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Clarithromycin (Clarithromycin) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to 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 (1300)
Death (155)
Life Threatening Events (110)
Disability (60)

Reports by Reaction Type

Drug Interaction (138)Dyspnoea (78)Renal Failure Acute (71)Vomiting (62)Pyrexia (61)Oedema Peripheral (61)Erythema (60)Diarrhoea (55)Nausea (52)Pruritus (51)Headache (48)Atrial Fibrillation (48)

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

Possible Clarithromycin side effects in 77 year old male

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

Patient: 77 year old male, weighing 47.0 kg (103.4 pounds)

Reactions: Interstitial Lung Disease, Bacterial Infection

Adverse event resulted in: death

Drug(s) suspected as cause:
Clarithromycin

Other drugs received by patient: Prednisolone; Ethambutol Hydrochloride; Rifampicin; Sulfasalazine; Ethyl Icosapentate; Rebamipide; Cherry Bark Extract; Loxoprofen Sodium



Possible Clarithromycin side effects in female

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

Patient: female

Reactions: Thinking Abnormal, Fatigue, Insomnia, Hypervigilance

Drug(s) suspected as cause:
Clarithromycin
    Dosage: to be taken every 12 hours
    Indication: Lower Respiratory Tract Infection

Clarithromycin
    Dosage: to be taken every 12 hrs replaced with paediatric syrup



Possible Clarithromycin side effects in male

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

Patient: male, weighing 77.2 kg (169.8 pounds)

Reactions: Sepsis, Pancytopenia

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
CC-4047
    Dosage: 4 milligram
    Administration route: Oral
    Start date: 2012-05-04
    End date: 2012-05-08

CC-4047
    Dosage: 4 milligram
    Administration route: Oral
    Indication: Multiple Myeloma
    Start date: 2012-04-12
    End date: 2012-04-16

CC-4047
    Dosage: 2 milligram
    Administration route: Oral
    Start date: 2012-05-08

CC-4047
    Dosage: 2 milligram
    Administration route: Oral
    Start date: 2012-04-27

Clarithromycin
    Dosage: 1000 milligram
    Administration route: Oral
    Indication: Multiple Myeloma
    Start date: 2012-04-12

Dexamethasone

Dexamethasone
    Dosage: 40 milligram
    Administration route: Oral
    Indication: Multiple Myeloma
    Start date: 2012-04-12

Revlimid
    Dosage: 5 milligram
    Administration route: Oral

Other drugs received by patient: Atenolol; Hydrocortisone; Omega-3 Fatty Acids; Potassium Chloride; Atorvastatin Calcium; Metformin HCL; Amlodipine; Vasotec; Glyburide; Zometa; Prilosec; Magnesium Oxide; Niaspan; Tylenol; Actos; Imodium; Valtrex; Aspirin; Darbepoetin Alfa-Polysorbate; Feosol; Hydrocortisone



Possible Clarithromycin side effects in male

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

Patient: male

Reactions: Chest Discomfort, Malaise, Face Oedema, Oedema Peripheral

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Clarithromycin



Possible Clarithromycin side effects in 63 year old female

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

Patient: 63 year old female

Reactions: Urticaria, Rash Maculo-Papular

Drug(s) suspected as cause:
Clarithromycin



Possible Clarithromycin side effects in 73 year old female

Reported by a physician from South Africa on 2012-08-25

Patient: 73 year old female

Reactions: Syncope, Dizziness

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Clarithromycin



Possible Clarithromycin side effects in male

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-24

Patient: male

Reactions: Renal Failure, Coma, Convulsion

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Acetaminophen
    Indication: Pain
    Start date: 2012-07-11

Acupan
    Indication: Pain
    Start date: 2012-07-16
    End date: 2012-07-27

Amikacin
    Indication: Atypical Mycobacterium Pericarditis
    Start date: 2012-07-11

Bactrim
    Administration route: Oral
    Indication: Atypical Mycobacterium Pericarditis
    Start date: 2012-07-13

Cernevit-12
    Indication: Vitamin Supplementation
    Start date: 2012-07-10
    End date: 2012-08-02

Clarithromycin
    Administration route: Oral
    Indication: Atypical Mycobacterium Pericarditis
    Start date: 2012-07-11

Isentress
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-05-01

Kaletra
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-03-01

Leucovorin Calcium
    Administration route: Oral
    Start date: 2012-07-10

Myambutol
    Dosage: 2 units
    Administration route: Oral
    Start date: 2012-07-11

Olanzapine
    Dosage: 1 unit
    Administration route: Oral
    Start date: 2012-01-01

Perikabiven
    Indication: Parenteral Nutrition
    Start date: 2012-07-10

Potassium Chloride
    Administration route: Oral
    Start date: 2012-07-10

Prazepam
    Dosage: 1 unit
    Administration route: Oral
    Start date: 2012-07-10

Rifabutin
    Administration route: Oral
    Indication: Atypical Mycobacterium Pericarditis
    Start date: 2012-07-11

Truvada
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-03-01



Possible Clarithromycin side effects in female

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-08-24

Patient: female, weighing 57.0 kg (125.4 pounds)

Reactions: Drug-Induced Liver Injury

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Clarithromycin

Other drugs received by patient: Avelox; Mucosolvan; Inavir; Antibiotics-Resistant Lactic Acid Bacteriae; Kakkontou; Medicon; Acetaminophen; Brocin; Apricot Kernal Water; Senega Syrup; Saibokuro (Herbal Medicine); Maoto; Keishito



Possible Clarithromycin side effects in female

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

Patient: female, weighing 30.0 kg (66.0 pounds)

Reactions: Transplant Failure, Hepatitis Fulminant

Adverse event resulted in: death, life threatening event, hospitalization, disablity

Drug(s) suspected as cause:
Acetaminophen
    Indication: Pyrexia

Alusa
    Indication: Pyrexia

Clarithromycin
    Indication: Pyrexia

Mucodyne
    Indication: Pyrexia



Possible Clarithromycin side effects in male

Reported by a health professional (non-physician/pharmacist) from Singapore on 2012-08-24

Patient: male

Reactions: Dyspnoea, Stridor, Wheezing

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ciprofloxacin HCL

Clarithromycin



Possible Clarithromycin side effects in female

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

Patient: female, weighing 15.2 kg (33.4 pounds)

Reactions: Drug-Induced Liver Injury

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Clarithromycin

Other drugs received by patient: Tipepidine Hibenzate; Onon; Nipolazin; Colistimethate Sodium W / Erythromycin Lactobio; Flomox; Mucodyne; Singulair; Periactin



Possible Clarithromycin side effects in 47 year old female

Reported by a health professional (non-physician/pharmacist) from Spain on 2012-08-24

Patient: 47 year old female

Reactions: Bipolar I Disorder, Psychotic Behaviour

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Clarithromycin

Other drugs received by patient: Omeprazole; Amoxicillin



Possible Clarithromycin side effects in 67 year old male

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

Patient: 67 year old male

Reactions: Large Intestine Perforation, Cardio-Respiratory Arrest, Pneumonia, Agranulocytosis, Pancytopenia, Septic Shock

Adverse event resulted in: life threatening event, hospitalization

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

Aspenon
    Indication: Arrhythmia Prophylaxis

Aspirin
    Dosage: combination granule
    Administration route: Oral
    Indication: Nasopharyngitis
    Start date: 2010-07-18

Clarithromycin
    Administration route: Oral
    Indication: Nasopharyngitis
    Start date: 2010-07-18

Doxazosin Mesylate
    Indication: Prophylaxis

Doxazosin Mesylate
    Indication: Hypertension

Lasix
    Indication: Product Used FOR Unknown Indication

Loxonin
    Indication: Product Used FOR Unknown Indication

Rabeprazole Sodium
    Indication: Drug Therapy

Voglibose
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Nsaid's; Cernilton; Prednisone TAB; Fosrenol; Warfarin Sodium; Opalmon; Sodium Polystyrene Sulfonate; Tamsulosin HCL; Atelec; Precipitated Calcium Carbonate; Colestimide; Olmesartan Medoxomil



Possible Clarithromycin side effects in male

Reported by a consumer/non-health professional from United Kingdom on 2012-08-23

Patient: male

Reactions: Jaundice, Faeces Pale, Nausea, Dizziness, Chromaturia, Rash, Decreased Appetite

Drug(s) suspected as cause:
Clarithromycin



Possible Clarithromycin side effects in 30 year old female

Reported by a health professional (non-physician/pharmacist) from Poland on 2012-08-23

Patient: 30 year old female

Reactions: Psychomotor Hyperactivity, Vomiting, Drug Effect Decreased, Body Mass Index Increased, Drug Interaction, Orthostatic Hypotension, Abnormal Behaviour, Condition Aggravated, Mucosal Dryness, Constipation, Menstrual Disorder, Diplopia, Oedema, Dizziness

Drug(s) suspected as cause:
Clarithromycin
    Indication: Respiratory Tract Infection

Gabapentin
    Indication: Post-Traumatic Epilepsy

Ketoconazole
    Dosage: 7 days
    Indication: Vaginal Lesion

Lamotrigine
    Indication: Post-Traumatic Epilepsy

Other drugs received by patient possibly interacting with the suspect drug:
Bromocriptine Mesylate
    Dosage: 7.5 mg/day
    Indication: Prolactinoma

Bromocriptine Mesylate
    Dosage: 15 mg

Bromocriptine Mesylate
    Dosage: 20 mg

Cabergoline
    Dosage: 0.25 mg, 2/week
    Indication: Prolactinoma

Cabergoline
    Dosage: 2 mg/ week

Oxcarbazepine
    Dosage: 1200 mg/day

Oxcarbazepine
    Dosage: 600 mg
    Indication: Post-Traumatic Epilepsy

Other drugs received by patient: Quinagolide



Possible Clarithromycin side effects in 36 year old male

Reported by a consumer/non-health professional from Germany on 2012-08-23

Patient: 36 year old male

Reactions: Overwork, Psychotic Disorder, Completed Suicide, Insomnia

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Clarithromycin
    Dosage: 750 mg, 1x/day
    Indication: Crohn's Disease

Mycobutin
    Dosage: 300 mg, 1x/day
    Administration route: Oral
    Indication: Crohn's Disease



Possible Clarithromycin side effects in

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

Patient:

Reactions: Pruritus, Hypersensitivity, Pain, Scab, Petechiae, Eczema, Erythema, Rash Pruritic, Oedema Peripheral, Blood Creatinine Increased, Stevens-Johnson Syndrome, Blister, Renal Failure Acute, Fluid Overload, Rash Generalised, Atrial Fibrillation, Toxic Epidermal Necrolysis, DRY Skin, Haemoglobin Decreased, Exfoliative Rash, Swelling, Rash Maculo-Papular

Adverse event resulted in: death

Drug(s) suspected as cause:
Bumetanide

Clarithromycin
    Dosage: 500 mg, bid
    Administration route: Oral
    Indication: Pneumonia
    Start date: 2012-05-12
    End date: 2012-05-21

Spironolactone

Zocor
    Administration route: Oral

Other drugs received by patient: Amiodarone HCL; Amoxicillin and Clavulanate Potassium; Furosemide; Methotrexate; Adenosine; Dioralyte; Fortisip; Heparin; Omeprazole; Adcal-D3; Teicoplanin; Warfarin Sodium; Dalteparin Sodium; Diclofenac Diethylamine; Folic Acid; Gentamicin; Metoclopramide; Bisoprolol Fumarate; Candesartan Cilexetil; Acetaminophen and Codeine Phosphate; Clotrimazole; Acetaminophen; Tramadol Hydrochloride



Possible Clarithromycin side effects in

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

Patient:

Reactions: Electrocardiogram QT Prolonged

Drug(s) suspected as cause:
Amiodarone HCL
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Chlorpromazine HCL
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Clarithromycin
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Domperidone
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Famotidine
    Dosage: unk
    Indication: Product Used FOR Unknown Indication



Possible Clarithromycin side effects in male

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

Patient: male

Reactions: Malaise, Chest Discomfort, Face Oedema, Oedema Peripheral

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Clarithromycin
    Dosage: 2 df per day
    Administration route: Oral
    Indication: Helicobacter Infection
    Start date: 2012-06-11
    End date: 2012-06-17

Levofloxacin
    Dosage: 2 df daily
    Administration route: Oral
    Indication: Helicobacter Infection
    Start date: 2011-06-11
    End date: 2012-06-17

Rabeprazole Sodium
    Dosage: 2 df
    Administration route: Oral
    Indication: Helicobacter Infection
    Start date: 2012-06-11
    End date: 2012-06-17



Possible Clarithromycin side effects in 67 year old male

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

Patient: 67 year old male

Reactions: Large Intestine Perforation, Agranulocytosis, Pancytopenia, Septic Shock

Adverse event resulted in: life threatening event, hospitalization

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

PL Gran.

Other drugs received by patient: Antiiarrhythmia; Nsaid's; Prednisone TAB; Hypotensive; PPI



Possible Clarithromycin side effects in female

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

Patient: female

Reactions: Dyspnoea, Erythema, Prurigo

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Clarithromycin
    Administration route: Oral
    Indication: Bronchitis
    Start date: 2011-01-26
    End date: 2011-01-27

Lamaline
    Indication: Bronchitis
    Start date: 2011-01-26
    End date: 2011-01-27

Polery Adulte
    Administration route: Oral
    Indication: Bronchitis
    Start date: 2011-01-26
    End date: 2011-01-27

Other drugs received by patient: Symbicort; Olmesartan Medoxomil and Hydrochlorothizide; Spiriva; Prednisolone; Nebivolol



Possible Clarithromycin side effects in male

Reported by a physician from Italy on 2012-08-21

Patient: male

Reactions: Malaise, Chest Discomfort, Face Oedema, Oedema Peripheral

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Clarithromycin
    Administration route: Oral
    Indication: Helicobacter Infection
    Start date: 2012-06-11

Levofloxacin
    Administration route: Oral
    Indication: Helicobacter Infection
    Start date: 2012-06-11

Rabeprazole Sodium
    Administration route: Oral
    Indication: Helicobacter Infection
    Start date: 2012-06-11
    End date: 2012-06-17



Possible Clarithromycin side effects in 65 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-21

Patient: 65 year old female

Reactions: Mania

Drug(s) suspected as cause:
Clarithromycin
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Omeprazole
    Dosage: unk
    Indication: Product Used FOR Unknown Indication



Possible Clarithromycin side effects in

Reported by a health professional (non-physician/pharmacist) from Iran (Islamic Republic OF) on 2012-08-21

Patient:

Reactions: Vomiting, Nausea, Headache, Toxicity To Various Agents, Drug Abuse, Convulsion, Suicidal Ideation, Depressed Level of Consciousness

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Acetaminophen

Acetaminophen
    Indication: Product Used FOR Unknown Indication

Benzodiazepine Derivatives
    Indication: Product Used FOR Unknown Indication

Clarithromycin
    Indication: Product Used FOR Unknown Indication

Naltrexone Hydrochloride
    Indication: Product Used FOR Unknown Indication

Tramadol Hydrochloride
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication



Possible Clarithromycin side effects in male

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

Patient: male

Reactions: Faeces Pale, Jaundice, Nausea, Dizziness, Chromaturia, Rash, Decreased Appetite

Drug(s) suspected as cause:
Clarithromycin



Possible Clarithromycin side effects in 79 year old female

Reported by a pharmacist from United Kingdom on 2012-08-21

Patient: 79 year old female, weighing 55.5 kg (122.0 pounds)

Reactions: Hypersensitivity, Pruritus, Pain, Scab, Petechiae, Eczema, Erythema, Rash Pruritic, Oedema Peripheral, Blood Creatinine Increased, Blister, Stevens-Johnson Syndrome, Renal Failure Acute, Fluid Overload, Rash Generalised, Atrial Fibrillation, Toxic Epidermal Necrolysis, DRY Skin, Haemoglobin Decreased, Exfoliative Rash, Swelling, Rash Maculo-Papular

Adverse event resulted in: death

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

Clarithromycin
    Dosage: 500 mg, 2x/day
    Administration route: Oral
    Indication: Pneumonia
    Start date: 2012-05-12
    End date: 2012-05-21

Spironolactone
    Dosage: unk

Zocor
    Dosage: unk
    Administration route: Oral

Other drugs received by patient: Amiodarone HCL; Diclofenac Diethylammonium Salt; Gentamicin; Adenosine; Furosemide; Candesartan Cilexetil; Amoxicillin and Clavulanate Potassium; Bisoprolol Fumarate; Adcal-D3; Dalteparin Sodium; Heparin; Clotrimazole; Fortisip; Omeprazole; Teicoplanin; Methotrexate; Folic Acid; Acetaminophen and Codeine Phosphate; Dioralyte; Metoclopramide; Tramadol HCL; Warfarin Sodium; Paracetamol



Possible Clarithromycin side effects in 79 year old female

Reported by a pharmacist from United Kingdom on 2012-08-20

Patient: 79 year old female, weighing 55.4 kg (121.9 pounds)

Reactions: Pruritus, Pulmonary Embolism, Eczema, Erythema, Rash Pruritic, Oedema Peripheral, Blood Creatinine Increased, Blister, Toxic Epidermal Necrolysis, Skin Tightness, Staphylococcal Scalded Skin Syndrome, Exfoliative Rash, Vasculitis, Rash Maculo-Papular, Hypersensitivity, Skin Exfoliation, Scab, Adverse Drug Reaction, Pain, Petechiae, Skin Swelling, Stevens-Johnson Syndrome, Renal Failure Acute, Fluid Overload, Rash Generalised, Atrial Fibrillation, DRY Skin, Rash, Pulmonary Fibrosis, Skin Irritation, Mucosal Erosion, Haemoglobin Decreased, Diarrhoea, Skin Erosion

Adverse event resulted in: death

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

Amoxicillin
    Indication: Product Used FOR Unknown Indication

Bumetanide
    Indication: Product Used FOR Unknown Indication

Clarithromycin
    Administration route: Oral
    Indication: Pneumonia
    Start date: 2012-05-12
    End date: 2012-05-21

Methotrexate
    Indication: Product Used FOR Unknown Indication

Simvastatin
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Spironolactone
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Dalteparin Sodium; Candesartan Cilexetil; Bisoprolol Fumarate; Bisoprolol Fumarate; Clotrimazole; Fortisip; Diclofenac Diethylammonium Salt; Adenosine; Furosemide; Acetaminophen; Tramadol HCL; Acetaminophen and Codeine Phosphate; Teicoplanin; Adcal-D3; Dioralyte; Gentamicin; Amoxicillin and Clavulanate Potassium; Heparin; Folic Acid; Omeprazole; Metoclopramide



Possible Clarithromycin side effects in 8 year old female

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

Patient: 8 year old female

Reactions: Drug-Induced Liver Injury, Hepatitis Fulminant

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Acetaminophen
    Indication: Pyrexia

Alusa
    Indication: Pyrexia

Clarithromycin
    Indication: Pyrexia

Mucodyne
    Indication: Pyrexia



Possible Clarithromycin side effects in 80 year old male

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

Patient: 80 year old male

Reactions: Hepatic Function Abnormal, Condition Aggravated

Adverse event resulted in: death

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

Clarithromycin

Other drugs received by patient: Lvfx; Mino; Frpm; Lvfx



Possible Clarithromycin side effects in 47 year old female

Reported by a physician from Spain on 2012-08-18

Patient: 47 year old female

Reactions: Bipolar I Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Clarithromycin

Other drugs received by patient: Amoxicillin; Omeprazole

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