Table 4.

Safety and tolerability of adalimumab in randomized controlled trials

Reference	Monthly incidence rate of withdrawals and adverse events in patients receiving adalimumab			Lethal/life threatening adverse events (n)
	Adverse events (any)	Serious adverse events	Most frequent adverse events1
Gordon 200648	25.2%2	1.9%2	Injection site pain 3.4%2 Increased blood triglycerides 2.3%2 Nausea 1.5%2 Dyspepsia 1.5%2	Malignant melanoma (n = 2) Breast cancer (n = 1) Gastric adenocarcinoma (n = 1) Coccidioidomycosis (n = 1) Recent onset latent tuberculosis (n = 1)
Menter 200849	55.4%2	0.7%2	Injection site reaction 3.3%2 Upper respiratory tract infection 1.9%2 Nasopharyngitis 1.4%2 Headache 1.3%2	Basal cell carcinoma (n = 3) Squamous cell carcinoma (n = 3) Breast cancer (n = 1) Melanoma in situ (n = 1) Tuberculosis (n = 1) Congestive heart failure (n = 1)
Saurat 200850	19.8%	0.5%	Nasopharyngitis 7.5% Headache 3.5% Arthralgia 1.5%	Pancreatitis (n = 1)
Mease 200557	Not reported	0.6%2	Nasopharyngitis 1.8%2	Viral meningitis (n = 1)
Gladman 200756			Injection site reaction 1.2 2	Myocardial infarction (n = 2)
Mease 200858			Hypertension 0.9%2	Pulmonary embolism (n = 1) Peritoneal tuberculosis (n = 1) B-cell nonHodgkin lymphoma (n = 1) Nonmelanoma skin cancer (n = 3)
Genovese 200759	18.9%2	0.7%2	Upper respiratory tract infection 4.9%2	Renal failure associated with rhabdomyolysis (n = 1)

¹Notes: Observed more frequently in an adalimumab group than placebo;

²within double-blind treatment period.