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Delursan Side Effects and Adverse Effects reported to US Food and Drug Administration (FDA)

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Porphyria Non-acute (8456306-2)
on Jun 11, 2012 Female from FRANCE , 48 years of age, was treated with Delursan. Directly after, patient experienced the unwanted or unexpected Delursan side effects: porphyria non-acute. Delursan dosage: N/A.
Associated medications used:
  • Folic Acid
  • Copegus
  • Boceprevir
  • Pegasys
  • Betaselen


Synovitis, Soft Tissue Disorder, Arthralgia (8231532-6)
Patient was taking Delursan. Patient felt the following 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
  • cholangitis
and. Delursan dosage: N/A.
Multiple prescriptions taken:
  • Irbesartan
  • Propranolol
  • Zoledronoc Acid (Unk Ukn, Unk)
  • Vitamin D
  • Calcium Carbonate


Synovitis, Arthralgia, Soft Tissue Disorder (8224739-5)
Adverse event was reported on Mar 14, 2012 by a Female taking Delursan (Dosage: N/A) was diagnosed with
  • cholangitis
and. Location: FRANCE , 55 years of age, After Delursan was administered, patient encountered several Delursan side effects: synovitis, arthralgia, soft tissue disorder.
Multiple concurrent drugs taken:
  • Calcium Carbonate
  • Zoledronoc Acid (Unk Ukn, Unk)
  • Propranolol
  • Irbesartan
  • Vitamin D


Cytolytic Hepatitis (7959980-X)
on Nov 28, 2011 Female from FRANCE , weighting 131.6 lb, was treated with Delursan. Directly after, patient experienced the unwanted or unexpected Delursan side effects: cytolytic hepatitis. Delursan dosage: 500 Mg, Bid.
Associated medications used:
  • 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 (7936995-9)
on Nov 14, 2011 Male from FRANCE , 58 years of age, weighting 156.5 lb, was treated with Delursan. Patient felt the following Delursan side effects: cytolytic hepatitis. Delursan dosage: N/A.
Multiple prescriptions taken:
  • Busulfan
  • Valium
  • Fludara
  • Pantoprazole
  • Fludara
  • Solu-medrol
  • Multi-vitamins
  • Zofran


Cytolytic Hepatitis (7936707-9)
Patient was taking Delursan. After Delursan was administered, patient encountered several 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.
Multiple concurrent drugs taken:
  • 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 (7875259-9)
Adverse event was reported on Oct 20, 2011 by a Female taking Delursan (Dosage: N/A) . Location: FRANCE , 53 years of age, Directly after, patient experienced the unwanted or unexpected Delursan side effects: hypoglycaemia, coma.
Associated medications used:
  • Voltaren
  • Aldalix
  • Aspirin
  • Stablon
  • Noctamid
  • Panos
  • Propranolol (160 Mg, 1x/day)
  • Atarax
Patient was hospitalized.

Liver Transplant Rejection (7580317-2)
on Jun 17, 2011 Male from FRANCE , weighting 149.9 lb, was diagnosed with
  • cholestasis
  • hypertension
and was treated with Delursan. Patient felt the following Delursan side effects: liver transplant rejection. Delursan dosage: N/A.
Multiple prescriptions taken:
  • Flodil Lp
  • Cyclosporine
  • Bipreterax
  • Neoral
  • Ribavirin
  • Cellcept
  • Peginterferon Alfa-2a


Cholestasis, Antimitochondrial Antibody Positive, Portal Hypertension, Biliary Cirrhosis Primary, Treatment Failure, Disease Progression (7381348-8)
on Mar 04, 2011 Female from FRANCE , 70 years of age, weighting 143.3 lb, was diagnosed with
  • biliary cirrhosis primary
and was treated with Delursan (ursodeoxycholic Acid) Tablet. After Delursan was administered, patient encountered several 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 (6896927-1)
Patient was taking Delursan (ursodeoxychloic Acid) 250mg Tablet. Directly after, patient experienced the unwanted or unexpected 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.
Associated medications used:
  • 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 (6455132-3)
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, Patient felt the following Delursan side effects: transient ischaemic attack.
Multiple prescriptions 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 (6027972-6)
on Dec 10, 2008 Female from FRANCE , 20 years of age, was diagnosed with
  • cholestasis
  • pain
  • autoimmune hepatitis
and was treated with Delursan (ursodesoxycholic Acid). After Delursan was administered, patient encountered several 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.
Multiple concurrent drugs taken:
  • 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 (5808083-9)
on Jun 26, 2008 Female from FRANCE , 56 years of age, was diagnosed with
  • cholestasis
and was treated with Delursan (ursodeoxycholic Acid). Directly after, patient experienced the unwanted or unexpected 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 (5731282-1)
Patient was taking Delursan (ursodeoxycholic Acid). Patient felt the following 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 prescriptions 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 (5692825-X)
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, After Delursan was administered, patient encountered several Delursan side effects: asthenia, hepatic enzyme increased, pruritus.
Multiple concurrent drugs taken:
  • 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 (5483897-6)
on Sep 26, 2007 Female from FRANCE , 88 years of age, was diagnosed with
  • cholelithiasis
  • atrial fibrillation
and was treated with Delursan (ursodeoxycholic Acid). Directly after, patient experienced the unwanted or unexpected 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.
Associated medications used:
  • 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 (5383614-4)
on Jun 21, 2007 Male from FRANCE , 47 years of age, was treated with Delursan (ursodeoxycholic Acid). Patient felt the following Delursan side effects: lung infection pseudomonal, oedema peripheral, pancytopenia, pneumonia, rash, renal failure acute. Delursan (ursodeoxycholic Acid) dosage: 500 Mg Oral.
Multiple prescriptions 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 (5116963-5)
Patient was taking Delursan (ursodesoxycholic Acid). After Delursan was administered, patient encountered several 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
  • hepatic pain
  • transaminases increased
  • leukaemia
and. Delursan (ursodesoxycholic Acid) dosage: 500 Mg Tablets Po. Patient was hospitalized.

Optic Neuritis, Scotoma, Visual Acuity Reduced (5024625-8)
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
  • cholangitis
  • spondyloarthropathy
and. Location: FRANCE , 51 years of age, Directly after, patient experienced the unwanted or unexpected Delursan side effects: optic neuritis, scotoma, visual acuity reduced.
Associated medications used:
  • 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 (4850769-7)
on Nov 29, 2005 Female from , 62 years of age, was diagnosed with
  • biliary cirrhosis primary
and was treated with Delursan. Patient felt the following Delursan side effects: cutaneous vasculitis, hepatic encephalopathy. Delursan dosage: N/A.
Multiple prescriptions 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 (4845753-3)
on Nov 28, 2005 Female from FRANCE , 62 years of age, was diagnosed with
  • biliary cirrhosis primary
and was treated with Delursan (ursodesoxycholic Acid). After Delursan was administered, patient encountered several Delursan side effects: cutaneous vasculitis, hepatic encephalopathy. Delursan (ursodesoxycholic Acid) dosage: Po.
Multiple concurrent drugs taken:
  • Insulin
  • Beta-carotene And Bilberry (difrarel)
  • Duphalac
Patient was hospitalized.

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Most drugs have a large list of nonsevere or mild adverse effects which do not rule out continued usage. These effects depend on individual sensitivity, and can include nausea, dizziness, diarrhea, malaise, vomiting, headache, dermatitis, dry mouth, etc. Check commonly reported side effects . These can be considered a form of pseudo-allergic reaction, as not all users experience these effects; many users experience none at all.

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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