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Samsca (Tolvaptan) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Samsca (Tolvaptan) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (406)
Death (113)
Life Threatening Events (20)
Disability (11)

Reports by Reaction Type

Hypernatraemia (60)Blood Urea Increased (50)Condition Aggravated (46)Thirst (45)Rapid Correction of Hyponatraemia (38)Hyponatraemia (37)Cardiac Failure (34)Wrong Technique in Drug Usage Process (33)Renal Impairment (26)Dehydration (24)Vomiting (19)Pyrexia (18)

Below are a few examples of reports where side effects / adverse reactions may be related to Samsca (Tolvaptan). For a complete list or a specific selection of reports, please use the links above.

Possible Samsca side effects in 80 year old female

Reported by a physician from Japan on 2012-08-09

Patient: 80 year old female, weighing 58.0 kg (127.6 pounds)

Reactions: Renal Impairment, Drug Effect Decreased, Dialysis, Circulatory Collapse

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Samsca

Other drugs received by patient: Procylin (Beraprost Sodium); Feburic (Febuxistat); Argamate (Calcium Polystryrene Sulfonate); Doxazosin Mesylate; Aspirin; Vasolator (Gluceyl Trinitrate); LAC-B (Bifldobacterium Lactis); Infedipine CR (Nifedipine); Hanp (Carpetide); Aldactone; Lansoprazole; Urso 250; Lasix; Crestor



Possible Samsca side effects in 73 year old male

Reported by a physician from Japan on 2012-08-09

Patient: 73 year old male

Reactions: Weight Decreased, Pulmonary Hypertension

Adverse event resulted in: death

Drug(s) suspected as cause:
Samsca
    Dosage: 15 mg milligram(s), qd, oral ; 3.75 mg milligram(s), qd, oral
    Administration route: Oral
    Indication: Right Ventricular Failure
    End date: 2012-07-09

Samsca
    Dosage: 15 mg milligram(s), qd, oral ; 3.75 mg milligram(s), qd, oral
    Administration route: Oral
    Indication: Right Ventricular Failure
    Start date: 2012-07-10

Other drugs received by patient: Lasix; Theo-DUR; Symbicort; Spiriva



Possible Samsca side effects in 58 year old male

Reported by a physician from Japan on 2012-08-09

Patient: 58 year old male, weighing 62.0 kg (136.4 pounds)

Reactions: Blood Pressure Decreased

Drug(s) suspected as cause:
Lasix

Samsca
    Dosage: 7.5 mg milligram(s), qam, oral
    Administration route: Oral
    Indication: Fluid Retention
    Start date: 2012-05-24
    End date: 2012-05-24

Other drugs received by patient: Dopamine Hydrochloride; Enalapril Maleate; Crestor (Rosuvastain Calcium); Humalog; Aspirin; Plavix; Sigmart (Nicorandil); Selara (Eplerenone); Lantus; Rabeprazole Sodium; Carvedilol



Possible Samsca side effects in 89 year old female

Reported by a physician from Japan on 2012-08-09

Patient: 89 year old female, weighing 48.0 kg (105.6 pounds)

Reactions: Aortic Valve Stenosis, Cardiac Failure, Condition Aggravated, Hypernatraemia

Adverse event resulted in: death

Drug(s) suspected as cause:
Samsca

Other drugs received by patient: Carvedilol; Magmitt (Magnesium Oxide); Pursennid (Sennoside A+B Calcium); Levofloxacin; Warfarin Sodium



Possible Samsca side effects in 67 year old male

Reported by a physician from Japan on 2012-08-09

Patient: 67 year old male, weighing 53.0 kg (116.6 pounds)

Reactions: White Blood Cell Count Decreased, Hypotension, Thirst

Drug(s) suspected as cause:
Premient (Hydrochlorothiazide, Losartan Potassium) Tablet
    Dosage: 1 df dosage form, daily dose, oral
    Administration route: Oral
    Indication: Cardiac Failure
    End date: 2011-12-18

Samsca
    Dosage: 15 mg milligram(s), qam, oral
    Administration route: Oral
    Indication: Fluid Retention
    Start date: 2011-12-13
    End date: 2011-12-24

Other drugs received by patient: Eplerenone; Tenomin (Atenolol) Tablet; Warfarin Sodium; Halfdigoxin (Digoxin) Tablet; Amoban (Zopiclone) Tablet; Ticlopidine HCL; Lasix



Possible Samsca side effects in 78 year old female

Reported by a physician from Japan on 2012-08-09

Patient: 78 year old female, weighing 39.0 kg (85.8 pounds)

Reactions: Blood Urea Increased, Cardiac Failure Chronic, Hepatic Function Abnormal, Condition Aggravated, Platelet Count Decreased, Hypernatraemia

Drug(s) suspected as cause:
Samsca
    Dosage: 15 mg milligram(s), qd
    Indication: Cardiac Failure
    Start date: 2012-06-13
    End date: 2012-06-18

Samsca
    Dosage: 15 mg milligram(s), qd
    Indication: Pleural Effusion
    Start date: 2012-06-13
    End date: 2012-06-18

Other drugs received by patient: Nitroderm; Miya BM (Clostridium Butyricum); Lasix; Vancomycin Hydrochloride



Possible Samsca side effects in 76 year old female

Reported by a health professional (non-physician/pharmacist) from Sweden on 2012-08-08

Patient: 76 year old female, weighing 69.0 kg (151.8 pounds)

Reactions: Off Label Use, Encephalopathy, Ascites, Disease Progression, Hepatic Cirrhosis

Adverse event resulted in: death

Drug(s) suspected as cause:
Samsca
    Dosage: 30 mg milligram(s), daily dose, oral, 30 mg milligram(s), daily dose, oral
    Administration route: Oral
    Indication: Hepatic Cirrhosis
    Start date: 2011-11-06
    End date: 2011-11-07

Samsca
    Dosage: 30 mg milligram(s), daily dose, oral, 30 mg milligram(s), daily dose, oral
    Administration route: Oral
    Indication: Hyponatraemia
    Start date: 2011-11-06
    End date: 2011-11-07

Samsca
    Dosage: 30 mg milligram(s), daily dose, oral, 30 mg milligram(s), daily dose, oral
    Administration route: Oral
    Indication: Hepatic Cirrhosis
    Start date: 2011-11-09
    End date: 2011-11-10

Samsca
    Dosage: 30 mg milligram(s), daily dose, oral, 30 mg milligram(s), daily dose, oral
    Administration route: Oral
    Indication: Hyponatraemia
    Start date: 2011-11-09
    End date: 2011-11-10

Other drugs received by patient: Omeprazole; Furosemid (Furosemid); Atrovent; Laktulos (Lactulose); Acetylcystein (Acetylcystein); Spironolactone



Possible Samsca side effects in male

Reported by a physician from Japan on 2012-08-06

Patient: male, weighing 62.0 kg (136.4 pounds)

Reactions: Blood Urea Increased

Drug(s) suspected as cause:
Samsca
    Dosage: 7.5 mg milligram(s), qam, oral
    Administration route: Oral
    Indication: Fluid Retention
    Start date: 2012-03-23
    End date: 2012-03-27

Torsemide
    Dosage: 8 mg milligram(s), daily dose, oral
    Administration route: Oral
    Indication: Cardiac Failure
    Start date: 2012-03-23
    End date: 2012-03-26

Other drugs received by patient: Diart (Azosemide); Allopurinol; Methylcobal (Mecobalamin); Lansoprazole; Warfarin Sodium; Hanp (Carperitide); Lasix; Lasix; Livalo; Lasix; Predopa (Dopamine Hydrochloride); Amiodarone HCL; Dobutrex



Possible Samsca side effects in 81 year old male

Reported by a physician from Japan on 2012-08-03

Patient: 81 year old male, weighing 61.0 kg (134.2 pounds)

Reactions: LOW Cardiac Output Syndrome, Volume Blood Decreased, Hypotension, Depressed Level of Consciousness, Decreased Ventricular Preload, Respiratory Depression, Cardiac Arrest, Oxygen Saturation Decreased

Adverse event resulted in: death

Drug(s) suspected as cause:
Samsca

Other drugs received by patient: Depakene-R (Valproate Sodium) Tablet; Hanp (Carperitide) Injection; Plavix; Crestor; Carvedilol; Aldactone; Aspirin; Magmitt (Magnesium Oxide) Tablet; Coversyl (Perindopril Erbumine) Tablet; Lasix



Possible Samsca side effects in 70 year old male

Reported by a physician from Japan on 2012-08-03

Patient: 70 year old male, weighing 79.0 kg (173.8 pounds)

Reactions: Pneumonia, Monoparesis, Cardiac Failure, Cerebrovascular Disorder

Drug(s) suspected as cause:
Samsca

Other drugs received by patient: Unisia (Candesartan Cilexetil Amlodipine Besilate Combined Drug) Table; Hanp (Carperitide) Injection; Carvedilol; Allopurinol; Lasix



Possible Samsca side effects in female

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-08-03

Patient: female, weighing 54.0 kg (118.8 pounds)

Reactions: Vomiting, Pruritus, Nausea, Rapid Correction of Hyponatraemia, General Physical Health Deterioration, Thirst, Blood Sodium Decreased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Samsca
    Dosage: 15 mg daily dose, oral
    Administration route: Oral
    Indication: Inappropriate Antidiuretic Hormone Secretion
    Start date: 2012-04-14

Samsca
    Dosage: 15 mg daily dose, oral
    Administration route: Oral
    Indication: Hyponatraemia
    Start date: 2012-04-14

Samsca
    Dosage: 15 mg daily dose, oral
    Administration route: Oral
    Indication: Inappropriate Antidiuretic Hormone Secretion
    Start date: 2011-12-21
    End date: 2011-12-21

Samsca
    Dosage: 15 mg daily dose, oral
    Administration route: Oral
    Indication: Hyponatraemia
    Start date: 2011-12-21
    End date: 2011-12-21

Samsca
    Dosage: 15 mg daily dose, oral
    Administration route: Oral
    Indication: Inappropriate Antidiuretic Hormone Secretion
    Start date: 2012-01-09
    End date: 2012-01-09

Samsca
    Dosage: 15 mg daily dose, oral
    Administration route: Oral
    Indication: Hyponatraemia
    Start date: 2012-01-09
    End date: 2012-01-09

Samsca
    Dosage: 15 mg daily dose, oral
    Administration route: Oral
    Indication: Inappropriate Antidiuretic Hormone Secretion
    Start date: 2012-03-30
    End date: 2012-04-08

Samsca
    Dosage: 15 mg daily dose, oral
    Administration route: Oral
    Indication: Hyponatraemia
    Start date: 2012-03-30
    End date: 2012-04-08

Samsca
    Dosage: 15 mg daily dose, oral
    Administration route: Oral
    Indication: Inappropriate Antidiuretic Hormone Secretion
    Start date: 2012-04-12
    End date: 2012-04-12

Samsca
    Dosage: 15 mg daily dose, oral
    Administration route: Oral
    Indication: Hyponatraemia
    Start date: 2012-04-12
    End date: 2012-04-12

Samsca
    Dosage: 15 mg daily dose, oral
    Administration route: Oral
    Indication: Inappropriate Antidiuretic Hormone Secretion
    Start date: 2012-02-02
    End date: 2012-02-02

Samsca
    Dosage: 15 mg daily dose, oral
    Administration route: Oral
    Indication: Hyponatraemia
    Start date: 2012-02-02
    End date: 2012-02-02

Samsca
    Dosage: 15 mg daily dose, oral
    Administration route: Oral
    Indication: Inappropriate Antidiuretic Hormone Secretion
    Start date: 2012-02-25
    End date: 2012-02-25

Samsca
    Dosage: 15 mg daily dose, oral
    Administration route: Oral
    Indication: Hyponatraemia
    Start date: 2012-02-25
    End date: 2012-02-25

Samsca
    Dosage: 15 mg daily dose, oral
    Administration route: Oral
    Indication: Inappropriate Antidiuretic Hormone Secretion
    Start date: 2012-02-22
    End date: 2012-02-22

Samsca
    Dosage: 15 mg daily dose, oral
    Administration route: Oral
    Indication: Hyponatraemia
    Start date: 2012-02-22
    End date: 2012-02-22

Samsca
    Dosage: 15 mg daily dose, oral
    Administration route: Oral
    Indication: Inappropriate Antidiuretic Hormone Secretion
    Start date: 2012-02-28
    End date: 2012-03-26

Samsca
    Dosage: 15 mg daily dose, oral
    Administration route: Oral
    Indication: Hyponatraemia
    Start date: 2012-02-28
    End date: 2012-03-26

Samsca
    Dosage: 15 mg daily dose, oral
    Administration route: Oral
    Indication: Inappropriate Antidiuretic Hormone Secretion
    Start date: 2012-01-17
    End date: 2012-01-17

Samsca
    Dosage: 15 mg daily dose, oral
    Administration route: Oral
    Indication: Hyponatraemia
    Start date: 2012-01-17
    End date: 2012-01-17

Other drugs received by patient: Saline (Saline), 0.9% Percent; Travegil (Clemastine); Prednisolon (Prednisolone Sodiuim Succinate); Clemastine Fumarate; Levothyroxine Sodium; Riopan (Magaldrate); Metoprolol Succinate; Emend; Pantozol (Pantoprazole); Fenofibrate; Emend (Apepitant); Metoclopramide; Nulytely; Granisetron (Granisetron Hydrochloride); Dimenhydrinate; Atacand; Metoclopramide Hydrochloride; Carboplatin; Ranitidine Hydrochloride; Bezafibrat (Bezafibrate); Zofran; Fortecortin (Dexamethasone); Riopan (Magaldrate); Zofran; Dimenhydrinate; Fraxiparin (Nadroparin Calciium); Zantac; Nacl (Nacl); Haldol; Fortecortin (Dexamethasone); Emend; Hyoscine HBR HYT; Pantoprazole Sodium; Ranitidine Hydrochloride; Etoposide; Novalgin (Metamizole Sodium); Vergentan (Alizapride Hydrochloride)



Possible Samsca side effects in 62 year old male

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-08-02

Patient: 62 year old male

Reactions: Pneumonia, Hypernatraemia

Adverse event resulted in: death

Drug(s) suspected as cause:
Samsca
    Dosage: 15 mg milligram(s), daily dose, unknown; 30 mg milligram(s), daily dose
    Indication: Hyponatraemia
    Start date: 2012-06-14
    End date: 2012-06-26

Samsca
    Dosage: 15 mg milligram(s), daily dose, unknown; 30 mg milligram(s), daily dose
    Indication: Hyponatraemia
    Start date: 2012-06-12
    End date: 2012-06-13

Other drugs received by patient: Electrolyte Solutions Solution; Naci (Naci)



Possible Samsca side effects in 83 year old male

Reported by a physician from Japan on 2012-08-02

Patient: 83 year old male, weighing 46.0 kg (101.2 pounds)

Reactions: Blood Urea Increased, Pneumonia Aspiration, Condition Aggravated, Hypernatraemia, Pyrexia, Somnolence, Loss of Consciousness, Speech Disorder, Cardiac Failure, Dehydration, Marasmus, Pleural Effusion

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Eplerenone
    Dosage: 50 mg milligram(s), qd, oral
    Administration route: Oral
    Indication: Cardiac Failure Congestive
    Start date: 2011-08-08
    End date: 2011-12-14

Eplerenone
    Dosage: 50 mg milligram(s), qd, oral
    Administration route: Oral
    Indication: Pleural Effusion
    Start date: 2011-08-08
    End date: 2011-12-14

Lasix
    Dosage: 40 mg milligram(s), qd, oral
    Administration route: Oral
    Indication: Pleural Effusion
    Start date: 2011-08-08
    End date: 2011-12-14

Lasix
    Dosage: 40 mg milligram(s), qd, oral
    Administration route: Oral
    Indication: Cardiac Failure Congestive
    Start date: 2011-08-08
    End date: 2011-12-14

Samsca
    Dosage: 7.5 mg milligram(s), bid, oral
    Administration route: Oral
    Indication: Cardiac Failure Congestive
    Start date: 2011-12-07
    End date: 2011-12-14

Samsca
    Dosage: 7.5 mg milligram(s), bid, oral
    Administration route: Oral
    Indication: Pleural Effusion
    Start date: 2011-12-07
    End date: 2011-12-14

Trichlormethiazide
    Dosage: 2 mg milligram(s), qd, oral
    Administration route: Oral
    Indication: Pleural Effusion
    Start date: 2010-12-15
    End date: 2011-12-14

Trichlormethiazide
    Dosage: 2 mg milligram(s), qd, oral
    Administration route: Oral
    Indication: Cardiac Failure Congestive
    Start date: 2010-12-15
    End date: 2011-12-14

Other drugs received by patient: Carvedilol; Simvastatin; Warfarin Sodium; Allopurinol



Possible Samsca side effects in

Reported by a physician from United States on 2012-08-02

Patient:

Reactions: Nephrogenic Diabetes Insipidus

Drug(s) suspected as cause:
Samsca



Possible Samsca side effects in 65 year old male

Reported by a individual with unspecified qualification from Germany on 2012-08-02

Patient: 65 year old male

Reactions: Wrong Technique in Drug Usage Process, Syncope, Rapid Correction of Hyponatraemia, Blood Sodium Increased, Polyuria, Blood Pressure Decreased

Drug(s) suspected as cause:
Samsca

Other drugs received by patient: Valproic Acid; Valdoxan (Agomelatin); Levodopa (Levodopa); Domperidone (Domperidone)



Possible Samsca side effects in

Reported by a pharmacist from Japan on 2012-08-01

Patient:

Reactions: Functional Gastrointestinal Disorder, Cardiac Failure, Condition Aggravated

Adverse event resulted in: death

Drug(s) suspected as cause:
Samsca



Possible Samsca side effects in 56 year old male

Reported by a physician from Japan on 2012-08-01

Patient: 56 year old male, weighing 56.0 kg (123.2 pounds)

Reactions: Blood Urea Increased, Restlessness, Abnormal Behaviour, Cerebral Haemorrhage

Drug(s) suspected as cause:
Aspirin
    Dosage: 100 mg milligram(s), daily dose, oral
    Administration route: Oral
    Indication: Prophylaxis

Samsca
    Dosage: 3.75 mg milligram(s), qam, oral
    Administration route: Oral
    Indication: Fluid Retention
    Start date: 2012-06-15
    End date: 2012-06-27

Warfarin Sodium
    Dosage: 3 mg milligram(s), daily dose, oral
    Administration route: Oral
    Indication: Prophylaxis

Other drugs received by patient: Selara (Eplernone); Tanatril (Imidapril Hydrochloride); Carvedilol; Lasix; Amiodarone HCL



Possible Samsca side effects in 86 year old female

Reported by a physician from Japan on 2012-08-01

Patient: 86 year old female, weighing 43.0 kg (94.6 pounds)

Reactions: Colitis Ischaemic, Abdominal Pain, Blood Urea Increased, Subileus, Constipation, Hepatic Enzyme Increased, Liver Disorder, Hepatic Artery Embolism

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Samsca

Other drugs received by patient: Lasix; Follamin (Folic Acid); Warfarin Sodium; Famotidine D (Famotidine); Ferromia (Ferrous Sodium Citrate); Aldactone; Juveia (Tocopheryl Acetate)



Possible Samsca side effects in 88 year old male

Reported by a physician from Japan on 2012-08-01

Patient: 88 year old male, weighing 76.0 kg (167.2 pounds)

Reactions: Renal Impairment, Renal Failure, Hyperkalaemia, Cardiac Failure, Haemodialysis

Drug(s) suspected as cause:
Enalapril Maleate
    Dosage: 5 mg milligram(s), daily dose, oral
    Administration route: Oral
    Indication: Cardiac Failure
    End date: 2012-07-01

Samsca
    Dosage: 15 mg milligram(s), qam, oral, 7.5 milligram(s), qam, oral
    Administration route: Oral
    Indication: Fluid Retention
    Start date: 2012-07-05

Samsca
    Dosage: 15 mg milligram(s), qam, oral, 7.5 milligram(s), qam, oral
    Administration route: Oral
    Indication: Fluid Retention
    Start date: 2012-06-28
    End date: 2012-07-04

Spironolactone
    Dosage: 25 mg milligram(s), daily dose, oral
    Administration route: Oral
    Indication: Cardiac Failure
    End date: 2012-07-01

Other drugs received by patient: Hanp (Carperitide); Lasix; Carvedilol; Pimobendan (Pimobendan); Allopurinol; Dopamine Hydrochloride; Warfarin Sodium



Possible Samsca side effects in 72 year old female

Reported by a physician from Japan on 2012-08-01

Patient: 72 year old female, weighing 52.9 kg (116.4 pounds)

Reactions: Haemoglobin Decreased, Pneumonia, Blood Urea Increased, Thirst

Drug(s) suspected as cause:
Hanp (Carperitide) Injection
    Dosage: 2000 mcg, daily dose, intravenous
    Indication: Cardiac Failure Congestive
    Start date: 2012-05-30
    End date: 2012-06-04

Lasix
    Dosage: 60 mg milligram(s), daily dose, intravenous
    Indication: Cardiac Failure Congestive
    Start date: 2012-05-27
    End date: 2012-06-08

Lasix
    Dosage: 40 mg milligram(s), daily dose, oral
    Administration route: Oral
    Indication: Cardiac Failure Congestive

Samsca
    Dosage: 7.5 mg milligram(s), qam, oral, 15 mg milligram(s) qam, oral
    Administration route: Oral
    Indication: Fluid Retention
    Start date: 2012-06-01

Samsca
    Dosage: 7.5 mg milligram(s), qam, oral, 15 mg milligram(s) qam, oral
    Administration route: Oral
    Indication: Fluid Retention
    Start date: 2012-05-31
    End date: 2012-05-31

Other drugs received by patient: Rocephin; Nexium; Nauzelin (Domperidone); Aromasin; Hisinalo (Glucose, Potassium Chloride, Sodium Lactate); Osteluc (Etodolac); Solita-T1 (Glucose, Sodium Chloride, Sodium Lactate); Warfarin Sodium; Norvasc; Oxycontin



Possible Samsca side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-31

Patient: female

Reactions: Dyspnoea, Hypotension

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Samsca



Possible Samsca side effects in male

Reported by a health professional (non-physician/pharmacist) from Spain on 2012-07-27

Patient: male, weighing 160.0 kg (352.0 pounds)

Reactions: Incorrect Drug Administration Rate, Wrong Technique in Drug Usage Process, Oedema Peripheral, Eczema, Headache

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Amlodipine
    Dosage: 5 mg milligram(s), daily dose, oral
    Administration route: Oral
    Indication: Hypertension
    Start date: 2011-08-08

Samsca
    Dosage: see image
    Administration route: Oral
    Indication: Inappropriate Antidiuretic Hormone Secretion
    Start date: 2012-01-04
    End date: 2012-01-25

Samsca
    Dosage: see image
    Administration route: Oral
    Indication: Inappropriate Antidiuretic Hormone Secretion
    Start date: 2011-07-08
    End date: 2011-10-14

Samsca
    Dosage: see image
    Administration route: Oral
    Indication: Inappropriate Antidiuretic Hormone Secretion
    Start date: 2011-10-25
    End date: 2011-10-25

Samsca
    Dosage: see image
    Administration route: Oral
    Indication: Inappropriate Antidiuretic Hormone Secretion
    Start date: 2012-01-25

Samsca
    Dosage: see image
    Administration route: Oral
    Indication: Inappropriate Antidiuretic Hormone Secretion
    Start date: 2011-10-28
    End date: 2011-11-30

Samsca
    Dosage: see image
    Administration route: Oral
    Indication: Inappropriate Antidiuretic Hormone Secretion
    Start date: 2011-11-30
    End date: 2012-01-04

Other drugs received by patient: Aspirin; Furosemide; Doxazosin Mesylate; Acetaminophen; Hidroferol (Calcifediol)



Possible Samsca side effects in 73 year old male

Reported by a physician from Japan on 2012-07-26

Patient: 73 year old male

Reactions: Pulmonary Hypertension, Chronic Obstructive Pulmonary Disease

Adverse event resulted in: death

Drug(s) suspected as cause:
Samsca
    Dosage: 15;3.75 mg, qd, oral
    Administration route: Oral
    Start date: 2012-07-10

Samsca
    Dosage: 15;3.75 mg, qd, oral
    Administration route: Oral
    End date: 2012-07-09

Other drugs received by patient: Lasix; Symbicort; Spiriva; Theodur (Theophyline)



Possible Samsca side effects in 83 year old female

Reported by a physician from Japan on 2012-07-26

Patient: 83 year old female, weighing 43.0 kg (94.6 pounds)

Reactions: Renal Impairment, Cardiac Failure, Disseminated Intravascular Coagulation, Condition Aggravated, Hypernatraemia, Thirst

Adverse event resulted in: death

Drug(s) suspected as cause:
Samsca
    Dosage: 15 mg milligram(s), qam, oral ; 7.5 mg milligram(s), qam, oral
    Administration route: Oral
    Indication: Fluid Retention
    Start date: 2012-05-19
    End date: 2012-05-28

Samsca
    Dosage: 15 mg milligram(s), qam, oral ; 7.5 mg milligram(s), qam, oral
    Administration route: Oral
    Indication: Fluid Retention
    Start date: 2012-05-29
    End date: 2012-05-29

Other drugs received by patient: Lasix; Urinorm (Benzbromarone); Lansoprazole; Doputamin (Dobutamine Hydrochloride); Sodium Polystyrene Sulfonate; Meropenem



Possible Samsca side effects in 80 year old male

Reported by a physician from Japan on 2012-07-25

Patient: 80 year old male, weighing 48.0 kg (105.6 pounds)

Reactions: Blood Urea Increased, Drug Hypersensitivity, Purpura, Pyrexia, Infection

Drug(s) suspected as cause:
Samsca

Other drugs received by patient: Celecoxib; Adalat; Minocycline HCL; Biofermin R (Streptococcus Faecalis); Bayaspirn (Acetylsalicylic Acid); Lasix; Depas (Etizolam); Brozom (Brotizolam); Takepron (Lansoprazole) Orodisperisble



Possible Samsca side effects in 84 year old male

Reported by a physician from Japan on 2012-07-25

Patient: 84 year old male, weighing 63.0 kg (138.6 pounds)

Reactions: Anaemia, Thirst

Drug(s) suspected as cause:
Samsca

Other drugs received by patient: Lasix; Aldactone; Torsemide



Possible Samsca side effects in male

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-07-25

Patient: male

Reactions: Confusional State, Drug Ineffective, Medication Error, Hyponatraemia, Disorientation, Somnolence

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Samsca
    Dosage: 15 mg milligram(s), qd, unk; 45 mg milligram(s), unk,
    Indication: Inappropriate Antidiuretic Hormone Secretion

Topotecan
    Dosage: unk
    Start date: 2012-03-21
    End date: 2012-03-25

Topotecan
    Dosage: unk
    Start date: 2012-04-23
    End date: 2012-04-27



Possible Samsca side effects in 76 year old female

Reported by a physician from Japan on 2012-07-25

Patient: 76 year old female, weighing 39.0 kg (85.8 pounds)

Reactions: Hepatic Function Abnormal, Blood Urea Increased, Hepatic Congestion, Platelet Count Decreased, Hypernatraemia

Drug(s) suspected as cause:
Samsca
    Dosage: 15 mg milligram(s), qd
    Indication: Pleural Effusion
    Start date: 2012-06-13
    End date: 2012-06-18

Samsca
    Dosage: 15 mg milligram(s), qd
    Indication: Cardiac Failure
    Start date: 2012-06-13
    End date: 2012-06-18

Other drugs received by patient: Miya BM (Clostridium Butyricum); Lasix; Nitroderm; Vancomycin Hydrochloride



Possible Samsca side effects in 61 year old male

Reported by a physician from Japan on 2012-07-24

Patient: 61 year old male, weighing 58.0 kg (127.6 pounds)

Reactions: Blood Urea Increased, Hypotension

Drug(s) suspected as cause:
Samsca

Other drugs received by patient: Hanp (Carperitide) Injection; Furosemide (Furosemide) Injection; Furosemide (Furosemide) Injection; Spironolactone



Possible Samsca side effects in 86 year old female

Reported by a physician from Japan on 2012-07-23

Patient: 86 year old female

Reactions: Hepatic Function Abnormal

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Samsca

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