Drug Safety Information for TERAZOL 7 (Terconazole)

Adverse Drug Reactions for TERAZOL 7* (Terconazole)

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 TERAZOL 7
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Pain*	42
2	Emotional distress	29
3	Injury	29
4	Anxiety	28
5	Pain in extremity	21
6	Dyspnoea	21
7	Depression	19
8	Nausea	19
9	Abdominal pain	18
10	Urinary tract infection	17
11	Pulmonary embolism	17
12	Asthenia	17
13	Headache	17
14	Cholecystitis chronic	16
15	Vomiting	16
16	Deep vein thrombosis	15
17	Fatigue	14
18	Arthralgia	13
19	Back pain	13
20	Chest pain	13

* This side effect also appears in "Top 10 Side Effects of TERAZOL 7 " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking TERAZOL 7
(associated with FDA Medwatch/FAERS Reports)

	Reason	# of FDA Reports
1	Fungal infection*	154
2	Vulvovaginal mycotic infection*	83
3	Product used for unknown indication	53
4	Antifungal treatment	24
5	Vulvovaginal burning sensation	14
6	Malaise	13
7	Foetal exposure during pregnancy	10
8	Ill-defined disorder	5
9	Vulvovaginal candidiasis	5
10	Insomnia	4

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

Types of Adverse Events for TERAZOL 7

Total Reports Filed with FDA: 2359

Number of FDA Adverse Event Reports by Patient Age for TERAZOL 7

Total Reports Filed with FDA: 2359*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Terconazole (Zazole, Terconazole, Terazol 7, Terazol 3)

Charts are based on 2359 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.

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.