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Tamiflu (Oseltamivir) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Tamiflu (Oseltamivir) 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 (496)
Death (71)
Life Threatening Events (22)
Disability (5)

Reports by Reaction Type

Abnormal Behaviour (53)Overdose (49)Maternal Exposure During Pregnancy (33)Pneumonia (30)Influenza (29)Hallucination (22)Vomiting (20)Pregnancy (20)NO Adverse Event (19)Acute Respiratory Distress Syndrome (18)Death (16)Convulsion (16)

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

Possible Tamiflu side effects in

Reported by a pharmacist from Brazil on 2012-08-23

Patient:

Reactions: Medication Error

Drug(s) suspected as cause:
Tamiflu



Possible Tamiflu side effects in female

Reported by a health professional (non-physician/pharmacist) from China on 2012-08-22

Patient: female, weighing 48.0 kg (105.6 pounds)

Reactions: White Blood Cell Count Decreased

Drug(s) suspected as cause:
Levofloxacin
    Indication: Antibiotic Therapy
    Start date: 2009-12-01
    End date: 2009-12-03

Tamiflu
    Administration route: Oral
    Indication: H1n1 Influenza
    Start date: 2009-11-30
    End date: 2009-12-04

Other drugs received by patient: Fructose Diphosphate Sodium; Tanreqing Injection; Moxifloxacin Hydrochloride; Tanreqing Injection



Possible Tamiflu side effects in male

Reported by a physician from Japan on 2012-08-13

Patient: male

Reactions: Hypoaesthesia, Abdominal Pain Upper, Muscle Spasms

Drug(s) suspected as cause:
Tamiflu

Other drugs received by patient: Amoxicillin; Sisaal



Possible Tamiflu side effects in male

Reported by a pharmacist from Australia on 2012-08-13

Patient: male

Reactions: Emotional Distress, Vomiting, Syncope, Hallucination

Drug(s) suspected as cause:
Tamiflu



Possible Tamiflu side effects in female

Reported by a physician from Sweden on 2012-08-10

Patient: female

Reactions: Ventricular Tachycardia

Drug(s) suspected as cause:
Tamiflu



Possible Tamiflu side effects in male

Reported by a consumer/non-health professional from Brazil on 2012-08-10

Patient: male

Reactions: Dizziness, Vision Blurred, Hypoaesthesia, Sinusitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tamiflu



Possible Tamiflu side effects in female

Reported by a physician from United Kingdom on 2012-08-08

Patient: female

Reactions: Convulsion

Drug(s) suspected as cause:
Tamiflu



Possible Tamiflu side effects in female

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

Patient: female

Reactions: Abnormal Behaviour

Drug(s) suspected as cause:
Tamiflu



Possible Tamiflu side effects in female

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

Patient: female, weighing 74.0 kg (162.8 pounds)

Reactions: Fall

Drug(s) suspected as cause:
Tamiflu

Other drugs received by patient: Gliclazide; Rilmenidine; Atorvastatin; Albuterol Sulate; Perindopril Arginine; Glargine; Ambroxol; Carvedilol; Theophylline; Indapamide



Possible Tamiflu side effects in male

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

Patient: male

Reactions: Delirium

Drug(s) suspected as cause:
Tamiflu
    Administration route: Oral
    Indication: Influenza

Tamiflu
    Administration route: Oral

Other drugs received by patient: Phenobarbital TAB; Quetiapine Fumarate; Quetiapine Fumarate



Possible Tamiflu side effects in 15 year old female

Reported by a individual with unspecified qualification from Japan on 2012-08-03

Patient: 15 year old female

Reactions: Abnormal Behaviour, Memory Impairment, Hallucination

Drug(s) suspected as cause:
Tamiflu
    Start date: 2009-09-09
    End date: 2009-09-10

Tamiflu
    Administration route: Oral
    Indication: Influenza
    Start date: 2009-09-08
    End date: 2009-09-08



Possible Tamiflu side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-03

Patient: female, weighing 79.8 kg (175.6 pounds)

Reactions: Malaise, Chest Discomfort, Nausea, Asthenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Robitussin Peak Cold Maximum Strength Multi-Symptom Cold
    Dosage: unk (two teaspoons), 6x/day
    Indication: Bronchitis
    Start date: 2012-07-24
    End date: 2012-07-28

Robitussin Peak Cold Maximum Strength Multi-Symptom Cold
    Indication: Pharyngitis

Robitussin Peak Cold Maximum Strength Multi-Symptom Cold
    Indication: Influenza

Tamiflu
    Dosage: unk

Other drugs received by patient: Effexor XR; Levothyroxine Sodium



Possible Tamiflu side effects in female

Reported by a health professional (non-physician/pharmacist) from France on 2012-07-31

Patient: female

Reactions: Rhabdomyolysis, Strongyloidiasis, Pyrexia, Headache, Abdominal Pain Upper, Dengue Fever, Arthralgia, Cough

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Ceftriaxon
    Dosage: 1 g qd intravenous (not otherwise specified)
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-04-14
    End date: 2012-04-18

Flagyl
    Dosage: 500 mg tid oral
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-04-12
    End date: 2012-04-24

Ofloxacin
    Dosage: 200 mg bid intravenous (not otherwise specified)
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-04-14
    End date: 2012-04-18

Tamiflu
    Dosage: 75 mg bid oral
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Tramadol HCL; Nexium; Lovenox; Doxycycline HCL



Possible Tamiflu side effects in 75 year old female

Reported by a physician from Sweden on 2012-07-30

Patient: 75 year old female

Reactions: Ventricular Tachycardia

Drug(s) suspected as cause:
Tamiflu



Possible Tamiflu side effects in female

Reported by a physician from France on 2012-07-27

Patient: female

Reactions: Rhabdomyolysis

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Ceftriaxone
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-04-14
    End date: 2012-04-18

Flagyl
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-04-14
    End date: 2012-04-24

Ofloxacin
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-04-14
    End date: 2012-04-18

Tamiflu
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-04-13
    End date: 2012-04-17

Other drugs received by patient: Tramadol Hydrochloride; Lovenox; Doxycycline HCL; Acupan; Nexium



Possible Tamiflu side effects in 15 year old female

Reported by a individual with unspecified qualification from Japan on 2012-07-27

Patient: 15 year old female

Reactions: Abnormal Behaviour, Memory Impairment, Hallucination

Drug(s) suspected as cause:
Tamiflu



Possible Tamiflu side effects in female

Reported by a physician from Hungary on 2012-07-25

Patient: female, weighing 74.0 kg (162.8 pounds)

Reactions: Head Injury, Fall

Drug(s) suspected as cause:
Tamiflu

Other drugs received by patient: Perindopril Arginine; Indapamide; Ambroxol; Gliclazide; Rilmenidine; Glargine; Theophylline; Carvedilol; Atorvastatin; Albuterol Sulate



Possible Tamiflu side effects in male

Reported by a pharmacist from Australia on 2012-07-24

Patient: male

Reactions: Emotional Distress, Syncope, Vomiting, Hallucination

Drug(s) suspected as cause:
Tamiflu



Possible Tamiflu side effects in 20 year old female

Reported by a consumer/non-health professional from Germany on 2012-07-24

Patient: 20 year old female

Reactions: Bronchopneumonia, Drug Administration Error, Hyperhidrosis

Drug(s) suspected as cause:
Tamiflu

Other drugs received by patient: Cefuroxime



Possible Tamiflu side effects in 63 year old female

Reported by a physician from Japan on 2012-07-24

Patient: 63 year old female

Reactions: Tubulointerstitial Nephritis, Pneumonia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tamiflu



Possible Tamiflu side effects in female

Reported by a physician from Japan on 2012-07-23

Patient: female, weighing 52.0 kg (114.4 pounds)

Reactions: Malaise, Muscle Spasms

Drug(s) suspected as cause:
Tamiflu

Other drugs received by patient: Acetaminophen



Possible Tamiflu side effects in male

Reported by a physician from United States on 2012-07-20

Patient: male, weighing 25.4 kg (55.9 pounds)

Reactions: Fatigue, Abasia, Muscular Weakness, Abdominal Pain Upper

Drug(s) suspected as cause:
Tamiflu

Other drugs received by patient: Zithromax



Possible Tamiflu side effects in 45 year old female

Reported by a consumer/non-health professional from United Kingdom on 2012-07-20

Patient: 45 year old female

Reactions: Tongue Discolouration, Fear, Ligament Pain, Headache, Pyrexia, Erythema, Abdominal Pain Upper, Myalgia, Fatigue, Malaise, Palpitations, Fibromyalgia, Irritable Bowel Syndrome, Cough, Nightmare, Nausea, Eye Inflammation, Stress, Tremor, Convulsion, Emotional Distress, Anxiety, Burning Sensation, Dysmenorrhoea, Sinus Headache, Ear Pain, Morbid Thoughts, Neurological Symptom, Influenza Like Illness

Drug(s) suspected as cause:
Tamiflu

Other drugs received by patient: Acyclovir; Acetaminophen; Ibuprofen



Possible Tamiflu side effects in male

Reported by a physician from United States on 2012-07-18

Patient: male

Reactions: Abasia, Asthenia, Abdominal Pain Upper

Drug(s) suspected as cause:
Tamiflu



Possible Tamiflu side effects in female

Reported by a physician from Canada on 2012-07-17

Patient: female

Reactions: Limb Reduction Defect, Maternal Exposure Timing Unspecified

Adverse event resulted in: death

Drug(s) suspected as cause:
Diclectin
    Indication: Product Used FOR Unknown Indication

Escitalopram
    Indication: Product Used FOR Unknown Indication

Tamiflu
    Indication: Product Used FOR Unknown Indication



Possible Tamiflu side effects in female

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

Patient: female, weighing 56.0 kg (123.2 pounds)

Reactions: Renal Failure, Oedema, Cardiac Failure Acute, Renal Failure Acute, Decreased Appetite

Adverse event resulted in: death

Drug(s) suspected as cause:
Pelex
    Administration route: Oral
    Indication: Pyrexia
    Start date: 2012-03-13
    End date: 2012-03-19

Tamiflu
    Administration route: Oral
    Indication: Influenza
    Start date: 2012-03-14
    End date: 2012-03-18

Other drugs received by patient: Norvasc; Glyburide; Aricept; Norvasc; Lantus; Lasix; Primperan (Japan); Aspirin



Possible Tamiflu side effects in 16 year old female

Reported by a physician from Canada on 2012-07-13

Patient: 16 year old female, weighing 60.0 kg (132.0 pounds)

Reactions: Abdominal Pain, Amylase Increased, Pancreatitis, Lipase Increased, Hypertriglyceridaemia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tamiflu

Other drugs received by patient: Benylin (Unk Ingredients); Lactase; Lantus; Humalog



Possible Tamiflu side effects in

Reported by a physician from Canada on 2012-07-11

Patient:

Reactions: Vomiting, Nausea, Dehydration

Drug(s) suspected as cause:
Tamiflu



Possible Tamiflu side effects in

Reported by a physician from Canada on 2012-07-11

Patient:

Reactions: Pancreatitis, Hypertriglyceridaemia

Drug(s) suspected as cause:
Tamiflu



Possible Tamiflu side effects in

Reported by a physician from Canada on 2012-07-11

Patient:

Reactions: Delirium

Drug(s) suspected as cause:
Tamiflu

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