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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
This is a report of a 67-year-old female patient (weight: NA) from US, suffering from the following symptoms/conditions: crohn^s disease,colitis ulcerative, who was treated with Asacol (dosage: Taken By Mouth, start time: Nov 30, 2013), combined with: NA. and developed a serious reaction and side effect(s). The consumer presented with:
  • Oropharyngeal Pain
  • Dysphagia
  • Speech Disorder
  • Unevaluable Event
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Asacol treatment in female patients, resulting in oropharyngeal pain side effect.

Peritonitis Bacterial, Intestinal Perforation, Abdominal Pain, Klebsiella Infection
This report suggests a potential Asacol (mesalazine) Modified-release Tablet, 400 Mg Peritonitis Bacterial, Intestinal Perforation, Abdominal Pain, Klebsiella Infection side effect(s) that can have serious consequences. A 85-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: diarrhoea and used Asacol (mesalazine) Modified-release Tablet, 400 Mg (dosage: NA) starting Mar 12, 2012. Soon after starting Asacol (mesalazine) Modified-release Tablet, 400 Mg the patient began experiencing various side effects, including:
  • Peritonitis Bacterial
  • Intestinal Perforation
  • Abdominal Pain
  • Klebsiella Infection
Drugs used concurrently:
  • Tirosint
  • Verapamil
  • Exforge
  • Coreg
  • Klonopin
The patient was hospitalized. Although Asacol (mesalazine) Modified-release Tablet, 400 Mg demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as peritonitis bacterial, may still occur.

Hemiparesis, Monoparesis, Cough, Asthenia, Vision Blurred, Visual Impairment, Weight Decreased, Decreased Appetite, Transient Ischaemic Attack
This Hemiparesis, Monoparesis, Cough, Asthenia, Vision Blurred, Visual Impairment, Weight Decreased, Decreased Appetite, Transient Ischaemic Attack problem was reported by a consumer or non-health professional from US. A 90-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: colitis ulcerative. On 2013 this consumer started treatment with Asacol Hd (dosage: NA). The following drugs were being taken at the same time:
  • Vitamins Nos ( Vitamins Nos)
  • Mineral Supplements
When commencing Asacol Hd, the patient experienced the following unwanted symptoms/side effects:
  • Hemiparesis
  • Monoparesis
  • Cough
  • Asthenia
  • Vision Blurred
  • Visual Impairment
  • Weight Decreased
  • Decreased Appetite
  • Transient Ischaemic Attack
The patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as hemiparesis, may become evident only after a product is in use by the general population.

Glomerulonephritis, Blood Creatinine Increased
This is a report of a 70-year-old male patient (weight: NA) from CA. The patient developed the following symptoms/conditions: colitis ulcerative and was treated with Asacol (dosage: NA) starting NS. Concurrently used drugs:
  • 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)
Soon after that, the consumer experienced the following side effects:
  • Glomerulonephritis
  • Blood Creatinine Increased
The patient was hospitalized. This opens a possibility that Asacol treatment could cause the above reactions, including glomerulonephritis, and some male subjects may be more susceptible.


Haematochezia, Product Quality Issue, Clostridium Difficile Infection
A 58-year-old female patient (weight: NA) from US with the following symptoms/conditions: colitis started Asacol Hd treatment (dosage: 2 Tabs, Three Times Daily, Taken By Mouth) on Jun 10, 2013. Soon after starting Asacol Hd treatment, the subject experienced various side effects, including:
  • Haematochezia
  • Product Quality Issue
  • Clostridium Difficile Infection
Concurrently used drugs: NA. This finding indicates that some female patients could be more vulnerable to Asacol Hd.

Pneumonia Viral, Epstein-barr Virus Infection
A 31-year-old male patient from US (weight: NA) experienced symptoms, such as: colitis ulcerative and was treated with Asacol Hd(dosage: NA). The treatment was initiated on 2003. After that a consumer reported the following side effect(s):
  • Pneumonia Viral
  • Epstein-barr Virus Infection
Concurrently used drugs, which potentially could have contributed to side effect(s) or affected Asacol Hd efficacy: NA.The patient was hospitalized.

Sepsis, Colitis Ulcerative, Nausea, Diarrhoea, Decreased Appetite, Weight Decreased, Abdominal Pain Upper, Pyrexia
In this report, Asacol was administered for the following condition: colitis ulcerative.A 66-year-old female consumer from US (weight: NA) started Asacol treatment (dosage: NA) on 2011.Sometime after starting the treatment, the patient complained of the following side effect(s):
  • Sepsis
  • Colitis Ulcerative
  • Nausea
  • Diarrhoea
  • Decreased Appetite
  • Weight Decreased
  • Abdominal Pain Upper
  • Pyrexia
A possible interaction with other drugs could have contributed to this reaction:
  • Delzicol
  • Asacol Hd
  • Tri-chlor (trichloroacetic Acid)
  • Crestor
  • Vitamin D/00318501/ (colecalciferol)
  • Inderal (propranolol Hydrochloride)
  • Synthroid (levothyroxine Sodium)
  • Prilosec/00661201/ (omeprazole)
The patient was hospitalized.Establishing a causal relationship between a specific drug and consumer's side effects is complex, but it is possible that in this report Asacol treatment could be related to the listed above side effect(s).

White Blood Cell Count Increased, Neutrophil Count Increased, Abdominal Pain Lower, Fatigue, Diarrhoea Haemorrhagic, Colitis Ulcerative
This is a report of the following Asacol side effect(s):
  • White Blood Cell Count Increased
  • Neutrophil Count Increased
  • Abdominal Pain Lower
  • Fatigue
  • Diarrhoea Haemorrhagic
  • Colitis Ulcerative
A 57-year-old female patient from US (weight: NA) presented with the following condition: colitis ulcerative and received a treatment with Asacol (dosage: Asacol Hd Dr 800mg One 3 Times A Da Oral) starting: Jun 09, 2013.The following concurrently used drugs could have generated interactions:
  • Lisinopril
  • Fluoxetine
  • Allegra
  • Simvastin
  • Calcium With Vitamin D
  • Ester C
  • Ubiquinol
  • Krill Oil
This report suggests that a Asacol treatment could be associated with the listed above side effect(s).

Nightmare
This Asacol report was submitted by a 80-year-old female consumer from GB (weight: NA). The patient was diagnosed with: NA and Asacol was administered (dosage: NA) starting: NS. The consumer developed a set of symptoms:
  • Nightmare
Other drugs used simultaneously:
  • 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)
Those unexpected symptoms could be linked to a Asacol treatment, however establishing a potential drug-safety problem requires a more detailed clinical analysis.

Skin Discolouration, Poor Peripheral Circulation, Burning Sensation, Pain In Extremity, Insomnia, Discomfort, Hypoaesthesia
This is a report of a possible correlation between Asacol use and the following symptoms/side effect(s):
  • Skin Discolouration
  • Poor Peripheral Circulation
  • Burning Sensation
  • Pain In Extremity
  • Insomnia
  • Discomfort
  • Hypoaesthesia
which could contribute to an assessment of Asacol risk profile.A 56-year-old female consumer from US (weight: NA) was suffering from colitis ulcerative and was treated with Asacol (dosage: NA) starting Mar 01, 2013.Other concurrent medications:
  • Sulfasalazine


Intestinal Perforation, Diverticulitis, Abdominal Distension
A 43-year-old male patient from US (weight: NA) presented with the following symptoms: colitis ulcerative and after a treatment with Asacol (mesalazine) Modified-release Tablet, 400 Mg (dosage: NA) experienced the following side effect(s):
  • Intestinal Perforation
  • Diverticulitis
  • Abdominal Distension
The treatment was started on 201307. Asacol (mesalazine) Modified-release Tablet, 400 Mg was used in combination with the following drugs:
  • Delzicol
  • Dicyclomine (dicycloverine)
The patient was hospitalized.This report could alert potential Asacol (mesalazine) Modified-release Tablet, 400 Mg consumers.

Haemorrhage
In this report, a 74-year-old male patient from US (weight: NA) was affected by a possible Asacol side effect.The patient was diagnosed with colitis,atrial fibrillation. After a treatment with Asacol (dosage: 800mg Once Daily Po, start date: Aug 01, 2003), the patient experienced the following side effect(s):
  • Haemorrhage
The following simultaneously used drugs could have led to this reaction:
  • Warfarin (4mg 1 Tablet Daily Po)
The findings here stress that side effects should be taken into consideration when evaluating a Asacol treatment.

Intestinal Obstruction, Abdominal Pain, Foreign Body
This is a report of a 47-year-old female patient from IT (weight: NA), who used Asacol (dosage: NA) for a treatment of colitis ulcerative. After starting a treatment on NS, the patient experienced the following side effect(s):
  • Intestinal Obstruction
  • Abdominal Pain
  • Foreign Body
The following drugs could possibly have interacted with the Asacol treatment NA.The patient was hospitalized.Taken together, these observations suggest that a Asacol treatment could be related to side effect(s), such as Intestinal Obstruction, Abdominal Pain, Foreign Body.

Gallbladder Disorder, Pain, Weight Decreased
This gallbladder disorder side effect was reported by a consumer or non-health professional from US. A 22-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA. The patient was prescribed Asacol (dosage: NA), which was started on NS. Concurrently used drugs: NA. When starting to take Asacol the consumer reported the following symptoms:
  • Gallbladder Disorder
  • Pain
  • Weight Decreased
These side effects may potentially be related to Asacol.

Flatulence, Abdominal Distension, Abdominal Pain, Abnormal Faeces, Frequent Bowel Movements, Defaecation Urgency, Mucous Stools, Pollakiuria, Dysuria
This is a Asacol side effect report of a 38-year-old male patient (weight:NA) from US, suffering from the following symptoms/conditions: colitis ulcerative, who was treated with Asacol (dosage:NA, start time: NS), combined with:
  • Zolpidem
  • Finasteride
  • Diphenhydramine
, and developed a serious reaction and a flatulence side effect. The patient presented with:
  • Flatulence
  • Abdominal Distension
  • Abdominal Pain
  • Abnormal Faeces
  • Frequent Bowel Movements
  • Defaecation Urgency
  • Mucous Stools
  • Pollakiuria
  • Dysuria
which developed after the beginning of treatment. This side effect report can indicate a possible existence of increased vulnerability to Asacol treatment in male patients suffering from colitis ulcerative, resulting in flatulence.

Atrial Fibrillation, Nasal Discomfort, Throat Irritation, Epistaxis, Swollen Tongue, Nasal Dryness, Lip Swelling, Eye Irritation
This report suggests a potential Asacol atrial fibrillation side effect(s) that can have serious consequences. A 69-year-old female patient from US (weight:NA) was diagnosed with the following health condition(s): colitis and used Asacol (dosage: NA) starting 2007. Soon after starting Asacol the patient began experiencing various side effects, including:
  • Atrial Fibrillation
  • Nasal Discomfort
  • Throat Irritation
  • Epistaxis
  • Swollen Tongue
  • Nasal Dryness
  • Lip Swelling
  • Eye Irritation
Drugs used concurrently:
  • Delzicol
Although Asacol demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as atrial fibrillation, may still occur.

Muscle Spasms, Rectal Haemorrhage, Diarrhoea, Pyrexia, White Blood Cell Count Increased
This muscle spasms problem was reported by a consumer or non-health professional from US. A 23-year-old male patient (weight: NA) was diagnosed with the following medical condition(s): colitis ulcerative.On NS a consumer started treatment with Asacol Hd (dosage: 2 Tab). The following drugs/medications were being taken at the same time: NA. When commencing Asacol Hd, the patient experienced the following unwanted symptoms /side effects:
  • Muscle Spasms
  • Rectal Haemorrhage
  • Diarrhoea
  • Pyrexia
  • White Blood Cell Count Increased
Although all drugs are carefully tested before they are licensed for use, they carry potential side effect risks. Some side effects, such as muscle spasms, may become evident only after a product is in use by the general population.

Large Intestine Perforation, Post Procedural Complication, Blister
This is a Asacol (mesalazine) Modified-release Tablet, 400 Mg side effect report of a 80-year-old female patient (weight: NA) from US. The patient developed the following symptoms/conditions: crohn^s disease and was treated with Asacol (mesalazine) Modified-release Tablet, 400 Mg (dosage: Three Tablets Twice Daily) starting 1988. Concurrently used drugs:
  • Loperamide (loperamide)
Soon after that, the consumer experienced the following of symptoms:
  • Large Intestine Perforation
  • Post Procedural Complication
  • Blister
The patient was hospitalized. This opens a possibility that Asacol (mesalazine) Modified-release Tablet, 400 Mg could cause large intestine perforation and that some female patients may be more susceptible.

Kidney Infection, Clostridium Difficile Colitis, Nephrolithiasis, Vomiting, Hyponatraemia, Hypokalaemia, Pyrexia, Diarrhoea
A 69-year-old female patient (weight: NA) from US with the following symptoms: colitis microscopic started Asacol treatment (dosage: NA) on NS. Soon after starting Asacol treatment, the consumer experienced several side effects, including:
  • Kidney Infection
  • Clostridium Difficile Colitis
  • Nephrolithiasis
  • Vomiting
  • Hyponatraemia
  • Hypokalaemia
  • Pyrexia
  • Diarrhoea
. Concurrently used drugs:
  • Tiazac /00489702/ (diltiazem Hydrochloride)
  • Lotensin?/00909102/ (benazepril Hydrochloride)
  • Hydrochlorothiazide (hydrochlorothiazide)
  • Toprol (metoprolol Succinate)
  • Evista (raloxifene Hydrochloride)
The patient was hospitalized. This finding indicates that some patients can be more vulnerable to developing Asacol side effects, such as kidney infection.

Thyroid Cancer
This thyroid cancer side effect was reported by a consumer or non-health professional from US. A 39-year-old male patient (weight:NA) experienced the following symptoms/conditions: colitis ulcerative.The patient was prescribed Asacol (dosage: 6-8 400 Mg Daily), which was started on 1993. Concurrently used drugs:
  • Amlodipine (amlodipine)
.When starting to take Asacol the consumer reported symptoms, such as:
  • Thyroid Cancer
These side effects may potentially be related to Asacol. The patient was hospitalized.

Atrial Fibrillation
This is a report of a 67-year-old female patient (weight: NA) from US, suffering from the following symptoms/conditions: colitis ulcerative, who was treated with Asacol (dosage: NA, start time: 2010), combined with:
  • Aleve (One Dose Only)
  • Benicar
  • Hydrochlorothiazide
and developed a serious reaction and side effect(s). The consumer presented with:
  • Atrial Fibrillation
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Asacol treatment in female patients, resulting in atrial fibrillation side effect. The patient was hospitalized.

Thyroid Cancer, Product Formulation Issue
This report suggests a potential Asacol Thyroid Cancer, Product Formulation Issue side effect(s) that can have serious consequences. A 39-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: colitis and used Asacol (dosage: 2 Pills Twice A Day) starting NS. Soon after starting Asacol the patient began experiencing various side effects, including:
  • Thyroid Cancer
  • Product Formulation Issue
Drugs used concurrently: NA.The patient was hospitalized and became disabled. Although Asacol demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as thyroid cancer, may still occur.

Thyroid Cancer
This Thyroid Cancer problem was reported by a consumer or non-health professional from US. A 39-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: colitis. On NS this consumer started treatment with Asacol (dosage: 2 Pills). The following drugs were being taken at the same time: NA. When commencing Asacol, the patient experienced the following unwanted symptoms/side effects:
  • Thyroid Cancer
The patient was hospitalized and became disabled.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as thyroid cancer, may become evident only after a product is in use by the general population.

Urticaria, Rash, Pruritus, Hepatic Enzyme Abnormal
This is a report of a 53-year-old female patient (weight: NA) from US. The patient developed the following symptoms/conditions: diverticulitis and was treated with Asacol (dosage: 2 Tablets, Tid, Po) starting Feb 20, 2013. Concurrently used drugs: NA.Soon after that, the consumer experienced the following side effects:
  • Urticaria
  • Rash
  • Pruritus
  • Hepatic Enzyme Abnormal
This opens a possibility that Asacol treatment could cause the above reactions, including urticaria, and some female subjects may be more susceptible.

Blood Alkaline Phosphatase Increased, Aspartate Aminotransferase Increased, Alanine Aminotransferase Increased
A 22-year-old male patient (weight: NA) from US with the following symptoms/conditions: colitis ulcerative started Asacol Hd treatment (dosage: NA) on Jan 22, 2013. Soon after starting Asacol Hd treatment, the subject experienced various side effects, including:
  • Blood Alkaline Phosphatase Increased
  • Aspartate Aminotransferase Increased
  • Alanine Aminotransferase Increased
Concurrently used drugs: NA. This finding indicates that some male patients could be more vulnerable to Asacol Hd.

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Top 10 Asacol Side Effects for Women

Women Side EffectsReports
Diarrhoea 25
Colitis Ulcerative 22
Injection Site Pain 20
Fatigue 17
Abdominal Pain 16
Arthralgia 16
Condition Aggravated 16
Nausea 15
Pain 13
Pyrexia 13

Top 10 Asacol Side Effects for Men

Men Side EffectsReports
Diarrhoea 16
Crohn's Disease 13
Abdominal Pain 11
Dyspnoea 11
Arthralgia 10
Pyrexia 10
Colitis Ulcerative 9
Chest Pain 8
Condition Aggravated 8
Dizziness 8

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

    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

    Did You Have a Asacol Side Effect?

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    How Effective is Asacol for You?

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    Asacol Safety Alerts, Active Ingredients, Usage Information

    NDC0179-0111
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NameASACOL
    Namemesalamine
    Dosage FormTABLET, DELAYED RELEASE
    RouteORAL
    On market since20120223
    LabelerKAISER FOUNDATION HOSPITALS
    Active Ingredient(s)MESALAMINE
    Strength(s)400
    Unit(s)mg/1
    Pharma ClassAminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient]

    Asacol Dosage, Warnings, Usage.

    Side Effects reported to FDA: 514

    Asacol safety alerts: No

    Reported deaths: 14

    Reported hospitalizations: 244

    Latest Asacol clinical trials