Drug Safety Information for AVITA (Tretinoin)

Adverse Drug Reactions for AVITA* (Tretinoin)

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 AVITA
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Retinoic acid syndrome107
2Pain*100
3Pyrexia97
4Anxiety89
5Headache88
6Nausea81
7Depression74
8Dyspnoea71
9Drug ineffective69
10Vomiting64
11Sepsis64
12Fatigue63
13Pulmonary embolism60
14Deep vein thrombosis59
15Abdominal pain57
16Injury57
17Diarrhoea57
18Febrile neutropenia55
19Rash55
20Drug interaction53

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

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

Reason # of FDA Reports
1Acute promyelocytic leukaemia1290
2Acne*1135
3Product used for unknown indication469
4Acute myeloid leukaemia427
5Skin disorder96
6Ephelides78
7Therapeutic skin care topical75
8Rosacea56
9Acne cystic*47
10Skin wrinkling45

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


Types of Adverse Events for AVITA

Total Reports Filed with FDA: 10019


Number of FDA Adverse Event Reports by Patient Age for AVITA

Total Reports Filed with FDA: 10019*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Tretinoin (Tretin-x, Tretin.x, Renova, Refissa, Avita, Vesanoid, Tretinoin, Retin-a, Retin-a micro, Atralin, Retin-a-micro)

Charts are based on 10019 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 AVITA Reviews and Review Summary .

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.

Visit   DrugInformer.com more on AVITA's side effects.