Drug Safety Information for STELARA (Ustekinumab)

FDA Safety-related Labeling Changes for STELARA (USTEKINUMAB) Biological Drug: Safety Information Link

Required post-approval safety study:

Provide data analyses from the Nordic Database Initiative regarding the occurrence of serious infection, tuberculosis, opportunistic infections, malignancy, hypersensitivity reactions, autoimmune disease, neurologic or demyelinating disease, cardiovascular, gastrointestinal or hematologic adverse events with exposure to ustekinumab. Due Date: 2020-12-15

Required post-approval safety study:

Enroll 4,000 Stelara(TM) (ustekinumab)-treated subjects into the Psoriasis Longitudinal Assessment and Registry, (PSOLAR) and follow for 8 years from the time of enrollment. Subjects will be followed for the occurrence of serious infection, tuberculosis, opportunistic infections, malignancy, hypersensitivity reactions, autoimmune disease, neurologic or demyelinating disease, cardiovascular, gastrointestinal or hematologic adverse events, Due Date: 2020-12-01

Required post-approval safety study:

Provide data analyses from the Pregnancy Research Initiative (study C0168T71). Due Date: 2021-12-15

Original FDA Drug Approval Date for STELARA: 2009-09-25

Adverse Drug Reactions for STELARA* (Ustekinumab)

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 STELARA
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Psoriasis	991
2	Drug ineffective	700
3	Drug dose omission	532
4	Pneumonia	298
5	Headache	266
6	Arthralgia	253
7	Fatigue	184
8	Myocardial infarction	182
9	Psoriatic arthropathy	176
10	Cellulitis	163
11	Off label use	155
12	Lower respiratory tract infection	147
13	Dizziness	141
14	Weight decreased	135
15	Inappropriate schedule of drug administration	130
16	Cerebrovascular accident	129
17	Nausea	127
18	Drug effect decreased	126
19	Pain	126
20	Therapeutic response decreased	122

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

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

	Reason	# of FDA Reports
1	Psoriasis	13664
2	Product used for unknown indication	3160
3	Psoriatic arthropathy	1508
4	Crohn's disease	494
5	Pustular psoriasis	157
6	Erythrodermic psoriasis	52
7	Hidradenitis	34
8	Seborrhoeic dermatitis	27
9	Ill-defined disorder	26
10	Pityriasis rubra pilaris	19

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

Types of Adverse Events for STELARA

Total Reports Filed with FDA: 20286

Number of FDA Adverse Event Reports by Patient Age for STELARA

Total Reports Filed with FDA: 20286*

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

Charts are based on 20286 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.