Clinoril (Sulindac) - Adverse Event Reports - All Cases

Colitis Ischaemic (2),  Pneumonia (2),  Pneumocystis Jiroveci Pneumonia (2),  Large Intestinal Ulcer (2),  Diarrhoea (2),  Haemoptysis (1),  Cholestasis (1),  Listeria Sepsis (1),  Liver Abscess (1),  Hepatitis Toxic (1)

Adverse event in female receiving Clinoril (Sulindac)

Reported by a physician from Japan on 2007-10-16

Patient: female, weighing 60.0 kg (132.0 pounds)

Adverse reactions / side effects: Pneumocystis Jiroveci Pneumonia

Adverse event resulted in: life threatening event, hospitalization

Suspect drug(s):
Clinoril
    Dosage: improvement with discontinuation of drug
    Administration route: Oral
    Indication: Rheumatoid Arthritis

Iscotin
    Dosage: improvement with discontinuation of drug
    Administration route: Oral
    Indication: Antibiotic Prophylaxis

Predonine
    Administration route: Oral
    Indication: Rheumatoid Arthritis

Remicade

Remicade

Remicade
    Indication: Rheumatoid Arthritis

Rheumatrex
    Administration route: Oral

Rheumatrex
    Dosage: improvement with discontinuation of drug
    Administration route: Oral

Rheumatrex
    Administration route: Oral
    Indication: Rheumatoid Arthritis

Sucralfate
    Administration route: Oral
    Indication: Prophylaxis

Thyradin S
    Dosage: dose = 50 rg
    Administration route: Oral
    Indication: Autoimmune Thyroiditis

Other drugs received by patient: Foliamin; Adrenal Hormone Preparations; Famotidine

Adverse event in female receiving Clinoril (Sulindac)

Reported by a physician from Japan on 2007-10-04

Patient: female, weighing 57.0 kg (125.4 pounds)

Adverse reactions / side effects: Abdominal Pain Lower, Therapeutic Response Decreased, Diarrhoea, Urinary Tract Infection Bacterial, Listeria Sepsis, Shock

Adverse event resulted in: hospitalization

Suspect drug(s):
Clinoril
    Administration route: Oral
    Indication: Rheumatoid Arthritis

Cyclosporine
    Administration route: Oral
    Indication: Rheumatoid Arthritis

Itrizole
    Administration route: Oral
    Indication: Antifungal Prophylaxis

Methotrexate
    Administration route: Oral

Methotrexate
    Administration route: Oral
    Indication: Rheumatoid Arthritis

Methycobal
    Indication: Neuropathy Peripheral

Norvasc
    Indication: Hypertension

Prednisolone
    Administration route: Oral
    Indication: Rheumatoid Arthritis

Remicade

Remicade

Remicade

Remicade

Remicade

Remicade

Remicade

Remicade

Remicade

Remicade
    Indication: Rheumatoid Arthritis

Other drugs received by patient: Iscotin; Adrenal Hormone Preparations; Foliamin; Ulgut; Amlodipine; Protecadin; Bonalon

Adverse event in 59 year old female receiving Clinoril (Sulindac)

Reported by a consumer/non-health professional from United States on 2007-07-23

Patient: 59 year old female, weighing 163.0 kg (358.6 pounds)

Adverse reactions / side effects: Peptic Ulcer Haemorrhage

Adverse event resulted in: hospitalization, disablity

Suspect drug(s):
Arixtra
    Dosage: 2.5mg per day
    Start date: 2007-06-26
    End date: 2007-07-01

Aspirin
    Administration route: Oral
    Indication: Drug USE FOR Unknown Indication

Clinoril
    Dosage: 200mg twice per day
    Indication: Drug USE FOR Unknown Indication
    End date: 2007-07-01

Other drugs received by patient: NO Concurrent Medication

Adverse event in male receiving Clinoril (Sulindac)

Reported by a physician from United Kingdom on 2007-07-19

Patient: male, weighing 3.0 kg (6.6 pounds)

Adverse reactions / side effects: Neonatal Respiratory Depression, Pulse Waveform Abnormal

Adverse event resulted in: hospitalization

Suspect drug(s):
Clinoril (Sulindac)

Adverse event in 25 year old female receiving Clinoril (Sulindac)

Reported by a physician from United Kingdom on 2007-07-19

Patient: 25 year old female

Adverse reactions / side effects: Drug Exposure During Pregnancy, PRE-Eclampsia

Suspect drug(s):
Clinoril (Sulindac)

Adverse event in 64 year old female receiving Clinoril (Sulindac)

Reported by a physician from Japan on 2007-06-21

Patient: 64 year old female, weighing 38.0 kg (83.6 pounds)

Adverse reactions / side effects: Pneumonia, Large Intestinal Ulcer

Adverse event resulted in: death, hospitalization

Suspect drug(s):
Clinoril
    Administration route: Oral
    Indication: Pain
    Start date: 1990-01-01
    End date: 1994-03-19

Clinoril
    Administration route: Oral
    End date: 1996-10-01

Clinoril
    Administration route: Oral
    Indication: Rheumatoid Arthritis
    Start date: 1990-01-01
    End date: 1994-03-19

Clinoril
    Administration route: Oral
    End date: 1996-10-01

Other drugs received by patient: Prednisolone Acetate; Teprenone; Pepcid; Nifedipine

Adverse event in 33 year old female receiving Clinoril (Sulindac)

Reported by a individual with unspecified qualification from Japan on 2007-06-07

Patient: 33 year old female

Adverse reactions / side effects: Hydronephrosis, Haematuria, Toxic Epidermal Necrolysis, Hepatic Failure, Pseudomonal Bacteraemia, Ascites, Herpes Zoster, Pneumocystis Jiroveci Pneumonia, Renal Failure, Diarrhoea, Respiratory Failure, Pancreatic Pseudocyst, Pancreatitis, Liver Abscess

Adverse event resulted in: death, life threatening event, hospitalization

Suspect drug(s):
Acetaminophen
    Administration route: Oral
    Indication: Nasopharyngitis
    Start date: 2005-02-02
    End date: 2005-02-07

Calonal
    Administration route: Oral
    Indication: Nasopharyngitis
    Start date: 2005-02-02
    End date: 2005-02-07

Clinoril
    Administration route: Oral
    Indication: SLE Arthritis
    Start date: 2005-01-19
    End date: 2005-02-07

Cytotec
    Administration route: Oral
    Indication: SLE Arthritis
    Start date: 2005-01-19
    End date: 2005-02-07

NEO-Amunoll
    Administration route: Oral
    Indication: Nasopharyngitis
    Start date: 2005-02-02
    End date: 2005-02-07

Other drugs received by patient: Prednisolone; Prednisolone

Adverse event in 64 year old female receiving Clinoril (Sulindac)

Reported by a physician from Japan on 2007-06-01

Patient: 64 year old female, weighing 38.0 kg (83.6 pounds)

Adverse reactions / side effects: Pneumonia, Large Intestinal Ulcer

Adverse event resulted in: death, hospitalization

Suspect drug(s):
Clinoril
    Administration route: Oral
    Indication: Pain
    Start date: 1990-01-01
    End date: 1994-03-19

Clinoril
    Administration route: Oral
    End date: 1996-10-01

Clinoril
    Administration route: Oral
    Indication: Rheumatoid Arthritis
    Start date: 1990-01-01
    End date: 1994-03-19

Clinoril
    Administration route: Oral
    End date: 1996-10-01

Other drugs received by patient: Prednisolone Acetate; Teprenone; Pepcid; Nifedipine

Adverse event in 71 year old male receiving Clinoril (Sulindac)

Reported by a physician from Ireland on 2007-05-31

Patient: 71 year old male

Adverse reactions / side effects: Haemoptysis

Adverse event resulted in: death

Suspect drug(s):
Clinoril
    Dosage: 800 mg/daily po
    Administration route: Oral
    Indication: Chemotherapy
    Start date: 2003-06-26
    End date: 2003-06-26

Clinoril
    Dosage: 800 mg/daily po
    Administration route: Oral
    Indication: Neoplasm Malignant
    Start date: 2003-06-26
    End date: 2003-06-26

Epirubicin
    Dosage: 126 mg/m2[2]/1x iv
    Indication: Chemotherapy
    Start date: 2003-06-26
    End date: 2003-06-26

Epirubicin
    Dosage: 126 mg/m2[2]/1x iv
    Indication: Neoplasm Malignant
    Start date: 2003-06-26
    End date: 2003-06-26

Other drugs received by patient: Dexamethasone 0.5mg TAB; Granisetron; Megestrol Acetate; Omeprazole

Adverse event in 75 year old male receiving Clinoril (Sulindac)

Reported by a physician from United States on 2007-05-17

Patient: 75 year old male

Adverse reactions / side effects: Cholestasis, Hepatitis Toxic

Adverse event resulted in: death, hospitalization

Suspect drug(s):
Clinoril (Sulindac)

Adverse event in 68 year old female receiving Clinoril (Sulindac)

Reported by a individual with unspecified qualification from United States on 2007-02-28

Patient: 68 year old female

Adverse reactions / side effects: Colitis Ischaemic, Rectal Haemorrhage

Adverse event resulted in: hospitalization

Suspect drug(s):
Clinoril
    Dosage: 200 mg/daily/po
    Administration route: Oral
    Indication: Arthritis
    Start date: 2007-01-01
    End date: 2007-01-26

Clopidogrel Bisulfate UNK
    Start date: 2006-03-04
    End date: 2007-01-24

Placebo (Unspecified) UNK
    Dosage: see image
    Start date: 2006-03-04
    End date: 2007-01-24

Placebo (Unspecified) UNK
    Dosage: see image
    Start date: 2006-03-04
    End date: 2007-01-24

Other drugs received by patient: Enbrel

Adverse event in female receiving Clinoril (Sulindac)

Reported by a physician from United States on 2007-02-16

Patient: female

Adverse reactions / side effects: Colitis Ischaemic

Adverse event resulted in: hospitalization

Suspect drug(s):
Aggrenox VS. Placebo
    Dosage: unk
    Administration route: Oral
    Indication: Prophylaxis
    Start date: 2006-03-04
    End date: 2007-01-26

Clinoril
    Administration route: Oral
    Start date: 2007-01-07
    End date: 2007-01-26

Clopidogrel
    Dosage: unk
    Administration route: Oral
    Indication: Prophylaxis
    Start date: 2006-03-04
    End date: 2007-01-26

Dipyridamole + Aspirin
    Dosage: unk
    Administration route: Oral

Micardis VS. Placebo
    Dosage: unk
    Administration route: Oral
    Indication: Prophylaxis
    Start date: 2006-03-04
    End date: 2007-01-26

Other drugs received by patient: Enbrel