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Zyvox (Linezolid) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Zyvox (Linezolid) 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 (563)
Death (99)
Life Threatening Events (41)
Disability (19)

Reports by Reaction Type

Nausea (36)Drug Interaction (31)Vomiting (31)Platelet Count Decreased (29)Diarrhoea (27)Death (25)Renal Failure Acute (25)Hyponatraemia (25)Anaemia (24)Serotonin Syndrome (23)Thrombocytopenia (22)Malaise (21)

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

Possible Zyvox side effects in 65 year old female

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-08-27

Patient: 65 year old female, weighing 64.0 kg (140.8 pounds)

Reactions: Drug Interaction, Renal Failure Acute

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Amiodarone HCL
    Dosage: 200 mg, qd
    Administration route: Oral
    Indication: Atrial Fibrillation
    Start date: 2008-09-01
    End date: 2008-10-10

Ramipril
    Dosage: 2.5 mg, qd
    Administration route: Oral
    Indication: Hypertension
    Start date: 2008-09-01
    End date: 2008-10-09

Zyvox
    Dosage: unk
    Start date: 2008-10-25
    End date: 2009-01-27

Zyvox
    Dosage: 600 mg, bid
    Administration route: Oral
    Indication: Intervertebral Discitis
    Start date: 2008-09-22
    End date: 2008-10-09

Other drugs received by patient possibly interacting with the suspect drug:
Spironolactone
    Dosage: 100 mg, qd
    Administration route: Oral
    Indication: Hypertension
    Start date: 2008-09-01
    End date: 2008-10-09

Torsemide
    Dosage: 10 mg, bid
    Administration route: Oral
    Indication: Hypertension
    Start date: 2008-07-29

Xipamide
    Dosage: 10 mg, qd
    Administration route: Oral
    Indication: Hypertension
    Start date: 2008-07-29
    End date: 2008-10-08

Other drugs received by patient: Acetaminophen; Enoxaparin Sodium; Simvastatin; Amitriptyline HCL; Novalgin; Omeprazole; Oxycodone HCL; Metoprolol Tartrate; Digitoxin TAB



Possible Zyvox side effects in

Reported by a consumer/non-health professional from Japan on 2012-08-27

Patient:

Reactions: NO Adverse Event

Drug(s) suspected as cause:
Betamethasone Valerate
    Dosage: unk
    Start date: 2012-04-10
    End date: 2012-05-07

Flagyl
    Dosage: 1000 mg, unk
    Administration route: Oral
    Indication: Pseudomembranous Colitis
    Start date: 2012-04-03
    End date: 2012-04-04

Flagyl
    Dosage: 1000 unk, unk
    Administration route: Oral
    Start date: 2012-04-29
    End date: 2012-05-12

Vancomycin HCL
    Dosage: 1 mg, unk
    Start date: 2012-04-16
    End date: 2012-04-29

Zyvox
    Dosage: 1200 mg, unk
    Start date: 2012-05-02
    End date: 2012-05-15

Other drugs received by patient: Dorner; Aldactone; Dorner; Lebenin; Olopatadine HCL; Plavix; Pydoxal; Clobetasol Propionate; Hirudoid; Aspara K; Yunasupin; Vancomycin HCL; Gentamicin Sulfate; Nizoral; Hirudoid; Prednisolone; Plavix; Lebenin; Aspara K; Trichlormethiazide; Myser (Difluprednate); Myser (Difluprednate); Methylprednisolone Sodium Succinate



Possible Zyvox side effects in 68 year old male

Reported by a physician from Japan on 2012-08-27

Patient: 68 year old male, weighing 37.0 kg (81.4 pounds)

Reactions: Pneumonia, Hepatic Function Abnormal, Platelet Count Decreased, Hyponatraemia

Adverse event resulted in: death

Drug(s) suspected as cause:
Zyvox
    Dosage: 600 mg, 2x/day
    Indication: Pneumonia Staphylococcal
    Start date: 2012-05-07
    End date: 2012-05-19

Zyvox
    Dosage: 600 mg, 2x/day
    Start date: 2012-05-26
    End date: 2012-06-01

Other drugs received by patient: Meropenem; Teicoplanin; Picillibacta



Possible Zyvox side effects in 90 year old female

Reported by a pharmacist from Japan on 2012-08-24

Patient: 90 year old female

Reactions: Hyponatraemia

Drug(s) suspected as cause:
Zyvox

Other drugs received by patient: Rocephin; Lasix; Soldactone; Lasix; Physio; Physio; Thiospen; Amigrand; Hanp; Vitamedin Intravenous; Elaspol; Soldactone; Intralipid 10%; Solita-T 3G; Lactec; Ascorbic Acid



Possible Zyvox side effects in male

Reported by a pharmacist from United States on 2012-08-23

Patient: male

Reactions: Drug Withdrawal Syndrome

Drug(s) suspected as cause:
Zyvox



Possible Zyvox side effects in 84 year old male

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

Patient: 84 year old male

Reactions: Disseminated Intravascular Coagulation, Platelet Count Decreased

Adverse event resulted in: death, life threatening event

Drug(s) suspected as cause:
Famotidine
    Dosage: 40 mg, 1x/day
    Indication: Gastric Ulcer Haemorrhage
    Start date: 2012-07-18
    End date: 2012-07-30

Zyvox
    Dosage: 1200 mg, 1x/day
    Indication: Pneumonia
    Start date: 2012-07-17
    End date: 2012-07-27

Other drugs received by patient: Lasix; Methylprednisolone Sodium Succinate; Bisolvon



Possible Zyvox side effects in 22 month old female

Reported by a physician from United States on 2012-08-23

Patient: 22 month old female, weighing 10.0 kg (22.0 pounds)

Reactions: Neutropenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Zyvox



Possible Zyvox side effects in 54 year old male

Reported by a consumer/non-health professional from United States on 2012-08-21

Patient: 54 year old male, weighing 77.1 kg (169.6 pounds)

Reactions: Drug Ineffective

Drug(s) suspected as cause:
Zyvox



Possible Zyvox side effects in 77 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-20

Patient: 77 year old female

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Zyvox



Possible Zyvox side effects in 15 year old male

Reported by a physician from United States on 2012-08-17

Patient: 15 year old male, weighing 47.0 kg (103.4 pounds)

Reactions: Blood Bilirubin Increased, Agitation, Insomnia, Drug Interaction, Faeces Discoloured

Drug(s) suspected as cause:
Zyvox

Other drugs received by patient possibly interacting with the suspect drug:
Sinemet
    Dosage: unk
    Indication: Quadriplegia
    End date: 2012-07-01

Sinemet
    Dosage: unk
    Start date: 2012-07-01

Other drugs received by patient: Vancomycin; Baclofen; Tylenol; Albuterol



Possible Zyvox side effects in

Reported by a physician from Japan on 2012-08-17

Patient:

Reactions: Ileus

Adverse event resulted in: death

Drug(s) suspected as cause:
Zyvox



Possible Zyvox side effects in 77 year old female

Reported by a physician from United States on 2012-08-16

Patient: 77 year old female, weighing 79.4 kg (174.6 pounds)

Reactions: Movement Disorder, Oral Mucosal Blistering, Drug Ineffective, Mouth Ulceration, Oropharyngeal Pain, Rash, Limb Discomfort, Dyspepsia, Chest Pain, Skin Odour Abnormal

Drug(s) suspected as cause:
Zyvox

Other drugs received by patient: Lipitor



Possible Zyvox side effects in 82 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-16

Patient: 82 year old female

Reactions: Anaemia, Neutropenia, Thrombocytopenia

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Calciparine
    Dosage: 5000 iu, 2x/day
    Indication: Thrombosis Prophylaxis
    Start date: 2012-04-14
    End date: 2012-04-25

Gentamicin
    Dosage: 420 mg, 1x/day
    Indication: Staphylococcal Sepsis
    Start date: 2012-04-14
    End date: 2012-04-16

Orbenin CAP
    Dosage: 2 g, 4x/day
    Indication: Staphylococcal Sepsis
    Start date: 2012-04-14
    End date: 2012-04-16

Zyvox
    Dosage: 600 mg, 2x/day
    Indication: Staphylococcal Sepsis
    Start date: 2012-04-16
    End date: 2012-04-22

Other drugs received by patient: Atacand; Depakene; Previscan; Cordarone; Levothyroxine Sodium; Pantoprazole Sodium; Lercanidipine; Prednisone TAB; Keppra



Possible Zyvox side effects in 70 year old male

Reported by a pharmacist from Japan on 2012-08-15

Patient: 70 year old male

Reactions: Haemodialysis

Drug(s) suspected as cause:
Zyvox



Possible Zyvox side effects in 11 year old male

Reported by a consumer/non-health professional from United States on 2012-08-15

Patient: 11 year old male

Reactions: Glossodynia

Drug(s) suspected as cause:
Zyvox



Possible Zyvox side effects in 87 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-14

Patient: 87 year old female

Reactions: Agitation, Confusional State

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tazobactam
    Dosage: unk
    Indication: Escherichia Infection
    Start date: 2012-07-17
    End date: 2012-07-21

Zyvox
    Dosage: unk
    Indication: Escherichia Infection
    Start date: 2012-07-17
    End date: 2012-07-21

Other drugs received by patient: Augmentin '500'; Rocephin



Possible Zyvox side effects in 52 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-14

Patient: 52 year old female

Reactions: Anaemia, Condition Aggravated, Thrombocytopenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ofloxacin
    Dosage: unk
    Administration route: Oral
    Indication: Infection
    Start date: 2012-06-04
    End date: 2012-07-17

Zyvox
    Dosage: 600 mg, 2x/day
    Administration route: Oral
    Indication: Infection
    Start date: 2012-06-04
    End date: 2012-07-14

Other drugs received by patient: Alprazolam; Nexium; Zolpidem; Sodium Bicarbonate; Humalog; Lantus; Prograf; Cell Cept; Prednisolone; Singulair



Possible Zyvox side effects in 65 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-14

Patient: 65 year old male, weighing 66.0 kg (145.2 pounds)

Reactions: Weight Decreased, Vomiting, Mycobacterium Chelonae Infection, Hyperkalaemia, Hypercreatininaemia, Rectal Haemorrhage, Reticulocyte Count Decreased, Diarrhoea, RED Blood Cell Count Decreased, Megakaryocytes Abnormal, Neutropenia, Thrombocytopenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Clarithromycin
    Dosage: 500 mg, 2x/day
    Start date: 2012-05-31
    End date: 2012-06-26

Ketoprofen
    Dosage: 100-300 mg, daily
    Administration route: Oral
    Indication: Juvenile Arthritis

Methotrexate
    Dosage: 20 mg, weekly
    Administration route: Oral
    Indication: Juvenile Arthritis

Prednisone TAB
    Dosage: 3 mg, daily
    Administration route: Oral
    Indication: Juvenile Arthritis

Zyvox
    Dosage: 7.8 mg/l, unknown
    Start date: 2012-06-28

Zyvox
    Dosage: 600 mg, 2x/day
    Start date: 2012-05-31
    End date: 2012-06-26

Other drugs received by patient: Sertraline; Bisoprolol; Metformin; Tetrazepam; Pantoprazole; Aspegic 1000



Possible Zyvox side effects in

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

Patient:

Reactions: Platelet Count Decreased, Erythema Multiforme

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Betamethasone
    Dosage: unk mg, unk
    Start date: 2012-04-10
    End date: 2012-05-07

Flagyl
    Dosage: 1000 mg, unk
    Start date: 2012-04-29
    End date: 2012-05-12

Flagyl
    Dosage: 1000 mg, unk
    Administration route: Oral
    Indication: Pseudomembranous Colitis
    Start date: 2012-04-03
    End date: 2012-04-04

Vancomycin Hydrochloride
    Dosage: 1 g, unk
    Start date: 2012-04-16
    End date: 2012-04-29

Zyvox
    Dosage: 1200 mg, unk

Other drugs received by patient: Lebenin; Yunasupin; Gentamicin Sulfate; Dorner; Lebenin; Pydoxal; Nizoral; Methylprednisolone Sodium Succinate; Targocid; Dorner; Myser (Difluprednate); Olopatadine HCL; Prednisolone; Nicoranta; Plavix; Trichlormethiazide; Vancomycin Hydrochloride; Aspara K; Myser (Difluprednate); Plavix; Aldactone; Aspara K



Possible Zyvox side effects in 77 year old female

Reported by a consumer/non-health professional from United States on 2012-08-13

Patient: 77 year old female, weighing 79.4 kg (174.6 pounds)

Reactions: Movement Disorder, Oral Mucosal Blistering, Drug Ineffective, Mouth Ulceration, Oropharyngeal Pain, Rash, Limb Discomfort, Dyspepsia, Skin Odour Abnormal, Chest Pain

Drug(s) suspected as cause:
Zyvox

Other drugs received by patient: Lipitor



Possible Zyvox side effects in 45 year old female

Reported by a consumer/non-health professional from United States on 2012-08-13

Patient: 45 year old female, weighing 51.2 kg (112.7 pounds)

Reactions: Rash

Drug(s) suspected as cause:
Zyvox



Possible Zyvox side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-13

Patient: female

Reactions: Malaise, Infection

Drug(s) suspected as cause:
Lipitor
    Dosage: unk

Zoloft
    Dosage: unk

Zyvox
    Dosage: unk



Possible Zyvox side effects in female

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

Patient: female

Reactions: Viral Infection

Drug(s) suspected as cause:
Zyvox



Possible Zyvox side effects in

Reported by a physician from United States on 2012-08-09

Patient:

Reactions: Psychiatric Symptom, Depression

Drug(s) suspected as cause:
Zyvox



Possible Zyvox side effects in 24 year old male

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

Patient: 24 year old male

Reactions: Burning Sensation, Rash Generalised, Alopecia

Drug(s) suspected as cause:
Zyvox



Possible Zyvox side effects in 92 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-07

Patient: 92 year old male

Reactions: Anaemia, Thrombocytopenia

Adverse event resulted in: death

Drug(s) suspected as cause:
Zyvox

Other drugs received by patient: Acetaminophen; Betamethasone; Nexium; Ceftriaxone; Fluconazole; Digoxin; Tazobactam; Noxafil; Furosemide



Possible Zyvox side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-07

Patient: female

Reactions: Diarrhoea

Drug(s) suspected as cause:
Zyvox

Other drugs received by patient: Acidophilus



Possible Zyvox side effects in 65 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-07

Patient: 65 year old male, weighing 66.0 kg (145.2 pounds)

Reactions: Weight Decreased, Vomiting, Pancytopenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Clarithromycin
    Dosage: 500 mg, 2x/day
    Administration route: Oral
    Start date: 2012-05-31
    End date: 2012-06-26

Zyvox
    Dosage: 600 mg, 2x/day
    Administration route: Oral
    Start date: 2012-05-31
    End date: 2012-06-26

Other drugs received by patient: Prednisone TAB; Ketoprofen; Sertraline; Aspegic 1000; Methotrexate; Tetrazepam; Bisoprolol; Metformin; Pantoprazole



Possible Zyvox side effects in 78 year old male

Reported by a pharmacist from Japan on 2012-08-07

Patient: 78 year old male

Reactions: Angiopathy

Drug(s) suspected as cause:
Zyvox



Possible Zyvox side effects in 46 year old male

Reported by a physician from United States on 2012-08-06

Patient: 46 year old male

Reactions: Anxiety, Malaise, Nausea, Visual Impairment, Vision Blurred, Dizziness, Feeling Abnormal

Drug(s) suspected as cause:
Zyvox

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