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Asacol Side Effects

Report Asacol Side Effects

If you experienced any harmful or unwanted effects of Asacol, please share your experience. This could help to raise awareness about Asacol side effects, identify uknown risks and inform health professionals and patients taking Asacol.

Examples: headache, dizziness


The most commonly reported Asacol side effects are:
I Woke Up (14 reports)
My Enti (9 reports)
Diarrhea (7 reports)
Some Stomach Cramps (4 reports)
Fever (3 reports)
Fever, Some Stomach Cramps, Diarrhea (3 reports)
Bloody Diarrhea (2 reports)
Hair Loss (2 reports)
Joint Pain (2 reports)

If you have experienced a side effect listed above, you can check a box to report it.


To view a complete list of submitted side effects, please follow the link Asacol side effects . You can also compare Asacol side effects or view FDA reports.

Asacol Side Effects reported to FDA

The following Asacol reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
The FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.


The appearance of Asacol on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has identified a causal relationship between the drug and the listed risk.

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Nephrotic Syndrome, Hypercholesterolaemia, Glomerulonephritis Minimal Lesion, Hypoproteinaemia, Hypoalbuminaemia
on Mar 14, 2013 Male from US , 50 years of age, was diagnosed with and was treated with Asacol. Directly after, patient experienced the unwanted or unexpected Asacol side effects: nephrotic syndrome, hypercholesterolaemia, glomerulonephritis minimal lesion, hypoproteinaemia, hypoalbuminaemia. Asacol dosage: N/A.

Hypoaesthesia, Pain In Extremity, Vasodilatation, Local Swelling
Patient was taking Asacol. Patient felt the following Asacol side effects: hypoaesthesia, pain in extremity, vasodilatation, local swelling on Mar 18, 2013 from US Additional patient health information: Female , 53 years of age, weighting 142.0 lb, was diagnosed with and. Asacol dosage: N/A.

Vomiting, Abdominal Pain Upper, Diarrhoea, Lethargy, Dehydration
Adverse event was reported on Apr 04, 2013 by a Male taking Asacol (Dosage: 1200 Mg Three Times Daily, Oral) was diagnosed with and. Location: US , 19 years of age, weighting 142.0 lb, After Asacol was administered, patient encountered several Asacol side effects: vomiting, abdominal pain upper, diarrhoea, lethargy, dehydration.
Multiple concurrent drugs taken: Patient was hospitalized.

Suicidal Ideation, Tinnitus
on Mar 01, 2013 Female from GB , 51 years of age, weighting 186.3 lb, was diagnosed with and was treated with Asacol. Directly after, patient experienced the unwanted or unexpected Asacol side effects: suicidal ideation, tinnitus. Asacol dosage: N/A.


Clostridium Difficile Infection, Diarrhoea, Abdominal Pain Upper, Economic Problem
on Jan 24, 2013 Male from US , 78 years of age, was treated with Asacol. Patient felt the following Asacol side effects: clostridium difficile infection, diarrhoea, abdominal pain upper, economic problem. Asacol dosage: N/A.
Multiple prescriptions taken: Patient was hospitalized.

Dehydration, Oedema, Skin Ulcer, Diarrhoea, Constipation, Blister, Defaecation Urgency, Abdominal Pain
Patient was taking Asacol Hd. After Asacol was administered, patient encountered several Asacol side effects: dehydration, oedema, skin ulcer, diarrhoea, constipation, blister, defaecation urgency, abdominal pain on Feb 12, 2013 from US Additional patient health information: Male , 80 years of age, was diagnosed with and. Asacol Hd dosage: (three 800 Mg Tablets (2400 Mg) Twice Daily.
Multiple concurrent drugs taken:
  • Rowasa (mesalazine)
  • Canasa (mesalazine)
  • Lac-hydrin (ammonium Lactate)
  • Vitamin D3 (colecalciferol)
  • Proctofoam Hc (hydrocortisone Acetate, Pramocaine Hydrochloride)
  • Bisacodyl (bisacodyl)
  • Colace (docusate Sodium)
  • Msm (methylsulfonylmethane)
Patient was hospitalized.

Musculoskeletal Stiffness, Pyrexia, Tremor, Chills, Constipation, Oropharyngeal Pain, Abdominal Pain Upper, Nausea, Diarrhoea
Adverse event was reported on Dec 31, 2012 by a Female taking Asacol Hd (Dosage: 1600 Mg In A.m. And 1600 Mg In P.m.) was diagnosed with and. Location: US , 69 years of age, Directly after, patient experienced the unwanted or unexpected Asacol side effects: musculoskeletal stiffness, pyrexia, tremor, chills, constipation, oropharyngeal pain, abdominal pain upper, nausea, diarrhoea.
Associated medications used:
  • Omeprazole (omeprazole0
  • Simvastatin (simvastatin)
  • Diovan (valsartan)
  • Lovaza (omega-3 Marine Triglycerides)
  • Calcium (calcium)
  • Aspirin (acetylsalicylic Acid)
Patient was hospitalized.

Dysphagia
on Nov 21, 2012 Male from GB , 65 years of age, was treated with Asacol Hd (mesalazine) Modified-release Tablet, 800mg. Patient felt the following Asacol side effects: dysphagia. Asacol Hd (mesalazine) Modified-release Tablet, 800mg dosage: N/A. Patient was hospitalized.

Hepatic Lesion, Hepatic Steatosis, Hepatic Enzyme Increased, Blood Creatinine Increased
on Nov 14, 2012 Male from US , 62 years of age, was diagnosed with and was treated with Asacol. After Asacol was administered, patient encountered several Asacol side effects: hepatic lesion, hepatic steatosis, hepatic enzyme increased, blood creatinine increased. Asacol dosage: Two 400 Mg Tablets Three Times Daily, Oral.
Multiple concurrent drugs taken:

Hepatic Lesion, Hepatic Steatosis, Hepatic Enzyme Increased, Blood Creatinine Increased
Patient was taking Asacol. Directly after, patient experienced the unwanted or unexpected Asacol side effects: hepatic lesion, hepatic steatosis, hepatic enzyme increased, blood creatinine increased on Oct 03, 2013 from US Additional patient health information: Male , 62 years of age, weighting 177.9 lb, was diagnosed with and. Asacol dosage: Two 400 Mg Tablets Three Times Daily, Oral.
Associated medications used:

Renal Failure Chronic, Tubulointerstitial Nephritis
Adverse event was reported on Dec 27, 2012 by a Male taking Asacol (Dosage: N/A) was diagnosed with and. Location: CA , 45 years of age, weighting 180.8 lb, Patient felt the following Asacol side effects: renal failure chronic, tubulointerstitial nephritis.
Multiple prescriptions taken:

Pneumothorax, Chest Pain, Dyspnoea
on Oct 15, 2012 Male from US , 20 years of age, weighting 140.0 lb, was diagnosed with and was treated with Asacol Hd. After Asacol was administered, patient encountered several Asacol side effects: pneumothorax, chest pain, dyspnoea. Asacol Hd dosage: N/A. Patient was hospitalized.

Pericardial Effusion, Pericarditis, Viral Infection
on Sep 04, 2012 Male from US , 61 years of age, was diagnosed with and was treated with Asacol. Directly after, patient experienced the unwanted or unexpected Asacol side effects: pericardial effusion, pericarditis, viral infection. Asacol dosage: N/A. Patient was hospitalized.

Loss Of Consciousness, Malaise, Diarrhoea, Abdominal Pain, Vomiting, Cold Sweat, Dizziness, Blood Pressure Increased
Patient was taking Asacol. Patient felt the following Asacol side effects: loss of consciousness, malaise, diarrhoea, abdominal pain, vomiting, cold sweat, dizziness, blood pressure increased on Aug 31, 2012 from US Additional patient health information: Male , 78 years of age, was diagnosed with and. Asacol dosage: N/A.
Multiple prescriptions taken: Patient was hospitalized.

Lung Neoplasm Malignant
Adverse event was reported on Aug 31, 2012 by a Male taking Asacol (Dosage: N/A) was diagnosed with and. Location: GB , 75 years of age, After Asacol was administered, patient encountered several Asacol side effects: lung neoplasm malignant.

Atrial Fibrillation, Pericarditis, Diarrhoea, Cardiac Output Decreased, Dehydration, Hypovolaemia, Cardiac Disorder, Vomiting, Pyrexia
on Oct 19, 2012 Male from US , 60 years of age, weighting 147.0 lb, was diagnosed with and was treated with Asacol Hd. Directly after, patient experienced the unwanted or unexpected Asacol side effects: atrial fibrillation, pericarditis, diarrhoea, cardiac output decreased, dehydration, hypovolaemia, cardiac disorder, vomiting, pyrexia. Asacol Hd dosage: N/A.
Associated medications used: Patient was hospitalized.

Off Label Use, Unevaluable Event
on Aug 14, 2012 Male from GB , child 7 years of age, weighting 44.09 lb, was diagnosed with and was treated with Asacol. Patient felt the following Asacol side effects: off label use, unevaluable event. Asacol dosage: , Oral.
Multiple prescriptions taken:
  • Prednisolone
  • Valganciclovir Hydrochloride
  • Ursodiol
  • Tacrolimus
  • Omeprazole
  • Nystatin
  • Acetaminophen
  • Piperacillin Sodium\tazobactam Sodium
Patient was hospitalized.

Hydronephrosis, Glomerulonephritis Chronic, Haemoglobin Decreased, Blood Creatinine Increased, Renal Impairment, Haemodialysis
Patient was taking Asacol. After Asacol was administered, patient encountered several Asacol side effects: hydronephrosis, glomerulonephritis chronic, haemoglobin decreased, blood creatinine increased, renal impairment, haemodialysis on Feb 04, 2013 from DK Additional patient health information: Male , 22 years of age, . Asacol dosage: Oral.
Multiple concurrent drugs taken:
  • Pentasa (Oral)
  • Oxcarbazepine
  • Cortisone (coritsone)
Patient was hospitalized.

Dyspnoea, Visual Impairment, Mental Disorder, Weight Decreased, Adverse Event
Adverse event was reported on Jun 21, 2012 by a Male taking Asacol (Dosage: N/A) . Location: NETHERLANDS , 28 years of age, Directly after, patient experienced the unwanted or unexpected Asacol side effects: dyspnoea, visual impairment, mental disorder, weight decreased, adverse event.
Associated medications used:

Thrombocytopenia, Malaise
on Dec 08, 2011 Male from UNITED STATES , 61 years of age, was treated with Asacol. Patient felt the following Asacol side effects: thrombocytopenia, malaise. Asacol dosage: N/A.
Multiple prescriptions taken:

Thermal Burn, Oral Fungal Infection, Abdominal Discomfort
on Dec 12, 2011 Male from UNITED STATES , 71 years of age, weighting 210.0 lb, was treated with Asacol. After Asacol was administered, patient encountered several Asacol side effects: thermal burn, oral fungal infection, abdominal discomfort. Asacol dosage: ^long Time^.
Multiple concurrent drugs taken:

Proctitis, Colonic Polyp, Gastrointestinal Inflammation, Ileitis, Gastrointestinal Erosion, Excessive Granulation Tissue, Sigmoiditis, Colitis
Patient was taking Asacol. Directly after, patient experienced the unwanted or unexpected Asacol side effects: proctitis, colonic polyp, gastrointestinal inflammation, ileitis, gastrointestinal erosion, excessive granulation tissue, sigmoiditis, colitis on Jun 18, 2012 from UNITED STATES Additional patient health information: Female , weighting 135.1 lb, was diagnosed with and. Asacol dosage: N/A.
Associated medications used: Patient was hospitalized.

Deep Vein Thrombosis
Adverse event was reported on Jun 18, 2012 by a Female taking Asacol (Dosage: N/A) . Location: UNITED STATES , 30 years of age, weighting 157.0 lb, Patient felt the following Asacol side effects: deep vein thrombosis.
Multiple prescriptions taken:
  • Flagyl (500 Mg, Bid)
  • Anucort-hc (25 Mg, Tid)
  • Ibuprofen
  • Prednisone
  • Iron Sulfatethiamin Compound Tab
Patient was hospitalized.

Cardiac Disorder, Respiratory Arrest, Crohn's Disease, Diverticulitis, Painful Defaecation, Dyspnoea
on Jun 18, 2012 Male from UNITED STATES , weighting 145.1 lb, was diagnosed with and was treated with Asacol. After Asacol was administered, patient encountered several Asacol side effects: cardiac disorder, respiratory arrest, crohn's disease, diverticulitis, painful defaecation, dyspnoea. Asacol dosage: N/A.
Multiple concurrent drugs taken:
  • Multi-vitamin
  • Humira ((160 Mg, Loading Dose))
  • Mercaptopurine
  • Nexium (For Years)
  • Lipitor
  • Vitamin D
  • Prednisone Tab
  • Humira ((80 Mg, Second Loading Dose))


Gingival Bleeding, Stomatitis, Asthenia, Toothache, Influenza, Gingival Pain, Colitis Ulcerative
on Apr 16, 2012 Female from UNITED STATES , 84 years of age, was treated with Asacol. Directly after, patient experienced the unwanted or unexpected Asacol side effects: gingival bleeding, stomatitis, asthenia, toothache, influenza, gingival pain, colitis ulcerative. Asacol dosage: 1 Df, Qd.
Associated medications used:
  • Aciphex
  • Multi-vitamins
  • Vitamin D
  • Prolia (Unk Unk, Q6mo)
  • Citrical D


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Record and Track Your Side Effects

It is very important to keep track of all side effects and discuss them with your doctor. If you think you may have a medical emergency, call your doctor or 911 immediately.

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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.

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Before Taking Asacol

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Discuss Asacol Side Effects

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