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Nitrofurantoin (Nitrofurantoin) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to 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 (149)
Death (9)
Life Threatening Events (20)
Disability (7)

Reports by Reaction Type

Nausea (22)Vomiting (16)Urinary Tract Infection (14)Glaucoma (11)Pierre Robin Syndrome (11)Pyrexia (11)Cleft Palate (11)Malaise (11)Developmental Delay (11)Craniosynostosis (11)Diarrhoea (11)Hyperbilirubinaemia (10)

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

Possible Nitrofurantoin side effects in 55 year old female

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

Patient: 55 year old female

Reactions: Lung Disorder, Autoimmune Hepatitis, Neurodermatitis, Sjogren's Syndrome

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Nitrofurantoin



Possible Nitrofurantoin side effects in 52 year old female

Reported by a physician from United States on 2012-08-24

Patient: 52 year old female

Reactions: Drug Hypersensitivity

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

Clavulanic Acid
    Dosage: unk

Codeine Sulfate
    Dosage: unk

Hydrocodone
    Dosage: unk

Hydromorphone HCL
    Dosage: unk

Morphine Sulfate
    Dosage: unk

Nitrofurantoin
    Dosage: unk

Oxycodone Hydrochloride
    Dosage: unk



Possible Nitrofurantoin side effects in 66 year old female

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

Patient: 66 year old female

Reactions: Skin Burning Sensation, Erythema, Skin Irritation

Drug(s) suspected as cause:
Nitrofurantoin

Other drugs received by patient: Atorvastatin



Possible Nitrofurantoin side effects in female

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

Patient: female, weighing 62.6 kg (137.7 pounds)

Reactions: Nausea, Maternal Exposure During Pregnancy, Premature Labour

Drug(s) suspected as cause:
Midrin
    Indication: Headache
    Start date: 2005-10-21

Migquin
    Indication: Product Used FOR Unknown Indication
    Start date: 2005-10-24

Nitrofurantoin
    Indication: Product Used FOR Unknown Indication
    Start date: 2005-11-29

Topamax
    Dosage: 1 each evening for 1 week
    Administration route: Oral
    Start date: 2005-10-21

Topamax
    Dosage: every pm for a week
    Administration route: Oral

Topamax
    Dosage: every pm
    Administration route: Oral
    Indication: Headache

Topamax
    Dosage: every pm for a week
    Administration route: Oral



Possible Nitrofurantoin side effects in 87 year old female

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

Patient: 87 year old female

Reactions: Polyuria, Hyponatraemia, Convulsion

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Nitrofurantoin

Other drugs received by patient: Rivastigime Tartrate; Metoprolol Tartrate; Furosemide; Ramipril



Possible Nitrofurantoin side effects in 72 year old female

Reported by a physician from United Kingdom on 2012-08-22

Patient: 72 year old female

Reactions: Haemoptysis, Pneumonitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Nitrofurantoin

Other drugs received by patient: Calcium



Possible Nitrofurantoin side effects in 41 year old female

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

Patient: 41 year old female

Reactions: Metrorrhagia

Drug(s) suspected as cause:
Nitrofurantoin

Other drugs received by patient: Oral Contraceptive NOS



Possible Nitrofurantoin side effects in 55 year old female

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

Patient: 55 year old female

Reactions: Autoimmune Hepatitis, Interstitial Lung Disease, Pulmonary Eosinophilia, Immune System Disorder, Neurodermatitis, Sjogren's Syndrome, Multi-Organ Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Nitrofurantoin

Other drugs received by patient: Levothyroxine Sodium



Possible Nitrofurantoin side effects in 87 year old female

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

Patient: 87 year old female

Reactions: Pulmonary Fibrosis

Drug(s) suspected as cause:
Nitrofurantoin

Other drugs received by patient: Oxygen



Possible Nitrofurantoin side effects in 84 year old male

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

Patient: 84 year old male

Reactions: Feeling Abnormal, Abdominal Pain Upper

Drug(s) suspected as cause:
Nitrofurantoin

Other drugs received by patient: Fish OIL; Trazodone Hydrochloride; Aspirin; Neurontin; Glucosamine; Simvastatin; Levoxyl; Vitamin TAB; Calcium; Benazepril Hydrochloride; Sumatriptan; Folic Acid; Milk OF Magnesia TAB; Sanctura; Prilosec; Piroxicam



Possible Nitrofurantoin side effects in 69 year old female

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

Patient: 69 year old female

Reactions: Night Sweats, Abdominal Discomfort, Malaise, Chills, Asthenia, Muscle Spasms

Drug(s) suspected as cause:
Nitrofurantoin
    Administration route: Oral
    Indication: Urinary Tract Infection
    Start date: 2012-01-06
    End date: 2012-01-06

Nitrofurantoin
    Administration route: Oral
    Start date: 2012-04-20
    End date: 2012-04-20

Other drugs received by patient: Vitamin TAB; Hyzaar; Vagifem; Aspirin



Possible Nitrofurantoin side effects in 72 year old female

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

Patient: 72 year old female, weighing 72.6 kg (159.7 pounds)

Reactions: Fibromyalgia, Arthralgia, Headache

Drug(s) suspected as cause:
Nitrofurantoin
    Indication: Urinary Tract Infection
    Start date: 2011-09-09
    End date: 2011-09-10

Nitrofurantoin
    Start date: 2011-09-10
    End date: 2011-09-11

Nitrofurantoin
    Start date: 2011-09-11
    End date: 2011-09-11



Possible Nitrofurantoin side effects in female

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

Patient: female

Reactions: LIP Swelling, Swelling Face, Rash

Drug(s) suspected as cause:
Nitrofurantoin

Other drugs received by patient: Mucinex



Possible Nitrofurantoin side effects in 82 year old female

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-08-17

Patient: 82 year old female, weighing 60.0 kg (132.0 pounds)

Reactions: Rhabdomyolysis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Nitrofurantoin
    Dosage: 500 mg, unk
    Administration route: Oral
    Indication: Urinary Tract Infection
    End date: 2012-01-24

Simvastatin
    Dosage: 20 mg/ day
    Administration route: Oral
    Indication: Hyperlipidaemia
    End date: 2012-01-24

Other drugs received by patient: Axura; Pantoprazole; Aspirin



Possible Nitrofurantoin side effects in 55 year old female

Reported by a health professional (non-physician/pharmacist) from Serbia on 2012-08-16

Patient: 55 year old female

Reactions: Jaundice, Weight Decreased, Rales, Pyrexia, Hepatomegaly, Interstitial Lung Disease, Skin Discolouration, DRY Mouth, Hypoxia, Chronic Hepatitis, Splenomegaly, Sjogren's Syndrome, Hypocapnia, Cough, Dyspnoea, Nausea, Rash Papular, Neurodermatitis, Arthralgia, Hypergammaglobulinaemia, Asthenia, DRY Eye

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Nitrofurantoin



Possible Nitrofurantoin side effects in 74 year old female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-13

Patient: 74 year old female

Reactions: Dyspnoea, Lethargy

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Nitrofurantoin



Possible Nitrofurantoin side effects in

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

Patient: , weighing 86.3 kg (189.8 pounds)

Reactions: Abdominal Discomfort, Flatulence, Haematuria, Underdose

Drug(s) suspected as cause:
Niaspan
    Indication: High Density Lipoprotein Decreased
    Start date: 2011-08-23

Nitrofurantoin
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Plavix; Aspirin; Nitrofurantoin



Possible Nitrofurantoin side effects in

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

Patient:

Reactions: Drug Intolerance, Paraesthesia

Drug(s) suspected as cause:
Ciproflaxacin

Clarithromycin

Demerol

Doxycycline HCL

Levaquin

Lipitor

Nitrofurantoin

Vioxx

Zocor
    Administration route: Oral



Possible Nitrofurantoin side effects in 69 year old male

Reported by a pharmacist from United States on 2012-08-01

Patient: 69 year old male, weighing 107.8 kg (237.2 pounds)

Reactions: Malaise, Rash, Pyrexia, Asthenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Nitrofurantoin



Possible Nitrofurantoin side effects in female

Reported by a physician from United States on 2012-08-01

Patient: female

Reactions: Drug Hypersensitivity

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

Clavulanate Potassium
    Dosage: unk

Codeine Sulfate
    Dosage: unk

Hydrocodone Bitartrate
    Dosage: unk

Hydromorphone Hydrochloride
    Dosage: unk

Morphine Sulfate
    Dosage: unk

Nitrofurantoin
    Dosage: unk

Oxycodone HCL
    Dosage: unk



Possible Nitrofurantoin side effects in

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

Patient:

Reactions: Drug-Induced Liver Injury

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Amoxicillin and Clavulanate Potassium
    Indication: Product Used FOR Unknown Indication

Diclofenac Sodium
    Indication: Product Used FOR Unknown Indication

Infliximab, Recombinant
    Indication: Product Used FOR Unknown Indication

Nitrofurantoin
    Indication: Product Used FOR Unknown Indication

Phenytoin
    Indication: Product Used FOR Unknown Indication



Possible Nitrofurantoin side effects in 73 year old female

Reported by a pharmacist from United Kingdom on 2012-07-29

Patient: 73 year old female

Reactions: Back Pain, Jaundice, Liver Function Test Abnormal, Lethargy

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Nitrofurantoin
    Administration route: Oral
    Indication: Urinary Tract Infection
    Start date: 2012-05-22
    End date: 2012-05-25

Pazopanib
    Administration route: Oral
    Indication: Renal Cell Carcinoma
    Start date: 2012-03-01
    End date: 2012-05-26

Other drugs received by patient: Dihydrocodeine Bitartrate INJ; Prednisolone; Amitriptyline Hydrochloride; Fluoxetine HCL



Possible Nitrofurantoin side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-27

Patient: female

Reactions: Cleft LIP and Palate, Maternal Drugs Affecting Foetus, Amniotic Band Syndrome, Premature Baby, Anophthalmos, Bicuspid Aortic Valve, Cryptophthalmos, Tongue Disorder, Heart Disease Congenital, Microphthalmos, Optic Nerve Hypoplasia, Pterygium Colli

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Midrin
    Indication: Foetal Exposure During Pregnancy

Migquin
    Indication: Foetal Exposure During Pregnancy
    Start date: 2005-10-24

Nitrofurantoin
    Indication: Foetal Exposure During Pregnancy
    Start date: 2005-11-29

Topamax

Topamax
    Indication: Foetal Exposure During Pregnancy

Topamax
    Start date: 2005-10-21

Topamax



Possible Nitrofurantoin side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-26

Patient: female, weighing 62.6 kg (137.7 pounds)

Reactions: Nausea, Maternal Exposure During Pregnancy, Premature Labour

Drug(s) suspected as cause:
Midrin
    Indication: Headache
    Start date: 2005-10-21

Migquin
    Indication: Product Used FOR Unknown Indication
    Start date: 2005-10-24

Nitrofurantoin
    Indication: Product Used FOR Unknown Indication
    Start date: 2005-11-29

Topamax
    Dosage: every pm for a week
    Administration route: Oral

Topamax
    Dosage: 1 each evening for 1 week
    Administration route: Oral
    Start date: 2005-10-21

Topamax
    Dosage: every pm for a week
    Administration route: Oral

Topamax
    Dosage: every pm
    Administration route: Oral
    Indication: Headache



Possible Nitrofurantoin side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-23

Patient: female, weighing 76.8 kg (169.0 pounds)

Reactions: Movement Disorder, Pain, Pyrexia, Erythema, Malaise, Chest Pain, Dizziness, Blood Pressure Increased, Dyspnoea, Nausea, Pain in Extremity, Retching, Tremor, Rash Macular, Dysstasia, Renal Impairment, Arthralgia

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Nitrofurantoin



Possible Nitrofurantoin side effects in female

Reported by a pharmacist from United States on 2012-07-23

Patient: female, weighing 90.0 kg (198.0 pounds)

Reactions: Back Pain, Klebsiella Infection, Malaise, Nausea, Chills, Pollakiuria, Pyrexia

Drug(s) suspected as cause:
Nitrofurantoin
    Dosage: 100mg bid po
    Administration route: Oral
    Indication: Urinary Tract Infection
    Start date: 2012-04-10
    End date: 2012-04-16

Nitrofurantoin
    Dosage: 100mg bid po
    Administration route: Oral
    Indication: Urinary Tract Infection
    Start date: 2012-06-15
    End date: 2012-06-15

Other drugs received by patient: Lactobacillus; Esomeprazole; Amlodipine; Atenolol; Sertraline



Possible Nitrofurantoin side effects in 66 year old female

Reported by a consumer/non-health professional from United Kingdom on 2012-07-20

Patient: 66 year old female

Reactions: Urinary Tract Infection, Skin Burning Sensation, Erythema, Skin Irritation

Drug(s) suspected as cause:
Atorvastatin
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-01-01

Nitrofurantoin
    Indication: Bladder Disorder

Nitrofurantoin
    Indication: Urinary Tract Infection



Possible Nitrofurantoin side effects in 66 year old female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-07-19

Patient: 66 year old female

Reactions: Urinary Tract Infection, Skin Burning Sensation, Erythema, Skin Irritation

Drug(s) suspected as cause:
Atorvastatin
    Dosage: 10 mg, unknown
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-01-01

Nitrofurantoin
    Indication: Bladder Disorder

Nitrofurantoin
    Indication: Urinary Tract Infection



Possible Nitrofurantoin side effects in

Reported by a health professional (non-physician/pharmacist) from Iceland on 2012-07-19

Patient:

Reactions: Drug-Induced Liver Injury

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Amoxicillin and Clavulanate Potassium
    Indication: Product Used FOR Unknown Indication

Diclofenac
    Indication: Product Used FOR Unknown Indication

Infliximab, Recombinant
    Indication: Product Used FOR Unknown Indication

Nitrofurantoin
    Indication: Product Used FOR Unknown Indication

Phenytoin
    Indication: Product Used FOR Unknown Indication



Possible Nitrofurantoin side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-18

Patient: female, weighing 59.0 kg (129.7 pounds)

Reactions: Vomiting, Nausea, Mucous Stools, Headache, Judgement Impaired, Rash, Myalgia, Fatigue, Malaise, Diarrhoea, Dizziness, Cough

Drug(s) suspected as cause:
Nitrofurantoin

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