Delzicol Side Effects

Generic name: mesalamine

Medically reviewed by Philip Thornton, DipPharm. Last updated on Jun 7, 2024.

Note: This document provides detailed information about Delzicol Side Effects associated with mesalamine. Some dosage forms listed on this page may not apply specifically to the brand name Delzicol.

Applies to mesalamine: rectal enema, rectal suppository.

Other dosage forms:

• oral capsule delayed release, oral capsule extended release, oral tablet delayed release, oral tablet enteric coated

Serious side effects of Delzicol

Along with its needed effects, mesalamine (the active ingredient contained in Delzicol) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking mesalamine:

More common

• back pain, severe
• bladder pain
• bloody, black, or tarry stools
• bloody or cloudy urine
• bright red blood in the stool
• change in the frequency of urination or amount of urine
• chills
• cough
• diarrhea, severe
• difficult, burning, or painful urination
• dizziness
• fast heartbeat
• fever
• general feeling of discomfort or illness
• headache, severe
• increased sensitivity of the skin to sunlight
• itching, skin rash
• joint pain
• loss of appetite
• lower back or side pain
• muscle aches and pains
• nausea or vomiting
• pain in the groin or genitals
• redness or other discoloration of the skin
• runny nose
• severe sunburn
• sharp back pain just below the ribs
• shivering
• sore throat
• stomach cramps, tenderness, pain, or swelling
• sweating
• trouble sleeping
• unusual tiredness or weakness
• watery or bloody diarrhea
• yellow eyes or skin

Less common

• anxiety
• blue or pale skin
• chest pain, possibly moving to the left arm, neck, or shoulder

Incidence not known

• agitation
• blistering, peeling, or loosening of the skin
• chest discomfort
• coma
• confusion
• dark-colored urine
• decreased urine output
• depression
• difficulty with breathing
• drowsiness
• high fever
• hostility
• inability to move the arms and legs
• increased thirst
• irritability
• lethargy
• light-colored stools
• muscle twitching
• painful or difficult urination
• pale skin
• rapid weight gain
• red, irritated eyes
• red skin lesions often with a purple center
• seizures
• sores, ulcers, or white spots on the lips or in the mouth
• sudden numbness and weakness in the arms and legs
• swelling of the face, hands, ankles, feet, or lower legs
• swollen glands
• trouble breathing
• unexplained or unusual bleeding or bruising
• weakness

Other side effects of Delzicol

Some side effects of mesalamine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• bloated or full feeling
• constipation
• excess air or gas in the stomach or bowels
• gas or flatulence
• headache, mild
• passing gas
• stomach cramps or pain, mild

Less common

• blemishes on the skin
• diarrhea
• dizziness
• flushing, redness of the skin
• hives or welts
• leg pain
• loss of hair
• pimples
• rectal pain or irritation
• unusually warm skin

For healthcare professionals

Applies to mesalamine: compounding powder, oral capsule extended release, oral delayed release capsule, oral delayed release tablet, rectal enema, rectal kit, rectal suppository.

General

The most common adverse events were headache, eructation, and aggravation of ulcerative colitis.^[Ref]

Gastrointestinal

• Very common (10% or more): Eructation (up to 16%), ulcerative colitis aggravated (up to 15%)
• Common (1% to 10%): Abdominal pain/cramps/discomfort, diarrhea, flatulence, nausea, gastroenteritis, gastrointestinal hemorrhage, rectal disorder, stool abnormalities (color or texture change), urinary frequency, dyspepsia, vomiting, bloating, rectal distension, pain on insertion of tip (enema formulation), hemorrhoids, rectal pain, colitis, constipation, abdominal distension
• Uncommon (0.1% to 1%): Acute pancreatitis, melena (bloody diarrhea), rectal pain/soreness/burning, pancolitis, neonate diarrhea, anal discomfort, defecation urgency, colitis ulcer (proctitis ulcer), glossitis, rectal polyp, pancreatitis, application site irritation (rectal foam formulation), painful rectal tenesmus, rectal urgency
• Rare (less than 0.1%): Increased amylase
• Frequency not reported: Duodenal ulcer, dysphagia, esophageal ulcer, fecal incontinence, GI bleeding, mouth ulcer, oral candidiasis, rectal bleeding, rectal polyp, mild indigestion and cramping, bloody diarrhea, stomatitis, abdominal enlargement, lipase increase
• Postmarketing reports: Frequent bowel movements, mucus stools, painful defecation, proctalgia, rectal discharge, stomach discomfort, gastritis, dry mouth, oral ulcers, perforated peptic ulcer, amylase increased^[Ref]

Nervous system

• Very common (10% or more): Headache (up to 24%)
• Common (1% to 10%): Dizziness
• Uncommon (0.1% to 1%): Paresthesia, peripheral neuropathy, somnolence, tremor,
• Very rare (less than 0.01%): Vertigo
• Frequency not reported: Neuropathy, mild disorientation
• Postmarketing reports: Guillain-Barre syndrome, hypertonia, transverse myelitis, hyperesthesia, taste perversion, tinnitus^[Ref]

Other

• Very common (10% or more): Pain (up to 14%)
• Common (1% to 10%): Asthenia, fatigue, pyrexia, infection
• Uncommon (0.1% to 1%): Ear pain, peripheral edema
• Rare (less than 0.1%): Drug fever
• Frequency not reported: Malaise, mesalamine-induced acute intolerance syndrome, plugged ears, adenovirus infection, aching, decreased body mass index,
• Postmarketing reports: Medication residue, elevated alkaline phosphatase, elevated GGT, elevated LDH, ear congestion^[Ref]

Respiratory

• Very common (10% or more): Nasopharyngitis (up to 15%)
• Common (1% to 10%): Upper respiratory tract infection, influenza like symptoms, rhinitis, cold/sore throat
• Uncommon (0.1% to 1%): Allergic and fibrotic lung reactions, dyspnea, cough, bronchospasm, pleural effusion, alveolitis, pulmonary eosinophilia, lung infiltration, pneumonitis, pharyngolaryngeal pain
• Very rare (less than 0.01%): Eosinophilic pneumonia
• Frequency not reported: Hypersensitivity pneumonitis (including interstitial pneumonitis, allergic alveolitis, eosinophilic pneumonitis, stuffy head, interstitial pulmonary fibrosis, bronchiolitis obliterans, sinusitis
• Postmarketing reports: Fibrosing alveolitis, asthma exacerbation, pleuritis, bronchitis^[Ref]

Cardiovascular

• Common (1% to 10%): Hypertension, vasodilation,
• Uncommon (0.1% to 1%): Pericarditis, myocarditis, pericardial effusion, tachycardia, hypotension
• Frequency not reported: Chest pain, T-wave abnormalities, Kawasaki-like syndrome^[Ref]

Dermatologic

• Common (1% to 10%): Rash, alopecia, urticaria, pruritus, acne
• Uncommon (0.1% to 1%): Lupus erythematosus syndrome, allergic exanthema, increased sweating, angioedema, Stevens-Johnson syndrome, face edema
• Very rare (less than 0.01%): Reversible alopecia, bullous skin reactions including erythema multiforme
• Frequency not reported: Dry skin, eczema, erythema nodosum, nail disorder, photosensitivity, lichen planus, ecchymosis
• Postmarketing reports: Prurigo, erythema, psoriasis, pyoderma gangrenosum^[Ref]

Musculoskeletal

• Common (1% to 10%): Back pain, arthralgia, leg/joint pain
• Uncommon (0.1% to 1%): Myalgia, chills, myositis, arthritis
• Frequency not reported: Leg cramps, lower back discomfort, muscle cramps, neck pain
• Postmarketing reports: Joint disorder, rheumatoid arthritis^[Ref]

Hepatic

• Common (1% to 10%): Hepatic function abnormal, increased alanine aminotransferase
• Uncommon (0.1% to 1%): Hepatitis, increased liver enzymes (transaminase activity), intrahepatic cholestasis, increased bilirubin
• Very rare (less than 0.01%): Hepatotoxicity (including cirrhosis, hepatic failure), changes in liver function parameters
• Frequency not reported: GGTP increase, SGOT increase, SGPT increase, sclerosing cholangitis, increased alkaline phosphatase
• Postmarketing reports: Jaundice, cholestatic jaundice, liver necrosis, cholecystitis^[Ref]

Metabolic

• Common (1% to 10%): Anorexia
• Frequency not reported: Thirst, edema
• Postmarketing reports: Increased appetite, gout^[Ref]

Ocular

• Common (1% to 10%): Vision abnormalities
• Uncommon (0.1% to 1%): Conjunctivitis
• Postmarketing reports: Blurred vision, eye pain^[Ref]

Renal

• Uncommon (0.1% to 1%): Acute or chronic interstitial nephritis, renal insufficiency, renal failure, nephrotoxicity
• Very rare (less than 0.01%): Nephrotic syndrome, urine discoloration
• Frequency not reported: Creatinine clearance decreased
• Postmarketing reports: Minimal change nephropathy, elevated serum creatinine and BUN^[Ref]

Hematologic

• Uncommon (0.1% to 1%): Thrombocytopenia, aplastic anemia, hemolytic anemia, agranulocytosis, leukopenia, neutropenia, pancytopenia, platelet count decreased
• Very rare (less than 0.01%): Eosinophilia (as part of an allergic reaction), anemia, bone marrow depression
• Frequency not reported: Thrombocythemia
• Postmarketing reports: Granulocytopenia, lymphadenopathy^[Ref]

Hypersensitivity

• Uncommon (0.1% to 1%): Allergic reaction, anaphylactic reaction, drug reaction with eosinophilia and systemic symptoms (DRESS)
• Frequency not reported: Anaphylactic shock, angioedema^[Ref]

Genitourinary

• Uncommon (0.1% to 1%): Oligospermia (reversible), UTI/urinary burning
• Frequency not reported: Albuminuria, amenorrhea, breast pain, hematuria, hypomenorrhea, menorrhagia, metrorrhagia, urinary frequency
• Postmarketing reports: Dysuria, urinary urgency, epididymitis^[Ref]

Psychiatric

• Uncommon (0.1% to 1%): Insomnia
• Frequency not reported: Depression, anxiety, decreased libido
• Postmarketing reports: Nervousness, confusion, emotional lability, confusion^[Ref]

Frequently asked questions

• What are 7 mesalamine side effects to be aware of?

Further information

Delzicol side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer