Exjade Side Effects

Generic Name: deferasirox

Please note - some side effects for Exjade may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Exjade - for the Consumer

Exjade

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Exjade:

Cough; diarrhea; headache; nausea; stomach pain; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody or tarry stools; chills; dark urine or decreased amount of urine; decreased hearing, hearing loss, or other hearing problems; fever; pale stools; persistent sore throat or cough; severe or persistent stomach pain; severe or persistent vomiting or diarrhea; unusual bruising or bleeding; unusual tiredness or fatigue; vision changes (eg, blurred or cloudy vision, decreased vision); vomit that looks like coffee grounds; yellowing of the skin or eyes.

Exjade Side Effects - for the Professional

Exjade

The most frequently occurring adverse reactions are diarrhea, vomiting, nausea, abdominal pain, skin rashes, and increases in serum creatinine. (6.1)

Side Effects by Body System

General

General side effects including pyrexia (18.9%), headache (15.9%), abdominal pain (13.9%), influenza (10.8%), upper abdominal pain (7.8%), and fatigue (6.1%) have been reported.

Respiratory

Respiratory side effects including cough (13.9%), nasopharyngitis (13.2%), pharyngolaryngeal pain (10.5%), respiratory tract infection (9.5%), bronchitis (9.1%), pharyngitis (7.8%), and rhinitis (6.1%) have been reported.

Gastrointestinal

Gastrointestinal side effects including diarrhea (11.8%), nausea (10.5%), vomiting (10.1%), and upper gastrointestinal ulceration and hemorrhage have been reported.

Renal

Nonprogressive increases in serum creatinine have been noted in 38% of deferasirox-treated patients and appear to be dose related. These increases were within the normal range in 94% of patients. Deferasirox dosages had been adjusted once serum creatinine elevations were detected during the study. Dose reduction, interruption, or discontinuation should be considered for elevations in serum creatinine. If there is a progressive increase in serum creatinine beyond the age-appropriate upper limit of normal, deferasirox should be interrupted. Once the creatinine has returned to within the normal range, therapy with deferasirox may be reinitiated at a lower dose followed by gradual dose escalation, if the clinical benefit is expected to outweigh potential risks.

Intermittent proteinuria (urine protein/creatinine ratio greater than 0.6 mg/mg) has been reported in 18.6% of deferasirox treated patients. Monthly monitoring is recommended.

Renal side effects including increased creatinine, intermittent proteinuria, and renal tubulopathy have been reported. Cases of acute renal failure have also been reported in the context of severe complications relating to the underlying disease.

Dermatologic

Dermatologic side effects including rash (8.4%), urticaria (3.7%), and leukocytoclastic vasculitis have been reported.

Musculoskeletal

Musculoskeletal side effects including arthralgia (7.4%) and back pain (5.7%) have been reported.

Immunologic

Immunologic side effects including acute tonsillitis (6.4%) have been reported.

Other

Other side effects including ear infection (5.4%), high-frequency hearing loss, and decreased hearing have been reported.

Hepatic

Hepatic side effects have included two patients with drug-induced hepatitis and two patients with increased serum transaminases who discontinued use of deferasirox because of these hepatic abnormalities. There have been postmarketing reports of hepatic failure, some with a fatal outcome, in patients treated with deferasirox. Most of these events occurred in patients greater than 55 years of age. Seventeen of the patients in the clinical trials developed elevations in SGPT/ALT levels greater than five times the upper limit of normal at two consecutive visits.

Most reports of hepatic failure involved patients with significant comorbidities, including liver cirrhosis and multiorgan failure.

Increases in transaminases were not dose related.

Hematologic

Although most of these patients had preexisting hematologic disorders that are frequently associated with bone marrow failure, a contributory role for deferasirox could not be excluded.

Hematologic side effects have included cytopenias such as agranulocytosis, neutropenia, and thrombocytopenia.

Hypersensitivity

If reactions are severe, deferasirox should be discontinued and appropriate medical intervention instituted.

Hypersensitivity side effects including anaphylaxis and angioedema have been reported.

Ocular

Ocular side effects including lens opacities, cataracts, elevations in intraocular pressure, and retinal disorders have been reported with deferasirox therapy in less than 1% of patients in clinical trials.

Ophthalmic testing (including slit lamp examinations and dilated fundoscopy) are recommended before the start of deferasirox treatment and thereafter every 12 months.

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