Zilretta
- Generic Name: triamcinolone acetonide extended-release injectable suspension
- Brand Name: Zilretta
Zilretta (Triamcinolone Acetonide Extended-Release Injectable Suspension) side effects drug center
Zilretta Side Effects Center
What Is Zilretta?
Zilretta (triamcinolone acetonide extended-release injectable suspension) is an extended-release synthetic corticosteroid indicated as an intra-articular injection for the management of osteoarthritis pain of the knee.
What Are Side Effects of Zilretta?
Common side effects of Zilretta include:
Dosage for Zilretta
The dose of Zilretta is 32 mg administered as a single intra-articular injection in the knee. Zilretta may interact with:
- aminoglutethimide,
- amphotericin B injection,
- potassium-depleting agents,
- antibiotics,
- anticholinesterases,
- anticoagulants,
- antidiabetics,
- antitubercular drugs,
- barbiturates,
- phenytoin,
- carbamazepine,
- rifampin,
- ketoconazole,
- cholestyramine,
- cyclosporine,
- digitalis glycosides,
- estrogens (including oral contraceptives),
- nonsteroidal anti-inflammatory drugs (NSAIDs),
- and vaccines
What Drugs, Substances, or Supplements Interact with Zilretta?
Tell your doctor all medications and supplements you use and all vaccines you recently received.
Zilretta During Pregnancy and Breastfeeding
Tell your doctor if you are pregnant or plan to become pregnant before using Zilretta; it is unknown how it would affect a fetus. It is unknown if intra-articular administration of Zilretta could result in sufficient systemic absorption to produce detectable quantities in breast milk. Consult your doctor before breastfeeding.
Additional Information
Our Zilretta (triamcinolone acetonide extended-release injectable suspension) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
Zilretta Consumer Information
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
- (after injection into a joint space) increased pain or swelling, joint stiffness, fever, and general ill feeling;
- blurred vision, tunnel vision, eye pain, or seeing halos around lights;
- unusual changes in mood or behavior;
- swelling, rapid weight gain, feeling short of breath;
- stomach cramps, vomiting, diarrhea, bloody or tarry stools, rectal irritation;
- sudden numbness or weakness (especially on one side of the body);
- a seizure (convulsions);
- severe headache, blurred vision, pounding in your neck or ears;
- increased pressure inside the skull--severe headaches, ringing in your ears, dizziness, nausea, vision problems, pain behind your eyes; or
- signs of low adrenal gland hormones--flu-like symptoms, headache, depression, weakness, tiredness, diarrhea, vomiting, stomach pain, craving salty foods, and feeling light-headed.
Certain side effects may be more likely with long-term use or repeated doses of triamcinolone injection.
Steroids can affect growth in children. Tell your doctor if your child is not growing at a normal rate while using this medicine.
Common side effects may include:
- skin changes (acne, dryness, redness, bruising, discoloration);
- increased hair growth, or thinning hair;
- nausea, bloating, appetite changes;
- stomach or side pain;
- cough, runny or stuffy nose;
- headache, sleep problems (insomnia);
- a wound that is slow to heal;
- sweating more than usual; or
- changes in your menstrual periods.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Zilretta (Triamcinolone Acetonide Extended-Release Injectable Suspension)
Zilretta Professional Information
SIDE EFFECTS
The following serious adverse reactions are described elsewhere in the labeling.
- Serious Neurologic Adverse Reactions with Epidural and Intrathecal Administration [see WARNINGS AND PRECAUTIONS]
- Hypersensitivity Reactions [see WARNINGS AND PRECAUTIONS]
- Joint Infection and Damage [see WARNINGS AND PRECAUTIONS]
- Increased Risk of Infections [see WARNINGS AND PRECAUTIONS]
- Alterations in Endocrine Function [see WARNINGS AND PRECAUTIONS]
- Cardiovascular Effects [see WARNINGS AND PRECAUTIONS]
- Renal Effects [see WARNINGS AND PRECAUTIONS]
- Increased Intraocular Pressure [see WARNINGS AND PRECAUTIONS]
- Gastrointestinal Perforation [see WARNINGS AND PRECAUTIONS]
- Alternations in Bone Density [see WARNINGS AND PRECAUTIONS]
- Behavioral and Mood Disturbances [see WARNINGS AND PRECAUTIONS]
Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The data below reflect exposure to a single 32 mg intra-articular injection of ZILRETTA in clinical studies in patients with moderate to severe pain due to osteoarthritis of the knee. Clinical studies included randomized, double-blind, parallel-group, placebo and/or active-controlled, and pharmacokinetic/pharmacodynamic studies with follow-up ranging from 6-24 weeks. A total of 424 patients received ZILRETTA and 262 received placebo. Treatment emergent adverse reactions reported by greater than or equal to 1% of patients in the ZILRETTA arms are summarized below (Table 1 and 2).
Overall, the incidence and nature of adverse reactions was similar to that observed with placebo.
Table 1: Most Commonly Reported Treatment-Emergent Adverse Reactions with ZILRETTA (Incidence ≥1%) in Patients with Osteoarthritis of the Knee
| 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% |
The safety of repeat administration of ZILRETTA was evaluated in a multicenter, open-label, single-arm study in patients with osteoarthritis pain of the knee. A total of 179 patients received a repeat injection on or after Week 12 (median 16.6 weeks) and were followed for 52 weeks from the initial injection. As assessed by adverse event rates for the periods of baseline to second dose and second dose to the comparable period after the second dose, there were higher rates of reported mild to moderate arthralgia after the second dose (16%) than after the first dose (6%). The data from this study are insufficient to fully characterize the safety of repeat administration of ZILRETTA. [See also Nonclinical Toxicology].
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].
Cardiovascular: Bradycardia, cardiac arrest, cardiac arrhythmias, cardiac enlargement, circulatory collapse, congestive heart failure, hypertension [see WARNINGS AND PRECAUTIONS], 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], fluid retention, sodium retention.
Gastrointestinal: Abdominal distention, bowel/bladder dysfunction (after intrathecal administration) [see WARNINGS AND PRECAUTIONS], 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], ulcerative esophagitis.
Metabolic: Negative nitrogen balance due to protein catabolism.
Musculoskeletal: Aseptic necrosis of femoral and humeral heads, calcinosis (following intra-articular or intralesional use), Charcot-like arthropathy, loss of muscle mass, muscle weakness, osteoporosis, pathologic fracture of long bones, post injection flare (following intra-articular use), steroid myopathy, tendon rupture, vertebral compression fractures.
Neurologic/Psychiatric: Convulsions, depression, emotional instability, euphoria, headache, increased intracranial pressure with papilledema (pseudotumor cerebri) usually following discontinuation of treatment, insomnia, mood swings, neuritis, neuropathy, paresthesia, personality changes, psychiatric disorders [see WARNINGS AND PRECAUTIONS], vertigo. Arachnoiditis, meningitis, paraparesis/paraplegia, and sensory disturbances have occurred after intrathecal administration. Spinal cord infarction, paraplegia, quadriplegia, cortical blindness, and stroke (including brainstem) have been reported after epidural administration of corticosteroids [see WARNINGS AND PRECAUTIONS].
Ophthalmic: Exophthalmos, glaucoma, increased intraocular pressure [see WARNINGS AND PRECAUTIONS], posterior subcapsular cataracts, rare instances of blindness associated with periocular injections.
Other: Abnormal fat deposits, decreased resistance to infection, hiccups, increased or decreased motility and number of spermatozoa, malaise, moon face, weight gain.
Read the entire FDA prescribing information for Zilretta (Triamcinolone Acetonide Extended-Release Injectable Suspension)
&Copy; Zilretta Patient Information is supplied by Cerner Multum, Inc. and Zilretta Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.