This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Metronidazole 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 (574)
Death (60)
Life Threatening Events (45)
Disability (37)
Reports by Reaction Type
Vomiting (66),
Nausea (56),
Pyrexia (31),
Toxic Encephalopathy (31),
Dizziness (30),
Diarrhoea (30),
Dysarthria (29),
Hepatotoxicity (27),
Oedema (26),
Drug Rash With Eosinophilia and Systemic Symptoms (25),
Paraesthesia (25),
Gait Disturbance (24)
Below are a few examples of reports where side effects / adverse reactions may be related to Metronidazole. For a complete list or a specific selection of reports, please use the links above.
Possible Metronidazole side effects in 36 year old male
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-27
Patient: 36 year old male, weighing 100.5 kg (221.1 pounds)
Reactions: Anxiety, Tinnitus, Paranoia, Visual Impairment, Hallucination, Feeling Abnormal
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Metronidazole
Other drugs received by patient: Trimovate
Possible Metronidazole side effects in 53 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-25
Patient: 53 year old male
Reactions: Oromandibular Dystonia, Encephalopathy
Drug(s) suspected as cause:
Metronidazole
Possible Metronidazole side effects in 65 year old female
Reported by a pharmacist from Switzerland on 2012-08-24
Patient: 65 year old female, weighing 55.3 kg (121.7 pounds)
Reactions: Vomiting, Pruritus, Chills, Pyrexia, Drug Rash With Eosinophilia and Systemic Symptoms, Eosinophilia, Hepatic Enzyme Increased, C-Reactive Protein Increased, Oedema Peripheral, Rash Erythematous, Lymphocyte Morphology Abnormal
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Acetaminophen
Indication: Product Used FOR Unknown Indication
Start date: 2012-01-01
End date: 2012-05-25
Keppra
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Metronidazole
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2012-04-26
End date: 2012-05-25
Pantoprazole
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2012-04-01
End date: 2012-05-25
Rocephin
Indication: Product Used FOR Unknown Indication
Start date: 2012-04-26
End date: 2012-05-21
Other drugs received by patient: Calcium Carbonate; Clindamycin HCL; Amoxicillin; Konakion; Meropenem; Prednisone TAB; Clemastine Fumarate
Possible Metronidazole side effects in 53 year old female
Reported by a physician from France on 2012-08-23
Patient: 53 year old female
Reactions: Drug Rash With Eosinophilia and Systemic Symptoms
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Azithromycin
Dosage: unk
Indication: Product Used FOR Unknown Indication
Metronidazole
Dosage: unk
Indication: Product Used FOR Unknown Indication
Spiramycin
Dosage: unk
Indication: Product Used FOR Unknown Indication
Possible Metronidazole side effects in 53 year old female
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-23
Patient: 53 year old female, weighing 65.0 kg (143.0 pounds)
Reactions: Migraine, Diarrhoea, Vision Blurred
Drug(s) suspected as cause:
Metronidazole
Dosage: 3 df, qd
Indication: Dental Care
Start date: 2012-07-27
Sertraline Hydrochloride
Dosage: 1 df, qd
Administration route: Oral
Indication: Depressed Mood
Start date: 2012-07-31
End date: 2012-08-01
Other drugs received by patient: Zapain; Elleste-Duet
Possible Metronidazole side effects in 17 year old male
Reported by a physician from Poland on 2012-08-23
Patient: 17 year old male
Reactions: Rhabdomyolysis, Disseminated Intravascular Coagulation, Pancytopenia, Pyrexia, Renal Failure, Neutropenia, Clostridial Infection, Septic Shock
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Cefepime
Doxorubicin Hydrochloride
Indication: Ewing's Sarcoma
Etoposide
Indication: Ewing's Sarcoma Metastatic
Ifosfamide
Indication: Ewing's Sarcoma Metastatic
Meropenem
Metronidazole
Netromycin
Vancocin Hydrochloride
Vincristine
Indication: Ewing's Sarcoma Metastatic
Other drugs received by patient: Fluconazole; Caspofungin Acetate
Possible Metronidazole side effects in
Reported by a health professional (non-physician/pharmacist) from Germany on 2012-08-23
Patient:
Reactions: Haemorrhage, Drug Interaction
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Amoxicillin
Indication: Product Used FOR Unknown Indication
Amoxicillin and Clavulanate Potassium
Dosage: unk
Indication: Product Used FOR Unknown Indication
Ciprofloxacin
Dosage: unk
Indication: Product Used FOR Unknown Indication
Clopidegrel
Dosage: unk
Indication: Product Used FOR Unknown Indication
Diclofenac Sodium
Indication: Product Used FOR Unknown Indication
Ibuprofen
Indication: Product Used FOR Unknown Indication
Ketoprofen
Dosage: unk
Indication: Product Used FOR Unknown Indication
Levofloxacin
Dosage: unk
Indication: Product Used FOR Unknown Indication
Marcumar
Dosage: unk
Indication: Product Used FOR Unknown Indication
Metronidazole
Indication: Product Used FOR Unknown Indication
Moxifloxacin
Indication: Product Used FOR Unknown Indication
Naproxen
Dosage: unk
Indication: Product Used FOR Unknown Indication
Ofloxacin
Indication: Product Used FOR Unknown Indication
Sulfamethoxazole Trimethoprim
Dosage: unk
Indication: Product Used FOR Unknown Indication
Possible Metronidazole side effects in
Reported by a consumer/non-health professional from United States on 2012-08-22
Patient:
Reactions: Confusional State, Nausea, Ileitis, Gait Disturbance, Amnesia
Drug(s) suspected as cause:
Metronidazole
Possible Metronidazole side effects in 69 year old male
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-22
Patient: 69 year old male
Reactions: Hepatitis Acute
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Amoxicillin and Clavulanate Potassium
Dosage: 1 df, 3x/day; strenght 250/125
Indication: Tooth Infection
Start date: 2012-04-16
Clindamycin HCL
Dosage: unk
Start date: 2012-04-26
Metronidazole
Dosage: unk, thrice in a day
Indication: Tooth Infection
Start date: 2012-04-16
Other drugs received by patient: Ramipril; Betahistine Dihydrochloride; Simvastatin
Possible Metronidazole side effects in 53 year old female
Reported by a pharmacist from United Kingdom on 2012-08-22
Patient: 53 year old female, weighing 65.0 kg (143.0 pounds)
Reactions: Migraine, Diarrhoea, Vision Blurred
Drug(s) suspected as cause:
Metronidazole
Dosage: 200 mg, 3x/day
Indication: Dental Care
Start date: 2012-07-27
Sertraline Hydrochloride
Dosage: 50 mg, 1x/day
Administration route: Oral
Indication: Depressed Mood
Start date: 2012-07-31
End date: 2012-08-01
Other drugs received by patient: Elleste-Duet; Acetaminophen and Codeine Phosphate
Possible Metronidazole side effects in 65 year old male
Reported by a consumer/non-health professional from United States on 2012-08-22
Patient: 65 year old male
Reactions: Multi-Organ Failure, Metabolic Acidosis, Rash, Rash Morbilliform, Drug Rash With Eosinophilia and Systemic Symptoms, Eosinophilia, Rash Pruritic
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Fluconazole
Indication: Evidence Based Treatment
Levofloxacin
Indication: Evidence Based Treatment
Metronidazole
Indication: Evidence Based Treatment
Vancomycin
Indication: Evidence Based Treatment
Possible Metronidazole side effects in female
Reported by a physician from France on 2012-08-22
Patient: female
Reactions: Dyspnoea, Palpitations, Cytolytic Hepatitis, Depression
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Acetaminophen
Indication: Pain
Start date: 2012-06-05
End date: 2012-06-08
Amlodipine
Administration route: Oral
Start date: 2012-06-02
Arixtra
Indication: Thrombosis Prophylaxis
Start date: 2012-05-01
Bisoprolol Fumarate
Administration route: Oral
Indication: Cardiac Failure
Start date: 2012-06-07
End date: 2012-06-08
Ceftriaxon
Indication: Antibiotic Therapy
Start date: 2012-06-05
End date: 2012-06-09
Crestor
Administration route: Oral
Indication: Dyslipidaemia
Start date: 2012-01-01
End date: 2012-06-08
Digoxin
Administration route: Oral
Indication: Cardiac Failure
Start date: 2012-06-01
Lasix
Administration route: Oral
Indication: Cardiac Failure
Start date: 2012-05-30
End date: 2012-06-05
Metronidazole
Indication: Antibiotic Therapy
Start date: 2012-06-08
End date: 2012-06-09
Potassium Chloride
Administration route: Oral
Indication: Hypokalaemia
Start date: 2012-05-30
Risperdal
Administration route: Oral
Indication: Depression
Start date: 2012-05-01
End date: 2012-06-13
Venlafaxine
Administration route: Oral
Indication: Depression
End date: 2012-06-12
Zymad
Administration route: Oral
Indication: Vitamin D Deficiency
Start date: 2012-06-06
End date: 2012-06-07
Other drugs received by patient: Transpipeg; Aspirin; Ferrous Sulfate TAB
Possible Metronidazole side effects in
Reported by a physician from France on 2012-08-22
Patient:
Reactions: Histiocytosis Haematophagic, Drug Rash With Eosinophilia and Systemic Symptoms
Drug(s) suspected as cause:
Azithromycin
Dosage: unk, unknown
Indication: Product Used FOR Unknown Indication
Metronidazole
Dosage: unk, unknown
Indication: Product Used FOR Unknown Indication
Spiramycin
Dosage: unk, unknown
Indication: Product Used FOR Unknown Indication
Possible Metronidazole side effects in 56 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-21
Patient: 56 year old female
Reactions: Abdominal Pain, Confusional State, Hypercapnia, Tachycardia, Hypotension, Mental Status Changes, Urinary Tract Infection Enterococcal, Pneumocystis Jiroveci Pneumonia, Respiratory Failure, Intestinal Dilatation, Diarrhoea, Hypoxia, Abdominal Distension, Clostridial Infection, Colectomy Total
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Levofloxacin
Dosage: 250 mg, 1x/day
Indication: Antibiotic Prophylaxis
Linezolid
Dosage: 600 mg, 2x/day
Indication: Urinary Tract Infection Enterococcal
Metronidazole
Dosage: 500 mg, 3x/day
Indication: Clostridium Test Positive
Pentamidine
Dosage: 1 in 28 d (every 28 days)
Indication: Pneumocystis Jiroveci Infection
Prednisone
Dosage: 10 mg, daily
Indication: Chronic Graft Versus Host Disease
Sulfamethoxazole and Trimethoprim
Dosage: unk
Indication: Pneumocystis Jiroveci Pneumonia
Sulfamethoxazole Trimethoprim
Dosage: one double strength tablet twice daily, every monday and tuesday
Administration route: Oral
Indication: Prophylaxis
Sulfamethoxazole Trimethoprim
Dosage: unk
Vancomycin HCL
Dosage: 125 mg, 4x/day
Administration route: Oral
Indication: Clostridium Test Positive
Vancomycin HCL
Dosage: 125 mg, 4x/day
Administration route: Oral
Other drugs received by patient: Aciclovir; Fluconazole
Possible Metronidazole side effects in 53 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-21
Patient: 53 year old male
Reactions: Oromandibular Dystonia, Unresponsive To Stimuli, Encephalopathy
Drug(s) suspected as cause:
Metronidazole
Possible Metronidazole side effects in 60 year old female
Reported by a health professional (non-physician/pharmacist) from Spain on 2012-08-21
Patient: 60 year old female, weighing 55.5 kg (122.1 pounds)
Reactions: Anaphylactic Reaction
Drug(s) suspected as cause:
Metronidazole
Possible Metronidazole side effects in female
Reported by a physician from France on 2012-08-20
Patient: female
Reactions: Cytolytic Hepatitis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Acetaminophen
Dosage: 3g per day
Indication: Pain
Start date: 2012-06-05
End date: 2012-06-08
Amlodipine
Dosage: 2mg per day
Administration route: Oral
Indication: Hypertension
Start date: 2012-06-02
Arixtra
Dosage: 2.5mg per day
Indication: Thrombosis Prophylaxis
Start date: 2012-05-01
Bisoprolol Fumarate
Dosage: 1.25mg per day
Administration route: Oral
Indication: Cardiac Failure
Start date: 2012-06-07
End date: 2012-06-08
Ceftriaxone
Dosage: 1g per day
Indication: Product Used FOR Unknown Indication
Start date: 2012-06-05
End date: 2012-06-09
Cholecalciferol
Dosage: 2unit per day
Administration route: Oral
Indication: Vitamin D Deficiency
Start date: 2012-06-06
End date: 2012-06-07
Crestor
Dosage: 10mg per day
Administration route: Oral
Indication: Dyslipidaemia
Start date: 2012-01-01
End date: 2012-06-08
Digoxin
Administration route: Oral
Indication: Cardiac Failure
Start date: 2012-06-01
Lasix
Dosage: 80mg per day
Administration route: Oral
Indication: Cardiac Failure
Start date: 2012-05-30
End date: 2012-06-05
Metronidazole
Dosage: 1.5g per day
Indication: Product Used FOR Unknown Indication
Start date: 2012-06-08
End date: 2012-06-09
Potassium Chloride
Dosage: 4tab per day
Administration route: Oral
Indication: Hypokalaemia
Start date: 2012-05-30
Risperidone
Dosage: 2mg per day
Administration route: Oral
Indication: Depression
Start date: 2012-05-01
End date: 2012-06-13
Venlafaxine
Administration route: Oral
Indication: Depression
End date: 2012-06-12
Other drugs received by patient: Ferrous Sulfate TAB; Transipeg; Aspirin
Possible Metronidazole side effects in female
Reported by a physician from India on 2012-08-17
Patient: female, weighing 58.0 kg (127.6 pounds)
Reactions: Gastroenteritis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
BI 1356
Dosage: 5 mg
Indication: Type 2 Diabetes Mellitus
Start date: 2012-03-02
Capsule.esamino
Dosage: unit: -
Administration route: Oral
Indication: Vitamin Supplementation
Start date: 2012-08-09
Inj.emeset
Dosage: 4 mg
Indication: Nausea
Start date: 2012-08-08
End date: 2012-08-09
Metronidazole
Dosage: 500 mg
Indication: Diarrhoea
Start date: 2012-08-08
End date: 2012-08-09
Naphazoline HCL
Dosage: 1000 mg
Administration route: Oral
Indication: Enteritis Infectious
Start date: 2012-08-09
Ofloxacin
Dosage: 400 mg
Indication: Enteritis Infectious
Start date: 2012-08-08
End date: 2012-08-09
Pantaprozole Sodium
Dosage: 40 mg
Indication: Hyperchlorhydria
Start date: 2012-08-08
End date: 2012-08-09
Tablet. Ofloxacin
Dosage: 400 mg
Administration route: Oral
Indication: Enteritis Infectious
Start date: 2012-08-09
Tablet.emeset
Dosage: 8 mg
Administration route: Oral
Indication: Nausea
Start date: 2012-08-09
Tablet.razep
Dosage: 40 mg
Administration route: Oral
Indication: Hyperchlorhydria
Start date: 2012-08-09
Tablet.vsl 3
Dosage: unit: -
Administration route: Oral
Indication: Medical Diet
Start date: 2012-08-09
Possible Metronidazole side effects in
Reported by a individual with unspecified qualification from Spain on 2012-08-17
Patient:
Reactions: Ischaemic Stroke, Anaphylactic Reaction, Cerebrovascular Spasm
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Adrenalin IN OIL INJ
Dosage: 0.3 mg, unknown
Adrenalin IN OIL INJ
Dosage: 0.5 mg, single
Indication: Anaphylactic Reaction
Metronidazole
Dosage: 125 mg, single
Administration route: Oral
Indication: Diagnostic Procedure
Other drugs received by patient: Simvastatin
Possible Metronidazole side effects in 74 year old female
Reported by a health professional (non-physician/pharmacist) from France on 2012-08-17
Patient: 74 year old female
Reactions: Cytolytic Hepatitis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Acetaminophen
Indication: Pain
Start date: 2012-06-05
End date: 2012-06-08
Amlodipine
Administration route: Oral
Start date: 2012-06-02
Arixtra
Start date: 2012-05-01
Bisoprolol Fumarate
Administration route: Oral
Start date: 2012-06-07
End date: 2012-06-08
Ceftriaxone
Start date: 2012-06-05
End date: 2012-06-09
Colecalciferol
Administration route: Oral
Indication: Vitamin D Deficiency
Start date: 2012-06-06
End date: 2012-06-07
Crestor
Administration route: Oral
Start date: 2012-01-01
End date: 2012-06-08
Digoxin
Administration route: Oral
Start date: 2012-06-01
Lasix
Administration route: Oral
Start date: 2012-05-30
End date: 2012-06-05
Metronidazole
Start date: 2012-06-08
End date: 2012-06-09
Potassium Chloride
Administration route: Oral
Start date: 2012-05-30
Risperdal
Administration route: Oral
Start date: 2012-05-01
End date: 2012-06-13
Venlafaxine
Administration route: Oral
End date: 2012-06-04
Venlafaxine
Administration route: Oral
Start date: 2012-06-05
End date: 2012-06-12
Other drugs received by patient: Polyethylene Glycol; Aspirin; Ferrous Sulfate TAB
Possible Metronidazole side effects in 53 year old female
Reported by a physician from France on 2012-08-15
Patient: 53 year old female
Reactions: Drug Rash With Eosinophilia and Systemic Symptoms
Drug(s) suspected as cause:
Azithromycin
Metronidazole
Spiramycin
Possible Metronidazole side effects in female
Reported by a physician from India on 2012-08-15
Patient: female, weighing 2.4 kg (5.2 pounds)
Reactions: Renal Failure, Foetal Exposure During Pregnancy
Drug(s) suspected as cause:
Acetaminophen
Dosage: unk
Amoxicillin and Clavulanate Potassium
Dosage: unk
Metronidazole
Dosage: unk
Pennsaid
Dosage: unk
Ranitidine
Dosage: unk
Possible Metronidazole side effects in 31 year old
Reported by a health professional (non-physician/pharmacist) from Spain on 2012-08-14
Patient: 31 year old
Reactions: Parkinsonism
Drug(s) suspected as cause:
Metronidazole
Dosage: unk
Quetiapine Fumarate
Dosage: 300 mg/day
Possible Metronidazole side effects in 44 year old female
Reported by a physician from United States on 2012-08-14
Patient: 44 year old female
Reactions: Vomiting, Convulsion, Loss of Consciousness
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Amoxicillin
Dosage: unk
Indication: Helicobacter Infection
Metronidazole
Dosage: unk
Administration route: Oral
Indication: Helicobacter Infection
Omeprazole
Dosage: unk
Indication: Helicobacter Infection
Viibryd
Dosage: 10 mg, daily
Indication: Depression
Start date: 2012-07-13
Possible Metronidazole side effects in 82 year old male
Reported by a physician from Australia on 2012-08-14
Patient: 82 year old male
Reactions: Bacteraemia, Staphylococcal Infection, Treatment Failure
Adverse event resulted in: hospitalization, disablity
Drug(s) suspected as cause:
Gentamicin
Indication: Device Related Infection
Metronidazole
Indication: Device Related Infection
Timentin
Indication: Device Related Infection
Vancomycin
Indication: Device Related Infection
Vancomycin
Indication: Antibiotic Prophylaxis
Other drugs received by patient: Warfarin Sodium
Possible Metronidazole side effects in 36 year old female
Reported by a health professional (non-physician/pharmacist) from Turkey on 2012-08-14
Patient: 36 year old female
Reactions: Oligohydramnios, Maternal Exposure During Pregnancy
Drug(s) suspected as cause:
Hydrochlorothiazide, Spironolactone
Indication: Hirsutism
Metronidazole
Dosage: 500 mg, qd
Indication: Genital Infection
Ornidazole
Dosage: 500 mg, bid
Administration route: Oral
Indication: Genital Infection
Possible Metronidazole side effects in 48 year old male
Reported by a physician from Germany on 2012-08-14
Patient: 48 year old male, weighing 95.0 kg (209.0 pounds)
Reactions: Dermatitis Allergic, Pancreatitis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Cefuroxime Sodium
Dosage: unk
Enbrel
Dosage: 50 mg, weekly
Indication: Rheumatoid Arthritis
Start date: 2010-02-25
End date: 2011-07-05
Metronidazole
Dosage: unk
Other drugs received by patient: Ramipril; Torsemide; Omep / 00661201 /; Diclofenac Sodium
Possible Metronidazole side effects in female
Reported by a health professional (non-physician/pharmacist) from Turkey on 2012-08-10
Patient: female, weighing 0.4 kg (0.9 pounds)
Reactions: Limb Reduction Defect, Bradycardia Foetal, Foetal Exposure During Pregnancy, Limb Hypoplasia Congenital, Foetal Arrhythmia
Adverse event resulted in: death
Drug(s) suspected as cause:
Hydrochlorothiazide, Spironolactone
Dosage: 1 df, maternal dose
Metronidazole
Dosage: maternal dose:500 mg qd
Ornidazole
Dosage: maternal dose: 500 mg bid
Possible Metronidazole side effects in 64 year old male
Reported by a individual with unspecified qualification from United States on 2012-08-10
Patient: 64 year old male, weighing 89.8 kg (197.6 pounds)
Reactions: Renal Failure Acute
Drug(s) suspected as cause:
Cefuroxime Sodium
Dosage: 1.5 gm; iv
Metronidazole
Dosage: 500 mg; 1500 mg; iv
Indication: Antibiotic Prophylaxis
Start date: 2012-06-29
End date: 2012-06-30
Other drugs received by patient: Amoxicillin and Clavulanate Potassium
Possible Metronidazole side effects in 64 year old male
Reported by a pharmacist from United Kingdom on 2012-08-09
Patient: 64 year old male, weighing 90.0 kg (198.0 pounds)
Reactions: Glomerular Filtration Rate Decreased, Blood Creatinine Increased, Renal Failure Acute
Drug(s) suspected as cause:
Cefuroxime
Dosage: unk
Indication: Product Used FOR Unknown Indication
Metronidazole
Dosage: 500 mg, tid
Indication: Product Used FOR Unknown Indication
Start date: 2012-06-29
End date: 2012-06-30
Metronidazole
Dosage: unk
Other drugs received by patient: Amoxicillin and Clavulanate Potassium
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