Drug Safety Information for VANIQA (Eflornithine hydrochloride)

Adverse Drug Reactions for VANIQA* (Eflornithine 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 VANIQA
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Drug ineffective	61
2	Product quality issue	39
3	Hair growth abnormal*	18
4	Rash	17
5	Acne	15
6	Alopecia	15
7	Pain	14
8	Arthralgia	14
9	Nausea	14
10	Erythema	13
11	Vomiting	12
12	Pain in extremity	11
13	Injury	11
14	Dyspnoea	10
15	Fatigue	10
16	Anxiety	9
17	Pulmonary embolism	9
18	Abdominal pain	9
19	Abortion spontaneous	8
20	Dizziness	8

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

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

	Reason	# of FDA Reports
1	Product used for unknown indication	240
2	Hair growth abnormal	233
3	Hirsutism	64
4	Hypertrichosis	25
5	Depilation	18
6	African trypanosomiasis	16
7	Maternal exposure during pregnancy	5
8	Skin cosmetic procedure	2
9	Hair disorder	2
10	Encephalitis	2

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

Types of Adverse Events for VANIQA

Total Reports Filed with FDA: 1320

Number of FDA Adverse Event Reports by Patient Age for VANIQA

Total Reports Filed with FDA: 1320*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Eflornithine hydrochloride (Ornidyl, Eflornithine, Vaniqa)

Charts are based on 1320 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.