Drug Safety Information for OTEZLA (Apremilast)

FDA Safety-related Labeling Changes for OTEZLA (APREMILAST) Rx Drug: Safety Information Link

Diarrhea, nausea, and vomiting Safety label updated

Required post-approval safety study:

A prospective, observational, controlled, pregnancy exposure registry study to monitor pregnancies exposed to apremilast with the primary objective to evaluate whether there is any increase in the risk of birth defects. Due Date: 2022-06-30

Original FDA Drug Approval Date for OTEZLA: 2014-03-21

Adverse Drug Reactions for OTEZLA* (Apremilast)

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 OTEZLA
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Diarrhoea	1844
2	Nausea	1839
3	Headache	1479
4	Drug ineffective	523
5	Vomiting	373
6	Abdominal discomfort	370
7	Abdominal pain upper	317
8	Depression	290
9	Weight decreased	282
10	Psoriasis	261
11	Fatigue	234
12	Arthralgia	206
13	Decreased appetite	193
14	Dizziness	188
15	Insomnia	186
16	Pain	171
17	Migraine	163
18	Malaise	160
19	Abdominal pain	157
20	Adverse drug reaction	147

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

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

	Reason	# of FDA Reports
1	Psoriatic arthropathy	8888
2	Psoriasis	4711
3	Product used for unknown indication	1476
4	Rheumatoid arthritis	97
5	Behcet's syndrome	39
6	Arthritis	23
7	Eczema	20
8	Ankylosing spondylitis	15
9	Erythema multiforme	9
10	Prostatic specific antigen	9

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

Types of Adverse Events for OTEZLA

Total Reports Filed with FDA: 15539

Number of FDA Adverse Event Reports by Patient Age for OTEZLA

Total Reports Filed with FDA: 15539*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Apremilast (Otezla)

Charts are based on 15539 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.