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Furadantin (Nitrofurantoin) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Furadantin (Nitrofurantoin) 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 (23)
Death (2)
Disability (1)

Reports by Reaction Type

Colitis Microscopic (4)Vomiting (4)Abdominal Pain (3)Hepatitis (3)Acute Generalised Exanthematous Pustulosis (3)Cholelithiasis (3)Diarrhoea (3)Jaundice (2)Urticaria (2)Pyrexia (2)Interstitial Lung Disease (2)Hepatotoxicity (2)

Possible Furadantin side effects in 53 year old female

Reported by a pharmacist from France on 2012-07-12

Patient: 53 year old female

Reactions: Vomiting, Dyspnoea, Throat Irritation, Diarrhoea, Rash Erythematous

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Valacyclovir Hydrochloride
    Dosage: 500mg twice per day
    Administration route: Oral
    Indication: Genital Herpes
    Start date: 2012-05-21
    End date: 2012-05-22

Furadantin
    Dosage: 50mg unknown
    Administration route: Oral
    Indication: Cystitis
    Start date: 2012-05-15
    End date: 2012-05-22



Possible Furadantin side effects in female

Reported by a physician from France on 2012-07-11

Patient: female

Reactions: Skin Plaque, Rash Pruritic

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Furadantin
    Dosage: 100mg per day
    Administration route: Oral
    Indication: Escherichia Infection
    Start date: 2012-05-26
    End date: 2012-05-26

Potassium Chloride
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-05-18

Amoxicillin and Clavulanate Potassium
    Administration route: Oral
    Indication: Escherichia Infection
    Start date: 2012-05-21
    End date: 2012-05-26

Fluticasone Propionate / Salmeterol
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Aspegic 1000; Atorvastatin; Tiorfan; Spiriva; Escitalopram; Betamethasone; Ceftriaxone; Acetaminophen; Zolpidem Tartrate; Clonazepam; Cetirizine; Fusidic Acid; Lyrica



Possible Furadantin side effects in female

Reported by a health professional (non-physician/pharmacist) from France on 2012-06-01

Patient: female

Reactions: Craniosynostosis, Scaphocephaly, Foetal Exposure During Pregnancy

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Augmentin '125'
    Indication: Product Used FOR Unknown Indication

Furadantin
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-01-01



Possible Furadantin side effects in 76 year old female

Reported by a individual with unspecified qualification from France on 2012-05-10

Patient: 76 year old female, weighing 54.0 kg (118.8 pounds)

Reactions: Rash Generalised, Chills, Hypotension, Cytolytic Hepatitis, Pyrexia, Drug Rash With Eosinophilia and Systemic Symptoms, Eosinophilia, Dermatitis Exfoliative, Pharyngeal Erythema, Keratitis, Pharyngitis, Inflammation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Furadantin
    Indication: Dysuria
    Start date: 2012-03-14
    End date: 2012-03-15

Furadantin
    Indication: Antibiotic Prophylaxis
    Start date: 2012-03-14
    End date: 2012-03-15

Furadantin
    Start date: 2012-03-04
    End date: 2012-03-10

Furadantin
    Start date: 2012-03-04
    End date: 2012-03-10

Other drugs received by patient: Monurol; Avlocardyl / 00030001 /; Procoralan; Cipralan



Possible Furadantin side effects in 54 year old female

Reported by a individual with unspecified qualification from France on 2012-05-09

Patient: 54 year old female

Reactions: Rales, Hepatitis, Lymphocytic Infiltration, Alveolitis, Lung Disorder, Interstitial Lung Disease, Bronchiectasis, Pulmonary Eosinophilia, Cough, Influenza

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Furadantin



Possible Furadantin side effects in 79 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-04-26

Patient: 79 year old female

Reactions: Breast Cancer, Acute Pulmonary Oedema, Lung Disorder, Interstitial Lung Disease, Bronchiectasis, Tuberculosis, Parkinson's Disease, Pulmonary Fibrosis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Furadantin
    Dosage: po
    Administration route: Oral
    Indication: Urinary Tract Infection
    Start date: 1999-12-01
    End date: 2001-05-01

Nicergoline Hydrochloride
    Dosage: po
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 1999-12-01
    End date: 2001-05-01

Vagostabyl (Vagostabyl)
    Dosage: po
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 1999-12-01
    End date: 2001-05-01

Colchicine
    Dosage: po
    Start date: 1999-12-01
    End date: 2001-05-01

Other drugs received by patient: Paroxetine Hydrochloride; Aspirin; Xyloric



Possible Furadantin side effects in female

Reported by a health professional (non-physician/pharmacist) from France on 2012-04-09

Patient: female

Reactions: Cholelithiasis, Jaundice, Abdominal Pain, Vomiting, Hepatic Fibrosis, Hepatotoxicity, Epstein-Barr Virus Test Positive, Epstein-Barr Virus Antibody Positive

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Furadantin
    Dosage: 4 to 5 days per month
    Administration route: Oral
    End date: 2011-10-13

Voltaren
    Dosage: unk
    Administration route: Oral
    Start date: 2011-10-04
    End date: 2011-10-13

Lipanor
    Dosage: unk
    Administration route: Oral
    End date: 2011-10-13

Other drugs received by patient: Zolpidem Tartrate; Folic Acid; Umuline; Amlodipine Besylate; Eupressyl; Novorapid; Bisoprolol Fumarate



Possible Furadantin side effects in 80 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-03-15

Patient: 80 year old female

Reactions: Acute Generalised Exanthematous Pustulosis, Fatigue, Hepatitis Acute, Coma, Asthenia, Renal Failure Acute, Discomfort

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Furadantin
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-04-19
    End date: 2011-04-22

Noroxin
    Administration route: Oral
    Indication: Urinary Tract Infection
    Start date: 2011-04-04
    End date: 2011-04-12

Bactrim
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-04-18
    End date: 2011-04-19

Other drugs received by patient: Escitalopram Oxalate; Acetaminophen; Xanax; Levothyroxine Sodium; Bisoprolol Fumarate; Fluindione; Risperdal



Possible Furadantin side effects in 80 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-03-12

Patient: 80 year old female

Reactions: Acute Generalised Exanthematous Pustulosis, Hepatitis Acute

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Noroxin
    Administration route: Oral
    Indication: Urinary Tract Infection
    Start date: 2011-04-04
    End date: 2011-04-12

Furadantin
    Start date: 2011-04-19
    End date: 2011-04-22

Bactrim
    Indication: Urinary Tract Infection
    Start date: 2011-04-18
    End date: 2011-04-19

Other drugs received by patient: Risperdal; Risperdal; Risperdal; Bisoprolol Fumarate; Previscan; Acetaminophen; Levothyroxine Sodium; Escitalopram Oxalate; Xanax



Possible Furadantin side effects in 70 year old female

Reported by a individual with unspecified qualification from France on 2012-03-12

Patient: 70 year old female

Reactions: Purpura, Varicose Vein

Drug(s) suspected as cause:
Furadantin



Possible Furadantin side effects in female

Reported by a health professional (non-physician/pharmacist) from France on 2012-03-12

Patient: female

Reactions: Blood Alkaline Phosphatase Increased, Jaundice, Blood Bilirubin Increased, Abdominal Pain, Vomiting, Hepatic Fibrosis, Alanine Aminotransferase Increased, Cholelithiasis, Gamma-Glutamyltransferase Increased, Liver Function Test Abnormal, Aspartate Aminotransferase Increased, Epstein-Barr Virus Test Positive, Epstein-Barr Virus Antibody Positive, Bilirubin Conjugated Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Voltaren
    Dosage: unk
    Administration route: Oral
    End date: 2011-10-13

Furadantin
    Dosage: unk
    End date: 2011-10-13

Lipanor
    Dosage: unk
    End date: 2011-10-13

Other drugs received by patient: Zolpidem; Folic Acid; Umuline; Novorapid; Eupressyl; Bisoprolol Fumarate; Amlodipine Besylate



Possible Furadantin side effects in 70 year old male

Reported by a physician from France on 2012-02-17

Patient: 70 year old male

Reactions: Abdominal Pain, Diarrhoea, Abnormal Faeces, Urticaria Chronic, Abdominal Pain Upper, Colitis Microscopic

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Xanax
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 1995-01-01

Lercanidipine
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2000-01-01

Furadantin
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-11-01
    End date: 2010-12-01

Ezetimibe
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 1995-01-01

Irbesartan + Hydrochlorothiazide
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2000-01-01
    End date: 2011-02-15



Possible Furadantin side effects in 70 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-02-08

Patient: 70 year old male

Reactions: Colitis Microscopic

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Zetia
    Administration route: Oral
    Start date: 1995-01-01

Anafranil
    Administration route: Oral
    Start date: 1995-01-01

Xanax
    Administration route: Oral
    Start date: 1995-01-01

Furadantin
    Administration route: Oral
    Start date: 2010-11-01
    End date: 2010-12-01

Lercanidipine
    Administration route: Oral
    Start date: 2000-01-01

Irbesartan + Hydrochlorothiazide
    Administration route: Oral
    Start date: 2000-01-01
    End date: 2011-02-15

Other drugs received by patient: Indapamide



Possible Furadantin side effects in 71 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-02-02

Patient: 71 year old male

Reactions: Hepatitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Furadantin
    Dosage: 50 mg, unk
    Indication: Prostatitis
    Start date: 2011-07-01
    End date: 2011-07-01

Prednisone TAB
    Dosage: 50 mg/day

Bisoprolol Fumarate
    Dosage: 2.5 mg, 1x/day in the morning
    End date: 2011-07-01

Atorvastatin
    Dosage: 40 mg, 1x/day at night
    Administration route: Oral
    End date: 2011-07-01

Imuran
    Dosage: 150 mg, 1x/day at lunch time
    Administration route: Oral
    Start date: 2011-05-01
    End date: 2011-07-01

Ramipril
    Dosage: 1.5 mg, 1x/day in the morning
    End date: 2011-07-01

Other drugs received by patient: Aspirin; Nexium; Princi-B; Acetaminophen; Lantus; Calcium Carbonate; Acetaminophen



Possible Furadantin side effects in 70 year old male

Reported by a consumer/non-health professional from France on 2012-01-11

Patient: 70 year old male

Reactions: Urticaria, Colitis Microscopic

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lercanidipine
    Start date: 2000-01-01

Ezetimibe
    Start date: 1995-01-01

Furadantin
    Start date: 2010-11-01
    End date: 2010-12-01

Irbesartan and Hydrochlorothiazide
    Start date: 2000-01-01
    End date: 2011-02-15

Anafranil
    Start date: 1995-01-01

Xanax
    Start date: 1995-01-01



Possible Furadantin side effects in 70 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-01-04

Patient: 70 year old male

Reactions: Urticaria, Colitis Microscopic

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ezetimibe
    Dosage: unk
    Administration route: Oral
    Start date: 1995-01-01

Anafranil
    Dosage: unk
    Administration route: Oral
    Start date: 1995-01-01

Lercanidipine
    Dosage: unk
    Administration route: Oral
    Start date: 2000-01-01

Irbesartan and Hydrochlorothiazide
    Dosage: unk
    Administration route: Oral
    Start date: 2000-01-01
    End date: 2011-02-15

Furadantin
    Dosage: unk
    Administration route: Oral
    Start date: 2010-11-01
    End date: 2010-12-01

Xanax
    Dosage: unk
    Administration route: Oral
    Start date: 1995-01-01

Other drugs received by patient: Indapamide



Possible Furadantin side effects in 56 year old male

Reported by a physician from Sweden on 2011-12-16

Patient: 56 year old male

Reactions: Dyspnoea, Urinary Tract Infection, Laryngeal Oedema, Throat Tightness, Tonsil Cancer

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Furadantin
    Dosage: unk
    Administration route: Oral
    Indication: Urinary Tract Infection
    Start date: 2010-12-15
    End date: 2011-01-11

Ramipril
    Dosage: 10 mg, 1x/day
    Administration route: Oral
    Indication: Cardiac Disorder
    Start date: 2007-01-01
    End date: 2011-01-21

Other drugs received by patient: Aspirin; Nitrolingual; Metoprolol; Omeprazole



Possible Furadantin side effects in 76 year old female

Reported by a individual with unspecified qualification from France on 2011-12-15

Patient: 76 year old female, weighing 55.0 kg (121.0 pounds)

Reactions: Purpura, Pyrexia, Mixed Liver Injury

Drug(s) suspected as cause:
Furadantin

Other drugs received by patient: Uvedose; Estradiol Valerate



Possible Furadantin side effects in 78 year old female

Reported by a individual with unspecified qualification from France on 2011-11-15

Patient: 78 year old female

Reactions: Hepatic Function Abnormal, Sepsis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Furadantin

Other drugs received by patient: Hyperium; Prednisone; Omeprazole



Possible Furadantin side effects in 85 year old female

Reported by a individual with unspecified qualification from France on 2011-11-09

Patient: 85 year old female

Reactions: Acute Generalised Exanthematous Pustulosis, Generalised Erythema, Eosinophilia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Furadantin
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-07-17
    End date: 2011-07-23

Rocephin
    Start date: 2011-06-20
    End date: 2011-06-27

Augmentin '250'
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-07-17
    End date: 2011-07-23

Rocephin
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-06-08
    End date: 2011-06-18



Possible Furadantin side effects in 85 year old female

Reported by a physician from France on 2011-11-08

Patient: 85 year old female

Reactions: Vomiting, Diarrhoea, Nausea, Dehydration, Condition Aggravated, Vertigo

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Bactrim
    Indication: Urinary Tract Infection

Furadantin
    Dosage: 6 dosage forms daily
    Administration route: Oral
    Indication: Urinary Tract Infection
    Start date: 2011-08-24
    End date: 2011-08-26



Possible Furadantin side effects in 71 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2011-10-13

Patient: 71 year old male

Reactions: Pulmonary Hypertension, Ventricular Extrasystoles, Bundle Branch Block Right, Cholestasis, Tricuspid Valve Incompetence, Hepatitis, Cholelithiasis, Hepatotoxicity, Mitral Valve Incompetence, Aortic Valve Incompetence, Atrioventricular Block First Degree

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Prednisone
    Dosage: 50 mg/day

Imuran
    Dosage: 150 mg, 1x/day at lunch time
    Administration route: Oral
    Start date: 2011-05-01
    End date: 2011-07-01

Furadantin
    Dosage: 50 mg, unk
    Start date: 2011-07-01
    End date: 2011-07-01

Ramipril
    Dosage: 1.5 mg, 1x/day in the morning
    End date: 2011-07-01

Atorvastatin Calcium
    Dosage: 40 mg, 1x/day at night
    Administration route: Oral
    End date: 2011-07-01

Bisoprolol
    Dosage: 2.5 mg, 1x/day in the morning
    End date: 2011-07-01

Other drugs received by patient: Lantus; Princi-B; Aspirin; Calcium Carbonate; Nexium; Acetaminophen



Possible Furadantin side effects in 86 year old female

Reported by a physician from Denmark on 2011-10-03

Patient: 86 year old female

Reactions: Bedridden, General Physical Health Deterioration, Mental Disorder, Eating Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Fosamax
    Dosage: 70 mg;qw;po
    Administration route: Oral
    Start date: 2008-08-10
    End date: 2011-08-03

Simvastatin
    Dosage: 40 mg; po
    Administration route: Oral
    Start date: 2008-08-14
    End date: 2011-08-02

Bisoprolol Fumarate
    Dosage: 5 mg; po
    Administration route: Oral
    Start date: 2008-08-14
    End date: 2011-08-03

Furadantin
    Dosage: 100 mg; po
    Administration route: Oral
    Start date: 2011-08-02
    End date: 2011-08-03

Niferex (Polysaccharide-Iron Complex)
    Dosage: 100 mg; po
    Administration route: Oral
    Start date: 2011-08-02
    End date: 2011-08-05

Mianserin (Mianserin)
    Dosage: 60 mg; po
    Administration route: Oral
    Start date: 2008-08-10
    End date: 2011-08-02

Other drugs received by patient: Triobe; Calcevita; Levothyroxine Sodium; Lithionit

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