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Asacol Side Effects

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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.

Asacol Side Effects Reported to FDA



Asacol Side Effect Report#9888119
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 health 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): Oropharyngeal Pain, Dysphagia, Speech Disorder, Unevaluable Event 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.
Asacol Side Effect Report#9869974
Peritonitis Bacterial, Intestinal Perforation, Abdominal Pain, Klebsiella Infection
This report suggests a potential Asacol (mesalazine) Modified-release Tablet, 400 Mg Peritonitis Bacterial 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. After starting Asacol (mesalazine) Modified-release Tablet, 400 Mg the patient began experiencing various side effects, including: Peritonitis Bacterial, Intestinal Perforation, Abdominal Pain, Klebsiella InfectionAdditional 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.
Asacol Side Effect Report#9702862
Hemiparesis, Monoparesis, Cough, Asthenia, Vision Blurred, Visual Impairment, Weight Decreased, Decreased Appetite, Transient Ischaemic Attack
This Hemiparesis 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 using 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 AttackThe 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.
Asacol Side Effect Report#9631083
Glomerulonephritis, Blood Creatinine Increased
This Glomerulonephritis side effect was reported by a consumer or non-health professional from CA. A 70-year-old male patient (weight:NA) experienced the following symptoms/conditions: colitis ulcerative.The patient was prescribed Asacol (drug dosage: NA), which was initiated on 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)
.After starting to take Asacol the consumer reported adverse symptoms, such as: Glomerulonephritis, Blood Creatinine IncreasedThese side effects may potentially be related to Asacol. The patient was hospitalized.
Asacol Side Effect Report#9552459
Haematochezia, Product Quality Issue, Clostridium Difficile Infection
This is a report of a 58-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: colitis, who was treated with Asacol Hd (dosage: 2 Tabs, Three Times Daily, Taken By Mouth, start time:
Jun 10, 2013), combined with: NA. and developed a serious reaction and side effect(s): Haematochezia, Product Quality Issue, Clostridium Difficile Infection after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Asacol Hd treatment in female patients, resulting in Haematochezia side effect.
Asacol Side Effect Report#9523909
Pneumonia Viral, Epstein-barr Virus Infection
This report suggests a potential Asacol Hd Pneumonia Viral side effect(s) that can have serious consequences. A 31-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: colitis ulcerative and used Asacol Hd (dosage: NA) starting 2003. After starting Asacol Hd the patient began experiencing various side effects, including: Pneumonia Viral, Epstein-barr Virus InfectionAdditional drugs used concurrently: NA.The patient was hospitalized. Although Asacol Hd demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Pneumonia Viral, may still occur.
Asacol Side Effect Report#9518764
Sepsis, Colitis Ulcerative, Nausea, Diarrhoea, Decreased Appetite, Weight Decreased, Abdominal Pain Upper, Pyrexia
This Sepsis problem was reported by a pharmacist from US. A 66-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: colitis ulcerative. On 2011 this consumer started treatment with Asacol (dosage: NA). The following drugs were being taken at the same time:
  • Delzicol
  • Asacol Hd
  • Tri-chlor (trichloroacetic Acid)
  • Crestor
  • Vitamin D/00318501/ (colecalciferol)
  • Inderal (propranolol Hydrochloride)
  • Synthroid (levothyroxine Sodium)
  • Prilosec/00661201/ (omeprazole)
When using Asacol, the patient experienced the following unwanted symptoms/side effects: Sepsis, Colitis Ulcerative, Nausea, Diarrhoea, Decreased Appetite, Weight Decreased, Abdominal Pain Upper, PyrexiaThe 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 Sepsis, may become evident only after a product is in use by the general population.
Asacol Side Effect Report#9507862
White Blood Cell Count Increased, Neutrophil Count Increased, Abdominal Pain Lower, Fatigue, Diarrhoea Haemorrhagic, Colitis Ulcerative
This White Blood Cell Count Increased side effect was reported by a pharmacist from US. A 57-year-old female patient (weight:NA) experienced the following symptoms/conditions: colitis ulcerative.The patient was prescribed Asacol (drug dosage: Asacol Hd Dr 800mg One 3 Times A Da Oral), which was initiated on
Jun 09, 2013. Concurrently used drugs:
  • Lisinopril
  • Fluoxetine
  • Allegra
  • Simvastin
  • Calcium With Vitamin D
  • Ester C
  • Ubiquinol
  • Krill Oil
.After starting to take Asacol the consumer reported adverse symptoms, such as: White Blood Cell Count Increased, Neutrophil Count Increased, Abdominal Pain Lower, Fatigue, Diarrhoea Haemorrhagic, Colitis UlcerativeThese side effects may potentially be related to Asacol.
Asacol Side Effect Report#9476112
Nightmare
This is a report of a 80-year-old female patient (weight: NA) from GB, suffering from the following health symptoms/conditions: NA, who was treated with Asacol (dosage: NA, start time: NS), combined with:
  • 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)
and developed a serious reaction and side effect(s): Nightmare after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Asacol treatment in female patients, resulting in Nightmare side effect.
Asacol Side Effect Report#9461626
Skin Discolouration, Poor Peripheral Circulation, Burning Sensation, Pain In Extremity, Insomnia, Discomfort, Hypoaesthesia
This report suggests a potential Asacol Skin Discolouration side effect(s) that can have serious consequences. A 56-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: colitis ulcerative and used Asacol (dosage: NA) starting
Mar 01, 2013. After starting Asacol the patient began experiencing various side effects, including: Skin Discolouration, Poor Peripheral Circulation, Burning Sensation, Pain In Extremity, Insomnia, Discomfort, HypoaesthesiaAdditional drugs used concurrently:
  • Sulfasalazine
Although Asacol demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Skin Discolouration, may still occur.
Asacol Side Effect Report#9457732
Intestinal Perforation, Diverticulitis, Abdominal Distension
This Intestinal Perforation problem was reported by a consumer or non-health professional from US. A 43-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: colitis ulcerative. On 201307 this consumer started treatment with Asacol (mesalazine) Modified-release Tablet, 400 Mg (dosage: NA). The following drugs were being taken at the same time:
  • Delzicol
  • Dicyclomine (dicycloverine)
When using Asacol (mesalazine) Modified-release Tablet, 400 Mg, the patient experienced the following unwanted symptoms/side effects: Intestinal Perforation, Diverticulitis, Abdominal DistensionThe 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 Intestinal Perforation, may become evident only after a product is in use by the general population.
Asacol Side Effect Report#9434238
Haemorrhage
This Haemorrhage side effect was reported by a consumer or non-health professional from US. A 74-year-old male patient (weight:NA) experienced the following symptoms/conditions: colitis,atrial fibrillation.The patient was prescribed Asacol (drug dosage: 800mg Once Daily Po), which was initiated on
Aug 01, 2003. Concurrently used drugs:
  • Warfarin (4mg 1 Tablet Daily Po)
.After starting to take Asacol the consumer reported adverse symptoms, such as: HaemorrhageThese side effects may potentially be related to Asacol.
Asacol Side Effect Report#9414397
Intestinal Obstruction, Abdominal Pain, Foreign Body
This is a report of a 47-year-old female patient (weight: NA) from IT, suffering from the following health symptoms/conditions: colitis ulcerative, who was treated with Asacol (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Intestinal Obstruction, Abdominal Pain, Foreign Body after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Asacol treatment in female patients, resulting in Intestinal Obstruction side effect. The patient was hospitalized.
Asacol Side Effect Report#9411953
Gallbladder Disorder, Pain, Weight Decreased
This report suggests a potential Asacol Gallbladder Disorder side effect(s) that can have serious consequences. A 22-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Asacol (dosage: NA) starting NS. After starting Asacol the patient began experiencing various side effects, including: Gallbladder Disorder, Pain, Weight DecreasedAdditional drugs used concurrently: NA. Although Asacol demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Gallbladder Disorder, may still occur.
Asacol Side Effect Report#9402453
Flatulence, Abdominal Distension, Abdominal Pain, Abnormal Faeces, Frequent Bowel Movements, Defaecation Urgency, Mucous Stools, Pollakiuria, Dysuria
This Flatulence problem was reported by a pharmacist from US. A 38-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: colitis ulcerative. On NS this consumer started treatment with Asacol (dosage: NA). The following drugs were being taken at the same time:
  • Zolpidem
  • Finasteride
  • Diphenhydramine
When using Asacol, the patient experienced the following unwanted symptoms/side effects: Flatulence, Abdominal Distension, Abdominal Pain, Abnormal Faeces, Frequent Bowel Movements, Defaecation Urgency, Mucous Stools, Pollakiuria, DysuriaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Flatulence, may become evident only after a product is in use by the general population.
Asacol Side Effect Report#9353686
Atrial Fibrillation, Nasal Discomfort, Throat Irritation, Epistaxis, Swollen Tongue, Nasal Dryness, Lip Swelling, Eye Irritation, Eye Irritation
This Atrial Fibrillation side effect was reported by a consumer or non-health professional from US. A 69-year-old female patient (weight:NA) experienced the following symptoms/conditions: colitis.The patient was prescribed Asacol (drug dosage: NA), which was initiated on 2007. Concurrently used drugs:
  • Delzicol
.After starting to take Asacol the consumer reported adverse symptoms, such as: Atrial Fibrillation, Nasal Discomfort, Throat Irritation, Epistaxis, Swollen Tongue, Nasal Dryness, Lip Swelling, Eye Irritation, Eye IrritationThese side effects may potentially be related to Asacol.
Asacol Side Effect Report#9321063
Muscle Spasms, Rectal Haemorrhage, Diarrhoea, Pyrexia, White Blood Cell Count Increased
This is a report of a 23-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: colitis ulcerative, who was treated with Asacol Hd (dosage: 2 Tab, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Muscle Spasms, Rectal Haemorrhage, Diarrhoea, Pyrexia, White Blood Cell Count Increased after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Asacol Hd treatment in male patients, resulting in Muscle Spasms side effect.
Asacol Side Effect Report#9316434
Large Intestine Perforation, Post Procedural Complication, Blister
This report suggests a potential Asacol (mesalazine) Modified-release Tablet, 400 Mg Large Intestine Perforation side effect(s) that can have serious consequences. A 80-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: crohn^s disease and used Asacol (mesalazine) Modified-release Tablet, 400 Mg (dosage: Three Tablets Twice Daily) starting 1988. After starting Asacol (mesalazine) Modified-release Tablet, 400 Mg the patient began experiencing various side effects, including: Large Intestine Perforation, Post Procedural Complication, BlisterAdditional drugs used concurrently:
  • Loperamide (loperamide)
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 Large Intestine Perforation, may still occur.
Asacol Side Effect Report#9305872
Kidney Infection, Clostridium Difficile Colitis, Nephrolithiasis, Vomiting, Hyponatraemia, Hypokalaemia, Pyrexia, Diarrhoea
This Kidney Infection problem was reported by a consumer or non-health professional from US. A 69-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: colitis microscopic. On NS this consumer started treatment with Asacol (dosage: NA). The following drugs were being taken at the same time:
  • Tiazac /00489702/ (diltiazem Hydrochloride)
  • Lotensin?/00909102/ (benazepril Hydrochloride)
  • Hydrochlorothiazide (hydrochlorothiazide)
  • Toprol (metoprolol Succinate)
  • Evista (raloxifene Hydrochloride)
When using Asacol, the patient experienced the following unwanted symptoms/side effects: Kidney Infection, Clostridium Difficile Colitis, Nephrolithiasis, Vomiting, Hyponatraemia, Hypokalaemia, Pyrexia, DiarrhoeaThe 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 Kidney Infection, may become evident only after a product is in use by the general population.
Asacol Side Effect Report#9286312
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 (drug dosage: 6-8 400 Mg Daily), which was initiated on 1993. Concurrently used drugs:
  • Amlodipine (amlodipine)
.After starting to take Asacol the consumer reported adverse symptoms, such as: Thyroid CancerThese side effects may potentially be related to Asacol. The patient was hospitalized.
Asacol Side Effect Report#9285701
Atrial Fibrillation
This is a report of a 67-year-old female patient (weight: NA) from US, suffering from the following health 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): Atrial Fibrillation 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.
Asacol Side Effect Report#9280019
Thyroid Cancer, Product Formulation Issue
This report suggests a potential Asacol Thyroid Cancer 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. After starting Asacol the patient began experiencing various side effects, including: Thyroid Cancer, Product Formulation IssueAdditional 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.
Asacol Side Effect Report#9274695
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 using Asacol, the patient experienced the following unwanted symptoms/side effects: Thyroid CancerThe 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.
Asacol Side Effect Report#9248326
Urticaria, Rash, Pruritus, Hepatic Enzyme Abnormal
This Urticaria side effect was reported by a consumer or non-health professional from US. A 53-year-old female patient (weight:NA) experienced the following symptoms/conditions: diverticulitis.The patient was prescribed Asacol (drug dosage: 2 Tablets, Tid, Po), which was initiated on
Feb 20, 2013. Concurrently used drugs: NA..After starting to take Asacol the consumer reported adverse symptoms, such as: Urticaria, Rash, Pruritus, Hepatic Enzyme AbnormalThese side effects may potentially be related to Asacol.
Asacol Side Effect Report#9221514
Blood Alkaline Phosphatase Increased, Aspartate Aminotransferase Increased, Alanine Aminotransferase Increased
This is a report of a 22-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: colitis ulcerative, who was treated with Asacol Hd (dosage: NA, start time:
Jan 22, 2013), combined with: NA. and developed a serious reaction and side effect(s): Blood Alkaline Phosphatase Increased, Aspartate Aminotransferase Increased, Alanine Aminotransferase Increased after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Asacol Hd treatment in male patients, resulting in Blood Alkaline Phosphatase Increased side effect.


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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.


What are common 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

What are common 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

Track Your Side Effects

Note Your Observations

It is really important to keep track of your health 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

    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.

    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 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.

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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