Drug Safety Information for HUMIRA (Adalimumab)
Safety-related Labeling Changes for HUMIRA (ADALIMUMAB) Rx Drug: FDA Link
Safety-related Labeling Changes for CYLTEZO (ADALIMUMAB-ADBM) Biological Drug: FDA Link
Required post-approval safety study:
A study in inflammatory bowel disease (IBD) patients treated with Humira (adalimumab) in which you will bank tissue or blood samples (as appropriate) and then analyze them to identify genetic mutations and other biomarkers that predispose these patients to developing Hepatosplenic T-Cell Lymphoma (HSTCL). Due Date: 2020-09-30
Required post-approval safety study:
Conduct Study Protocol P10-262, an 800-patient observational study, with inclusion of a reference group, of pediatric patients 4 to 17 years of age with moderately to severely active polyarticular juvenile idiopathic arthritis (JIA). Due Date: 2021-12-31
Required post-approval safety study:
Enhanced pharmacovigilance program for reports of malignancy in pediatric, adolescent, and young adult (less than or equal to 30 years of age) patients treated with Humira (adalimumab), for a period of up to 10 years to collect data that will be analyzed to better define the risk of this serious adverse event. The enhanced pharmacovigilance program includes the following: 1) active query of reporters to obtain additional clinical information related to malignancy diagnoses 2) expedited reporting to FDA of all initial and follow-up reports of any malignancy in pediatric, adolescent, and young adult patients. Due Date: 2020-03-31
Required post-approval safety study:
Conduct a prospective, multi-center registry including 5000 adult psoriasis patients treated with Humira in the United States. This registry will characterize and assess the incidence of serious adverse events (including serious infections, tuberculosis, opportunistic infections, malignancies, hypersensitivity reactions, autoimmune reactions and deaths) as well as other adverse events of interest in the study cohort. All enrolled study patients will be evaluated for a period of at least 10 years with comprehensive annual reports provided to the Agency. Collect data on the patient characteristics, demographics and drug exposure (including dose, duration and time to onset of adverse event). The collection of data will be via active surveillance methods and data will be validated by a review of medical records as per the guidance for industry titled Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment. Due Date: 2023-01-31
Required post-approval safety study:
A multi-center observational study of Humira (adalimumab) in adults with moderately to severely active ulcerative colitis treated in a routine clinical setting, to assess the long-term safety as measured by the incidence of opportunistic infections and malignancies. Long-term effectiveness should be assessed as a secondary goal. The proposed study should follow patients for a period of at least 10 years from time of enrollment in order to ascertain adverse events with longer latency periods such as malignancies. The primary analysis is to summarize safety data for patients on adalimumab and patients on non-biologic immunomodulator therapy. The study should be adequately sized to sufficiently detect a doubling of the risk of lymphoma events in each treatment group. A secondary analysis is to summarize safety data for patients on adalimumab and patients on the combination of adalimumab and non-biologic immunomodulator therapy. In addition, the study is to document and evaluate effects of withdrawal and re-treatment with adalimumab and switching with other tumor necrosis factor (TNF)-blockers or biologics. Due Date: 2029-12-31
Original FDA Drug Approval Date for HUMIRA: 2002-12-31
Adverse Drug Reactions for HUMIRA* (Adalimumab)
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 HUMIRA
(reported in FDA Medwatch/FAERS Reports)
| Side Effect | # of FDA Reports | |
|---|---|---|
| 1 | Injection site pain | 28865 |
| 2 | Drug ineffective | 18475 |
| 3 | Arthralgia* | 13276 |
| 4 | Pain* | 11636 |
| 5 | Fatigue* | 10800 |
| 6 | Incorrect dose administered | 10679 |
| 7 | Headache* | 9738 |
| 8 | Injection site erythema | 9384 |
| 9 | Psoriasis | 9258 |
| 10 | Nausea* | 8633 |
| 11 | Nasopharyngitis | 8056 |
| 12 | Pyrexia | 7764 |
| 13 | Injection site haematoma | 7752 |
| 14 | Diarrhoea | 7691 |
| 15 | Crohn's disease | 7084 |
| 16 | Pain in extremity | 6850 |
| 17 | Rash* | 6714 |
| 18 | Injection site haemorrhage | 6461 |
| 19 | Cough | 6422 |
| 20 | Drug dose omission | 5997 |
* This side effect also appears in "Top 10 Side Effects of HUMIRA " in the drug's Review Summary based on AskaPatient reviews.
Top 10 Reasons for Taking HUMIRA
(associated with FDA Medwatch/FAERS Reports)
| Reason | # of FDA Reports | |
|---|---|---|
| 1 | Rheumatoid arthritis* | 247718 |
| 2 | Crohn's disease* | 177228 |
| 3 | Psoriasis* | 76058 |
| 4 | Psoriatic arthropathy* | 69840 |
| 5 | Product used for unknown indication | 46344 |
| 6 | Ankylosing spondylitis* | 32002 |
| 7 | Colitis ulcerative* | 29424 |
| 8 | Juvenile arthritis | 4132 |
| 9 | Arthritis* | 2083 |
| 10 | Maternal exposure timing unspecified | 1781 |
*Also a top-10 reason in AskaPatient Review Summary.
Types of Adverse Events for HUMIRA
Total Reports Filed with FDA: 726361
Number of FDA Adverse Event Reports by Patient Age for HUMIRA
Total Reports Filed with FDA: 726361*
* Reports for drugs with the same active ingredients have been aggregated in this analysis: Adalimumab (Humira)
Charts are based on 726361 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 HUMIRA 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.