Preferred Term (MedDRA) ZILRETTA 

(N=424) Placebo 

(N=262) 

Sinusitis  2%  1%  

Cough  2%  1%  

Contusions  2%  1%  

Table 2: Most Commonly Reported Treatment-Emergent Injected Knee Adverse Reactions with ZILRETTA (Incidence ≥1%) in Patients with Osteoarthritis of the Knee  

Preferred Term (MedDRA)

ZILRETTA 

(N=424)

Placebo 

(N=262)

Joint Swelling  3%  2%  

Contusions  2%  1%  

Corticosteroid Adverse Reactions 

The following adverse reactions, presented alphabetically by body system, are from voluntary reports or clinical studies of corticosteroids. Because some of these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. 

Anaphylactic reactions: Anaphylaxis including death, angioedema [see Warnings and Precautions ( 5.3)] . 

Cardiovascular: Bradycardia, cardiac arrest, cardiac arrhythmias, cardiac enlargement, circulatory collapse, congestive heart failure, hypertension [see Warnings and Precautions ( 5.7)] , fat embolism, hypertrophic cardiomyopathy in premature infants, myocardial rupture following recent myocardial infarction, pulmonary edema, syncope, tachycardia, thromboembolism, thrombophlebitis, vasculitis. 

Dermatologic: Acne, allergic dermatitis, cutaneous and subcutaneous atrophy, dry scaly skin, ecchymoses and petechiae, edema, erythema, hyperpigmentation, hypopigmentation, impaired wound healing, increased sweating, lupus erythematosus-like lesions, purpura, rash, sterile abscess, striae, suppressed reactions to skin tests, thin fragile skin, thinning scalp hair, urticaria. 

Endocrine: Decreased carbohydrate and glucose tolerance, development of Cushingoid state, glycosuria, hirsutism, hypertrichosis, increased requirements for insulin or oral hypoglycemic agents in diabetes, manifestations of latent diabetes mellitus, menstrual irregularities, secondary adrenocortical and pituitary unresponsiveness (particularly in times of stress, as in trauma, surgery, or illness), suppression of growth in pediatric patients. 

Fluid and electrolyte disturbances: Congestive heart failure in susceptible patients [see Warnings and Precautions ( 5.7)] , fluid retention, sodium retention. 

Gastrointestinal: Abdominal distention, bowel/bladder dysfunction (after intrathecal administration) [see Warnings and Precautions ( 5.2)] , elevation in serum liver enzyme levels (usually reversible upon discontinuation), hepatomegaly, increased appetite, nausea, pancreatitis, peptic ulcer with possible perforation and hemorrhage, perforation of the small and large intestine (particularly in patients with inflammatory bowel disease) [see Warnings and Precautions ( 5.10)] , ulcerative esophagitis. 

Metabolic: Negative nitrogen balance due to protein catabolism.