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Zithromax (Azithromycin) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Zithromax (Azithromycin) 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 (533)
Death (45)
Life Threatening Events (39)
Disability (15)

Reports by Reaction Type

Drug Hypersensitivity (40)Drug Ineffective (34)Diarrhoea (32)Rash (29)Pyrexia (28)Dyspnoea (21)Hypersensitivity (20)Urticaria (19)Malaise (19)Pneumonia (19)Rhabdomyolysis (17)Nausea (16)

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

Possible Zithromax side effects in 38 year old male

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

Patient: 38 year old male, weighing 43.0 kg (94.6 pounds)

Reactions: Electrocardiogram QT Prolonged, Ventricular Tachycardia, Ventricular Fibrillation

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Zithromax

Other drugs received by patient: Hydrocortone; Midazolam; Norepinephrine Bitartrate; Cefepime Dihydrochloride Hydrate; Lactec; Isotonic Sodium Chloride; Plasma Protein Fraction (Human); Fentanyl; Humulin R



Possible Zithromax side effects in

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

Patient:

Reactions: Migraine

Drug(s) suspected as cause:
Azithromycin
    Dosage: 250 mg, unk (tablets)

Brompheniramine Maleate
    Dosage: unk

Zithromax
    Dosage: unk



Possible Zithromax side effects in 87 year old female

Reported by a physician from Japan on 2012-08-22

Patient: 87 year old female, weighing 42.4 kg (93.3 pounds)

Reactions: Renal Impairment, Atrioventricular Block, Stress Cardiomyopathy, Long QT Syndrome

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Omegacin
    Dosage: unk
    Indication: Pneumonia
    Start date: 2012-06-04
    End date: 2012-06-10

Zithromax
    Dosage: 500 mg, 1x/day
    Indication: Respiratory Tract Infection
    Start date: 2012-06-04
    End date: 2012-06-08

Zithromax
    Indication: Pneumonia



Possible Zithromax side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-22

Patient: female

Reactions: Anxiety, Seasonal Allergy, Drug Ineffective, Sinus Headache

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

Zithromax
    Dosage: unk



Possible Zithromax side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-20

Patient: female

Reactions: Malaise, Dependence

Drug(s) suspected as cause:
Zithromax



Possible Zithromax side effects in 102 year old female

Reported by a consumer/non-health professional from United States on 2012-08-20

Patient: 102 year old female, weighing 51.2 kg (112.7 pounds)

Reactions: Activities of Daily Living Impaired, Blindness

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Zithromax

Other drugs received by patient: Nitro-DUR; Diovan



Possible Zithromax side effects in

Reported by a pharmacist from Japan on 2012-08-20

Patient:

Reactions: Pneumonia, Drug Ineffective

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Zithromax



Possible Zithromax side effects in 49 year old female

Reported by a consumer/non-health professional from United States on 2012-08-17

Patient: 49 year old female

Reactions: Flushing, Dyspnoea, Immediate Post-Injection Reaction

Drug(s) suspected as cause:
Copaxone
    Dosage: 20 mg, unk
    Indication: Multiple Sclerosis
    Start date: 2012-07-07

Zithromax
    Dosage: unk
    Indication: Bronchitis
    Start date: 2012-07-01
    End date: 2012-07-01



Possible Zithromax side effects in 12 year old female

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

Patient: 12 year old female, weighing 39.0 kg (85.8 pounds)

Reactions: Nausea, Loss of Consciousness

Drug(s) suspected as cause:
Acetaminophen
    Indication: Mycoplasma Infection

Acetaminophen
    Dosage: 300 mg/day, as needed
    Administration route: Oral
    Indication: Upper Respiratory Tract Inflammation
    Start date: 2012-07-24
    End date: 2012-07-24

Zithromax
    Dosage: 500 mg, 1x/day
    Administration route: Oral
    Indication: Mycoplasma Infection
    Start date: 2012-07-24
    End date: 2012-07-24

Zithromax
    Indication: Respiratory Tract Inflammation



Possible Zithromax side effects in 58 year old female

Reported by a consumer/non-health professional from United States on 2012-08-17

Patient: 58 year old female, weighing 68.0 kg (149.7 pounds)

Reactions: Flushing, Malaise, Oral Candidiasis, Fungal Infection, Rash

Drug(s) suspected as cause:
Zithromax
    Dosage: 250 mg, unk
    Indication: Upper Respiratory Tract Infection

Zithromax
    Indication: Influenza



Possible Zithromax side effects in 12 year old female

Reported by a pharmacist from Japan on 2012-08-16

Patient: 12 year old female, weighing 39.0 kg (85.8 pounds)

Reactions: Nausea, Loss of Consciousness

Drug(s) suspected as cause:
Acetaminophen
    Indication: Mycoplasma Infection

Acetaminophen
    Dosage: 300 mg/day, as needed
    Administration route: Oral
    Indication: Upper Respiratory Tract Inflammation
    Start date: 2012-07-24
    End date: 2012-07-24

Zithromax
    Dosage: 500 mg, 1x/day
    Administration route: Oral
    Indication: Mycoplasma Infection
    Start date: 2012-07-24
    End date: 2012-07-24

Zithromax
    Indication: Respiratory Tract Inflammation



Possible Zithromax side effects in 18 year old female

Reported by a physician from United States on 2012-08-14

Patient: 18 year old female, weighing 69.3 kg (152.6 pounds)

Reactions: Pneumonia, Respiratory Disorder, Urinary Tract Infection, Toxic Epidermal Necrolysis

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Lamictal
    Indication: Anger

Lamictal
    Indication: Bipolar I Disorder

Lamictal
    Dosage: 50 mg, extended tab
    Administration route: Oral
    Indication: Bipolar Disorder
    Start date: 2012-02-23
    End date: 2012-03-08

Naproxen
    Dosage: 500 mg, as needed
    Indication: Ligament Sprain
    Start date: 2012-02-22

Zithromax
    Dosage: 250 mg, daily (2 on 1st day and once daily for 4 days): duration of treatment: 5 days
    Administration route: Oral
    Indication: Sinusitis
    Start date: 2012-03-07
    End date: 2012-03-09

Other drugs received by patient: Flexeril



Possible Zithromax side effects in 18 year old female

Reported by a physician from United States on 2012-08-14

Patient: 18 year old female, weighing 69.3 kg (152.6 pounds)

Reactions: Pneumonia, Respiratory Disorder, Urinary Tract Infection, Toxic Epidermal Necrolysis

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Lamictal
    Dosage: 50 mg, extended tab
    Administration route: Oral
    Indication: Bipolar Disorder
    Start date: 2012-02-23
    End date: 2012-03-08

Lamictal
    Indication: Bipolar I Disorder

Lamictal
    Indication: Anger

Naproxen
    Dosage: 500 mg, as needed
    Indication: Ligament Sprain
    Start date: 2012-02-22

Zithromax
    Dosage: 250 mg, daily (2 on 1st day and once daily for 4 days): duration of treatment: 5 days
    Administration route: Oral
    Indication: Sinusitis
    Start date: 2012-03-07
    End date: 2012-03-09

Other drugs received by patient: Flexeril



Possible Zithromax side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-14

Patient: female

Reactions: Dependence

Drug(s) suspected as cause:
Zithromax



Possible Zithromax side effects in 22 year old male

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

Patient: 22 year old male, weighing 53.0 kg (116.6 pounds)

Reactions: Cytolytic Hepatitis, Cholestasis

Drug(s) suspected as cause:
Pravastatin
    Dosage: 40 mg, 1x/day
    Administration route: Oral
    End date: 2012-07-26

Zithromax
    Dosage: 2 df, 1x/day
    Administration route: Oral
    End date: 2012-07-26

Other drugs received by patient: Tenormin; Bactrim; Cell Cept; Domperidone; Valganciclovir; Vitamin D; Tacrolimus; Prednisone TAB; Tranxene; Imodium; Creon; Nexium



Possible Zithromax side effects in 93 year old female

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

Patient: 93 year old female, weighing 42.2 kg (92.8 pounds)

Reactions: Hypoglycaemia, Drug Interaction

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Zithromax

Other drugs received by patient possibly interacting with the suspect drug:
Amaryl
    Dosage: 1 mg, 1x/day
    Administration route: Oral
    Indication: Type 2 Diabetes Mellitus
    Start date: 2009-06-18
    End date: 2012-07-18

Other drugs received by patient: Detantol; Methista; Posterisan Forte; Senevacul; Shinluck; Zesulan; Acecol



Possible Zithromax side effects in 82 year old male

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

Patient: 82 year old male

Reactions: Pneumonia, Blood Potassium Increased

Adverse event resulted in: death

Drug(s) suspected as cause:
Zithromax



Possible Zithromax side effects in 46 year old

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

Patient: 46 year old

Reactions: Drug Hypersensitivity

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

Phenergan HCL
    Dosage: unk

Phentermine
    Dosage: unk

Tetracycline HCL
    Dosage: unk

Tizanidine
    Dosage: unk

Zithromax
    Dosage: unk



Possible Zithromax side effects in 57 year old female

Reported by a physician from United States on 2012-08-10

Patient: 57 year old female

Reactions: Nausea, Drug Hypersensitivity

Drug(s) suspected as cause:
Zithromax



Possible Zithromax side effects in 40 year old female

Reported by a physician from Japan on 2012-08-09

Patient: 40 year old female

Reactions: Haematochezia

Drug(s) suspected as cause:
Zithromax

Other drugs received by patient: Mucodyne



Possible Zithromax side effects in 27 year old male

Reported by a pharmacist from Japan on 2012-08-09

Patient: 27 year old male

Reactions: NO Adverse Event

Drug(s) suspected as cause:
Zithromax



Possible Zithromax side effects in 75 year old female

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

Patient: 75 year old female

Reactions: Haematochezia, Polyp, Enterocolitis

Drug(s) suspected as cause:
Ibruprofen
    Indication: Nasopharyngitis

Ibruprofen
    Dosage: 100 mg, 3x/day
    Administration route: Oral
    Indication: Cough
    Start date: 2012-05-07
    End date: 2012-05-08

Toclase
    Dosage: 30 mg, 2x/day
    Administration route: Oral
    Indication: Cough
    Start date: 2012-05-07
    End date: 2012-05-08

Toclase
    Indication: Nasopharyngitis

Zithromax
    Dosage: 500 mg, 1x/day
    Administration route: Oral
    Indication: Cough
    Start date: 2012-05-07
    End date: 2012-05-08

Zithromax
    Indication: Nasopharyngitis

Other drugs received by patient: Crestor; Baycaron



Possible Zithromax side effects in 12 year old female

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

Patient: 12 year old female

Reactions: Nausea, Loss of Consciousness

Drug(s) suspected as cause:
Acetaminophen
    Dosage: 300 mg/day
    Start date: 2012-07-24

Zithromax
    Dosage: 500 mg, 1x/day
    Administration route: Oral
    Indication: Pneumonia Mycoplasmal
    Start date: 2012-07-24



Possible Zithromax side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-06

Patient: female

Reactions: Abdominal Discomfort

Drug(s) suspected as cause:
Zithromax



Possible Zithromax side effects in 57 year old female

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

Patient: 57 year old female

Reactions: Nausea, Drug Hypersensitivity

Drug(s) suspected as cause:
Zithromax



Possible Zithromax side effects in

Reported by a consumer/non-health professional from United States on 2012-08-06

Patient:

Reactions: Oral Candidiasis, Fungal Infection

Drug(s) suspected as cause:
Zithromax



Possible Zithromax side effects in 68 year old female

Reported by a consumer/non-health professional from United States on 2012-08-02

Patient: 68 year old female

Reactions: Drug Ineffective

Drug(s) suspected as cause:
Zithromax



Possible Zithromax side effects in 27 year old male

Reported by a pharmacist from Japan on 2012-08-01

Patient: 27 year old male

Reactions: NO Adverse Event

Drug(s) suspected as cause:
Zithromax



Possible Zithromax side effects in 40 year old female

Reported by a physician from Japan on 2012-07-31

Patient: 40 year old female

Reactions: Haematochezia

Drug(s) suspected as cause:
Zithromax

Other drugs received by patient: Mucodyne



Possible Zithromax side effects in 68 year old female

Reported by a pharmacist from Japan on 2012-07-31

Patient: 68 year old female

Reactions: Hallucination, Auditory, Hallucination, Visual

Drug(s) suspected as cause:
Vfend
    Dosage: 100 mg, 2x/day
    Administration route: Oral

Zithromax
    Dosage: 500 mg, 1x/day
    Administration route: Oral
    Indication: Pneumonia
    Start date: 2012-06-15
    End date: 2012-06-17

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