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Sulindac (Sulindac) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to 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 (26)
Death (10)
Life Threatening Events (2)

Reports by Reaction Type

Respiratory Arrest (8)Cardiac Arrest (8)Toxicity To Various Agents (7)Gastrointestinal Haemorrhage (3)Intentional Drug Misuse (3)Renal Failure (3)Weight Decreased (2)Trigeminal Neuralgia (2)Death (2)Abdominal Discomfort (2)Cardio-Respiratory Arrest (2)Decreased Appetite (2)

Possible Sulindac side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-03

Patient: male, weighing 115.8 kg (254.7 pounds)

Reactions: Flushing, Pruritus, Hypersensitivity, Nasopharyngitis, Sinus Disorder, Erythema, Paraesthesia

Drug(s) suspected as cause:
Sulindac
    Dosage: at night
    Start date: 2012-06-10

Niaspan
    Indication: Blood Cholesterol Decreased

Niaspan
    Dosage: at bedtime
    Indication: Blood Triglycerides Increased
    Start date: 2012-05-21

Other drugs received by patient: Aspirin; Lisinopril; Omeprazole; Byetta; Pravastatin; Zyrtec; Fish OIL; SAW Palmetto; Celexa; MV; Metformin Hydrochloride



Possible Sulindac side effects in 71 year old female

Reported by a pharmacist from United States on 2012-07-27

Patient: 71 year old female, weighing 70.5 kg (155.1 pounds)

Reactions: Haemoglobin Decreased, Gastrointestinal Haemorrhage, Haematocrit Decreased, Helicobacter Test Positive, Gastric Ulcer

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ibuprofen
    Dosage: 400mg tid po
    Administration route: Oral
    Indication: Pain

Prednisone TAB
    Dosage: 30mg daily po
    Administration route: Oral
    Indication: Arthritis

Lovenox
    Dosage: ? daily sq

Sulindac
    Dosage: 150 mg bid po recent
    Administration route: Oral
    Indication: Arthritis

Other drugs received by patient: Norco; Vitamin; Lidoderm; Flexeril; VIT D3; Amlodipine; Tramadol HCL; Captopril; Protonix; Gabapentin; Hydrochlorothiazide; Fish OIL



Possible Sulindac side effects in 89 year old male

Reported by a pharmacist from United States on 2012-07-12

Patient: 89 year old male, weighing 75.7 kg (166.5 pounds)

Reactions: Dyspnoea, Anaemia, Dizziness, Melaena, Gastritis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Naproxen
    Dosage: 375 mg tid po
    Administration route: Oral
    Indication: Pain
    Start date: 2011-01-11
    End date: 2012-02-16

Sulindac
    Dosage: 150 mg bid po
    Administration route: Oral
    Indication: Pain
    Start date: 2011-11-15
    End date: 2012-02-16



Possible Sulindac side effects in 62 year old male

Reported by a pharmacist from United States on 2012-07-05

Patient: 62 year old male, weighing 107.7 kg (236.9 pounds)

Reactions: LIP Swelling, Angioedema

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lisinopril and Hydrochlorothiazide
    Dosage: mg po
    Administration route: Oral
    Indication: Hypertension
    Start date: 2011-10-12
    End date: 2012-05-14

Sulindac
    Dosage: mg po
    Administration route: Oral
    Indication: Pain
    Start date: 2012-04-05
    End date: 2012-05-14



Possible Sulindac side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-20

Patient: male, weighing 104.8 kg (230.5 pounds)

Reactions: Gastrointestinal Haemorrhage

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Aspirin
    Indication: Ill-Defined Disorder
    End date: 2011-10-01

Aspirin
    Start date: 2011-11-08

Sulindac
    Indication: Ill-Defined Disorder

Xarelto
    Administration route: Oral
    Indication: Knee Arthroplasty
    Start date: 2011-11-08
    End date: 2011-11-01

Xarelto
    Administration route: Oral
    Indication: Thrombosis Prophylaxis
    Start date: 2011-11-08
    End date: 2011-11-01

Other drugs received by patient: Allopurinol; Benicar; Prilosec; Amlodipine; Bumex; Gabapentin; Insulin Aspart; Hydralazine Hydrochloride; Simvastatin; Lantus; Symlin; Mentax



Possible Sulindac side effects in 74 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-04

Patient: 74 year old male, weighing 104.8 kg (230.5 pounds)

Reactions: Gastrointestinal Haemorrhage

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Aspirin
    Start date: 2011-11-08

Xarelto
    Administration route: Oral
    Indication: Knee Arthroplasty
    Start date: 2011-11-08

Xarelto
    Administration route: Oral
    Indication: Thrombosis Prophylaxis
    Start date: 2011-11-08

Sulindac
    Indication: Ill-Defined Disorder

Aspirin
    Indication: Ill-Defined Disorder
    End date: 2011-10-01

Other drugs received by patient: Amlodipine; Lantus; Symlin; Hydralazine HCL; Benicar; Allopurinol; Simvastatin; Insulin Aspart; Prilosec; Bumex; Gabapentin; Mentax



Possible Sulindac side effects in female

Reported by a physician from United States on 2012-05-01

Patient: female

Reactions: Drug Ineffective

Drug(s) suspected as cause:
Sulindac

Other drugs received by patient: Prednisone; Prevacid; Toprol-XL; Prednisone; Lorazepam; Bentyl 20 MG



Possible Sulindac side effects in male

Reported by a individual with unspecified qualification from United States on 2012-05-01

Patient: male, weighing 86.3 kg (189.8 pounds)

Reactions: Abdominal Rigidity, Muscle Swelling, Oesophageal Discomfort, Gastrooesophageal Reflux Disease, Proctalgia

Drug(s) suspected as cause:
Sulindac



Possible Sulindac side effects in 54 year old male

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

Patient: 54 year old male

Reactions: Intentional Overdose, Respiratory Arrest, Cardiac Arrest

Adverse event resulted in: death

Drug(s) suspected as cause:
Alprazolam
    Dosage: unk
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Cyclobenzaprine HCL
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

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

Duloxetine Hydrochloride
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Methadone HCL
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication



Possible Sulindac side effects in 55 year old female

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

Patient: 55 year old female, weighing 72.6 kg (159.7 pounds)

Reactions: Pruritus Generalised, Rash Generalised, Urticaria, Eye Swelling, Thermal Burn

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Sulindac



Possible Sulindac side effects in female

Reported by a consumer/non-health professional from United States on 2012-03-01

Patient: female, weighing 81.7 kg (179.6 pounds)

Reactions: Product Quality Issue, Renal Failure, Breakthrough Pain, Adverse Event

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tramadol HCL
    Dosage: 100 mg once daily
    Administration route: Oral
    Indication: Breakthrough Pain
    End date: 2012-02-15

Tramadol HCL
    Dosage: 50mg/ 6 hours after 100mg as needed
    Administration route: Oral
    Indication: Neuropathy Peripheral

Tramadol HCL
    Dosage: 100 mg once daily
    Administration route: Oral
    End date: 2012-02-15

Tramadol HCL
    Dosage: 50mg/ 6 hours after 100mg as needed
    Administration route: Oral

Sulindac
    Indication: Product Used FOR Unknown Indication
    Start date: 2009-12-01
    End date: 2009-12-01



Possible Sulindac side effects in 59 year old male

Reported by a consumer/non-health professional from United States on 2012-01-23

Patient: 59 year old male, weighing 79.4 kg (174.6 pounds)

Reactions: Jaundice

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Sulindac
    Dosage: 1 pill
    Administration route: Oral
    Indication: Carpal Tunnel Syndrome
    Start date: 2011-12-15
    End date: 2011-12-21

Sulindac
    Dosage: 1 pill
    Administration route: Oral
    Indication: Arthritis
    Start date: 2011-12-15
    End date: 2011-12-21



Possible Sulindac side effects in 55 year old female

Reported by a pharmacist from United States on 2012-01-19

Patient: 55 year old female, weighing 50.5 kg (111.1 pounds)

Reactions: Drug Rash With Eosinophilia and Systemic Symptoms

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Sulindac

Other drugs received by patient: Salsalate



Possible Sulindac side effects in 54 year old male

Reported by a physician from United States on 2012-01-17

Patient: 54 year old male

Reactions: Respiratory Arrest, Intentional Drug Misuse, Toxicity To Various Agents, Cardiac Arrest

Adverse event resulted in: death

Drug(s) suspected as cause:
Alprazolam
    Indication: Product Used FOR Unknown Indication
    End date: 2010-01-01

Duloxetine Hydrochloride
    Indication: Product Used FOR Unknown Indication
    End date: 2010-01-01

Methadone HCL
    Indication: Product Used FOR Unknown Indication
    End date: 2010-01-01

Sulindac
    Indication: Product Used FOR Unknown Indication
    End date: 2010-01-01

Cyclobenzaprine
    Indication: Product Used FOR Unknown Indication
    End date: 2010-01-01



Possible Sulindac side effects in 54 year old male

Reported by a physician from United States on 2012-01-17

Patient: 54 year old male

Reactions: Respiratory Arrest, Toxicity To Various Agents, Intentional Drug Misuse, Cardiac Arrest

Adverse event resulted in: death

Drug(s) suspected as cause:
Duloxetine Hydrochloride
    Indication: Product Used FOR Unknown Indication
    End date: 2010-01-01

Cyclobenzaprine
    Indication: Product Used FOR Unknown Indication
    End date: 2010-01-01

Sulindac
    Indication: Product Used FOR Unknown Indication
    End date: 2010-01-01

Methadone HCL
    Indication: Product Used FOR Unknown Indication
    End date: 2010-01-01

Alprazolam
    Indication: Product Used FOR Unknown Indication
    End date: 2010-01-01



Possible Sulindac side effects in 54 year old male

Reported by a physician from United States on 2012-01-17

Patient: 54 year old male

Reactions: Respiratory Arrest, Toxicity To Various Agents, Cardiac Arrest

Adverse event resulted in: death

Drug(s) suspected as cause:
Alprazolam
    Indication: Product Used FOR Unknown Indication
    End date: 2010-01-01

Methadone HCL
    Indication: Product Used FOR Unknown Indication
    End date: 2010-01-01

Sulindac
    Indication: Product Used FOR Unknown Indication
    End date: 2010-01-01

Cyclobenzaprine
    Indication: Product Used FOR Unknown Indication
    End date: 2010-01-01

Duloxetine Hydrochloride
    Indication: Product Used FOR Unknown Indication
    End date: 2010-01-01



Possible Sulindac side effects in 54 year old male

Reported by a physician from United States on 2012-01-17

Patient: 54 year old male

Reactions: Respiratory Arrest, Intentional Drug Misuse, Toxicity To Various Agents, Cardiac Arrest

Adverse event resulted in: death

Drug(s) suspected as cause:
Cyclobenzaprine
    Indication: Product Used FOR Unknown Indication
    End date: 2010-01-01

Sulindac
    Indication: Product Used FOR Unknown Indication
    End date: 2010-01-01

Duloxetine Hydrochloride
    Indication: Product Used FOR Unknown Indication
    End date: 2010-01-01

Alprazolam
    Indication: Product Used FOR Unknown Indication
    End date: 2010-01-01

Methadone HCL
    Indication: Product Used FOR Unknown Indication
    End date: 2010-01-01



Possible Sulindac side effects in 54 year old male

Reported by a physician from United States on 2012-01-12

Patient: 54 year old male

Reactions: Poisoning, Respiratory Arrest, Cardiac Arrest

Adverse event resulted in: death

Drug(s) suspected as cause:
Alprazolam
    Dosage: (df oral)
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Cyclobenzaprine
    Dosage: (df oral)
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Methadone HCL
    Dosage: (df oral)
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Sulindac
    Dosage: (df oral)
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Duloxetime Hydrochloride
    Dosage: (df oral)
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication



Possible Sulindac side effects in 54 year old male

Reported by a physician from United States on 2012-01-11

Patient: 54 year old male

Reactions: Toxicity To Various Agents

Adverse event resulted in: death

Drug(s) suspected as cause:
Duloxetime Hydrochloride
    Administration route: Oral

Alprazolam
    Administration route: Oral

Sulindac
    Administration route: Oral

Cyclobenzaprine
    Administration route: Oral

Methadone HCL
    Administration route: Oral



Possible Sulindac side effects in 54 year old male

Reported by a physician from United States on 2012-01-06

Patient: 54 year old male

Reactions: Cardio-Respiratory Arrest, Toxicity To Various Agents

Adverse event resulted in: death

Drug(s) suspected as cause:
Alprazolam
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

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

Methadone HCL
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

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

Duloxetime Hydrochloride
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication



Possible Sulindac side effects in 54 year old male

Reported by a physician from United States on 2012-01-05

Patient: 54 year old male

Reactions: Death, Cardio-Respiratory Arrest, Respiratory Arrest, Toxicity To Various Agents, Cardiac Arrest

Adverse event resulted in: death

Drug(s) suspected as cause:
Methadone HCL
    Dosage: unk, unknown
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Cyclobenzaprine
    Dosage: unk, unknown
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Alprazolam
    Dosage: unk, unknown
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Sulindac
    Dosage: unk, unknown
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Duloxetime Hydrochloride
    Dosage: unk, unknown
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication



Possible Sulindac side effects in 54 year old male

Reported by a physician from United States on 2011-12-29

Patient: 54 year old male

Reactions: Death, Respiratory Arrest, Cardiac Arrest

Adverse event resulted in: death

Drug(s) suspected as cause:
Duloxetine Hydrochloride
    Dosage: unk
    Administration route: Oral

Methadone HCL
    Dosage: unk
    Administration route: Oral

Cyclobenzaprine HCL
    Dosage: unk
    Administration route: Oral

Alprazolam
    Dosage: unk
    Administration route: Oral

Sulindac
    Dosage: unk
    Administration route: Oral



Possible Sulindac side effects in female

Reported by a health professional (non-physician/pharmacist) from France on 2011-12-06

Patient: female

Reactions: Spinal Compression Fracture, Spinal Fracture, Gastritis Erosive, Ileitis, Lower Gastrointestinal Haemorrhage

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Nabumetone
    Indication: Bone Pain
    Start date: 2010-11-01
    End date: 2010-11-19

Indomethacin
    Indication: Bone Pain
    Start date: 2010-11-01
    End date: 2010-11-19

Sulindac
    Indication: Bone Pain
    Start date: 2010-11-01
    End date: 2010-11-19

Mobic
    Indication: Bone Pain
    Start date: 2010-11-01
    End date: 2010-11-19

Ibuprofen
    Indication: Bone Pain
    Start date: 2010-11-01
    End date: 2010-11-19

Aceclofenac
    Indication: Bone Pain
    Start date: 2010-11-01
    End date: 2010-11-19

Tiaprofenic Acid
    Indication: Bone Pain
    Start date: 2010-11-01
    End date: 2010-11-19

Lodine
    Indication: Bone Pain
    Start date: 2010-11-01
    End date: 2010-11-19

Nifluril
    Indication: Bone Pain
    Start date: 2010-11-01
    End date: 2010-11-19

Piroxicam
    Indication: Bone Pain
    Start date: 2010-11-01
    End date: 2010-11-19

Minalfene
    Indication: Bone Pain
    Start date: 2010-11-01
    End date: 2010-11-19

Ketoprofen
    Indication: Bone Pain
    Start date: 2010-11-01
    End date: 2010-11-19

Naproxen
    Indication: Bone Pain
    Start date: 2010-11-01
    End date: 2010-11-19

Tenoxicam
    Indication: Bone Pain
    Start date: 2010-11-01
    End date: 2010-11-19

Diclofenac Sodium
    Indication: Bone Pain
    Start date: 2010-11-01
    End date: 2010-11-19

Flurbiprofen
    Indication: Bone Pain
    Start date: 2010-11-01
    End date: 2010-11-19

Other drugs received by patient: Sterogyl; Acebutolol; Pravastatin; Plavix; Ramipril; Levothyroxine Sodium



Possible Sulindac side effects in 64 year old male

Reported by a pharmacist from United States on 2011-10-18

Patient: 64 year old male, weighing 87.9 kg (193.4 pounds)

Reactions: Gastric Haemorrhage

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Sulindac



Possible Sulindac side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2011-10-06

Patient: female, weighing 73.0 kg (160.6 pounds)

Reactions: Weight Decreased, Abdominal Discomfort, Vomiting, Renal Failure, Trigeminal Neuralgia, Decreased Appetite

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Sulindac
    Indication: Arthritis
    End date: 2011-09-01

Rebif
    Indication: Multiple Sclerosis
    Start date: 2003-06-17
    End date: 2011-09-05

Metformin HCL
    Indication: Type 2 Diabetes Mellitus
    End date: 2011-09-01

Other drugs received by patient: Unspecified Medications



Possible Sulindac side effects in female

Reported by a consumer/non-health professional from United States on 2011-10-03

Patient: female, weighing 73.0 kg (160.6 pounds)

Reactions: Weight Decreased, Abdominal Discomfort, Renal Failure, Vomiting, Trigeminal Neuralgia, Decreased Appetite

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Sulindac
    Indication: Arthritis
    End date: 2011-09-01

Rebif
    Indication: Multiple Sclerosis
    Start date: 2003-06-17
    End date: 2011-09-05

Metformin HCL
    Indication: Type 2 Diabetes Mellitus
    End date: 2011-09-01

Other drugs received by patient: Unspecified Medications

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