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 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 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 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, 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 2012-01-17
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 2012-01-12
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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