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Fluvirin

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Fluvirin

Fluvirin Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Fluvirin (influenza virus vaccine) is used to prevent infection caused by influenza virus. The vaccine is redeveloped each year to contain specific strains of inactivated (killed) flu virus that are recommended by public health officials for that year. It is a "killed virus" vaccine. Common side effects include soreness/redness/swelling/bruising at the injection site that may last for up to 1-2 days. Fever, muscle aches, headache or weakness may also occur.

The dose of Fluvirin for adults and children 9 years and older is a single 0.5-mL intramuscular injection administered preferably in the region of the deltoid muscle of the upper arm. Children aged 4 to 8 years should receive 2 doses of vaccine if they have not been vaccinated previously at any time with any influenza virus vaccine. Fluvirin may interact with phenytoin, theophylline, blood thinners, steroids, medicines to treat or prevent organ transplant rejection, or medications to treat psoriasis, rheumatoid arthritis, or other autoimmune disorders. Tell your doctor all medications and supplements you use. Fluvirin vaccine is recommended during pregnancy. Ask your doctor about the benefits and risks. It is unknown if this vaccine passes into breast milk. Consult your doctor before breastfeeding.

Our Fluvirin (influenza virus 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.

Fluvirin in Detail - Patient Information: Side Effects

Influenza virus injectable (killed virus) vaccine will not cause you to become ill with the flu virus that it contains. However, you may have flu-like symptoms at any time during flu season that may be caused by other strains of influenza virus.

You should not receive a booster vaccine if you had a life-threatening allergic reaction after the first shot.

Keep track of any and all side effects you have after receiving this vaccine. If you ever need to receive influenza virus vaccine in the future, you will need to tell your doctor if the previous shot caused any side effects.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • severe weakness or unusual feeling in your arms and legs (may occur 2 to 4 weeks after you receive the vaccine);
  • high fever;
  • seizure (convulsions); or
  • unusual bleeding.

Less serious side effects may include:

  • low fever, chills;
  • mild fussiness or crying;
  • redness, bruising, pain, swelling, or a lump where the vaccine was injected;
  • headache, tired feeling; or
  • joint or muscle pain.

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 Fluvirin (Influenza Virus Vaccine) »

What is Patient Information Overview?

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

Fluvirin Overview - Patient Information: Side Effects

SIDE EFFECTS: Soreness/redness/swelling/bruising at the injection site may occur and may last for up to 1-2 days. Fever, muscle aches, headache or weakness may also occur. If any of these effects continue beyond 2 days or become bothersome, tell your doctor.

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.

If your doctor has directed you to receive this vaccine, remember that 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.

Tell your doctor right away if any of these rare but very serious side effects occur: mental/mood changes, seizures.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, severe dizziness, itching/swelling (especially of the face/tongue/throat), 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 Fluvirin (Influenza Virus Vaccine)»

What is Prescribing information?

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

Fluvirin FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Overall Adverse Reaction Profile

Serious allergic reactions, including anaphylactic shock, have been observed in individuals receiving FLUVIRIN® during postmarketing surveillance.

Clinical Trial Experience

Adverse event information from clinical trials provides a basis for identifying adverse events that appear to be related to vaccine use and for approximating the rates of these events. However, because clinical trials are conducted under widely varying conditions, the 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 rates observed in clinical practice.

Adult and Geriatric Subjects

Safety data were collected in a total of 2768 adult and geriatric subjects (18 years of age and older) who have received FLUVIRIN® in 29 clinical studies since 1982.

In 9 clinical studies since 1997, among 1261 recipients of FLUVIRIN®, 745 (59%) were women; 1211 (96%) were White, 23 (2%) Asian, 15 (1%) Black and 12 (1%) other; 370 (29%) of subjects were elderly ( ≥ 65 years of age). All studies have been conducted in the UK, apart from a study run in the US in 2005-2006 where FLUVIRIN® was used as a comparator for an unlicensed vaccine.

After vaccination, the subjects were observed for 30 minutes for hypersensitivity or other immediate reactions. Subjects were instructed to complete a diary card for three days following immunization (i.e. Day 1 to 4) to collect local and systemic reactions (see Tables 2 and 3). All local and systemic adverse events were considered to be at least possibly related to the vaccine. Local and systemic reactions mostly began between day 1 and day 2. The overall adverse events reported in clinical trials since 1998 in at least 5% of the subjects are summarized in Table 4.

TABLE 2: Solicited Adverse Events in the First 72-96 Hours After Administration of FLUVIRIN® in Adult (18-64 years of age) and Geriatric ( ≥ 65 years of age) Subjects

  1998-1999*§ 1999-2000*§ 2000-2001 *§
18-64 yrs ≥ 65 yrs 18-64 yrs ≥ 65 yrs 18-64 yrs ≥ 65 yrs
N = 66 N =44 N = 76 N = 34 N = 75 N = 35
Local Adverse Events
  Pain 16 (24%) 4 (9%) 16(21%) - 9 (12%) -
  Mass 7(11%) 1 (2%) 4 (5%) - 8(11%) 1 (3%)
  Inflammation 5 (8%) 2 (5%) 6 (8%) - 7 (9%) 1 (3%)
  Ecchymosis 4 (6%) 1 (2%) 3 (4%) 1 (3%) 4 (5%) -
  Edema 2 (3%) 1 (2%) 1 d%) 2 (6%) 3 (4%) 1 (3%)
  Reaction  2 (3%) - 2 (3%) - 4 (5%) 1 (3%)
  Flemorrhage - - 1 d%) - - -
Systemic Adverse Events
  Headache 7(11%) 1 (2%) 17(22%) 3 (9%) 4 (5%) -
  Fatigue 3 (5%) 2 (5%) 4 (5%) 1 (3%) 3 (4%) -
  Malaise 2 (3%) 1 (2%) 2 (3%) 1 (3%) 1 d%) -
 Myalgia 1 (2%) - 2 (3%) - - -
  Fever 1 (2%) - 1 d%) - - -
  Arthralgia - 1 (2%) - 1 (3%) - -
  Sweating - - 3 (4%) - 1 d%) 1 (3%)
  2001-2002*" 2002-2003*" 2004-2005*"
18-64 yrs ≥ 65 yrs 18-64 yrs ≥ 65 yrs 18-64 yrs ≥ 65 yrs
N =75 N = 35 N = 107 N = 88 N =74 N = 61
Local Adverse Events
  Pain 12(16%) 1 (3%) 14(13%) 7 (8%) 15 (20%) 9 (15%)
  Mass 4 (5%) 1 (3%) - - - -
  Ecchymosis 2 (3%) - 3 (3%) 3 (3%) 2 (3%) 1 (2%)
  Edema 2 (3%) 1 (3%) 6 (6%) 2 (2%) - -
  Erythema 5 (7%) - 11 (10%) 5 (6%) 16 (22%) 5 (8%)
  Swelling - - - - 11 (15%) 4 (7%)
  Reaction - - 2 (2%) - - -
  Induration - - 14(13%) 3 (3%) 11 (15%) 1 (2%)
  Pruritus - - 1 d%) - - -
Systemic Adverse Events
  Headache 8(11%) 1 (3%) 12(11%) 9(10%) 14 (19%) 3 (5%)
  Fatigue 1 d%) 1 (3%) - - 5 (7%) 2 (3%)
  Malaise 3 (4%) - 3 (3%) 4 (5%) 1 (1%) 1 (2%)
  Myalgia 3 (4%) - 5 (5%) 3 (3%) 8(11%) 1 (2%)
  Fever - - - 1 (1%) - -
  Arthralgia - - 2 (2%) - 1 (1%) -
  Sweating 3 (4%) 1 (3%) - 2 (2%) - -
  Shivering - - - 1 d%) - -
Results reported to the nearest whole percent; Fever defined as > 38°C
- not reported
* Solicited adverse events in the first 72 hours after administration of FLUVIRIN®
§ Solicited adverse events reported by COSTART preferred term
^ Solicited adverse events reported by MEDDRA preferred term

TABLE 3: Solicited Adverse Events in the First 72 Hours After Administration of FLUVIRIN® in Adult Subjects (18-49 years of age).

  2005-2006 US Trial FLUVIRIN®
N = 304
Local Adverse Events
  Pain 168 (55%)
  Erythema 48 (16%)
  Ecchymosis 22 (7%)
  Induration 19(6%)
  Swelling 16(5%)
Systemic Adverse Events
  Headache 91 (30%)
  Myalgia 64 (21%)
  Malaise 58 (19%)
  Fatigue 56 (18%)
  Sore throat 23 (8%)
  Chills 22 (7%)
  Nausea 21 (7%)
  Arthralgia 20 (7%)
  Sweating 17(6%)
  Cough 18(6%)
  Wheezing 4(1%)
Systemic Adverse Events
  Chest tightness 4(1%)
  Other difficulties breathing 3(1%)
  Facial edema -
Results reported to the nearest whole percent
- not reported

TABLE 4: Adverse Events Reported by at least 5% of Subjects in Clinical Trials since 1998 Results reported to the nearest whole percent; Fever defined as > 38°C

  1998-1999§ 1999-2000§ 2000-2001§
18-64 yrs ≥ 65 yrs 18-64 yrs ≥ 65 yrs 18-64 yrs ≥ 65 yrs
N = 66 N = 44 N = 76 N = 34 N = 75 N = 35
Adverse Events
  Fatigue 8 (12%) 2 (5%) 8(11%) 2 (6%) 5 (7%)
  Back pain 4 (6%) 3 (7%) - - - -
  Cough increased 2 (3%) 2 (5%) - - - -
  Ecchymosis 4 (6%) 1 (2%) 4 (5%) 1 (3%) 5 (7%) -
  Fever 3 (5%) - - - - -
  Headache 12(18%) 5(11%) 22 (29%) 5(15%) 14(19%) 2 (6%)
  Infection 3 (5%) 2 (5%) - - - -
  Malaise 4 (6%) 4 (9%) 4 (5%) 1 (3%) - -
  Migraine 4 (6%) 1 (2%) - - - -
  Myalgia 4 (6%) 1 (2%) - - - -
  Sweating 5 (8%) 1 (2%) - - - -
  Rhinitis 3 (5%) 1 (2%) - - 5 (7%) 2 (6%)
  Pharingitis 6 (9%) 1 (2%) 10(13%) - 6 (8%) -
  Arthralgia - - - 2 (6%) - -
  Injection site pain 16(24%) 4 (9%) 16(21%) - 9(12%) -
  Injection site ecchymosis 4 (6%) 1 (2%) _ _ 4 (5%) _
  Injection site mass 7(11%) 1 (2%) 4 (5%) - 8(11%) 1 (3%)
  Injection site edema - - 1(1%) 2 (6%) - -
  Injection site inflammation 5 (8%) 2 (5%) 6 (8%) _ 7 (9%) 1 (3%)
  Injection site reaction - - - - 4 (5%) 1 (3%)
  2001-2002^ 2002-2003" 2004-2005"
18-64 yrs ≥ 65 yrs 18-64 yrs ≥ 65 yrs 18-64 yrs ≥ 65 yrs
N = 75 N = 35 N = 107 N = 88 N = 74 N = 61
Adverse Events
  Fatigue 5 (7%) 4(11%) 11 (10%) 8 (9%) 4 (5%) 2 (3%)
  Hypertension - - 1 d%) 4 (5%) - -
  Rinorrhea - - 2 (2%) 5 (6%) - -
  Headache 20 (27%) 2 (6%) 35 (33%) 18(20%) 12(16%) 1 (2%)
  Malaise 6 (8%) 1 (3%) 13 (12%) 8 (9%) - -
  Myalgia 4 (5%) 1 (3%) 10 (9%) 4 (5%) - -
  Sweating 3 (4%) 3 (9%) 2 (2%) 5 (6%) - -
  Rhinitis 4 (5%) - - - - -
  Pharingitis - - - - 6 (8%) -
  Arthralgia - - 5 (5%) 4 (5%) - -
  Sore throat 4 (5%) 1 (3%) 5 (5%) 4 (5%) - -
  Injection site pain 13(17%) 3 (9%) 14 (13%) 7 (8%) 6 (8%) 2 (3%)
  Injection site ecchymosis 4 (5%) 1 (3%) 4 (4%) 4 (5%) _ _
  Injection site erythema 5 (7%) 2 (6%) 11 (10%) 5 (6%) 4 (5%) -
  Injection site mass 4 (5%) 1 (3%) - - - -
  Injection site edema - - 6 (6%) 2 (2%) 4 (5%) 1 (2%)
  Injection site induration - - 14 (13%) 3 (3%) 7 (9%) -
- not reaching the cut-off of 5%
§ Solicited adverse events reported by COSTART preferred term
^ Solicited adverse events reported by MEDDRA preferred term

Adults (18 to 64 years of age)

In adult subjects, solicited local adverse events occurred with similar frequency in all trials. The most common solicited adverse events occurring in the first 96 hours after administration (Tables 2 and 3) were associated with the injection site (such as pain, erythema, mass, induration and swelling) but were generally mild/moderate and transient. The most common solicited systemic adverse events were headache and myalgia.

The most common overall events in adult subjects (18-64 years of age) were headache, fatigue, injection site reactions (pain, mass, erythema, and induration) and malaise (Table 4).

Geriatric Subjects (65 years of age and older)

In geriatric subjects, solicited local and systemic adverse events occurred less frequently than in adult subjects. The most common solicited local and systemic adverse events were injection site pain, and headache (Tables 2 and 3). All were considered mild/moderate and were transient.

The most common overall events in elderly subjects ( ≥ 65 years of age) were headache and fatigue.

Only 11 serious adverse events in adult and geriatric subjects (18 years and older) have been reported to date from all the trials performed. These serious adverse events were a minor stroke experienced by a 67 year old subject 14 days after vaccination (1990), death of an 82 year old subject 35 days after vaccination (1990) in very early studies; death of a 72 year old subject 19 days after vaccination (1998-1999), a hospitalization for hemorrhoid ectomy of a 38 year old male subject (1999-2000), a severe respiratory tract infection experienced by a 74 year old subject 12 days after vaccination (2002-2003), a planned transurethral resection of the prostate in a subject with prior history of prostatism (2004-2005), two cases of influenza (2005-2006), a drug overdose (2005-2006), cholelithiasis (2005-2006) and a nasal septal operation (2005-2006). None of these events were considered causally related to vaccination.

Clinical Trial Experience in Pediatric Subjects

In 1987 a clinical study was carried out in 38 'at risk' children aged between 4 and 12 years (17 females and 21 males). To record the safety of FLUVIRIN®, participants recorded their symptoms on a diary card during the three days after vaccination and noted any further symptoms they thought were attributable to the vaccine. The only reactions recorded were tenderness at the site of vaccination in 21% of the participants on day 1, which was still present in 16% on day 2 and 5% on day 3. In one child, the tenderness was also accompanied by redness at the site of injection for two days. The reactions were not age-dependent and there was no bias towards the younger children.

Three clinical studies were carried out between 1995 and 2004 in a total of 520 pediatric subjects (age range 6 - 47 months). Of these, 285 healthy subjects plus 41 'at risk' subjects received FLUVIRIN®. No serious adverse events were reported.

FLUVIRIN® should only be used for the immunization of persons aged 4 years and over.

Postmarketing Experience

The following additional adverse reactions have been reported during postapproval use of FLUVIRIN®. Because these reactions 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 vaccine exposure. Adverse events described here are included because: a) they represent reactions which are known to occur following immunizations generally or influenza immunizations specifically; b) they are potentially serious; or c) the frequency of reporting.

  • Body as a whole: Local injection site reactions (including pain, pain limiting limb movement, redness, swelling, warmth, ecchymosis, induration), hot flashes/flushes; chills; fever; malaise; shivering; fatigue; asthenia; facial edema.
  • Immune system disorders: Hypersensitivity reactions (including throat and/or mouth edema). In rare cases, hypersensitivity reactions have lead to anaphylactic shock and death.
  • Cardiovascular disorders: Vasculitis (in rare cases with transient renal involvement), syncope shortly after vaccination.
  • Digestive disorders: Diarrhea; nausea; vomiting; abdominal pain.
  • Blood and lymphatic disorders: Local lymphadenopathy; thrombocytopenia (some very rare cases were severe with platelet counts less than 5,000 per mm³).
  • Metabolic and nutritional disorders: Loss of appetite.
  • Musculoskeletal: Arthralgia; myalgia; myasthenia.
  • Nervous system disorders: Headache; dizziness; neuralgia; paraesthesia; confusion; febrile convulsions; Guillain-Barré Syndrome; myelitis (including encephalomyelitis and transverse myelitis); neuropathy (including neuritis); paralysis (including Bell's Palsy).
  • Respiratory disorders: Dyspnea; chest pain; cough; pharyngitis; rhinitis.
  • Skin and appendages: Stevens-Johnson syndrome; sweating; pruritus; urticaria; rash (including non-specific, maculopapular, and vesiculobulbous).
  • General disorders and administration site conditions: Injection site cellulitis-like reaction (very rare cases of swelling, pain, and redness were large and extended to the entire arm)

Other Adverse Reactions Associated with Influenza Vaccination

Anaphylaxis has been reported after administration of FLUVIRIN®. Although FLUVIRIN® contains only a limited quantity of egg protein, this protein can induce immediate hypersensitivity reactions among persons who have severe egg allergy. Allergic reactions include hives, angioedema, allergic asthma, and systemic anaphylaxis [see CONTRAINDICATIONS].

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 enceph-alopathy, optic neuritis/neuropathy, partial facial paralysis, and brachial plexus neuropathy have been reported.

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

Read the entire FDA prescribing information for Fluvirin (Influenza Virus Vaccine) »

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Fluvirin - User Reviews

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