Drug Safety Information for FLAGYL I.V. (Metronidazole hydrochloride)

Adverse Drug Reactions for FLAGYL I.V.* (Metronidazole hydrochloride)

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 FLAGYL I.V.
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Diarrhoea38
2Nausea*35
3Pyrexia30
4Pain23
5Fatigue*23
6Weight decreased22
7Vomiting21
8Dyspnoea18
9Sepsis17
10Abdominal pain17
11Injury15
12Headache*14
13Anaemia13
14Rash13
15Hypertension13
16Arthralgia12
17Muscle spasms12
18Pancytopenia12
19Renal failure12
20Multi-organ failure12

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

Top 10 Reasons for Taking FLAGYL I.V.
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Product used for unknown indication208
2Amoebiasis81
3Crohn's disease*40
4Vaginal infection33
5Colitis31
6Rosacea25
7Prophylaxis23
8Diarrhoea23
9Infection22
10Clostridial infection19

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


Types of Adverse Events for FLAGYL I.V.

Total Reports Filed with FDA: 2352


Number of FDA Adverse Event Reports by Patient Age for FLAGYL I.V.

Total Reports Filed with FDA: 2352*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Metronidazole hydrochloride (Flagyl i.v., Metro, Metronidazol)

Charts are based on 2352 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 FLAGYL I.V. Reviews and Review Summary .

Historical 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.