This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Asacol HD (Mesalamine) 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 (4)
Life Threatening Events (1)
Reports by Reaction Type
Back Pain (1),
Tinnitus (1),
Colitis Ulcerative (1),
Pain in Extremity (1),
Rectal Haemorrhage (1),
Condition Aggravated (1),
Pyrexia (1),
Hepatic Enzyme Increased (1),
Hypercholesterolaemia (1),
Arthralgia (1),
Dizziness (1),
Sinusitis (1)
Possible Asacol HD side effects in 54 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-04-19
Patient: 54 year old female, weighing 62.6 kg (137.7 pounds)
Reactions: Pyrexia, Hepatic Enzyme Increased
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Asacol HD
Possible Asacol HD side effects in 53 year old female
Reported by a pharmacist from United States on 2012-04-18
Patient: 53 year old female
Reactions: Back Pain, Tinnitus, Pain in Extremity, Arthralgia, Sinusitis
Drug(s) suspected as cause:
Asacol HD
Possible Asacol HD side effects in 47 year old female
Reported by a consumer/non-health professional from United States on 2012-04-16
Patient: 47 year old female, weighing 8640.9 kg (19010.0 pounds)
Reactions: Colitis Ulcerative, Condition Aggravated
Drug(s) suspected as cause:
Asacol HD
Possible Asacol HD side effects in 52 year old male
Reported by a consumer/non-health professional from United States on 2012-01-05
Patient: 52 year old male
Reactions: Hypercholesterolaemia, Rectal Haemorrhage, Dizziness
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Asacol HD
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