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Clinoril (Sulindac) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Clinoril (Sulindac) 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 (17)
Death (1)

Reports by Reaction Type

Pancreatitis Chronic (4)Drug Hypersensitivity (4)Portal Venous GAS (3)Malaise (3)Adverse Event (3)Enteritis (3)Muscle Spasms (3)Renal Impairment (3)Diarrhoea (3)Abasia (2)Diverticulitis (2)Intentional Drug Misuse (2)

Possible Clinoril side effects in

Reported by a pharmacist from United States on 2012-08-03

Patient:

Reactions: Dyspnoea, Pain, Visual Impairment, Drug Hypersensitivity, Generalised Oedema

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Clinoril

Other drugs received by patient: Plaquenil



Possible Clinoril side effects in

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

Patient:

Reactions: Drug Hypersensitivity

Drug(s) suspected as cause:
Clinoril



Possible Clinoril side effects in female

Reported by a physician from United States on 2012-06-18

Patient: female

Reactions: Rosacea, Psoriatic Arthropathy

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Remicade
    Start date: 2012-01-01

Clinoril
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Remicade
    Indication: Psoriatic Arthropathy
    Start date: 2011-11-01

Remicade
    Dosage: dose: } 5 mg/kg



Possible Clinoril side effects in 84 year old female

Reported by a physician from United States on 2012-06-06

Patient: 84 year old female

Reactions: Pancreatitis Chronic

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Hydrodiuril
    Administration route: Oral

Clinoril
    Administration route: Oral

Prinivil
    Administration route: Oral



Possible Clinoril side effects in 86 year old female

Reported by a individual with unspecified qualification from United States on 2012-05-29

Patient: 86 year old female, weighing 64.4 kg (141.7 pounds)

Reactions: Diverticulitis, Abasia, Intentional Drug Misuse, Helicobacter Infection, Stupor, Discomfort, Speech Disorder, Malaise, Gastric Infection, Diarrhoea, Adverse Event, Abdominal Distension, Muscle Spasms

Drug(s) suspected as cause:
Nexium
    Administration route: Oral

Nexium
    Administration route: Oral
    Start date: 2012-05-19

Nexium
    Administration route: Oral
    Indication: Gastrooesophageal Reflux Disease
    Start date: 2005-01-01

Nexium
    Administration route: Oral
    Start date: 2012-02-01

Nexium
    Administration route: Oral
    Start date: 2012-02-01

Nexium
    Administration route: Oral
    Indication: Gastric Infection
    Start date: 2005-01-01

Nexium
    Administration route: Oral
    Start date: 2012-05-19

Nexium
    Administration route: Oral
    Start date: 2012-02-01

Nexium
    Administration route: Oral

Nexium
    Administration route: Oral

Clinoril
    Administration route: Oral

Nexium
    Administration route: Oral
    Start date: 2012-05-19

Nexium
    Administration route: Oral
    Indication: Dyspepsia
    Start date: 2005-01-01

Selegiline HCL
    Administration route: Oral

Other drugs received by patient: Many Pills



Possible Clinoril side effects in 86 year old female

Reported by a individual with unspecified qualification from United States on 2012-05-29

Patient: 86 year old female, weighing 64.4 kg (141.7 pounds)

Reactions: Diverticulitis, Abasia, Helicobacter Infection, Intentional Drug Misuse, Stupor, Discomfort, Speech Disorder, Malaise, Gastric Infection, Diarrhoea, Adverse Event, Abdominal Distension, Muscle Spasms

Drug(s) suspected as cause:
Nexium
    Administration route: Oral
    Start date: 2012-02-01

Nexium
    Administration route: Oral
    Start date: 2012-02-01

Selegiline HCL
    Administration route: Oral

Nexium
    Administration route: Oral

Nexium
    Administration route: Oral
    Indication: Gastrooesophageal Reflux Disease
    Start date: 2005-01-01

Nexium
    Administration route: Oral
    Indication: Gastric Infection
    Start date: 2005-01-01

Nexium
    Administration route: Oral
    Indication: Dyspepsia
    Start date: 2005-01-01

Nexium
    Administration route: Oral
    Start date: 2012-05-19

Nexium
    Administration route: Oral
    Start date: 2012-05-19

Clinoril
    Administration route: Oral

Nexium
    Administration route: Oral

Nexium
    Administration route: Oral

Nexium
    Administration route: Oral
    Start date: 2012-02-01

Nexium
    Administration route: Oral
    Start date: 2012-05-19

Other drugs received by patient: Many Pills



Possible Clinoril side effects in 86 year old female

Reported by a consumer/non-health professional from United States on 2012-05-24

Patient: 86 year old female

Reactions: Malaise, Diarrhoea, Adverse Event, Muscle Spasms

Drug(s) suspected as cause:
Nexium
    Administration route: Oral
    Indication: Gastrooesophageal Reflux Disease
    Start date: 2005-01-01

Selegiline HCL
    Administration route: Oral

Nexium
    Administration route: Oral

Clinoril
    Administration route: Oral

Other drugs received by patient: Many Pills



Possible Clinoril side effects in 84 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-15

Patient: 84 year old female

Reactions: Pancreatitis Chronic

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Hydrodiuril
    Administration route: Oral

Prinivil
    Administration route: Oral

Clinoril
    Administration route: Oral



Possible Clinoril side effects in 84 year old female

Reported by a physician from United States on 2012-05-14

Patient: 84 year old female

Reactions: Pancreatitis Chronic

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Hydrodiuril
    Administration route: Oral

Clinoril
    Administration route: Oral

Prinivil
    Administration route: Oral



Possible Clinoril side effects in 84 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-07

Patient: 84 year old female

Reactions: Pancreatitis Acute, Syncope, Pancreatitis Necrotising, Ileus, Obstruction, Hypoxia, Atrial Fibrillation, Pancreatitis Chronic, Biliary Tract Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Clinoril
    Dosage: 400 mg (200 mg, 2 in 1 d), unknown
    Indication: Product Used FOR Unknown Indication

Hydrochlorothiazide
    Dosage: (12.5 mg, 1 d), unknown
    Indication: Product Used FOR Unknown Indication

Lisinopril
    Dosage: (10 mg, 1 d), unknown
    Indication: Product Used FOR Unknown Indication



Possible Clinoril side effects in 84 year old female

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-04-16

Patient: 84 year old female

Reactions: Renal Impairment, Portal Venous GAS, Enteritis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Clinoril
    Administration route: Oral

Clinoril
    Administration route: Oral
    Indication: Chondrocalcinosis Pyrophosphate



Possible Clinoril side effects in female

Reported by a physician from United States on 2012-04-11

Patient: female, weighing 84.0 kg (184.8 pounds)

Reactions: Drug Hypersensitivity

Drug(s) suspected as cause:
Clinoril
    Dosage: unk

Cleocin Hydrochloride
    Dosage: unk



Possible Clinoril side effects in 84 year old female

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-04-05

Patient: 84 year old female

Reactions: Renal Impairment, Portal Venous GAS, Enteritis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Clinoril
    Administration route: Oral

Clinoril
    Administration route: Oral
    Indication: Chondrocalcinosis Pyrophosphate



Possible Clinoril side effects in 84 year old female

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-03-28

Patient: 84 year old female

Reactions: Renal Impairment, Portal Venous GAS, Enteritis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Clinoril
    Administration route: Oral
    Indication: Chondrocalcinosis Pyrophosphate

Clinoril
    Administration route: Oral



Possible Clinoril side effects in female

Reported by a physician from United States on 2012-03-16

Patient: female

Reactions: Drug Hypersensitivity

Drug(s) suspected as cause:
Clinoril
    Dosage: unk

Cleocin Hydrochloride
    Dosage: unk



Possible Clinoril side effects in 54 year old female

Reported by a physician from United States on 2012-01-23

Patient: 54 year old female

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Clinoril
    Administration route: Oral

Duloxetine Hydrochloride
    Administration route: Oral

Cyclobenzaprine HCL
    Administration route: Oral

Methadon HCL TAB
    Administration route: Oral

Alprazolam
    Administration route: Oral



Possible Clinoril side effects in 62 year old female

Reported by a physician from United States on 2011-11-29

Patient: 62 year old female

Reactions: Gastrointestinal Haemorrhage, Nausea, Anaemia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Clinoril

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