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I Woke Up (14)
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Diarrhea (7)
Some Stomach Cramps (4)
Fever (3)
Fever, Some Stomach Cramps, Diarrhea (3)
Bloody Diarrhea (2)
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Asacol Side Effects and Adverse Effects reported to US Food and Drug Administration (FDA)

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Showing 1-25 of 471 

Pyrexia, Hepatic Enzyme Increased (8299800-X)
on Apr 19, 2012 Female from UNITED STATES , 54 years of age, weighting 138.0 lb, was diagnosed with
  • crohn's disease
and was treated with Asacol Hd. Directly after, patient experienced the unwanted or unexpected Asacol side effects: pyrexia, hepatic enzyme increased. Asacol Hd dosage: 1600 Mgm.

Renal Impairment, Haemodialysis, Hydronephrosis, Haemoglobin Decreased, Blood Creatinine Increased, Glomerulonephritis Chronic (8299460-8)
Patient was taking Asacol. Patient felt the following Asacol side effects: renal impairment, haemodialysis, hydronephrosis, haemoglobin decreased, blood creatinine increased, glomerulonephritis chronic on Apr 04, 2012 from DENMARK Additional patient health information: Male , 22 years of age, was diagnosed with
  • crohn's disease
and. Asacol dosage: Oral.
Multiple prescriptions taken:
  • Cortisone (coritsone)
  • Pentasa (Oral)
  • Oxcarbazepine
Patient was hospitalized.

Hemiparesis, Haemorrhage Intracranial, Continuous Haemodiafiltration (8290662-3)
Adverse event was reported on Apr 13, 2012 by a Male taking Asacol (Dosage: N/A) . Location: UNITED STATES , 84 years of age, weighting 202.4 lb, After Asacol was administered, patient encountered several Asacol side effects: hemiparesis, haemorrhage intracranial, continuous haemodiafiltration.
Multiple concurrent drugs taken:
  • Digoxin
  • Dabigatran 150 Mg Bid Oral (150 Mg Bid Oral)
  • Diltiazem Hcl
Patient was hospitalized and became disabled.

Colitis Ulcerative, Condition Aggravated (8287317-8)
on Apr 16, 2012 Female from UNITED STATES , 47 years of age, weighting 19050 lb, was diagnosed with
  • colitis
and was treated with Asacol Hd. Directly after, patient experienced the unwanted or unexpected Asacol side effects: colitis ulcerative, condition aggravated. Asacol Hd dosage: 800 Mg.


Nausea, Nasal Congestion, Influenza, Nasopharyngitis (8284427-6)
on May 26, 2011 Male from UNITED STATES , 24 years of age, was treated with Asacol Hd. Patient felt the following Asacol side effects: nausea, nasal congestion, influenza, nasopharyngitis. Asacol Hd dosage: N/A.
Multiple prescriptions taken:
  • Nexium


Off Label Use (8284170-3)
Patient was taking Asacol. After Asacol was administered, patient encountered several Asacol side effects: off label use on Oct 05, 2011 from UNITED STATES Additional patient health information: Female , 61 years of age, weighting 248.9 lb, . Asacol dosage: N/A.
Multiple concurrent drugs taken:
  • Diovan
  • Nexium


Chest Discomfort, Hypoaesthesia, Infusion Related Reaction, Flushing, Tremor, Ocular Hyperaemia, Rash, Chills (8281670-7)
Adverse event was reported on Apr 04, 2012 by a Female taking Asacol (Dosage: N/A) . Location: UNITED STATES , weighting 111.0 lb, Directly after, patient experienced the unwanted or unexpected Asacol side effects: chest discomfort, hypoaesthesia, infusion related reaction, flushing, tremor, ocular hyperaemia, rash, chills.
Associated medications used:
  • Mercaptopurine
  • Prednisone Tab
  • Remicade


Chronic Myeloid Leukaemia Transformation, B Precursor Type Acute Leukaemia (8268906-3)
on May 13, 2009 Male from UNITED STATES , 70 years of age, weighting 205.0 lb, was treated with Asacol. Patient felt the following Asacol side effects: chronic myeloid leukaemia transformation, b precursor type acute leukaemia. Asacol dosage: N/A.
Multiple prescriptions taken:
  • Aspirin
  • Lipitor
  • Gleevec (400 Mg, Qd)
  • Toprol-xl
  • Zolpidem
  • Hytrin
  • Hydrochlorothiazide
  • Nexium (esomerprazole Magnesium)


Peroneal Nerve Palsy, Sciatica (8251134-5)
on Mar 22, 2012 Male from CANADA , weighting 165.3 lb, was treated with Asacol. After Asacol was administered, patient encountered several Asacol side effects: peroneal nerve palsy, sciatica. Asacol dosage: N/A.
Multiple concurrent drugs taken:
  • Remicade (Once Every 4-6 Weeks)
  • Gabapentin
  • Naproxen (aleve)


Anaemia, Pneumocystis Jiroveci Pneumonia (8249341-0)
Patient was taking Asacol. Directly after, patient experienced the unwanted or unexpected Asacol side effects: anaemia, pneumocystis jiroveci pneumonia on Mar 21, 2012 from JAPAN Additional patient health information: Male , 52 years of age, weighting 134.5 lb, was diagnosed with
  • colitis ulcerative
and. Asacol dosage: N/A.
Associated medications used:
  • Prednisolone
  • Prednisolone
  • Pentasa
  • Predonema
  • Prednisolone
  • Remicade
  • Remicade
  • Remicade
Patient was hospitalized.

Hypotension, Hepatic Enzyme Increased, Protein Urine Present, Dehydration, Heart Rate Decreased, Nasopharyngitis, Headache, Vomiting In Pregnancy, Dizziness (8246812-8)
Adverse event was reported on Mar 23, 2012 by a Female taking Asacol (Dosage: N/A) was diagnosed with
  • colitis ulcerative
  • contraception
  • vitamin supplementation
and. Location: UNITED STATES , weighting 191.2 lb, Patient felt the following Asacol side effects: hypotension, hepatic enzyme increased, protein urine present, dehydration, heart rate decreased, nasopharyngitis, headache, vomiting in pregnancy, dizziness.
Multiple prescriptions taken:
  • Lovenox
  • Multi-vitamins
Patient was hospitalized.

Cerebral Haemorrhage, Sepsis, Hepatosplenic T-cell Lymphoma, Respiratory Failure, Neuropathy Peripheral (8231069-4)
on Mar 13, 2012 Male from UNITED STATES , 24 years of age, weighting 151.5 lb, was treated with Asacol. After Asacol was administered, patient encountered several Asacol side effects: cerebral haemorrhage, sepsis, hepatosplenic t-cell lymphoma, respiratory failure, neuropathy peripheral. Asacol dosage: N/A.
Multiple concurrent drugs taken:
  • Mercaptopurine
  • Prednisone Tab
  • Remicade


Benign Breast Neoplasm (8231050-5)
on Mar 12, 2012 Female from CANADA , weighting 207.2 lb, was treated with Asacol. Directly after, patient experienced the unwanted or unexpected Asacol side effects: benign breast neoplasm. Asacol dosage: N/A.
Associated medications used:
  • Multi-vitamins
  • Aspirin


Systemic Lupus Erythematosus (8229269-2)
Patient was taking Asacol. Patient felt the following Asacol side effects: systemic lupus erythematosus on Mar 16, 2012 from UNITED STATES Additional patient health information: Female , 42 years of age, was diagnosed with
  • crohn's disease
  • stress
  • carcinoid syndrome
and. Asacol dosage: N/A.
Multiple prescriptions taken:
  • Wellbutrin
  • Sandostatin
  • Wellbutrin
  • Humira
  • Wellbutrin


Amniotic Fluid Volume Decreased, Haemorrhage In Pregnancy, Obstructed Labour, Caesarean Section, Incorrect Dose Administered (8222511-3)
Adverse event was reported on Mar 11, 2012 by a Female taking Asacol (Dosage: N/A) was diagnosed with
  • crohn's disease
  • pregnancy
and. Location: UNITED STATES , weighting 179.2 lb, After Asacol was administered, patient encountered several Asacol side effects: amniotic fluid volume decreased, haemorrhage in pregnancy, obstructed labour, caesarean section, incorrect dose administered.
Multiple concurrent drugs taken:
  • Multi-vitamins
  • Humira


Deep Vein Thrombosis, Pulmonary Embolism, Injury, Anxiety, Pain, Emotional Distress (8219128-3)
on Mar 13, 2012 Female from UNITED STATES , 35 years of age, weighting 175.0 lb, was diagnosed with
  • colitis ulcerative
and was treated with Asacol. Directly after, patient experienced the unwanted or unexpected Asacol side effects: deep vein thrombosis, pulmonary embolism, injury, anxiety, pain, emotional distress. Asacol dosage: 400 Mg, Unk.
Associated medications used:
  • Prednisone (40 Mg, Qd)
  • Yaz (Unk)
  • Yaz
  • Flagyl
Patient was hospitalized.

Paraesthesia, Pain In Extremity, Demyelination, Neuropathy Peripheral (8216894-8)
on Mar 13, 2012 Female from UNITED KINGDOM , 49 years of age, weighting 132.3 lb, was diagnosed with
  • crohn's disease
and was treated with Asacol. Patient felt the following Asacol side effects: paraesthesia, pain in extremity, demyelination, neuropathy peripheral. Asacol dosage: N/A.
Multiple prescriptions taken:
  • Loperamide
  • Azathioprine
  • Ferrous Sulfate Tab
  • Calcichew D3 Forte
  • Humira


Insomnia, Feeling Hot, Feeling Jittery, Syncope, Dyspnoea, Feeling Abnormal, Anxiety, Nervousness, Dizziness (8214842-8)
Patient was taking Asacol. After Asacol was administered, patient encountered several Asacol side effects: insomnia, feeling hot, feeling jittery, syncope, dyspnoea, feeling abnormal, anxiety, nervousness, dizziness on Mar 08, 2012 from UNITED STATES Additional patient health information: Male , weighting 155.0 lb, was diagnosed with
  • colitis ulcerative
  • pain
and. Asacol dosage: N/A.
Multiple concurrent drugs taken:
  • Nucynta Er (Once A Day)
  • Nucynta Er (2-3 Times As Necessary)
  • Nucynta Er


Fatigue, Mental Impairment, Vision Blurred, Lethargy, Balance Disorder (8186888-X)
Adverse event was reported on Oct 14, 2011 by a Female taking Asacol (measalazine) (Dosage: N/A) . Location: UNITED STATES , 69 years of age, Directly after, patient experienced the unwanted or unexpected Asacol side effects: fatigue, mental impairment, vision blurred, lethargy, balance disorder.
Associated medications used:
  • Synthroid (levothyroxine Sodium) (levothyroxine Sodium)
  • Claritin-d (loratadine, Pseudoephedrine) (loratadine, Pseudoephedrine)
  • Savella (12.5;25;50; Mg Bid (12.5;25;50 Mg, 2 In 1 D), Oral)
  • Savella (12.5;25;50; Mg Bid (12.5;25;50 Mg, 2 In 1 D), Oral)
  • Savella (12.5;25;50; Mg Bid (12.5;25;50 Mg, 2 In 1 D), Oral)
  • Savella (12.5;25;50; Mg Bid (12.5;25;50 Mg, 2 In 1 D), Oral)
  • Savella (12.5;25;50; Mg Bid (12.5;25;50 Mg, 2 In 1 D), Oral)
  • Hydrochlorothiazide


Cardiac Failure Congestive, Brain Natriuretic Peptide Increased, Cardiac Arrest, Myalgia, Peripancreatic Fluid Collection, Myocardial Infarction, Sinusitis, Arrhythmia, Allergic Myocarditis (8169949-0)
on Feb 28, 2012 Male from UNITED STATES , weighting 170.0 lb, was diagnosed with
  • colitis ulcerative
and was treated with Asacol. Patient felt the following Asacol side effects: cardiac failure congestive, brain natriuretic peptide increased, cardiac arrest, myalgia, peripancreatic fluid collection, myocardial infarction, sinusitis, arrhythmia, allergic myocarditis. Asacol dosage: 800 Mg.

Lip Swelling, Tinnitus, Dysphonia, Urticaria, Upper Airway Obstruction, Eye Discharge, Swelling Face, Ocular Hyperaemia (8165235-3)
on Jan 06, 2012 Female from CANADA , 59 years of age, was treated with Asacol. After Asacol was administered, patient encountered several Asacol side effects: lip swelling, tinnitus, dysphonia, urticaria, upper airway obstruction, eye discharge, swelling face, ocular hyperaemia. Asacol dosage: N/A.
Multiple concurrent drugs taken:
  • Softsoap Body Wash Shea Butter ((1.5 Fluid Ounces/once/ Topical))


Chronic Obstructive Pulmonary Disease (8158416-6)
Patient was taking Asacol. Directly after, patient experienced the unwanted or unexpected Asacol side effects: chronic obstructive pulmonary disease on Feb 13, 2012 from CANADA Additional patient health information: Female , weighting 260.1 lb, . Asacol dosage: N/A.
Associated medications used:
  • Imuran
  • Celexa
  • Remicade
  • Tylenol W/ Codeine No. 3
Patient was hospitalized.

Foetal Exposure During Pregnancy, Premature Baby (8153121-4)
Adverse event was reported on Feb 09, 2012 by a Female taking Asacol (Dosage: N/A) . Location: UNITED STATES , weighting 3.48 lb, Patient felt the following Asacol side effects: foetal exposure during pregnancy, premature baby.
Multiple prescriptions taken:
  • Prednisone (Daily Dose: 10 Mg)
  • Keflex (500 Mg)
  • Acyclovir
  • Augmentin '125'
  • Iv Steroids
  • Multi-vitamins


Syncope, Infusion Related Reaction, Headache, Dizziness (8152797-5)
on Nov 01, 2011 Female from CANADA , weighting 156.5 lb, was treated with Asacol. After Asacol was administered, patient encountered several Asacol side effects: syncope, infusion related reaction, headache, dizziness. Asacol dosage: N/A.
Multiple concurrent drugs taken:
  • Remicade
  • Imuran
  • Prednisone
  • Hydrocortisone


Aortic Aneurysm (8144514-X)
on Feb 02, 2012 Female from UNITED STATES , 37 years of age, was diagnosed with
  • colitis ulcerative
and was treated with Asacol. Directly after, patient experienced the unwanted or unexpected Asacol side effects: aortic aneurysm. Asacol dosage: Oral.

Showing 1-25 of 471 

Asacol Health Episodes

How Can Asacol Affect You?

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Most drugs have a large list of nonsevere or mild adverse effects which do not rule out continued usage. These effects depend on individual sensitivity, and can include nausea, dizziness, diarrhea, malaise, vomiting, headache, dermatitis, dry mouth, etc. Check commonly reported side effects . These can be considered a form of pseudo-allergic reaction, as not all users experience these effects; many users experience none at all.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

Asacol Information

Alternative ASACOL Names:MESALAMIN

Active Ingredient: MESALAMIN

Asacol Dosage, Warnings, Usage.

Side Effects reported to FDA: 471. View Asacol Adverse Reports

Asacol safety alerts: No

Reported deaths: 12

Reported hospitalizations: 208

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