Drug Safety Information for TAZORAC (Tazarotene)

FDA Safety-related Labeling Changes for TAZORAC (TAZAROTENE) Rx Drug: Safety Information Link

FDA Safety-related Labeling Changes for AVAGE (TAZAROTENE) Rx Drug: Safety Information Link

Adverse Drug Reactions for TAZORAC* (Tazarotene)

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 TAZORAC
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Erythema*57
2Pregnancy44
3Pain*42
4Skin exfoliation*39
5Pruritus*38
6Rash28
7Drug ineffective27
8Dry skin*26
9Headache23
10Burning sensation*22
11Skin irritation18
12Acne*17
13Off label use16
14Dyspnoea16
15Skin burning sensation16
16Injury16
17Abortion spontaneous16
18Psoriasis15
19Emotional distress15
20Anxiety15

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

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

Reason # of FDA Reports
1Acne*456
2Product used for unknown indication227
3Psoriasis*205
4Maternal exposure during pregnancy50
5Acne cystic*27
6Eczema25
7Skin disorder20
8Skin exfoliation16
9Nail disorder13
10Alopecia areata10

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


Types of Adverse Events for TAZORAC

Total Reports Filed with FDA: 2207


Number of FDA Adverse Event Reports by Patient Age for TAZORAC

Total Reports Filed with FDA: 2207*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Tazarotene (Fabior, Zorac, Tazorac, Avage)

Charts are based on 2207 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 TAZORAC 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.