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Jadenu Side Effects

Generic Name: deferasirox

Note: This page contains information about the side effects of deferasirox. Some of the dosage forms included on this document may not apply to the brand name Jadenu.

In Summary

Common side effects of Jadenu include: abdominal pain, cough, diarrhea, fever, headache, increased serum creatinine, influenza, nasopharyngitis, nausea, proteinuria, vomiting, and pharyngolaryngeal pain. Other side effects include: otic infection, respiratory tract infection, arthralgia, back pain, bronchitis, fatigue, increased serum alanine aminotransferase, pharyngitis, rhinitis, skin rash, tonsillitis, and upper abdominal pain. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to deferasirox: oral tablet, oral tablet for suspension

In addition to its needed effects, some unwanted effects may be caused by deferasirox (the active ingredient contained in Jadenu). In the event that any of these side effects do occur, they may require medical attention.

Major Side Effects

You should check with your doctor immediately if any of these side effects occur when taking deferasirox:

More common:
  • Abdominal or stomach pain
  • diarrhea
  • dizziness
  • earache or pain in the ear
  • nausea
  • voice changes
  • vomiting
Rare
  • Blindness
  • blurred vision
  • change in hearing
  • change in vision
  • pain or discomfort in the eye
Incidence not known:
  • 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 or skin rash
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • lethargy
  • 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
  • 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, oral tablet dispersible

General

The most common adverse events were abdominal pain, nausea, vomiting, diarrhea, skin rashes, and increases in serum creatinine. Gastrointestinal symptoms, increases in serum creatinine, and skin rash were dose related.[Ref]

Gastrointestinal

Very common (10% or more): Diarrhea (up to 47%), abdominal pain (28%), nausea (26%), vomiting (21%)
Common (1% to 10%): Abdominal pain upper, constipation, abdominal distension, dyspepsia
Uncommon (0.1% to 1%): Gastritis, gastrointestinal hemorrhage, gastric ulcer (including multiple ulcers), duodenal ulcer, esophagitis
Frequency not reported: Pancreatitis associated with gallstones
Postmarketing reports: Gastrointestinal perforation[Ref]

Renal

Very common (10% or more): Creatinine increased (38%)
Common (1% to 10%): Abnormal serum creatinine, abnormal creatinine clearance values
Uncommon (0.1% to 1%): Renal tubulopathy (Fanconi's Syndrome)
Postmarketing reports: Renal tubular necrosis, acute renal failure, tubulointerstitial nephritis[Ref]

Dermatologic

Very common (10% or more): Rash (13%)
Common (1% to 10%): Urticaria, pruritus
Uncommon (0.1% to 1%): Henoch Schonlein purpura, pigmentation disorder, erythema multiforme
Postmarketing reports: Stevens-Johnson syndrome, leukocytoclastic vasculitis, alopecia[Ref]

Genitourinary

Very common (10% or more): Intermittent proteinuria (18.6%)
Common (1% to 10%): Proteinuria
Uncommon (0.1% to 1%): Glycosuria[Ref]

Respiratory

Very common (10% or more): Cough (13.9%), nasopharyngitis (13.2%), influenza, (10.8%), pharyngolaryngeal pain (10.5%)
Common (1% to 10%): Respiratory tract infection, bronchitis, pharyngitis, acute tonsillitis, rhinitis[Ref]

Other

Very common (10% or more): Pyrexia (18.9%)
Common (1% to 10%): Death, fatigue, ear infection
Uncommon (0.1% to 1%): Drug fever, hearing loss[Ref]

Nervous system

Very common (10% or more): Headache (15.9%)
Uncommon (0.1% to 1%): Hyperactivity, dizziness[Ref]

Hepatic

Common (1% to 10%): Elevations in SGPT/ALT, gallstones, drug induced hepatitis, abnormal liver function tests, transaminases increased
Uncommon (0.1% to 1%): Cholelithiasis, hepatitis
Postmarketing reports: Hepatic failure[Ref]

Musculoskeletal

Common (1% to 10%): Arthralgia, back pain[Ref]

Ocular

Uncommon (0.1% to 1%): Cataract, maculopathy, early cataract, optic neuritis[Ref]

Metabolic

Uncommon (0.1% to 1%): Edema
Postmarketing reports: Metabolic acidosis[Ref]

Psychiatric

Uncommon (0.1% to 1%): Insomnia, sleep disorder, anxiety[Ref]

Hematologic

Postmarketing reports: Worsening anemia, cytopenias including neutropenia and thrombocytopenia, pancytopenia[Ref]

Hypersensitivity

Postmarketing reports: Hypersensitivity reactions (including anaphylaxis and angioedema)[Ref]

Immunologic

Frequency not reported: Atypical tuberculosis[Ref]

References

1. Cerner Multum, Inc. "Australian Product Information." O 0

2. "Product Information. Exjade (deferasirox)." Novartis Pharmaceuticals, East Hanover, NJ.

3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

Not all side effects for Jadenu may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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