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Deferasirox adverse events reported to FDA.

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Summary

FDA Adverse Reports: 24. View All

Deferasirox FDA safety alerts: 2007 2009

Reported deaths: 4

Reported hospitalizations: 8

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Often additional risks of using a medication, such as Deferasirox, become known after product is used by a larger number of patients, for a longer period of time, and by patients with different health characteristics from those studied before drug approval. This page allows You to Find answers and discuss health symptoms with other Deferasirox users, Learn more about unwanted side effects & find ways to reduce them. Browse Deferasirox Adverse Reports reported to FDA and participate in Deferasirox discussion, find alternative treatments and find ways to avoid or reduce risks associated with using Deferasirox. You can also Post a question to users community or Ask a Doctor. PatientsVille.com is Your Complete Guide to all common, undocumented and undisclosed side effects associated with drugs and vaccines. Browse More Drug Reports Here: A  B  C  D  E  F  G  H  I  J  K  L  M  N  O  P  Q  R  S  T  U  V  W  X  Y  Z

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Deferasirox Adverse Effect Reports (FDA)

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6938256-3 | Arthralgia, Cardiomyopathy, Liver Disorder, Proteinuria, Serum Ferritin Increased
on Aug 09, 2010 Female patient from ITALY , 20 years of age, was diagnosed with thalassaemia beta, iron overload and was treated with Deferasirox (View Usage). Patient experienced the following unwanted or unexpected effects: arthralgia, cardiomyopathy (What is cardiomyopathy?), liver disorder, proteinuria, serum ferritin increased. Deferasirox dosage: 30 Mg/kg/day. During the same period patient was treated with DEFERIPRONE (85 Mg/kg In Three Doses/day Administered On Alternating Days) (View Deferiprone Review and Deferiprone Label ), RED BLOOD CELLS (0.56 Ml Red Blood Cells/kg/day) (View Red Blood Cells Review and Red Blood Cells Label ).

6870606-9 | Arthralgia, Cardiomyopathy, Liver Disorder, Proteinuria, Serum Ferritin Increased
Patient was taking Deferasirox (View Usage). Patient had the following side effects: arthralgia, cardiomyopathy (What is cardiomyopathy?), liver disorder, proteinuria, serum ferritin increased on Jul 12, 2010 from ITALY Additional patient health information: Female patient , 20 years of age, was diagnosed with thalassaemia beta, iron overload and. Deferasirox dosage: 30 Mg/kg/day. During the same period patient was treated with DEFERIPRONE (85 Mg/kg In Three Doses/day Administered On Alternating Days) (View Deferiprone Review and Deferiprone Label ), RED BLOOD CELLS (0.56 Ml Red Blood Cells/kg/day) (View Red Blood Cells Review and Red Blood Cells Label ).

6839297-7 | Liver Function Test Abnormal, Nausea, Pyrexia, Rash, Rash Maculo-papular, Rash Pruritic, Renal Failure, Skin Lesion, Thrombocytopenia
Adverse event was reported on Jun 29, 2010 by a Female patient taking Deferasirox (View Usage) (Dosage: 1250 Mg Per Day) was diagnosed with iron overload and. Location: SPAIN , 64 years of age, After Deferasirox was administered, patient had the following side effects: liver function test abnormal, nausea (What is nausea?), pyrexia, rash (What is rash?), rash maculo-papular, rash pruritic, renal failure, skin lesion, thrombocytopenia. During the same period patient was treated with BLOOD TRANSFUSION, AUXILIARY PRODUCTS (View Blood Transfusion, Auxiliary Products Review and Blood Transfusion, Auxiliary Products Label ).

6755596-1 | Blood Bilirubin Increased, Blood Creatinine Increased, Hepatic Enzyme Increased, Pyrexia, Rash Maculo-papular, Skin Lesion, Type Iv Hypersensitivity Reaction, Vomiting
on May 25, 2010 Female patient from SPAIN , 64 years of age, was diagnosed with acute myeloid leukaemia, iron overload and was treated with Deferasirox (View Usage). Patient experienced the following unwanted or unexpected effects: blood bilirubin increased, blood creatinine increased, hepatic enzyme increased, pyrexia, rash maculo-papular, skin lesion, type iv hypersensitivity reaction, vomiting. Deferasirox dosage: 1250 Mg Per Day.


6753265-5 | Blood Bilirubin Increased, Blood Creatinine Increased, Hepatic Enzyme Increased, Pyrexia, Rash Maculo-papular, Skin Lesion, Type Iv Hypersensitivity Reaction
on May 25, 2010 Female patient from SPAIN , 64 years of age, was diagnosed with acute myeloid leukaemia, iron overload and was treated with Deferasirox (View Usage). Patient had the following side effects: blood bilirubin increased, blood creatinine increased, hepatic enzyme increased, pyrexia, rash maculo-papular, skin lesion, type iv hypersensitivity reaction. Deferasirox dosage: 1250 Mg Per Day.

6721298-0 | Abdominal Distension, Diarrhoea, Nausea
Patient was taking Deferasirox (View Usage). After Deferasirox was administered, patient had the following side effects: abdominal distension, diarrhoea, nausea (What is nausea?) on Apr 29, 2010 from UNITED STATES Additional patient health information: Female patient , weighting 148.4 lb, was diagnosed with lymphoma (What is lymphoma?) and. Deferasirox dosage: 1500 Mg Daily. During the same period patient was treated with AUGMENTIN '125' (View Augmentin '125' Review and Augmentin '125' Label ), DEXAMETHASONE (View Dexamethasone Review and Dexamethasone Label ), PROTONIX (View Protonix Review and Protonix Label ), TYLENOL 500 (View Tylenol-500 Review and Tylenol-500 Label ), ACYCLOVIR (View Acyclovir Review and Acyclovir Label ), GUAIFENESIN (View Guaifenesin Review and Guaifenesin Label ). Patient was hospitalized.

6666936-6 | Leukopenia, Myelofibrosis, Thrombocytopenia
Adverse event was reported on Mar 23, 2010 by a Male patient taking Deferasirox (View Usage) (Dosage: 1750 Mg/day) was diagnosed with haemochromatosis and. Location: FRANCE , 57 years of age, Patient experienced the following unwanted or unexpected effects: leukopenia, myelofibrosis, thrombocytopenia. During the same period patient was treated with TRILEPTAL (Unk) (View Trileptal Review and Trileptal Label ), NEURONTIN (Unk) (View Neurontin Review and Neurontin Label ), FOLIC ACID (Unk) (View Folic Acid Review and Folic Acid Label ), VITAMIN B1 TAB (Unk) (View Vitamin B1 Tab Review and Vitamin B1 Tab Label ), TOPIRAMATE (Unk) (View Topiramate Review and Topiramate Label ), LIORESAL (Unk) (View Lioresal Review and Lioresal Label ), EPOGEN (View Epogen Review and Epogen Label ), RED BLOOD CELLS (Unk) (View Red Blood Cells Review and Red Blood Cells Label ).

6664284-1 | Abdominal Pain Upper, Decreased Appetite, Faeces Discoloured, Gastric Ulcer, Haematemesis, Hepatomegaly, Nausea
on Mar 23, 2010 Female patient from BELGIUM , child 10 years of age, weighting 48.50 lb, was treated with Deferasirox (View Usage). Patient had the following side effects: abdominal pain upper, decreased appetite, faeces discoloured, gastric ulcer, haematemesis, hepatomegaly, nausea (What is nausea?). Deferasirox dosage: 625 Mg Daily. During the same period patient was treated with RED BLOOD CELLS (Once Every 2 Weeks) (View Red Blood Cells Review and Red Blood Cells Label ), FOLIC ACID (1 Mg Daily) (View Folic Acid Review and Folic Acid Label ). Patient was hospitalized.

6643085-4 | Abdominal Pain Upper, Decreased Appetite, Faeces Discoloured, Gastric Ulcer, Haematemesis, Hepatomegaly, Nausea
on Mar 08, 2010 Female patient from BELGIUM , child 10 years of age, weighting 48.50 lb, was treated with Deferasirox (View Usage). After Deferasirox was administered, patient had the following side effects: abdominal pain upper, decreased appetite, faeces discoloured, gastric ulcer, haematemesis, hepatomegaly, nausea (What is nausea?). Deferasirox dosage: 625 Mg Daily. During the same period patient was treated with RED BLOOD CELLS (Once Every 2 Weeks) (View Red Blood Cells Review and Red Blood Cells Label ), FOLIC ACID (1 Mg Daily) (View Folic Acid Review and Folic Acid Label ). Patient was hospitalized.

6567305-X | Blister, Inflammation, Muscle Necrosis, Oedema Peripheral, Skin Lesion Excision, Skin Necrosis
Patient was taking Deferasirox (View Usage). Patient experienced the following unwanted or unexpected effects: blister, inflammation, muscle necrosis, oedema peripheral, skin lesion excision, skin necrosis on Jan 19, 2010 from CROATIA (local name: Hrvatska) Additional patient health information: Female patient , 27 years of age, . Deferasirox dosage: . During the same period patient was treated with HAEMOPHILUS INFLUENZAE B (View Haemophilus Influenzae B Review and Haemophilus Influenzae B Label ), MENINGOCOCCAL VACCINES (View Meningococcal Vaccines Review and Meningococcal Vaccines Label ), PREDNISONE (View Prednisone Review and Prednisone Label ), ENOXAPARIN SODIUM (View Enoxaparin Sodium Review and Enoxaparin Sodium Label ).

6426453-5 | Anxiety, Crying, Erythema Multiforme, Glossodynia, Oropharyngeal Pain, Pharyngeal Oedema, Rash Papular, Stevens-johnson Syndrome, Swollen Tongue
Adverse event was reported on Oct 23, 2009 by a Female patient taking Deferasirox (View Usage) (Dosage: 1500 Mg, Qd) . Location: UNITED KINGDOM , 61 years of age, weighting 160.9 lb, Patient had the following side effects: anxiety (What is anxiety?), crying, erythema multiforme, glossodynia, oropharyngeal pain, pharyngeal oedema, rash papular, stevens-johnson syndrome, swollen tongue. During the same period patient was treated with ASPIRIN (75 Mg, Qd) (View Aspirin Review and Aspirin Label ), ATORVASTATIN (10 Mg, Qd) (View Atorvastatin Review and Atorvastatin Label ), BISOPROLOL (5 Mg, Qd) (View Bisoprolol Review and Bisoprolol Label ), CANDESARTAN CILEXETIL (45 Mg, Qd) (View Candesartan Cilexetil Review and Candesartan Cilexetil Label ), COD LIVER OIL (1 Df, Qd) (View Cod-liver Oil Review and Cod-liver Oil Label ), FYBOGEL (1 Df, Bid) (View Fybogel Review and Fybogel Label ), GLYCERYL TRINITRATE (Unk) (View Glyceryl Trinitrate Review and Glyceryl Trinitrate Label ), OMEPRAZOLE (20 Mg, Qd) (View Omeprazole Review and Omeprazole Label ).

6177487-X | Acute Lymphocytic Leukaemia Recurrent, Pulmonary Haemorrhage
on Apr 27, 2009 Male patient from GREECE , 38 years of age, was diagnosed with zygomycosis and was treated with Deferasirox (View Usage). After Deferasirox was administered, patient had the following side effects: acute lymphocytic leukaemia recurrent, pulmonary haemorrhage. Deferasirox dosage: 30 Mg/kg. During the same period patient was treated with CYCLOPHOSPHAMIDE (View Cyclophosphamide Review and Cyclophosphamide Label ), CLOFARABINE (View Clofarabine Review and Clofarabine Label ), AMPHOTERICIN B (View Amphotericin B Review and Amphotericin B Label ), POSACONAZOLE (View Posaconazole Review and Posaconazole Label ).

5956966-1 | Blood Creatinine Increased, Blood Urea Increased
on Nov 17, 2008 Male patient from UNITED STATES , 75 years of age, was diagnosed with myelodysplastic syndrome and was treated with Deferasirox (View Usage). Patient experienced the following unwanted or unexpected effects: blood creatinine increased, blood urea increased. Deferasirox dosage: 1250 Mg Every Day Po. Patient was hospitalized.

5953250-7 | Blood Creatinine Increased, Eosinophil Count, Kidney Fibrosis, Proteinuria, Renal Impairment, Tubulointerstitial Nephritis
Patient was taking Deferasirox (View Usage). Patient had the following side effects: blood creatinine increased, eosinophil count, kidney fibrosis, proteinuria, renal impairment, tubulointerstitial nephritis on Nov 06, 2008 from UNITED STATES Additional patient health information: Male patient , 62 years of age, was diagnosed with serum ferritin increased and. Deferasirox dosage: 2 G, Unk.

5942181-4 | Cholecystitis, Hepatic Enzyme Increased, Pancreatitis, Post Procedural Complication, Wheelchair User
Adverse event was reported on Nov 04, 2008 by a Male patient taking Deferasirox (View Usage) (Dosage: 2000 Mg Every Day Po) was diagnosed with myelodysplastic syndrome and. Location: UNITED STATES , 78 years of age, After Deferasirox was administered, patient had the following side effects: cholecystitis, hepatic enzyme increased, pancreatitis, post procedural complication, wheelchair user.

5920372-6 | Bradyphrenia, Hypocalcaemia, Paraesthesia
on Oct 09, 2008 Female patient from UNITED STATES , 43 years of age, was diagnosed with iron overload, sickle cell anaemia and was treated with Deferasirox (View Usage). Patient experienced the following unwanted or unexpected effects: bradyphrenia, hypocalcaemia, paraesthesia. Deferasirox dosage: 1500 Mg, Day, 20 Mg/kg. During the same period patient was treated with ATENOLOL (View Atenolol Review and Atenolol Label ), AMLODIPINE (View Amlodipine Review and Amlodipine Label ), LISINOPRIL (View Lisinopril Review and Lisinopril Label ), LANTHANUM CARBONATE (View Lanthanum Carbonate Review and Lanthanum Carbonate Label ), ALLOPURINOL (View Allopurinol Review and Allopurinol Label ), MULTI VITAMINS (View Multi-vitamins Review and Multi-vitamins Label ), FOLIC ACID (View Folic Acid Review and Folic Acid Label ). Patient was hospitalized.

5914873-4 | Blood Creatinine Increased, Epigastric Discomfort, Serum Ferritin Increased
on Oct 02, 2008 Male patient from ITALY , 76 years of age, was diagnosed with myelofibrosis and was treated with Deferasirox (View Usage). Patient had the following side effects: blood creatinine increased, epigastric discomfort, serum ferritin increased. Deferasirox dosage: 500 Mg/day.

5838409-1 | Blood Creatinine Increased, Eosinophil Count, Kidney Fibrosis, Nephritis Interstitial, Proteinuria, Renal Impairment
Patient was taking Deferasirox (View Usage). After Deferasirox was administered, patient had the following side effects: blood creatinine increased, eosinophil count, kidney fibrosis, nephritis interstitial, proteinuria, renal impairment on Jul 29, 2008 from UNITED STATES Additional patient health information: Male patient , 62 years of age, was diagnosed with serum ferritin increased and. Deferasirox dosage: 2 G, Unk.

5828983-3 | Bradyphrenia, Hypocalcaemia, Paraesthesia
Adverse event was reported on Jul 23, 2008 by a Female patient taking Deferasirox (View Usage) (Dosage: 1500 Mg, Day) was diagnosed with iron overload, sickle cell anaemia and. Location: UNITED STATES , 43 years of age, Patient experienced the following unwanted or unexpected effects: bradyphrenia, hypocalcaemia, paraesthesia. During the same period patient was treated with ATENOLOL (View Atenolol Review and Atenolol Label ), AMLODIPINE (View Amlodipine Review and Amlodipine Label ), LISINOPRIL (View Lisinopril Review and Lisinopril Label ), LANTHANUM CARBONATE (View Lanthanum Carbonate Review and Lanthanum Carbonate Label ), ALLOPURINOL (View Allopurinol Review and Allopurinol Label ), MULTI VITAMINS (View Multi-vitamins Review and Multi-vitamins Label ), FOLIC ACID (View Folic Acid Review and Folic Acid Label ). Patient was hospitalized.

5773343-7 | Disease Progression, Haemorrhage, Hepatectomy, Hepatic Necrosis, Multi-organ Failure, Peritonitis, Thoracotomy
on Jun 11, 2008 Female patient from FRANCE , 18 years of age, was treated with Deferasirox (View Usage). Patient had the following side effects: disease progression, haemorrhage, hepatectomy, hepatic necrosis, multi-organ failure, peritonitis, thoracotomy. Deferasirox dosage: 25 Mg/kg/day. During the same period patient was treated with AMPHOTERICIN B (10 Mg/kg/day) (View Amphotericin B Review and Amphotericin B Label ), CASPOFUNGIN (View Caspofungin Review and Caspofungin Label ).

5745112-5 | Abdominal Pain, Hepatic Function Abnormal
on May 16, 2008 Female patient from INDIA , child 11 years of age, was diagnosed with thalassaemia beta and was treated with Deferasirox (View Usage). After Deferasirox was administered, patient had the following side effects: abdominal pain (What is abdominal pain?), hepatic function abnormal. Deferasirox dosage: 400 Mg, Qd.

5741016-2 | Abdominal Pain
Patient was taking Deferasirox (View Usage). Patient experienced the following unwanted or unexpected effects: abdominal pain (What is abdominal pain?) on May 13, 2008 from INDIA Additional patient health information: Female patient , child 11 years of age, was diagnosed with thalassaemia beta and. Deferasirox dosage: 400 Mg, Qd.

5533289-6 | Blood Creatinine Increased, Blood Urea Increased, Cholecystectomy, Endoscopic Retrograde Cholangiopancreatography, Haemodialysis, Procedural Hypotension
Adverse event was reported on Nov 30, 2007 by a Male patient taking Deferasirox (View Usage) (Dosage: 1 Gram Daily Po) was diagnosed with iron overload, pain (What is pain?) and. Location: UNITED STATES , weighting 150.8 lb, Patient had the following side effects: blood creatinine increased, blood urea increased, cholecystectomy, endoscopic retrograde cholangiopancreatography, haemodialysis, procedural hypotension. During the same period patient was treated with KETOROLAC (30mg Q6h Iv) (View Ketorolac Review and Ketorolac Label ), IBUPROFEN (View Ibuprofen Review and Ibuprofen Label ), GENTAMICIN (View Gentamicin Review and Gentamicin Label ). Patient was hospitalized.

5294676-7 | Convulsion, Haemorrhage Intracranial, Loss Of Consciousness, Mydriasis, Pupil Fixed, Vomiting
on Apr 09, 2007 Male patient from UNITED STATES , weighting 130.1 lb, was diagnosed with sickle cell anaemia and was treated with Deferasirox (View Usage). After Deferasirox was administered, patient had the following side effects: convulsion, haemorrhage intracranial, loss of consciousness, mydriasis, pupil fixed, vomiting. Deferasirox dosage: 1250mg Daily. During the same period patient was treated with HYDROXYUREA (1500mg Daily) (View Hydroxyurea Review and Hydroxyurea Label ). Patient was hospitalized.


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To find out about documented side effects or safety concerns read either the drug label or the drug's package insert. You may also want to speak with your pharmacist or healthcare provider. All medicines have benefits and risks. The risks are the chances that something unwanted or unexpected could happen to you when you use them. You can protect yourself by searching summaries of recent safety alerts, adverse reports. Sometimes there are risks that only come to light after a medical product gets on the market and is used in a larger number of patients, for a longer period of time, and in patients whose health characteristics are different from those of the patients studied before approval.

Be aware of the following potential Deferasirox risks to be aware of: 1. Watch for any Serious adverse events, such as life-threatening situation, which can require an admission to hospital or longer-than-expected hospital stay, permanent disability, birth defect, miscarriage, stillbirth, or birth with serious disease requires medical care to prevent permanent damage
2. Any potential Deferasirox quality problem: suspected counterfeit product, potentially contaminated product indicated by suspicious odor or unusual color, inaccurate or unreadable product labeling
3. Potential Deferasirox use error: mixing up products with similar drug names or packaging, taking wrong dose of a drug because of confusing dosing instructions on label
4. When applicable, Problems with different manufacturer of same medicine: not getting same results from a generic drug as a brand name drug, or from another generic

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Deferasirox Reactions
Abdominal Distension
Abdominal PainWhat is Abdominal pain?
Abdominal Pain Upper
Arthralgia
Blood Bilirubin Increased
Blood Creatinine Increased
Blood Urea Increased
Bradyphrenia
CardiomyopathyWhat is Cardiomyopathy?
Decreased Appetite
Eosinophil Count
Faeces Discoloured
Gastric Ulcer
Haematemesis
Hepatic Enzyme Increased
Hepatomegaly
Hypocalcaemia
Kidney Fibrosis
Liver Disorder
NauseaWhat is Nausea?
Paraesthesia
Proteinuria
Pyrexia
Rash Maculo-papular
Renal Impairment
Serum Ferritin Increased
Skin Lesion
Thrombocytopenia
Type Iv Hypersensitivity Reaction
Vomiting
Deferasirox Side Effects Notice - The material on this site is for informational purposes only, and is not a substitute for medical advice, diagnosis or treatment provided by a qualified health care provider. PatientsVille.com does not provide medical advice, diagnosis or treatment. The information regarding Deferasirox adverse reports, reviews and polls contained on PatientsVille.com site has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of adverse drug reactions or for establishing or changing of patient treatments. Thank you for visiting Patientsville.com!