix and 22.6% for placebo). Unsolicited adverse events that occurred in ≥1% of recipients of Fluarix and at a rate greater than placebo included injection site pain (5.2% versus 1.3%), dysmenorrhea (1.3% versus 0.6%), and migraine (1.0% versus 0.0%).

Incidence of Adverse Events Reported in ≥1% of Subjects in Non-US Clinical Trials: The following additional adverse events have been observed in adults in non-US clinical trials with Fluarix. No adverse events were observed at an incidence of >10%.

General Disorders and Administration Site Conditions: Injection site ecchymosis, injection site induration, malaise.

Infections and Infestations: Rhinitis.

Musculoskeletal and Connective Tissue Disorders: Musculoskeletal pain, neck pain.

Skin and Subcutaneous Tissue Disorders: Sweating.

Serious Adverse Events: In the 4 clinical trials in adults (N = 10,923), there was a single case of anaphylaxis reported with Fluarix (<0.01%).

Children: In children 5 years to <18 years of age, the most common (≥10%) local and general adverse events were similar to those in adults but also included swelling at the injection site. In children 3 years to <5 years of age, the most common (≥10%) local and general adverse events included pain, redness, and swelling at the injection site, irritability, loss of appetite, and drowsiness.

A single-blind, active-controlled US study evaluated subjects 6 months to <18 years of age who received Fluarix (N = 2,081) or FLUZONE (N = 1,173), a US-licensed trivalent, inactivated influenza virus vaccine (Sanofi Pasteur SA) (Study 005). Children 6 months to <9 years of age with no history of influenza vaccination received 2 doses approximately 28 days apart. Children 6 months to <9 years of age with a history of influenza vaccination and children 9 years of age and older received 1 dose. Children 6 months to <3 years of age received 0.25 mL of Fluarix or comparator influenza vaccine, and children 3 years of age and older received 0.5 mL of Fluarix or comparator influenza vaccine.

Study subjects were 6 months to <18 years of age and 49% were female; 68% were white, 18% were black, 3% were Asian, and 11% were of other racial/ethnic groups.

Solicited local and general adverse events were collected using diary cards for 4 days (day of vaccination and the next 3 days). Unsolicited adverse events that occurred within 28 days of vaccination (day 0-27) after the first vaccination in all subjects and 21 days (day 0-20) after the second vaccination in unprimed subjects were recorded using diary cards.

The frequencies of solicited adverse events for children 3 years to <5 years of age and for children 5 years to <18 years of age were similar for Fluarix and the comparator vaccine (Table 3).

Table 3. Percentage of Subjects With Solicited Local Adverse Reactions or General Adverse Events Within 4 Daysa of First Vaccination With Fluarix or Comparator Influenza Vaccine by Age Group in Children 3 Years to <18 Years of Age

	Age Group: 3 Years to <5 Years		Age Group: 5 Years to <18 Years
	Fluarix N = 350 %	Comparator Influenza Vaccine N = 341 %	Fluarix N = 1,348 %	Comparator Influenza Vaccine N = 451 %
Local Adverse Reactions
Pain	35	38	56	56
Redness	23	20	18	16
Swelling	14	13	14	13
General Adverse Events
Irritability	21	22	–	–
Loss of appetite	13	15	–	–
Drowsiness	13	20	–	–
Fever	7	8	4	3
Muscle aches	–	–	29	29
Fatigue	–	–	20	19
Headache	–	–	15	16
Arthralgia	–	–	6	6
Shivering	–	–	3	4

a 4 days included day of vaccination and the subsequent 3 days.

In children who received a second dose of Fluarix or the comparator vaccine, the incidences of adverse events following the second dose were similar to those observed after the first dose.

Unsolicited adverse events that occurred in ≥1% of recipients of Fluarix 6 months to <18 years of age included upper respiratory tract infection (5.5%), pyrexia (4.8%), cough (4.7%), vomiting (3.2%), headache (2.8%), rhinorrhea (2.7%), diarrhea (2.5%), pharyngolaryngeal pain (2.4%), nasopharyngitis (2.3%), otitis media (2.0%), nasal congestion (1.8%), upper abdominal pain (1.4%), and upper respiratory tract congestion (1.0%). The incidences of these events were similar in recipients of the comparator vaccine.

Postmarketing Experience

Worldwide voluntary reports of adverse events received for Fluarix since market introduction of this vaccine are listed below. This list includes serious events or events which have causal connection to Fluarix. 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: Lymphadenopathy.

Cardiac Disorders: Tachycardia.

Ear and Labyrinth Disorders: Vertigo.

Eye Disorders: Conjunctivitis, eye irritation, eye pain, eye redness, eye swelling, eyelid swelling.

Gastrointestinal Disorders: Abdominal pain or discomfort, nausea, swelling of the mouth, throat, and/or tongue.

General Disorders and Administration Site Conditions: Asthenia, chest pain, chills, feeling hot, injection site mass, injection site reaction, injection site warmth, body aches.

Immune System Disorders: Anaphylactic reaction including shock, anaphylactoid reaction, hypersensitivity, serum sickness.

Infections and Infestations: Injection site abscess, injection site cellulitis, pharyngitis, rhinitis, tonsillitis.

Musculoskeletal and Connective Tissue Disorders: Pain in extremity.

Nervous System Disorders: Convulsion, dizziness, encephalomyelitis, facial palsy, facial paresis, Guillain-Barré syndrome, hypoesthesia, myelitis, neuritis, neuropathy, paresthesia.

Respiratory, Thoracic, and Mediastinal Disorders: Asthma, bronchospasm, cough, dyspnea, respiratory distress, stridor.

Skin and Subcutaneous Tissue Disorders: Angioedema, erythema, erythema multiforme, facial swelling, pruritus, rash, Stevens-Johnson syndrome, urticaria.

Vascular Disorders: Henoch-Schönlein purpura, vasculitis.

Adverse Events Associated With Influenza Vaccines

Immediate and presumably allergic reactions (e.g., hives, angioedema, allergic asthma, and systemic anaphylaxis) rarely occur after influenza vaccination. These reactions probably result from hypersensitivity to certain vaccine components, such as residual egg protein. Although Fluarix contains only a limited quantity of egg protein, this protein can induce immediate hypersensitivity reactions among persons who have severe egg allergy [see Contraindications (4)].

The 1976 swine influenza vaccine was associated with an increased frequency of Guillain-Barré syndrome (GBS). Evidence for a causal relation of GBS with subsequent vaccines prepared from other influenza viruses is unclear. If influenza vaccine does pose a risk, it is probably slightly more than 1 additional case/1 million persons vaccinated.

Neurological disorders temporally associated with influenza vaccination such as encephalopathy, optic neuritis/neuropathy, partial facial paralysis, and brachial plexus neuropathy have been reported.

Microscopic polyangitis (vasculitis) has been reported temporally associated with influenza vaccination.

Top

Side Effects by Body System - for Healthcare Professionals

Local

Local side effects have frequently included pain (54.7%), redness (17.5%), and swelling (9.3%). Ecchymosis, induration, injection site mass or abscess, injection site reaction or cellulitis, and warmth at the site of injection have also been reported.

Other

Other side effects have frequently included fatigue (19.7%), headache (19.3%), shivering (3.3%), and fever equal to/greater than 100.4 degrees Fahrenheit (1.7%). Malaise, sweating, vertigo, asthenia, chest pain, chills, and feeling hot have also been reported.

Musculoskeletal

Musculoskeletal side effects have frequently included muscle aches (23%) and arthralgia (6.4%). Pain in extremity has also been reported.

Hematologic

Hematologic side effects have included autoimmune hemolytic anemia, lymphadenopathy, and thrombocytopenia.

Cardiovascular

Cardiovascular side effects have included tachycardia, Henoch-Schonlein purpura, and vasculitis.

Ocular

Ocular side effects have included conjunctivitis, eye irritation, eye pain, eye redness, eye swelling, eyelid swelling.

Gastrointestinal

Gastrointestinal side effects have included abdominal pain or discomfort, nausea, swelling of the mouth, throat, and/or tongue.

Hypersensitivity

Hypersensitivity side effects have included anaphylactic reaction including shock, anaphylactoid reaction, hypersensitivity, and serum sickness.

Nervous system

Nervous system side effects have rarely included convulsion, dizziness, encephalomyelitis, facial palsy, facial paresis, Guillain-Barre syndrome, hypoesthesia, myelitis, neuritis, neuropathy, and paresthesia.

Respiratory

Respiratory side effects have included asthma, bronchospasm, cough, dyspnea, pneumonia, respiratory distress, stridor, pharyngitis, rhinitis, and tonsillitis.

Dermatologic

Dermatologic side effects have included angioneurotic edema, erythema, erythema multiforme, facial swelling, pruritus, rash, Stevens-Johnson syndrome, and urticaria.

Top

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This information does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug of drug combination is safe, effective, or appropriate for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of information provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.