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Asacol Side Effects

Common Asacol Side Effects

The most commonly reported Asacol side effects (click to view or check a box to report):

Diarrhoea (42)
Colitis Ulcerative (32)
Abdominal Pain (27)
Arthralgia (26)
Injection Site Pain (25)
Fatigue (25)
Crohn's Disease (24)
Condition Aggravated (24)
Pyrexia (23)
Nausea (17)
Dyspnoea (17)
Dizziness (16)
Malaise (16)
Headache (15)
Dehydration (14)
Asthenia (14)
Pain (14)
Vomiting (14)
Rash (13)
Chest Pain (12)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

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).
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 found a causal relationship between the drug and the listed risk.
Oropharyngeal Pain, Dysphagia, Speech Disorder, Unevaluable Event
on Feb 10, 2014 Female from US , 67 years of age, weighting 120.0 lb, was diagnosed with and was treated with Asacol. Directly after, patient experienced the unwanted or unexpected Asacol side effects: oropharyngeal pain, dysphagia, speech disorder, unevaluable event. Asacol dosage: Taken By Mouth.

Peritonitis Bacterial, Intestinal Perforation, Abdominal Pain, Klebsiella Infection
Patient was taking Asacol (mesalazine) Modified-release Tablet, 400 Mg. Patient felt the following Asacol side effects: peritonitis bacterial, intestinal perforation, abdominal pain, klebsiella infection on Feb 03, 2014 from US Additional patient health information: Female , 85 years of age, was diagnosed with and. Asacol (mesalazine) Modified-release Tablet, 400 Mg dosage: N/A.
Multiple prescriptions taken:
  • Tirosint
  • Verapamil
  • Exforge
  • Coreg
  • Klonopin
Patient was hospitalized.

Hemiparesis, Monoparesis, Cough, Asthenia, Vision Blurred, Visual Impairment, Weight Decreased, Decreased Appetite, Transient Ischaemic Attack
Adverse event was reported on Dec 11, 2013 by a Female taking Asacol Hd (Dosage: N/A) was diagnosed with and. Location: US , 90 years of age, After Asacol was administered, patient encountered several Asacol side effects: hemiparesis, monoparesis, cough, asthenia, vision blurred, visual impairment, weight decreased, decreased appetite, transient ischaemic attack.
Multiple concurrent drugs taken:
  • Vitamins Nos ( Vitamins Nos)
  • Mineral Supplements
Patient was hospitalized.

Glomerulonephritis, Blood Creatinine Increased
on Dec 04, 2013 Male from CA , 70 years of age, weighting 179.0 lb, was diagnosed with and was treated with Asacol. Directly after, patient experienced the unwanted or unexpected Asacol side effects: glomerulonephritis, blood creatinine increased. Asacol dosage: N/A.
Associated medications used:
  • Warfarin (warfarin)
  • Synthroid (levothyroxine Sodium)
  • Folic Acid (folic Acid)
  • Vitamin B Complex (vitamin B Complex)
  • Euro-fer (ferrous Fumarate)
  • Toloxin /00017701/ (digoxin)
  • Crestor (rosuvastatin Calcium)
  • Bisoprolol (bisoprolol)
Patient was hospitalized.


Haematochezia, Product Quality Issue, Clostridium Difficile Infection
on Sep 24, 2013 Female from US , 58 years of age, weighting 123.0 lb, was diagnosed with and was treated with Asacol Hd. Patient felt the following Asacol side effects: haematochezia, product quality issue, clostridium difficile infection. Asacol Hd dosage: 2 Tabs, Three Times Daily, Taken By Mouth.

Pneumonia Viral, Epstein-barr Virus Infection
Patient was taking Asacol Hd. After Asacol was administered, patient encountered several Asacol side effects: pneumonia viral, epstein-barr virus infection on Oct 03, 2013 from US Additional patient health information: Male , 31 years of age, was diagnosed with and. Asacol Hd dosage: N/A. Patient was hospitalized.

Sepsis, Colitis Ulcerative, Nausea, Diarrhoea, Decreased Appetite, Weight Decreased, Abdominal Pain Upper, Pyrexia
Adverse event was reported on Oct 18, 2013 by a Female taking Asacol (Dosage: N/A) was diagnosed with and. Location: US , 66 years of age, weighting 162.0 lb, Directly after, patient experienced the unwanted or unexpected Asacol side effects: sepsis, colitis ulcerative, nausea, diarrhoea, decreased appetite, weight decreased, abdominal pain upper, pyrexia.
Associated medications used:
  • Delzicol
  • Asacol Hd
  • Tri-chlor (trichloroacetic Acid)
  • Crestor
  • Vitamin D/00318501/ (colecalciferol)
  • Inderal (propranolol Hydrochloride)
  • Synthroid (levothyroxine Sodium)
  • Prilosec/00661201/ (omeprazole)
Patient was hospitalized.

White Blood Cell Count Increased, Neutrophil Count Increased, Abdominal Pain Lower, Fatigue, Diarrhoea Haemorrhagic, Colitis Ulcerative
on Sep 06, 2013 Female from US , 57 years of age, weighting 154.3 lb, was diagnosed with and was treated with Asacol. Patient felt the following Asacol side effects: white blood cell count increased, neutrophil count increased, abdominal pain lower, fatigue, diarrhoea haemorrhagic, colitis ulcerative. Asacol dosage: Asacol Hd Dr 800mg One 3 Times A Da Oral.
Multiple prescriptions taken:
  • Lisinopril
  • Fluoxetine
  • Allegra
  • Simvastin
  • Calcium With Vitamin D
  • Ester C
  • Ubiquinol
  • Krill Oil


Nightmare
on Aug 21, 2013 Female from GB , 80 years of age, weighting 170.2 lb, was treated with Asacol. After Asacol was administered, patient encountered several Asacol side effects: nightmare. Asacol dosage: N/A.
Multiple concurrent drugs taken:
  • Adcal /00751519/ (calcium Carbonate)
  • Adcal D3 (calcium Carbonate, Colecalciferol)
  • Amoxicillin (amoxicillin)
  • Bendroflumethiazide (bendroflumethiazide)
  • Losartan (losartan)
  • Mesalazine (mesalazine)
  • Paracetamol (paracetamol)
  • Prednisolone Sodium Phosphate (prednisolone Sodium Phosphate)


Skin Discolouration, Poor Peripheral Circulation, Burning Sensation, Pain In Extremity, Insomnia, Discomfort, Hypoaesthesia
Patient was taking Asacol. Directly after, patient experienced the unwanted or unexpected Asacol side effects: skin discolouration, poor peripheral circulation, burning sensation, pain in extremity, insomnia, discomfort, hypoaesthesia on Aug 15, 2013 from US Additional patient health information: Female , 56 years of age, weighting 127.0 lb, was diagnosed with and. Asacol dosage: N/A.
Associated medications used:
  • Sulfasalazine


Intestinal Perforation, Diverticulitis, Abdominal Distension
Adverse event was reported on Aug 09, 2013 by a Male taking Asacol (mesalazine) Modified-release Tablet, 400 Mg (Dosage: N/A) was diagnosed with and. Location: US , 43 years of age, Patient felt the following Asacol side effects: intestinal perforation, diverticulitis, abdominal distension.
Multiple prescriptions taken:
  • Delzicol
  • Dicyclomine (dicycloverine)
Patient was hospitalized.

Haemorrhage
on Jul 30, 2013 Male from US , 74 years of age, weighting 198.0 lb, was diagnosed with and was treated with Asacol. After Asacol was administered, patient encountered several Asacol side effects: haemorrhage. Asacol dosage: 800mg Once Daily Po.
Multiple concurrent drugs taken:
  • Warfarin (4mg 1 Tablet Daily Po)


Intestinal Obstruction, Abdominal Pain, Foreign Body
on Jul 17, 2013 Female from IT , 47 years of age, was diagnosed with and was treated with Asacol. Directly after, patient experienced the unwanted or unexpected Asacol side effects: intestinal obstruction, abdominal pain, foreign body. Asacol dosage: N/A. Patient was hospitalized.

Gallbladder Disorder, Pain, Weight Decreased
Patient was taking Asacol. Patient felt the following Asacol side effects: gallbladder disorder, pain, weight decreased on Apr 24, 2013 from US Additional patient health information: Female , 22 years of age, . Asacol dosage: N/A.

Flatulence, Abdominal Distension, Abdominal Pain, Abnormal Faeces, Frequent Bowel Movements, Defaecation Urgency, Mucous Stools, Pollakiuria, Dysuria
Adverse event was reported on Jul 12, 2013 by a Male taking Asacol (Dosage: N/A) was diagnosed with and. Location: US , 38 years of age, After Asacol was administered, patient encountered several Asacol side effects: flatulence, abdominal distension, abdominal pain, abnormal faeces, frequent bowel movements, defaecation urgency, mucous stools, pollakiuria, dysuria.
Multiple concurrent drugs taken:
  • Zolpidem
  • Finasteride
  • Diphenhydramine


Atrial Fibrillation, Nasal Discomfort, Throat Irritation, Epistaxis, Swollen Tongue, Nasal Dryness, Lip Swelling, Eye Irritation
on Jun 12, 2013 Female from US , 69 years of age, was diagnosed with and was treated with Asacol. Directly after, patient experienced the unwanted or unexpected Asacol side effects: atrial fibrillation, nasal discomfort, throat irritation, epistaxis, swollen tongue, nasal dryness, lip swelling, eye irritation. Asacol dosage: N/A.
Associated medications used:
  • Delzicol


Muscle Spasms, Rectal Haemorrhage, Diarrhoea, Pyrexia, White Blood Cell Count Increased
on May 30, 2013 Male from US , 23 years of age, weighting 170.0 lb, was diagnosed with and was treated with Asacol Hd. Patient felt the following Asacol side effects: muscle spasms, rectal haemorrhage, diarrhoea, pyrexia, white blood cell count increased. Asacol Hd dosage: 2 Tab.

Large Intestine Perforation, Post Procedural Complication, Blister
Patient was taking Asacol (mesalazine) Modified-release Tablet, 400 Mg. After Asacol was administered, patient encountered several Asacol side effects: large intestine perforation, post procedural complication, blister on May 22, 2013 from US Additional patient health information: Female , 80 years of age, was diagnosed with and. Asacol (mesalazine) Modified-release Tablet, 400 Mg dosage: Three Tablets Twice Daily.
Multiple concurrent drugs taken:
  • Loperamide (loperamide)
Patient was hospitalized.

Kidney Infection, Clostridium Difficile Colitis, Nephrolithiasis, Vomiting, Hyponatraemia, Hypokalaemia, Pyrexia, Diarrhoea
Adverse event was reported on May 20, 2013 by a Female taking Asacol (Dosage: N/A) was diagnosed with and. Location: US , 69 years of age, Directly after, patient experienced the unwanted or unexpected Asacol side effects: kidney infection, clostridium difficile colitis, nephrolithiasis, vomiting, hyponatraemia, hypokalaemia, pyrexia, diarrhoea.
Associated medications used:
  • Tiazac /00489702/ (diltiazem Hydrochloride)
  • Lotensin?/00909102/ (benazepril Hydrochloride)
  • Hydrochlorothiazide (hydrochlorothiazide)
  • Toprol (metoprolol Succinate)
  • Evista (raloxifene Hydrochloride)
Patient was hospitalized.

Thyroid Cancer
on May 03, 2013 Male from US , 39 years of age, was diagnosed with and was treated with Asacol. Patient felt the following Asacol side effects: thyroid cancer. Asacol dosage: 6-8 400 Mg Daily.
Multiple prescriptions taken:
  • Amlodipine (amlodipine)
Patient was hospitalized.

Atrial Fibrillation
on May 07, 2013 Female from US , 67 years of age, was diagnosed with and was treated with Asacol. After Asacol was administered, patient encountered several Asacol side effects: atrial fibrillation. Asacol dosage: N/A.
Multiple concurrent drugs taken:
  • Aleve (One Dose Only)
  • Benicar
  • Hydrochlorothiazide
Patient was hospitalized.

Thyroid Cancer, Product Formulation Issue
Patient was taking Asacol. Directly after, patient experienced the unwanted or unexpected Asacol side effects: thyroid cancer, product formulation issue on May 06, 2013 from US Additional patient health information: Male , 39 years of age, weighting 192.0 lb, was diagnosed with and. Asacol dosage: 2 Pills Twice A Day. Patient was hospitalized and became disabled.

Thyroid Cancer
Adverse event was reported on Apr 30, 2013 by a Male taking Asacol (Dosage: 2 Pills) was diagnosed with and. Location: US , 39 years of age, weighting 192.0 lb, Patient felt the following Asacol side effects: thyroid cancer. Patient was hospitalized and became disabled.

Urticaria, Rash, Pruritus, Hepatic Enzyme Abnormal
on Apr 19, 2013 Female from US , 53 years of age, weighting 210.0 lb, was diagnosed with and was treated with Asacol. After Asacol was administered, patient encountered several Asacol side effects: urticaria, rash, pruritus, hepatic enzyme abnormal. Asacol dosage: 2 Tablets, Tid, Po.

Blood Alkaline Phosphatase Increased, Aspartate Aminotransferase Increased, Alanine Aminotransferase Increased
on Apr 08, 2013 Male from US , 22 years of age, weighting 178.0 lb, was diagnosed with and was treated with Asacol Hd. Directly after, patient experienced the unwanted or unexpected Asacol side effects: blood alkaline phosphatase increased, aspartate aminotransferase increased, alanine aminotransferase increased. Asacol Hd dosage: N/A.

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Keep Track of Side Effects

Note Your Observations

It is really important to keep of your symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:

     

    Side Effects

    Scale

    Date & Time

    Other Medicine(s) or Treatment(s)

     

     

     

     

    Scale: 1 = very mild to 10 = very bad


    Track Online

  • User Sign In
  • Register to track your side effects

  • 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.

    Discuss Asacol Side Effects

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