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Biaxin (Clarithromycin) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Biaxin (Clarithromycin) 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 (133)
Death (8)
Life Threatening Events (2)
Disability (2)

Reports by Reaction Type

Drug Hypersensitivity (16)Drug Interaction (12)Nausea (12)Rash (11)Malaise (10)Drug Ineffective (9)Urticaria (9)Paraesthesia (8)Arthralgia (8)Thrombosis (7)Transient Ischaemic Attack (7)Vomiting (7)

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

Possible Biaxin side effects in 36 year old female

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

Patient: 36 year old female

Reactions: Drug Hypersensitivity

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

Effexor
    Dosage: unk

Paxil
    Dosage: unk

Biaxin
    Dosage: unk



Possible Biaxin side effects in 29 year old male

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

Patient: 29 year old male

Reactions: Chest Pain, Drug Interaction, Dizziness, Obstructive Airways Disorder

Drug(s) suspected as cause:
Biaxin

Other drugs received by patient possibly interacting with the suspect drug:
Fluticasone Propionate
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Prednisone TAB



Possible Biaxin side effects in female

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

Patient: female

Reactions: Oral Mucosal Blistering

Drug(s) suspected as cause:
Biaxin



Possible Biaxin side effects in 50 year old female

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

Patient: 50 year old female

Reactions: Oral Mucosal Blistering

Drug(s) suspected as cause:
Biaxin



Possible Biaxin side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-01

Patient:

Reactions: Drug Hypersensitivity

Drug(s) suspected as cause:
Provigil

Zetia
    Administration route: Oral

Zocor
    Administration route: Oral

Arthrotec
    Administration route: Oral

Livalo

Ambien CR

Lipitor
    Administration route: Oral

Sulfamethoxazole

Cefzil

PCE

Amoxicillin
    Dosage: 0.5, qd

Pravachol

Oxacillin Sodium

Biaxin

Ultram

Lortab



Possible Biaxin side effects in 74 year old female

Reported by a consumer/non-health professional from United States on 2012-06-29

Patient: 74 year old female, weighing 48.5 kg (106.7 pounds)

Reactions: Swelling Face, Nausea, Skin Cancer, Paraesthesia

Drug(s) suspected as cause:
Daliresp
    Administration route: Oral
    Indication: Chronic Obstructive Pulmonary Disease
    Start date: 2012-03-01

Biaxin
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-05-01

Other drugs received by patient: Spironolactone; Thyroid TAB; Acetaminophen



Possible Biaxin side effects in female

Reported by a physician from United States on 2012-06-26

Patient: female

Reactions: Drug Hypersensitivity

Drug(s) suspected as cause:
Arthrotec
    Dosage: unk
    Administration route: Oral

Sulfamethoxazole
    Dosage: unk

Ultram
    Dosage: unk

Lipitor
    Dosage: unk
    Administration route: Oral

Lortab
    Dosage: unk

Pravachol
    Dosage: unk

Oxacillin Sodium
    Dosage: unk

PCE
    Dosage: unk

Zetia
    Dosage: unk

Ambien CR
    Dosage: unk

Amoxicillin
    Dosage: 0.5 unk, 1x/day

Biaxin
    Dosage: unk

Cefzil
    Dosage: unk

Zocor
    Dosage: unk

Livalo
    Dosage: unk

Provigil
    Dosage: unk



Possible Biaxin side effects in

Reported by a physician from United States on 2012-06-21

Patient:

Reactions: Drug Hypersensitivity, Heart Rate Increased, Heart Rate Irregular

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

Biaxin
    Dosage: unk



Possible Biaxin side effects in male

Reported by a physician from United States on 2012-06-19

Patient: male

Reactions: Drug Hypersensitivity

Drug(s) suspected as cause:
Penicillin G Potassium
    Dosage: unk

Biaxin
    Dosage: unk



Possible Biaxin side effects in female

Reported by a physician from United States on 2012-06-14

Patient: female

Reactions: Drug Hypersensitivity

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

Vibramycin
    Dosage: unk

Percodan
    Dosage: unk

Nystatin
    Dosage: unk

Clonidine HCL
    Dosage: unk

Biaxin
    Dosage: unk

Demerol
    Dosage: unk

Bexxar
    Dosage: unk



Possible Biaxin side effects in 74 year old female

Reported by a consumer/non-health professional from United States on 2012-06-12

Patient: 74 year old female, weighing 48.5 kg (106.7 pounds)

Reactions: Swelling Face, Nausea, Skin Cancer, Paraesthesia

Drug(s) suspected as cause:
Biaxin
    Start date: 2012-05-01

Daliresp
    Dosage: 500 mcg
    Administration route: Oral
    Indication: Chronic Obstructive Pulmonary Disease
    Start date: 2012-03-01

Other drugs received by patient: Acetaminophen; Thyroid TAB; Spironolactone



Possible Biaxin side effects in male

Reported by a physician from United States on 2012-06-12

Patient: male

Reactions: Psychotic Disorder, Physical Assault

Drug(s) suspected as cause:
Biaxin



Possible Biaxin side effects in 61 year old female

Reported by a pharmacist from Canada on 2012-05-29

Patient: 61 year old female

Reactions: Sudden Hearing Loss, Oedema Peripheral, Deafness

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Rituximab
    Dosage: initial dose
    Indication: non-Hodgkin's Lymphoma
    Start date: 2007-11-01

Rituximab
    Dosage: maintenance dose, every 3 months
    End date: 2009-11-01

Biaxin
    Indication: Product Used FOR Unknown Indication
    Start date: 2009-11-12

Other drugs received by patient: Calcium; Prednisone; Vincristine Sulfate; Vitamin D; Amoxicillin and Clavulanate Potassium; Cyclophosphamide; Doxorubicin Hydrochloride



Possible Biaxin side effects in 61 year old female

Reported by a pharmacist from Canada on 2012-05-29

Patient: 61 year old female

Reactions: Sudden Hearing Loss, Oedema Peripheral, Deafness

Drug(s) suspected as cause:
Rituxan
    Indication: non-Hodgkin's Lymphoma
    Start date: 2007-11-01
    End date: 2009-11-01

Biaxin
    Indication: Product Used FOR Unknown Indication
    Start date: 2009-11-12

Other drugs received by patient: Chop (Cyclophosphamide, Hydroxydaunorubicin, Vincristine, Prednisone); Calcium; Calcium; Rituxan; Cyclophosphamide; Vitamin D; Prednisone; Amoxicillin and Clavulanate Potassium; Doxorubicin Hydrochloride; Vincristine Sulfate



Possible Biaxin side effects in male

Reported by a consumer/non-health professional from United States on 2012-05-25

Patient: male, weighing 89.4 kg (196.8 pounds)

Reactions: Anxiety, Blood Glucose Decreased, Agitation, Dyskinesia, Memory Impairment, Mobility Decreased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Biaxin



Possible Biaxin side effects in female

Reported by a consumer/non-health professional from United States on 2012-05-22

Patient: female, weighing 81.7 kg (179.6 pounds)

Reactions: Drug Ineffective, Fungal Infection, Urinary Tract Infection, Sinusitis, Infection

Drug(s) suspected as cause:
Omnicef
    Indication: Infection

Biaxin
    Administration route: Oral
    Indication: Infection

Remicade
    Indication: Crohn's Disease
    Start date: 2002-01-01
    End date: 2011-02-26

Zithromax
    Administration route: Oral
    Indication: Infection



Possible Biaxin side effects in female

Reported by a consumer/non-health professional from United States on 2012-05-18

Patient: female

Reactions: Drug Hypersensitivity

Drug(s) suspected as cause:
Prilosec

Nexium

Codeine Sulfate

Potassium Penicillin G

Biaxin



Possible Biaxin side effects in female

Reported by a consumer/non-health professional from United States on 2012-05-16

Patient: female

Reactions: Rash Generalised, Helicobacter Infection

Drug(s) suspected as cause:
Soliris
    Dosage: unk
    Indication: Paroxysmal Nocturnal Haemoglobinuria

Biaxin
    Dosage: 50 mg, bid
    Indication: Helicobacter Infection
    Start date: 2012-02-15
    End date: 2012-02-26

Amoxicillin
    Dosage: 500 mg, bid
    Indication: Helicobacter Infection
    Start date: 2012-02-15
    End date: 2012-02-26



Possible Biaxin side effects in 27 year old female

Reported by a physician from United States on 2012-05-15

Patient: 27 year old female

Reactions: Dyspnoea, Oedema Mouth

Drug(s) suspected as cause:
Biaxin



Possible Biaxin side effects in 45 year old female

Reported by a individual with unspecified qualification from United States on 2012-05-14

Patient: 45 year old female, weighing 79.4 kg (174.6 pounds)

Reactions: Drug Hypersensitivity, Swelling, Throat Tightness

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Biaxin
    Dosage: 2 once daily
    Indication: Nasopharyngitis
    Start date: 2006-12-06

Ciprofloxacin HCL
    Indication: Nasopharyngitis
    Start date: 2006-12-08

Other drugs received by patient: Amlodipine Besylate; Tramadol HCL; Dexilant; Premarin



Possible Biaxin side effects in 27 year old female

Reported by a consumer/non-health professional from United States on 2012-05-11

Patient: 27 year old female

Reactions: Dyspnoea, Oedema Mouth

Drug(s) suspected as cause:
Biaxin



Possible Biaxin side effects in male

Reported by a physician from Canada on 2012-05-11

Patient: male

Reactions: Acute Pulmonary Oedema, Cardiac Failure, Drug Interaction, Toxicity To Various Agents, Serotonin Syndrome

Adverse event resulted in: death

Drug(s) suspected as cause:
Biaxin

Other drugs received by patient possibly interacting with the suspect drug:
Biaxin
    Indication: Sinusitis

Nyquil
    Indication: Cough

Prozac
    Indication: Bipolar Disorder

Benylin DM
    Indication: Cough

Dextromorphan HBR
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Wellbutrin; Zyprexa; Restoril



Possible Biaxin side effects in 64 year old male

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

Patient: 64 year old male

Reactions: Acute Pulmonary Oedema, Cardiac Failure, Drug Interaction, Toxicity To Various Agents, Serotonin Syndrome

Adverse event resulted in: death

Drug(s) suspected as cause:
Biaxin

Other drugs received by patient possibly interacting with the suspect drug:
Nyquil
    Indication: Cough

Benylin DM
    Indication: Cough

Prozac
    Indication: Bipolar Disorder



Possible Biaxin side effects in 64 year old male

Reported by a physician from Canada on 2012-05-01

Patient: 64 year old male

Reactions: Acute Pulmonary Oedema, Cardiac Failure, Drug Interaction, Serotonin Syndrome, Toxicity To Various Agents

Adverse event resulted in: death

Drug(s) suspected as cause:
Biaxin

Other drugs received by patient possibly interacting with the suspect drug:
Nyquil
    Indication: Cough

Benylin DM
    Indication: Cough

Prozac
    Indication: Bipolar Disorder



Possible Biaxin side effects in female

Reported by a physician from United States on 2012-04-30

Patient: female

Reactions: Drug Hypersensitivity

Drug(s) suspected as cause:
E-Mycin
    Dosage: unk

Paxil
    Dosage: unk

Biaxin
    Dosage: unk

Tagamet
    Dosage: unk

Nexium
    Dosage: unk

Gabapentin
    Dosage: unk

Celexa
    Dosage: unk



Possible Biaxin side effects in 64 year old male

Reported by a physician from Canada on 2012-04-30

Patient: 64 year old male

Reactions: Cardiac Failure, Drug Interaction, Pulmonary Oedema, Toxicity To Various Agents, Serotonin Syndrome

Adverse event resulted in: death

Drug(s) suspected as cause:
Biaxin

Other drugs received by patient possibly interacting with the suspect drug:
Nyquil
    Indication: Cough

Benylin DM
    Indication: Cough

Prozac
    Indication: Bipolar Disorder



Possible Biaxin side effects in female

Reported by a physician from United States on 2012-04-18

Patient: female

Reactions: Drug Hypersensitivity

Drug(s) suspected as cause:
Oxycodone Hydrochloride
    Dosage: unk

Tramadol HCL
    Dosage: unk

Biaxin
    Dosage: unk



Possible Biaxin side effects in 23 year old male

Reported by a pharmacist from United States on 2012-04-12

Patient: 23 year old male

Reactions: Therapeutic Response Unexpected, Paralysis, Abnormal Behaviour, Toxicity To Various Agents, Aggression, Mania, Psychotic Disorder, Road Traffic Accident, Insomnia, Hallucination, Chemical Injury

Drug(s) suspected as cause:
Biaxin



Possible Biaxin side effects in

Reported by a individual with unspecified qualification from United States on 2012-04-10

Patient:

Reactions: Medication Error, Drug Name Confusion, Rectal Haemorrhage, Chest Pain, Drug Dispensing Error

Drug(s) suspected as cause:
Biaxin
    Dosage: tablet
    Administration route: Oral

Robaxin
    Dosage: tablet
    Administration route: Oral



Possible Biaxin side effects in female

Reported by a consumer/non-health professional from United States on 2012-04-09

Patient: female, weighing 58.5 kg (128.7 pounds)

Reactions: Thrombosis, Malaise, Fibromyalgia, Arthralgia, Atrial Fibrillation, Factor V Leiden Mutation, Transient Ischaemic Attack, Cardiac Disorder

Drug(s) suspected as cause:
Atorvastatin
    Dosage: 40 mg, unk
    Administration route: Oral
    Indication: Blood Cholesterol Increased

Clopidogrel
    Indication: Factor V Leiden Mutation

Tricor
    Indication: Factor V Leiden Mutation

Biaxin
    Indication: Product Used FOR Unknown Indication

Protonix
    Indication: Product Used FOR Unknown Indication

Warfarin Sodium
    Indication: Factor V Leiden Mutation

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