Drug Safety Information for NITROFURANTOIN (Nitrofurantoin)

Adverse Drug Reactions for NITROFURANTOIN* (Nitrofurantoin)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with NITROFURANTOIN
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Nausea*305
2Urinary tract infection301
3Pain*287
4Dyspnoea*260
5Headache*223
6Vomiting*211
7Fatigue*210
8Pyrexia194
9Diarrhoea189
10Asthenia182
11Anxiety*174
12Dizziness*165
13Malaise164
14Fall160
15Arthralgia145
16Rash134
17Chest pain132
18Drug ineffective131
19Cough131
20Injury126

* This side effect also appears in "Top 10 Side Effects of NITROFURANTOIN " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking NITROFURANTOIN
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Urinary tract infection*4133
2Product used for unknown indication2104
3Cystitis*838
4Prophylaxis urinary tract infection410
5Prophylaxis274
6Infection192
7Foetal exposure during pregnancy181
8Infection prophylaxis120
9Acne107
10Dysuria97

*Also a top-10 reason in AskaPatient Review Summary.


Types of Adverse Events for NITROFURANTOIN

Total Reports Filed with FDA: 22917


Number of FDA Adverse Event Reports by Patient Age for NITROFURANTOIN

Total Reports Filed with FDA: 22917*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Nitrofurantoin (Furalan, Furantoin, Furadoine, Furadantine, Furadantin, Nitrofurantoin)

Charts are based on 22917 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

Click to go back to search results and NITROFURANTOIN Reviews and Review Summary .

Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.

Visit   DrugInformer.com more on NITROFURANTOIN's side effects.