Drug Safety Information for ACTEMRA (Tocilizumab)

FDA Safety-related Labeling Changes for ACTEMRA (TOCILIZUMAB) Biological Drug: Safety Information Link

Required post-approval safety study:

A long-term safety study in 400 pediatric patients 2-17 years of age with polyarticular JIA (pJIA) treated with tocilizumab to evaluate for the risk of malignancies, serious infections, gastrointestinal perforation, and effects on growth. The study should include a control group of 400 pediatric pJIA patients treated with other biologics as standard of care. Patients should be followed for 5 years. Due Date: 2023-04-30

Original FDA Drug Approval Date for ACTEMRA: 2010-01-08

Adverse Drug Reactions for ACTEMRA* (Tocilizumab)

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 ACTEMRA
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Arthralgia	684
2	Drug ineffective	613
3	Pain	474
4	Rheumatoid arthritis	452
5	Pneumonia	426
6	Headache	343
7	Nausea	333
8	Pain in extremity	330
9	Weight increased	322
10	Fatigue	321
11	Malaise	320
12	Diarrhoea	312
13	Death	311
14	Nasopharyngitis	305
15	Dyspnoea	294
16	Weight decreased	286
17	Fall	277
18	Vomiting	262
19	Hypertension	260
20	Infusion related reaction	259

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

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

	Reason	# of FDA Reports
1	Rheumatoid arthritis	27812
2	Product used for unknown indication	2315
3	Juvenile arthritis	1447
4	Castleman's disease	618
5	Still's disease adult onset	219
6	Polyarthritis	107
7	Arthritis	104
8	Off label use	95
9	Takayasu's arteritis	89
10	Systemic lupus erythematosus	72

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

Types of Adverse Events for ACTEMRA

Total Reports Filed with FDA: 35947

Number of FDA Adverse Event Reports by Patient Age for ACTEMRA

Total Reports Filed with FDA: 35947*

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

Charts are based on 35947 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.