Drug Safety Information for METROGEL-VAGINAL (Metronidazole)

Safety-related Labeling Changes for FLAGYL (METRONIDAZOLE) Rx Drug: FDA Link

Safety-related Labeling Changes for FLAGYL I.V. RTU IN PLASTIC CONTAINER (METRONIDAZOLE) Rx Drug: FDA Link

Safety-related Labeling Changes for METRONIDAZOLE IN PLASTIC CONTAINER (METRONIDAZOLE) Rx Drug: FDA Link

Safety-related Labeling Changes for METRO I.V. IN PLASTIC CONTAINER (METRONIDAZOLE) Rx Drug: FDA Link

Safety-related Labeling Changes for FLAGYL ER (METRONIDAZOLE) Brand name discontinued; available as generic: FDA Link

Safety-related Labeling Changes for VANDAZOLE (METRONIDAZOLE) Rx Drug: FDA Link

Safety-related Labeling Changes for NUVESSA (METRONIDAZOLE) Rx Drug: FDA Link

Adverse Drug Reactions for METROGEL-VAGINAL* (Metronidazole)

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 METROGEL-VAGINAL
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Diarrhoea1379
2Nausea*1322
3Pyrexia1152
4Pain1137
5Vomiting1122
6Abdominal pain932
7Dyspnoea859
8Anxiety*768
9Drug hypersensitivity748
10Headache*712
11Dizziness*708
12Fatigue*681
13Asthenia662
14Drug ineffective641
15Hypotension628
16Rash609
17Injury596
18Anaemia571
19Sepsis567
20Renal failure acute523

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

Top 10 Reasons for Taking METROGEL-VAGINAL
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Product used for unknown indication10525
2Rosacea*1942
3Crohn's disease1493
4Infection*1422
5Clostridial infection1256
6Diverticulitis*1202
7Vaginitis bacterial*940
8Prophylaxis890
9Helicobacter infection745
10Urinary tract infection706

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


Types of Adverse Events for METROGEL-VAGINAL

Total Reports Filed with FDA: 115237


Number of FDA Adverse Event Reports by Patient Age for METROGEL-VAGINAL

Total Reports Filed with FDA: 115237*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Metronidazole (Rosadan, Satric, Metro i.v., Vagilen, Nuvessa, Vitazol, Metromidol, Metrogel-vaginal, Zidoval, Vandazole, Rozex, Metryl, Metrogyl, Flagyl s, Protostat, Clont, Metrolyl, Noritate, Flagyl er, Metronidazole, Metrolotion, Metrocream, Metrogel, Flagyl)

Charts are based on 115237 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 METROGEL-VAGINAL 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.