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Delursan Side Effects

Common Delursan Side Effects

The most commonly reported Delursan side effects (click to view or check a box to report):

Renal Failure Acute (3)
Cytolytic Hepatitis (3)
Gamma-glutamyltransferase Increased (2)
Haematuria (2)
Arthralgia (2)
Hepatic Encephalopathy (2)
Cutaneous Vasculitis (2)
Hepatic Enzyme Increased (2)
Soft Tissue Disorder (2)
Synovitis (2)
Oedema Peripheral (2)
Anaemia (1)
Anaemia Macrocytic (1)
Angiotensin Converting Enzyme Increased (1)
Amenorrhoea (1)
Abdominal Tenderness (1)
Small Intestinal Haemorrhage (1)
Constipation (1)
Abnormal Behaviour (1)
Alanine Aminotransferase Increased (1)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

Delursan Side Effects Reported to FDA

The following Delursan reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.


The appearance of Delursan on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.
Toxic Epidermal Necrolysis, Bladder Disorder, Haematuria, Graft Versus Host Disease In Intestine, Renal Failure Acute, Hepatitis Fulminant, Oedema
on Nov 01, 2013 Female from FR , 41 years of age, was treated with Delursan (ursodeoxycholic Acid) Tablet. Directly after, patient experienced the unwanted or unexpected Delursan side effects: toxic epidermal necrolysis, bladder disorder, haematuria, graft versus host disease in intestine, renal failure acute, hepatitis fulminant, oedema. Delursan (ursodeoxycholic Acid) Tablet dosage: 3 Df, Bid, Oral.
Associated medications used:
  • Fortum (1 Df, Qid, Intravenous)
  • Flagyl
  • Gentamicine
  • Ambisome
  • Bactrim (2 Df, 3x/weekly, Itravenous)
  • Noxafil
  • Cancidas
  • Folinic Acid (50mg, 3x/wk, Intravenous)
Patient was hospitalized.

Abnormal Behaviour, Rash Pruritic, Dry Skin, Miliaria, Transient Global Amnesia, Skin Lesion
Patient was taking Delursan. Patient felt the following Delursan side effects: abnormal behaviour, rash pruritic, dry skin, miliaria, transient global amnesia, skin lesion on Jan 16, 2014 from FR Additional patient health information: Female , 63 years of age, weighting 121.3 lb, was diagnosed with and. Delursan dosage: N/A.

Rash Maculo-papular, Burning Sensation, Eczema, Eosinophilia, Leukocytosis, Hypoalbuminaemia, Oedema Peripheral
Adverse event was reported on Apr 22, 2013 by a Female taking Delursan (ursodeoxycholic Acid) Tablet (Dosage: N/A) was diagnosed with and. Location: FR , 57 years of age, After Delursan was administered, patient encountered several Delursan side effects: rash maculo-papular, burning sensation, eczema, eosinophilia, leukocytosis, hypoalbuminaemia, oedema peripheral. Patient was hospitalized.

Pancreatic Cyst, Weight Decreased, Hepatic Steatosis
on Feb 04, 2013 Male from FR , 50 years of age, was diagnosed with and was treated with Delursan. Directly after, patient experienced the unwanted or unexpected Delursan side effects: pancreatic cyst, weight decreased, hepatic steatosis. Delursan dosage: 5 Df, Qd, Oral.
Associated medications used:
  • Kenzen



Porphyria Non-acute
on Jun 11, 2012 Female from FRANCE , 48 years of age, was treated with Delursan. Patient felt the following Delursan side effects: porphyria non-acute. Delursan dosage: N/A.
Multiple prescriptions taken:
  • Folic Acid
  • Copegus
  • Boceprevir
  • Pegasys
  • Betaselen


Synovitis, Soft Tissue Disorder, Arthralgia
Patient was taking Delursan. After Delursan was administered, patient encountered several Delursan side effects: synovitis, soft tissue disorder, arthralgia on Mar 16, 2012 from FRANCE Additional patient health information: Female , 55 years of age, was diagnosed with and. Delursan dosage: N/A.
Multiple concurrent drugs taken:
  • Irbesartan
  • Propranolol
  • Zoledronoc Acid (Unk Ukn, Unk)
  • Vitamin D
  • Calcium Carbonate


Synovitis, Arthralgia, Soft Tissue Disorder
Adverse event was reported on Mar 14, 2012 by a Female taking Delursan (Dosage: N/A) was diagnosed with and. Location: FRANCE , 55 years of age, Directly after, patient experienced the unwanted or unexpected Delursan side effects: synovitis, arthralgia, soft tissue disorder.
Associated medications used:
  • Calcium Carbonate
  • Zoledronoc Acid (Unk Ukn, Unk)
  • Propranolol
  • Irbesartan
  • Vitamin D


Cytolytic Hepatitis
on Nov 28, 2011 Female from FRANCE , weighting 131.6 lb, was treated with Delursan. Patient felt the following Delursan side effects: cytolytic hepatitis. Delursan dosage: 500 Mg, Bid.
Multiple prescriptions taken:
  • Cyclophosphamide (490 Mg, Qd)
  • Thymoglobulin (225 Mg, Qd)
  • Polaramine (10 Mg, Unk)
  • Solu-medrol (20 Mg, Tid)
  • Thymoglobulin (147.5 Mg, Once)
  • Thymoglobulin (3.5 Mg/kg, Qd)
  • Fludarabine Phosphate (49 Mg, Qd)
  • Sodium Bicarbonate (100 Ml, Qid)


Cytolytic Hepatitis
on Nov 14, 2011 Male from FRANCE , 58 years of age, weighting 156.5 lb, was treated with Delursan. After Delursan was administered, patient encountered several Delursan side effects: cytolytic hepatitis. Delursan dosage: N/A.
Multiple concurrent drugs taken:
  • Busulfan
  • Valium
  • Fludara
  • Pantoprazole
  • Fludara
  • Solu-medrol
  • Multi-vitamins
  • Zofran


Cytolytic Hepatitis
Patient was taking Delursan. Directly after, patient experienced the unwanted or unexpected Delursan side effects: cytolytic hepatitis on Nov 14, 2011 from FRANCE Additional patient health information: Female , weighting 131.6 lb, . Delursan dosage: 500 Mg, Bid.
Associated medications used:
  • Solu-medrol (20 Mg, Tid)
  • Thymoglobulin (147.5 Mg, Once)
  • Polaramine (10 Mg, Unk)
  • Fludarabine Phosphate (49 Mg, Qd)
  • Thymoglobulin (3.5 Mg/kg, Qd)
  • Cyclophosphamide (490 Mg, Qd)
  • Sodium Bicarbonate (100 Ml, Qid)


Hypoglycaemia, Coma
Adverse event was reported on Oct 20, 2011 by a Female taking Delursan (Dosage: N/A) . Location: FRANCE , 53 years of age, Patient felt the following Delursan side effects: hypoglycaemia, coma.
Multiple prescriptions taken:
  • Voltaren
  • Aldalix
  • Aspirin
  • Stablon
  • Noctamid
  • Panos
  • Propranolol (160 Mg, 1x/day)
  • Atarax
Patient was hospitalized.

Liver Transplant Rejection
on Jun 17, 2011 Male from FRANCE , weighting 149.9 lb, was diagnosed with and was treated with Delursan. After Delursan was administered, patient encountered several Delursan side effects: liver transplant rejection. Delursan dosage: N/A.
Multiple concurrent drugs taken:
  • Flodil Lp
  • Cyclosporine
  • Bipreterax
  • Neoral
  • Ribavirin
  • Cellcept
  • Peginterferon Alfa-2a


Cholestasis, Antimitochondrial Antibody Positive, Portal Hypertension, Biliary Cirrhosis Primary, Treatment Failure, Disease Progression
on Mar 04, 2011 Female from FRANCE , 70 years of age, weighting 143.3 lb, was diagnosed with and was treated with Delursan (ursodeoxycholic Acid) Tablet. Directly after, patient experienced the unwanted or unexpected Delursan side effects: cholestasis, antimitochondrial antibody positive, portal hypertension, biliary cirrhosis primary, treatment failure, disease progression. Delursan (ursodeoxycholic Acid) Tablet dosage: 500 Mg, Bid, Oral.

Toxic Skin Eruption
Patient was taking Delursan (ursodeoxychloic Acid) 250mg Tablet. Patient felt the following Delursan side effects: toxic skin eruption on Jul 22, 2010 from FRANCE Additional patient health information: Female , 80 years of age, . Delursan (ursodeoxychloic Acid) 250mg Tablet dosage: 250 Mg Tid Oral.
Multiple prescriptions taken:
  • Mysoline (250mg Bid Oral)
  • Hept A Myl (heptaminol) Tablet (187.8mg Qid Oral)
  • Stresam (etifoxine Hydrochloride)
  • Vastarel (trimetazidine) Tablet (35mg Bid Oral)
  • Calcium Carbonate
  • Fosavance (alendronic Acid, Colecalciferol)
Patient was hospitalized.

Transient Ischaemic Attack
Adverse event was reported on Nov 05, 2009 by a Male taking Delursan Tablets 250mg (ursodesoxycholic Acid) (Dosage: 250 Mg Oral) . Location: FRANCE , 47 years of age, After Delursan was administered, patient encountered several Delursan side effects: transient ischaemic attack.
Multiple concurrent drugs taken:
  • Xagrid (anagrelide) (2 Mg (0.5 Mg 4 Times A Day) Oral)
  • Previscan (fluindione) (15 Mg Oral)
  • Nexium (Oral)
  • Avlocardyl L.p. Prolonged Release Capsule (160 Mg Oral)
  • Acetaminophen (Oral)
  • Tardyferon (folic Acid) (Twice A Day Oral)
Patient was hospitalized.

Alanine Aminotransferase Increased, Anaemia Macrocytic, Anti-hbs Antibody Positive, Aspartate Aminotransferase Increased, C-reactive Protein Increased, Coagulation Factor Decreased, Gamma-glutamyltransferase Increased, Hepatic Enzyme Increased, Inflammation
on Dec 10, 2008 Female from FRANCE , 20 years of age, was diagnosed with and was treated with Delursan (ursodesoxycholic Acid). Directly after, patient experienced the unwanted or unexpected Delursan side effects: alanine aminotransferase increased, anaemia macrocytic, anti-hbs antibody positive, aspartate aminotransferase increased, c-reactive protein increased, coagulation factor decreased, gamma-glutamyltransferase increased, hepatic enzyme increased, inflammation. Delursan (ursodesoxycholic Acid) dosage: 500 Mg.
Associated medications used:
  • Augmentin '125'
  • Imurel (25 Mg)
  • Neoral (50 Mg)
Patient was hospitalized.

Amenorrhoea, Angiotensin Converting Enzyme Increased, Blood Alkaline Phosphatase Increased, Blood Creatinine Decreased, Disseminated Intravascular Coagulation, Gamma-glutamyltransferase Increased, Haemoglobin Decreased, Hepatosplenomegaly, Hyperproteinaemia
on Jun 26, 2008 Female from FRANCE , 56 years of age, was diagnosed with and was treated with Delursan (ursodeoxycholic Acid). Patient felt the following Delursan side effects: amenorrhoea, angiotensin converting enzyme increased, blood alkaline phosphatase increased, blood creatinine decreased, disseminated intravascular coagulation, gamma-glutamyltransferase increased, haemoglobin decreased, hepatosplenomegaly, hyperproteinaemia. Delursan (ursodeoxycholic Acid) dosage: 500 Mg (delursan) Oral. Patient was hospitalized.

Haematuria, Thrombocytopenia
Patient was taking Delursan (ursodeoxycholic Acid). After Delursan was administered, patient encountered several Delursan side effects: haematuria, thrombocytopenia on Apr 22, 2008 from FRANCE Additional patient health information: Female , 85 years of age, . Delursan (ursodeoxycholic Acid) dosage: N/A.
Multiple concurrent drugs taken:
  • Pantoprazole Sodium (Po)
  • Stablon (tianeptine) Tablets 12.5 Mg (1 Df, 2 Days Po)
  • Actonel
  • Calcidose (calcium Carbonate)
  • Potassium Chloride
  • Furosemide
  • Solupred (prednisolone)
  • Amiodarone Hcl
Patient was hospitalized.

Asthenia, Hepatic Enzyme Increased, Pruritus
Adverse event was reported on Mar 26, 2008 by a Female taking Delursan (ursodeoxycholic Acid) 250 Mg (Dosage: Oral) . Location: FRANCE , 48 years of age, Directly after, patient experienced the unwanted or unexpected Delursan side effects: asthenia, hepatic enzyme increased, pruritus.
Associated medications used:
  • Meteospasymol (alverine Citrate 60 Mg, Simethicone 300 Mg)
  • Spasfon (phloroglucinol, Trimethylphloroglucinol)
Patient was hospitalized.

Abdominal Tenderness, Anaemia, Constipation, Faecaloma, Flatulence, Pallor, Peritoneal Effusion, Renal Failure Acute, Small Intestinal Haemorrhage
on Sep 26, 2007 Female from FRANCE , 88 years of age, was diagnosed with and was treated with Delursan (ursodeoxycholic Acid). Patient felt the following Delursan side effects: abdominal tenderness, anaemia, constipation, faecaloma, flatulence, pallor, peritoneal effusion, renal failure acute, small intestinal haemorrhage. Delursan (ursodeoxycholic Acid) dosage: 250 Mg; Oral.
Multiple prescriptions taken:
  • Previscan (fluindione) (Oral)
  • Cordarone (Oral)
  • Deroxat (paroxetine) (Oral)
  • Folic Acid (Oral)
  • Omeprazole (Oral)
  • Primaxin (Oral)
Patient was hospitalized.

Lung Infection Pseudomonal, Oedema Peripheral, Pancytopenia, Pneumonia, Rash, Renal Failure Acute
on Jun 21, 2007 Male from FRANCE , 47 years of age, was treated with Delursan (ursodeoxycholic Acid). After Delursan was administered, patient encountered several Delursan side effects: lung infection pseudomonal, oedema peripheral, pancytopenia, pneumonia, rash, renal failure acute. Delursan (ursodeoxycholic Acid) dosage: 500 Mg Oral.
Multiple concurrent drugs taken:
  • Allopurinol (100 Mg Oral)
  • Certican (everolimus) (1.5 Mg Oral)
  • Cyclosporine (150 Mg Oral)
  • Aspegic (dl-lysine Acetylsalicylate) (100 Mg Oral)
  • Imuran (100 Mg Oral)
Patient was hospitalized.

Hepatic Pain, Jaundice, Transaminases Increased
Patient was taking Delursan (ursodesoxycholic Acid). Directly after, patient experienced the unwanted or unexpected Delursan side effects: hepatic pain, jaundice, transaminases increased on Sep 08, 2006 from FRANCE Additional patient health information: Male , 14 years of age, was diagnosed with and. Delursan (ursodesoxycholic Acid) dosage: 500 Mg Tablets Po. Patient was hospitalized.

Optic Neuritis, Scotoma, Visual Acuity Reduced
Adverse event was reported on May 22, 2006 by a Male taking Delursan (ursodesoxycholic Acid) (Dosage: 1 G Film-coated Tablets Po) was diagnosed with and. Location: FRANCE , 51 years of age, Patient felt the following Delursan side effects: optic neuritis, scotoma, visual acuity reduced.
Multiple prescriptions taken:
  • Methotrexate (10 Mg Po)
  • Remicade (400 Mg Iv)
  • Speciafoldine (folic Acid)
  • Cortan
  • Contramal Lp (tramadol Hydrochloride)
  • Acetaminophen
  • Forlax (macrogol)
  • Lansoprazole
Patient was hospitalized.

Cutaneous Vasculitis, Hepatic Encephalopathy
on Nov 29, 2005 Female from , 62 years of age, was diagnosed with and was treated with Delursan. After Delursan was administered, patient encountered several Delursan side effects: cutaneous vasculitis, hepatic encephalopathy. Delursan dosage: N/A.
Multiple concurrent drugs taken:
  • Lasilix
  • Captopril
  • Lopressor
  • Previscan
  • Sintrom
  • Nph Insulin (Dose: 20 Units On The Morning And 14 Units In The Evening.)
  • Lantus
  • Actrapid (Dose: 4 Units On The Morning And 4units On The Evening.)
Patient was hospitalized.

Cutaneous Vasculitis, Hepatic Encephalopathy
on Nov 28, 2005 Female from FRANCE , 62 years of age, was diagnosed with and was treated with Delursan (ursodesoxycholic Acid). Directly after, patient experienced the unwanted or unexpected Delursan side effects: cutaneous vasculitis, hepatic encephalopathy. Delursan (ursodesoxycholic Acid) dosage: Po.
Associated medications used:
  • Insulin
  • Beta-carotene And Bilberry (difrarel)
  • Duphalac
Patient was hospitalized.

Keep Track of Side Effects

Note Your Observations

It is really important to keep of your symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:

     

    Side Effects

    Scale

    Date & Time

    Other Medicine(s) or Treatment(s)

     

     

     

     

    Scale: 1 = very mild to 10 = very bad


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  • Register to track your side effects

  • You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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    Safety Alerts, Active Ingredients, Usage Information

    More About Delursan

    Side Effects reported to FDA: 25

    Delursan safety alerts: No

    Reported deaths: 1

    Reported hospitalizations: 5

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