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Relenza (Zanamivir) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Relenza (Zanamivir) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (109)
Death (8)
Life Threatening Events (3)

Reports by Reaction Type

Abnormal Behaviour (40)Hallucination (17)Delirium (17)Aggression (12)Screaming (10)Loss of Consciousness (8)Nausea (8)Convulsion (8)Depressed Level of Consciousness (8)Pyrexia (7)Decreased Appetite (7)Dyspnoea (7)

Below are a few examples of reports where side effects / adverse reactions may be related to Relenza (Zanamivir). For a complete list or a specific selection of reports, please use the links above.

Possible Relenza side effects in male

Reported by a physician from Japan on 2012-07-16

Patient: male, weighing 21.5 kg (47.3 pounds)

Reactions: Poor Quality Sleep, Nightmare, Fear, Depressed Level of Consciousness, Pyrexia, Hallucination

Drug(s) suspected as cause:
Relenza

Other drugs received by patient: Meiact; Leftose; Ibruprofen; Zesulan



Possible Relenza side effects in female

Reported by a physician from Japan on 2012-07-16

Patient: female

Reactions: Hypersensitivity, Dyspnoea, Anaphylactic Shock, Cardiac Failure Acute, Joint Stiffness, Pulse Absent, Depressed Level of Consciousness, Acute Respiratory Failure, Myocarditis

Adverse event resulted in: death

Drug(s) suspected as cause:
Relenza

Other drugs received by patient: Mucosta; Soldem; Ceftriaxone Sodium; Pelex; Levofloxacin; Acetaminophen; Soldem; Exacin; Unknown Drug



Possible Relenza side effects in 18 year old male

Reported by a pharmacist from Japan on 2012-07-05

Patient: 18 year old male

Reactions: Sudden Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Relenza

Other drugs received by patient: Acetaminophen



Possible Relenza side effects in female

Reported by a physician from Japan on 2012-07-03

Patient: female

Reactions: Drug Eruption, Rash, Erythema

Drug(s) suspected as cause:
Relenza
    Dosage: 20mg per day
    Indication: Influenza
    Start date: 2012-04-11
    End date: 2012-04-13

Mucodyne
    Dosage: 3iuax per day
    Administration route: Oral
    Indication: Nasopharyngitis
    Start date: 2012-04-11
    End date: 2012-04-13

Acetaminophen
    Administration route: Oral
    Indication: Nasopharyngitis
    Start date: 2012-04-11
    End date: 2012-04-13

Selbex
    Dosage: 3iuax per day
    Administration route: Oral
    Indication: Abdominal Pain Upper
    Start date: 2012-04-11
    End date: 2012-04-13

Astomin
    Dosage: 3iuax per day
    Administration route: Oral
    Indication: Nasopharyngitis
    Start date: 2012-04-11
    End date: 2012-04-13

Zithromax
    Dosage: 2iuax per day
    Administration route: Oral
    Indication: Infection
    Start date: 2012-04-11
    End date: 2012-04-12

Other drugs received by patient: Alloid G; Celestamine TAB; Epinastine Hydrochloride; Tathion



Possible Relenza side effects in 19 year old male

Reported by a pharmacist from Japan on 2012-06-15

Patient: 19 year old male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Relenza

Other drugs received by patient: Acetaminophen



Possible Relenza side effects in female

Reported by a physician from Japan on 2012-06-08

Patient: female

Reactions: Hypersensitivity, Dyspnoea, Anaphylactic Shock, Pulse Absent, Depressed Level of Consciousness, Joint Stiffness

Adverse event resulted in: death

Drug(s) suspected as cause:
Relenza

Other drugs received by patient: Levofloxacin; Soldem; Exacin; Mucosta; Soldem; Ceftriaxone Sodium; Pelex; Unknown Medication; Acetaminophen



Possible Relenza side effects in female

Reported by a physician from Japan on 2012-05-30

Patient: female, weighing 54.0 kg (118.8 pounds)

Reactions: Abnormal Behaviour, Delirium

Drug(s) suspected as cause:
Relenza

Other drugs received by patient: Mucosolvan; Clarithromycin; Acetaminophen; Unknown Drug; Isodine Gargle



Possible Relenza side effects in 36 year old female

Reported by a physician from Japan on 2012-05-30

Patient: 36 year old female

Reactions: Anaphylactic Shock

Adverse event resulted in: death

Drug(s) suspected as cause:
Relenza

Other drugs received by patient: Rocephin; Exacin; Soldem



Possible Relenza side effects in 21 year old female

Reported by a physician from Japan on 2012-05-29

Patient: 21 year old female

Reactions: Dyspnoea, Wheezing, Bronchospasm, Pallor

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Relenza
    Dosage: 20mg per day
    Indication: Influenza
    Start date: 2009-10-16

Voltaren
    Indication: Product Used FOR Unknown Indication



Possible Relenza side effects in 9 year old male

Reported by a physician from Japan on 2012-05-29

Patient: 9 year old male

Reactions: Speech Disorder, Dyspnoea, Wheezing, Bronchospasm, Respiratory Distress

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Relenza
    Dosage: 20mg per day
    Indication: Influenza
    Start date: 2012-03-17

Voltaren
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-03-17

Other drugs received by patient: Singulair



Possible Relenza side effects in female

Reported by a physician from Japan on 2012-05-24

Patient: female

Reactions: Abnormal Behaviour, Delirium

Drug(s) suspected as cause:
Relenza

Other drugs received by patient: Acetaminophen; Clarithromycin; Mucosolvan; Unknown Drug; Isodine Gargle



Possible Relenza side effects in male

Reported by a physician from Japan on 2012-05-23

Patient: male, weighing 22.0 kg (48.4 pounds)

Reactions: Agitation, Restlessness

Drug(s) suspected as cause:
Relenza

Other drugs received by patient: Ibruprofen; Meiact



Possible Relenza side effects in 7 year old male

Reported by a physician from Japan on 2012-05-22

Patient: 7 year old male

Reactions: Nightmare, Hallucination

Drug(s) suspected as cause:
Relenza

Other drugs received by patient: Ibruprofen; Meiact; Zesulan



Possible Relenza side effects in 9 year old male

Reported by a physician from Japan on 2012-05-17

Patient: 9 year old male

Reactions: Speech Disorder, Dyspnoea, Wheezing, Bronchospasm, Respiratory Distress

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Relenza

Other drugs received by patient: Singulair; Voltaren



Possible Relenza side effects in 21 year old female

Reported by a physician from Japan on 2012-05-17

Patient: 21 year old female

Reactions: Dyspnoea, Wheezing, Bronchospasm, Pallor

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Relenza



Possible Relenza side effects in male

Reported by a physician from Japan on 2012-05-16

Patient: male, weighing 22.0 kg (48.4 pounds)

Reactions: Agitation, Nightmare, Restlessness, Hallucination

Drug(s) suspected as cause:
Relenza

Other drugs received by patient: Ibruprofen; Meiact



Possible Relenza side effects in male

Reported by a physician from Japan on 2012-05-10

Patient: male

Reactions: Drug Eruption, Pruritus, Pyrexia, Headache, Erythema, Feeling Cold, Gamma-Glutamyltransferase Increased, Neck Pain, C-Reactive Protein Increased, Skin Discolouration, Bacterial Infection, Decreased Appetite, White Blood Cell Count Increased, Protein Urine Present, Vomiting, Blood Lactate Dehydrogenase Increased, Rash, Dysgeusia, Arthralgia, Diarrhoea, Depressed Level of Consciousness, Feeling Abnormal

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Relenza



Possible Relenza side effects in male

Reported by a physician from Japan on 2012-05-09

Patient: male, weighing 39.0 kg (85.8 pounds)

Reactions: Vision Blurred, Sleep Talking, Delirium

Drug(s) suspected as cause:
Relenza



Possible Relenza side effects in male

Reported by a physician from Japan on 2012-05-02

Patient: male, weighing 39.0 kg (85.8 pounds)

Reactions: Vision Blurred, Delirium

Drug(s) suspected as cause:
Relenza



Possible Relenza side effects in 29 year old male

Reported by a physician from Japan on 2012-05-02

Patient: 29 year old male

Reactions: Dysgeusia, Vomiting, Diarrhoea, Skin Discolouration, Depressed Level of Consciousness, Rash, Feeling Abnormal, Decreased Appetite

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Relenza



Possible Relenza side effects in 8 year old male

Reported by a pharmacist from Japan on 2012-04-25

Patient: 8 year old male, weighing 30.0 kg (66.0 pounds)

Reactions: Hallucination, Auditory, Dizziness, Abnormal Behaviour, Hallucination

Drug(s) suspected as cause:
Relenza



Possible Relenza side effects in 11 year old male

Reported by a physician from Japan on 2012-04-25

Patient: 11 year old male

Reactions: Vision Blurred, Delirium

Drug(s) suspected as cause:
Relenza



Possible Relenza side effects in

Reported by a consumer/non-health professional from Japan on 2012-04-25

Patient:

Reactions: Abdominal Pain, Nausea, Anaemia

Drug(s) suspected as cause:
Relenza



Possible Relenza side effects in female

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-04-24

Patient: female

Reactions: Hepatitis C

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Relenza

Other drugs received by patient: Chinese Medicine; Juvela N; Unknown Drug; Transamine CAP; Cinal; Alosenn; Pydoxal



Possible Relenza side effects in 12 year old female

Reported by a pharmacist from Japan on 2012-04-24

Patient: 12 year old female

Reactions: Nausea, Decreased Appetite

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Relenza
    Start date: 2012-04-01

Relenza
    Indication: Influenza
    Start date: 2012-01-01



Possible Relenza side effects in female

Reported by a consumer/non-health professional from Japan on 2012-04-18

Patient: female

Reactions: Ageusia, Anosmia

Drug(s) suspected as cause:
Relenza



Possible Relenza side effects in 7 year old female

Reported by a pharmacist from Japan on 2012-04-16

Patient: 7 year old female

Reactions: Screaming

Drug(s) suspected as cause:
Relenza



Possible Relenza side effects in male

Reported by a pharmacist from Japan on 2012-04-11

Patient: male

Reactions: Ageusia, Anosmia

Drug(s) suspected as cause:
Relenza



Possible Relenza side effects in female

Reported by a consumer/non-health professional from Japan on 2012-04-11

Patient: female

Reactions: Back Pain, Arthropathy, Syncope

Drug(s) suspected as cause:
Relenza



Possible Relenza side effects in female

Reported by a consumer/non-health professional from Japan on 2012-04-11

Patient: female

Reactions: Productive Cough, Conversion Disorder, Schizophrenia, Pyrexia, Photopsia, Pruritus Generalised, Palpitations, Screaming, Muscle Spasms, Ear Discomfort, Dyspnoea, Rhinorrhoea, DRY Skin, Convulsion, Dandruff, Affect Lability, Dysphonia, Asthenia

Drug(s) suspected as cause:
Relenza

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