Deferasirox Side Effects
Not all side effects for deferasirox may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.
For the Consumer
Applies to deferasirox: oral tablet for suspension
In addition to its needed effects, some unwanted effects may be caused by deferasirox. In the event that any of these side effects do occur, they may require medical attention.
You should check with your doctor immediately if any of these side effects occur when taking deferasirox:More common
- Abdominal pain
- earache or pain in the ear
- voice changes
- blurred vision
- change in hearing
- change in vision
- pain or discomfort in the eye
- Black, tarry stools
- bleeding gums
- blood in the urine or stools
- dark-colored urine
- decrease in urine amount
- general feeling of tiredness or weakness
- hives or welts
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- light-colored stools
- lower back or side pain
- pale skin
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- redness, soreness or itching of the skin
- skin rash
- sores, welting, or blisters
- stomach pain, continuing
- unusual bleeding or bruising
- vomiting of blood or material that looks like coffee grounds
- yellow eyes or skin
For Healthcare Professionals
Applies to deferasirox: oral tablet dispersible
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 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 side effects including diarrhea (11.8%), nausea (10.5%), vomiting (10.1%), and upper gastrointestinal ulceration and hemorrhage have been reported.
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. There have also been postmarketing reports of acute renal failure and tubulointerstitial nephritis.
Dermatologic side effects including rash (8.4%), urticaria (3.7%), and postmarketing reports of leukocytoclastic vasculitis, urticaria, and alopecia have been reported.
Musculoskeletal side effects including arthralgia (7.4%) and back pain (5.7%) have been reported.
Immunologic side effects including acute tonsillitis (6.4%) have been reported.
Other side effects including ear infection (5.4%), high-frequency hearing loss, and decreased hearing have been reported.
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 side effects have included cytopenias such as agranulocytosis, neutropenia, thrombocytopenia and postmarketing reports of worsening anemia.
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.
If reactions are severe, deferasirox should be discontinued and appropriate medical intervention instituted.
Hypersensitivity side effects including postmarketing reports of anaphylaxis and angioedema have been reported.
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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