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Delursan Side Effects

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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.

Delursan Side Effects Reported to FDA



Delursan Side Effect Report#9549251
Toxic Epidermal Necrolysis, Bladder Disorder, Haematuria, Graft Versus Host Disease In Intestine, Renal Failure Acute, Hepatitis Fulminant, Oedema
This is a report of a 41-year-old female patient (weight: NA) from FR, suffering from the following health symptoms/conditions: NA, who was treated with Delursan (ursodeoxycholic Acid) Tablet (dosage: 3 Df, Bid, Oral, start time:
Jun 05, 2013), combined with:
  • Fortum (1 Df, Qid, Intravenous)
  • Flagyl
  • Gentamicine
  • Ambisome
  • Bactrim (2 Df, 3x/weekly, Itravenous)
  • Noxafil
  • Cancidas
  • Folinic Acid (50mg, 3x/wk, Intravenous)
and developed a serious reaction and side effect(s): Toxic Epidermal Necrolysis, Bladder Disorder, Haematuria, Graft Versus Host Disease In Intestine, Renal Failure Acute, Hepatitis Fulminant, Oedema after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Delursan (ursodeoxycholic Acid) Tablet treatment in female patients, resulting in Toxic Epidermal Necrolysis side effect. The patient was hospitalized.
Delursan Side Effect Report#9417454
Abnormal Behaviour, Rash Pruritic, Dry Skin, Miliaria, Transient Global Amnesia, Skin Lesion
This report suggests a potential Delursan Abnormal Behaviour side effect(s) that can have serious consequences. A 63-year-old female patient (weight: NA) from FR was diagnosed with the following symptoms/conditions: biliary cirrhosis and used Delursan (dosage: NA) starting 201303. After starting Delursan the patient began experiencing various side effects, including: Abnormal Behaviour, Rash Pruritic, Dry Skin, Miliaria, Transient Global Amnesia, Skin LesionAdditional drugs used concurrently: NA. Although Delursan demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Abnormal Behaviour, may still occur.
Delursan Side Effect Report#9257740
Rash Maculo-papular, Burning Sensation, Eczema, Eosinophilia, Leukocytosis, Hypoalbuminaemia, Oedema Peripheral
This Rash Maculo-papular problem was reported by a health professional from FR. A 57-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: liver disorder,jaundice. On
Jul 17, 2012 this consumer started treatment with Delursan (ursodeoxycholic Acid) Tablet (dosage: NA). The following drugs were being taken at the same time: NA. When using Delursan (ursodeoxycholic Acid) Tablet, the patient experienced the following unwanted symptoms/side effects: Rash Maculo-papular, Burning Sensation, Eczema, Eosinophilia, Leukocytosis, Hypoalbuminaemia, Oedema PeripheralThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Rash Maculo-papular, may become evident only after a product is in use by the general population.
Delursan Side Effect Report#8963072
Pancreatic Cyst, Weight Decreased, Hepatic Steatosis
This Pancreatic Cyst side effect was reported by a physician from FR. A 50-year-old male patient (weight:NA) experienced the following symptoms/conditions: hepatic fibrosis.The patient was prescribed Delursan (drug dosage: 5 Df, Qd, Oral), which was initiated on 201107. Concurrently used drugs:
  • Kenzen
.After starting to take Delursan the consumer reported adverse symptoms, such as: Pancreatic Cyst, Weight Decreased, Hepatic SteatosisThese side effects may potentially be related to Delursan.
Delursan Side Effect Report#8456306-2
Porphyria Non-acute
This is a report of a 48-year-old female patient (weight: NA) from France, suffering from the following health symptoms/conditions: NA, who was treated with Delursan (dosage: NA, start time:
Jan 01, 2007), combined with:
  • Folic Acid
  • Copegus
  • Boceprevir
  • Pegasys
  • Betaselen
and developed a serious reaction and side effect(s): Porphyria Non-acute after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Delursan treatment in female patients, resulting in Porphyria Non-acute side effect.
Delursan Side Effect Report#8231532-6
Synovitis, Soft Tissue Disorder, Arthralgia
This report suggests a potential Delursan Synovitis side effect(s) that can have serious consequences. A 55-year-old female patient (weight: NA) from France was diagnosed with the following symptoms/conditions: cholangitis and used Delursan (dosage: NA) starting
Feb 09, 2012. After starting Delursan the patient began experiencing various side effects, including: Synovitis, Soft Tissue Disorder, ArthralgiaAdditional drugs used concurrently:
  • Irbesartan
  • Propranolol
  • Zoledronoc Acid (Unk Ukn, Unk)
  • Vitamin D
  • Calcium Carbonate
Although Delursan demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Synovitis, may still occur.
Delursan Side Effect Report#8224739-5
Synovitis, Arthralgia, Soft Tissue Disorder
This Synovitis problem was reported by a consumer or non-health professional from France. A 55-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: cholangitis. On
Feb 09, 2012 this consumer started treatment with Delursan (dosage: NA). The following drugs were being taken at the same time:
  • Calcium Carbonate
  • Zoledronoc Acid (Unk Ukn, Unk)
  • Propranolol
  • Irbesartan
  • Vitamin D
When using Delursan, the patient experienced the following unwanted symptoms/side effects: Synovitis, Arthralgia, Soft Tissue DisorderAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Synovitis, may become evident only after a product is in use by the general population.
Delursan Side Effect Report#7959980-X
Cytolytic Hepatitis
This Cytolytic Hepatitis side effect was reported by a physician from France. A female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Delursan (drug dosage: 500 Mg, Bid), which was initiated on
Feb 03, 2011. Concurrently used drugs:
  • 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)
.After starting to take Delursan the consumer reported adverse symptoms, such as: Cytolytic HepatitisThese side effects may potentially be related to Delursan.
Delursan Side Effect Report#7936995-9
Cytolytic Hepatitis
This is a report of a 58-year-old male patient (weight: NA) from France, suffering from the following health symptoms/conditions: NA, who was treated with Delursan (dosage: NA, start time:
Oct 06, 2011), combined with:
  • Busulfan
  • Valium
  • Fludara
  • Pantoprazole
  • Fludara
  • Solu-medrol
  • Multi-vitamins
  • Zofran
and developed a serious reaction and side effect(s): Cytolytic Hepatitis after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Delursan treatment in male patients, resulting in Cytolytic Hepatitis side effect.
Delursan Side Effect Report#7936707-9
Cytolytic Hepatitis
This report suggests a potential Delursan Cytolytic Hepatitis side effect(s) that can have serious consequences. A female patient (weight: NA) from France was diagnosed with the following symptoms/conditions: NA and used Delursan (dosage: 500 Mg, Bid) starting
Feb 03, 2011. After starting Delursan the patient began experiencing various side effects, including: Cytolytic HepatitisAdditional drugs used concurrently:
  • 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)
Although Delursan demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Cytolytic Hepatitis, may still occur.
Delursan Side Effect Report#7875259-9
Hypoglycaemia, Coma
This Hypoglycaemia problem was reported by a health professional from France. A 53-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Delursan (dosage: NA). The following drugs were being taken at the same time:
  • Voltaren
  • Aldalix
  • Aspirin
  • Stablon
  • Noctamid
  • Panos
  • Propranolol (160 Mg, 1x/day)
  • Atarax
When using Delursan, the patient experienced the following unwanted symptoms/side effects: Hypoglycaemia, ComaThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Hypoglycaemia, may become evident only after a product is in use by the general population.
Delursan Side Effect Report#7580317-2
Liver Transplant Rejection
This Liver Transplant Rejection side effect was reported by a physician from France. A male patient (weight:NA) experienced the following symptoms/conditions: cholestasis,hypertension.The patient was prescribed Delursan (drug dosage: NA), which was initiated on
Mar 10, 2010. Concurrently used drugs:
  • Flodil Lp
  • Cyclosporine
  • Bipreterax
  • Neoral
  • Ribavirin
  • Cellcept
  • Peginterferon Alfa-2a
.After starting to take Delursan the consumer reported adverse symptoms, such as: Liver Transplant RejectionThese side effects may potentially be related to Delursan.
Delursan Side Effect Report#7381348-8
Cholestasis, Antimitochondrial Antibody Positive, Portal Hypertension, Biliary Cirrhosis Primary, Treatment Failure, Disease Progression
This is a report of a 70-year-old female patient (weight: NA) from France, suffering from the following health symptoms/conditions: biliary cirrhosis primary, who was treated with Delursan (ursodeoxycholic Acid) Tablet (dosage: 500 Mg, Bid, Oral, start time:
Jan 01, 1989), combined with: NA. and developed a serious reaction and side effect(s): Cholestasis, Antimitochondrial Antibody Positive, Portal Hypertension, Biliary Cirrhosis Primary, Treatment Failure, Disease Progression after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Delursan (ursodeoxycholic Acid) Tablet treatment in female patients, resulting in Cholestasis side effect.
Delursan Side Effect Report#6896927-1
Toxic Skin Eruption
This report suggests a potential Delursan (ursodeoxychloic Acid) 250mg Tablet Toxic Skin Eruption side effect(s) that can have serious consequences. A 80-year-old female patient (weight: NA) from France was diagnosed with the following symptoms/conditions: NA and used Delursan (ursodeoxychloic Acid) 250mg Tablet (dosage: 250 Mg Tid Oral) starting
Jan 01, 2004. After starting Delursan (ursodeoxychloic Acid) 250mg Tablet the patient began experiencing various side effects, including: Toxic Skin EruptionAdditional drugs used concurrently:
  • 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)
The patient was hospitalized. Although Delursan (ursodeoxychloic Acid) 250mg Tablet demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Toxic Skin Eruption, may still occur.
Delursan Side Effect Report#6455132-3
Transient Ischaemic Attack
This Transient Ischaemic Attack problem was reported by a consumer or non-health professional from France. A 47-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Jan 01, 2000 this consumer started treatment with Delursan Tablets 250mg (ursodesoxycholic Acid) (dosage: 250 Mg Oral). The following drugs were being taken at the same time:
  • 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)
When using Delursan Tablets 250mg (ursodesoxycholic Acid), the patient experienced the following unwanted symptoms/side effects: Transient Ischaemic AttackThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Transient Ischaemic Attack, may become evident only after a product is in use by the general population.
Delursan Side Effect Report#6027972-6
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
This Alanine Aminotransferase Increased side effect was reported by a consumer or non-health professional from France. A 20-year-old female patient (weight:NA) experienced the following symptoms/conditions: cholestasis,pain,autoimmune hepatitis.The patient was prescribed Delursan (ursodesoxycholic Acid) (drug dosage: 500 Mg), which was initiated on NS. Concurrently used drugs:
  • Augmentin '125'
  • Imurel (25 Mg)
  • Neoral (50 Mg)
.After starting to take Delursan (ursodesoxycholic Acid) the consumer reported adverse symptoms, such as: 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, InflammationThese side effects may potentially be related to Delursan (ursodesoxycholic Acid). The patient was hospitalized.
Delursan Side Effect Report#5808083-9
Amenorrhoea, Angiotensin Converting Enzyme Increased, Blood Alkaline Phosphatase Increased, Blood Creatinine Decreased, Disseminated Intravascular Coagulation, Gamma-glutamyltransferase Increased, Haemoglobin Decreased, Hepatosplenomegaly, Hyperproteinaemia
This is a report of a 56-year-old female patient (weight: NA) from France, suffering from the following health symptoms/conditions: cholestasis, who was treated with Delursan (ursodeoxycholic Acid) (dosage: 500 Mg (delursan) Oral, start time:
Nov 13, 2007), combined with: NA. and developed a serious reaction and side effect(s): Amenorrhoea, Angiotensin Converting Enzyme Increased, Blood Alkaline Phosphatase Increased, Blood Creatinine Decreased, Disseminated Intravascular Coagulation, Gamma-glutamyltransferase Increased, Haemoglobin Decreased, Hepatosplenomegaly, Hyperproteinaemia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Delursan (ursodeoxycholic Acid) treatment in female patients, resulting in Amenorrhoea side effect. The patient was hospitalized.
Delursan Side Effect Report#5731282-1
Haematuria, Thrombocytopenia
This report suggests a potential Delursan (ursodeoxycholic Acid) Haematuria side effect(s) that can have serious consequences. A 85-year-old female patient (weight: NA) from France was diagnosed with the following symptoms/conditions: NA and used Delursan (ursodeoxycholic Acid) (dosage: NA) starting
Jan 01, 2007. After starting Delursan (ursodeoxycholic Acid) the patient began experiencing various side effects, including: Haematuria, ThrombocytopeniaAdditional drugs used concurrently:
  • 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
The patient was hospitalized. Although Delursan (ursodeoxycholic Acid) demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Haematuria, may still occur.
Delursan Side Effect Report#5692825-X
Asthenia, Hepatic Enzyme Increased, Pruritus
This Asthenia problem was reported by a consumer or non-health professional from France. A 48-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Oct 14, 2007 this consumer started treatment with Delursan (ursodeoxycholic Acid) 250 Mg (dosage: Oral). The following drugs were being taken at the same time:
  • Meteospasymol (alverine Citrate 60 Mg, Simethicone 300 Mg)
  • Spasfon (phloroglucinol, Trimethylphloroglucinol)
When using Delursan (ursodeoxycholic Acid) 250 Mg, the patient experienced the following unwanted symptoms/side effects: Asthenia, Hepatic Enzyme Increased, PruritusThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Asthenia, may become evident only after a product is in use by the general population.
Delursan Side Effect Report#5483897-6
Abdominal Tenderness, Anaemia, Constipation, Faecaloma, Flatulence, Pallor, Peritoneal Effusion, Renal Failure Acute, Small Intestinal Haemorrhage
This Abdominal Tenderness side effect was reported by a consumer or non-health professional from France. A 88-year-old female patient (weight:NA) experienced the following symptoms/conditions: cholelithiasis,atrial fibrillation.The patient was prescribed Delursan (ursodeoxycholic Acid) (drug dosage: 250 Mg; Oral), which was initiated on NS. Concurrently used drugs:
  • Previscan (fluindione) (Oral)
  • Cordarone (Oral)
  • Deroxat (paroxetine) (Oral)
  • Folic Acid (Oral)
  • Omeprazole (Oral)
  • Primaxin (Oral)
.After starting to take Delursan (ursodeoxycholic Acid) the consumer reported adverse symptoms, such as: Abdominal Tenderness, Anaemia, Constipation, Faecaloma, Flatulence, Pallor, Peritoneal Effusion, Renal Failure Acute, Small Intestinal HaemorrhageThese side effects may potentially be related to Delursan (ursodeoxycholic Acid). The patient was hospitalized.
Delursan Side Effect Report#5383614-4
Lung Infection Pseudomonal, Oedema Peripheral, Pancytopenia, Pneumonia, Rash, Renal Failure Acute
This is a report of a 47-year-old male patient (weight: NA) from France, suffering from the following health symptoms/conditions: NA, who was treated with Delursan (ursodeoxycholic Acid) (dosage: 500 Mg Oral, start time:
Nov 16, 2006), combined with:
  • 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)
and developed a serious reaction and side effect(s): Lung Infection Pseudomonal, Oedema Peripheral, Pancytopenia, Pneumonia, Rash, Renal Failure Acute after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Delursan (ursodeoxycholic Acid) treatment in male patients, resulting in Lung Infection Pseudomonal side effect. The patient was hospitalized.
Delursan Side Effect Report#5116963-5
Hepatic Pain, Jaundice, Transaminases Increased
This report suggests a potential Delursan (ursodesoxycholic Acid) Hepatic Pain side effect(s) that can have serious consequences. A 14-year-old male patient (weight: NA) from France was diagnosed with the following symptoms/conditions: hepatic pain,transaminases increased,leukaemia and used Delursan (ursodesoxycholic Acid) (dosage: 500 Mg Tablets Po) starting NS. After starting Delursan (ursodesoxycholic Acid) the patient began experiencing various side effects, including: Hepatic Pain, Jaundice, Transaminases IncreasedAdditional drugs used concurrently: NA.The patient was hospitalized. Although Delursan (ursodesoxycholic Acid) demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Hepatic Pain, may still occur.
Delursan Side Effect Report#5024625-8
Optic Neuritis, Scotoma, Visual Acuity Reduced
This Optic Neuritis problem was reported by a consumer or non-health professional from France. A 51-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: cholangitis,spondyloarthropathy. On
Feb 24, 2005 this consumer started treatment with Delursan (ursodesoxycholic Acid) (dosage: 1 G Film-coated Tablets Po). The following drugs were being taken at the same time:
  • Methotrexate (10 Mg Po)
  • Remicade (400 Mg Iv)
  • Speciafoldine (folic Acid)
  • Cortan
  • Contramal Lp (tramadol Hydrochloride)
  • Acetaminophen
  • Forlax (macrogol)
  • Lansoprazole
When using Delursan (ursodesoxycholic Acid), the patient experienced the following unwanted symptoms/side effects: Optic Neuritis, Scotoma, Visual Acuity ReducedThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Optic Neuritis, may become evident only after a product is in use by the general population.
Delursan Side Effect Report#4850769-7
Cutaneous Vasculitis, Hepatic Encephalopathy
This Cutaneous Vasculitis side effect was reported by a consumer or non-health professional from . A 62-year-old female patient (weight:NA) experienced the following symptoms/conditions: biliary cirrhosis primary.The patient was prescribed Delursan (drug dosage: NA), which was initiated on
Aug 18, 2005. Concurrently used drugs:
  • 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.)
.After starting to take Delursan the consumer reported adverse symptoms, such as: Cutaneous Vasculitis, Hepatic EncephalopathyThese side effects may potentially be related to Delursan. The patient was hospitalized.
Delursan Side Effect Report#4845753-3
Cutaneous Vasculitis, Hepatic Encephalopathy
This is a report of a 62-year-old female patient (weight: NA) from France, suffering from the following health symptoms/conditions: biliary cirrhosis primary, who was treated with Delursan (ursodesoxycholic Acid) (dosage: Po, start time: NS), combined with:
  • Insulin
  • Beta-carotene And Bilberry (difrarel)
  • Duphalac
and developed a serious reaction and side effect(s): Cutaneous Vasculitis, Hepatic Encephalopathy after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Delursan (ursodesoxycholic Acid) treatment in female patients, resulting in Cutaneous Vasculitis side effect. The patient was hospitalized.



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.

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    Medicine Name and Dosage:
    Side Effects Scale Date & Time Other Medicine(s) or Treatment(s)
    Scale: 1 = very mild to 10 = very bad

    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.

    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.

    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.

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    Side Effects reported to FDA: 25

    Delursan safety alerts: No

    Reported deaths: 1

    Reported hospitalizations: 5

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