Summary
More frequently reported side effects include: upper respiratory tract infection. Continue reading for a comprehensive list of adverse effects.
Applies to crofelemer: oral tablet delayed release.
Serious side effects of Crofelemer
Along with its needed effects, crofelemer 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 crofelemer:
Less common
- Abdominal or stomach pain
- bleeding after defecation
- full or bloated feeling
- pressure in the stomach
- swelling of the abdominal or stomach area
- uncomfortable swelling around the anus
Other side effects of Crofelemer
Some side effects of crofelemer 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
- Body aches or pain
- chills
- cough
- difficulty with breathing
- ear congestion
- fever
- headache
- loss of voice
- nasal congestion
- runny nose
- sneezing
- sore throat
- unusual tiredness or weakness
Less common
- Acid or sour stomach
- back pain
- belching
- bladder pain
- blemishes on the skin
- blistering, crusting, irritation, itching, or reddening of the skin
- bloody or cloudy urine
- cough producing mucus
- cracked, dry, scaly skin
- difficult, burning, or painful urination
- difficulty having a bowel movement (stool)
- difficulty with moving
- discouragement
- dizziness
- dry mouth
- excess air or gas in the stomach or intestines
- fear or nervousness
- feeling sad or empty
- frequent urge to urinate
- heartburn
- indigestion
- irritability
- loss of appetite
- loss of interest or pleasure
- lower back or side pain
- muscle aches
- muscle or bone pain
- muscle stiffness
- nausea and vomiting
- pain in the arms or legs
- pain in the groin or genitals
- pain in the joints
- pain or tenderness around the eyes and cheekbones
- painful blisters on the trunk of the body
- passing gas
- pimples
- sharp back pain just below the ribs
- stomach discomfort or upset
- tightness in the chest
- tiredness
- trouble concentrating
- trouble sleeping
- weakness
For Healthcare Professionals
Applies to crofelemer: oral delayed release tablet.
Dermatologic
Common (1% to 10%): Acne, dermatitis[Ref]
Gastrointestinal
Common (1% to 10%): Flatulence, nausea, hemorrhoids, abdominal distension, abdominal pain, constipation, dry mouth, dyspepsia, gastroenteritis[Ref]
General
The most common adverse reactions (greater than or equal to 3%) include upper respiratory tract infection, bronchitis, cough, flatulence and increased bilirubin.
Genitourinary
Common (1% to 10%): Urinary tract infection, pollakiuria[Ref]
Hematologic
Common (1% to 10%): Decreased white blood cell count[Ref]
Hepatic
Common (1% to 10%): Increased bilirubin, increased alanine aminotransferase, increased aspartate aminotransferase, increased conjugated bilirubin, increased unconjugated blood bilirubin, nephrolithiasis[Ref]
Musculoskeletal
Common (1% to 10%): Back pain, arthralgia, musculoskeletal pain, pain in extremity[Ref]
Nervous system
Common (1% to 10%): Dizziness[Ref]
Other
Common (1% to 10%): Giardiasis, herpes zoster, procedural pain, seasonal allergy[Ref]
Psychiatric
Common (1% to 10%): Anxiety, depression[Ref]
Respiratory
Common (1% to 10%): Upper respiratory tract infection, bronchitis, cough, nasopharyngitis, sinusitis[Ref]
