Drug Safety Information for NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) (Nitrofurantoin; nitrofurantoin, macrocrystalline)

Adverse Drug Reactions for NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)* (Nitrofurantoin; nitrofurantoin, macrocrystalline)

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 (MONOHYDRATE/MACROCRYSTALS)
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Urinary tract infection292
2Pain*252
3Nausea*239
4Dyspnoea225
5Asthenia170
6Anxiety170
7Fatigue*163
8Headache*163
9Pyrexia*150
10Dizziness*150
11Drug hypersensitivity142
12Vomiting133
13Diarrhoea130
14Injury126
15Abdominal pain123
16Chest pain117
17Depression117
18Drug ineffective111
19Back pain104
20Emotional distress102

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

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

Reason # of FDA Reports
1Urinary tract infection*2553
2Product used for unknown indication1765
3Cystitis*504
4Prophylaxis185
5Prophylaxis urinary tract infection163
6Sepsis69
7Infection prophylaxis64
8Dysuria57
9Infection*57
10Kidney infection*43

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


Types of Adverse Events for NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)

Total Reports Filed with FDA: 18281


Number of FDA Adverse Event Reports by Patient Age for NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)

Total Reports Filed with FDA: 18281*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Nitrofurantoin; nitrofurantoin, macrocrystalline (Macrobid)

Charts are based on 18281 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 (MONOHYDRATE/MACROCRYSTALS) 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.

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