Clenpiq

Note: This document contains side effect information about citric acid / magnesium oxide / sodium picosulfate. Some of the dosage forms listed on this page may not apply to the brand name Clenpiq.

Applies to citric acid/magnesium oxide/sodium picosulfate: oral powder for solution, oral solution

Along with its needed effects, citric acid / magnesium oxide / sodium picosulfate 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 citric acid / magnesium oxide / sodium picosulfate:

Incidence not known

• Bleeding of the rectum
• bloody stools
• confusion
• cough
• decreased urine output
• diarrhea
• dizziness or fainting
• dry mouth
• fast, slow, or irregular heartbeat
• fever
• headache
• hives, itching, skin rash
• increased thirst
• jerking or shaking of the muscles
• joint pain, stiffness, or swelling
• loss of bowel control
• loss of consciousness
• muscle pain or cramps
• nausea
• numbness or tingling in the hands, feet, or lips
• pinpoint red or purple spots on the skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• seizures
• stomach pain and tenderness
• swelling of the eyelids, face, lips, ankles, hands, or feet
• tightness in the chest
• troubled breathing or swallowing
• unusual tiredness or weakness
• vomiting

Some side effects of citric acid / magnesium oxide / sodium picosulfate 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:

Incidence not known

• Pain in the rectum

Applies to citric acid / magnesium oxide / sodium picosulfate: oral powder for reconstitution, oral solution

The most commonly reported side effects included headache, nausea, vomiting, and proctalgia.

Very common (10% or more): Low glomerular filtration rate (up to 28.5%)

Common (1% to 10%): High creatinine

Low GFR occurred in 28.5% of patients using the day-before regimen compared to 25.1% of patients using the split-dose regimen at 24 to 48 hours after the colonoscopy.

Orthostatic changes included changes in blood pressure and heart rate.

In a study, approximately 20% of pediatric patients 9 to 16 years of age given this drug had orthostatic changes for up to 5 days compared to 7% of patients given the comparator drug regimen (polyethylene glycol and electrolytes solution plus bisacodyl).

Very common (10% or more): Orthostatic changes (up to 20%)

Uncommon (0.1% to 1%): Orthostatic hypotension

Frequency not reported: Cardiac arrhythmias

Very common (10% or more): Hypermagnesemia (up to 11.6%)

Common (1% to 10%): Electrolyte abnormalities, hypochloremia, hypokalemia, hyponatremia, thirst

Uncommon (0.1% to 1%): Hypocalcemia

Frequency not reported: Abnormally low glucose levels (40 to 47 mg/dL), serious fluid and electrolyte abnormalities

Hypermagnesemia occurred in 11.6% of patients using the split-dose regimen compared to 8.7% of patients using the day-before regimen the day of the colonoscopy.

Abnormally low glucose levels were reported in asymptomatic pediatric patients, with one occurring at the colonoscopy, and one at the 5-day follow-up visit.

Hyponatremia has occurred with/without convulsions.

Common (1% to 10%): Abdominal distention, abdominal fullness, abdominal pain, anal discomfort, bloating, dry mouth, nausea, proctalgia, vomiting

Uncommon (0.1% to 1%): Abdominal cramps, anal irritation, aphthoid ileal ulcers/mild reversible aphthoid ileal ulcers, fecal incontinence

Frequency not reported: Abdominal bloating, colonic mucosal ulceration, diarrhea, flatulence, ischemic colitis, ulcerative colitis, watery diarrhea

Postmarketing reports: Severe diarrhea

Since abdominal bloating, distention, pain/cramping, and watery diarrhea were predicted to occur as part of the colon cleansing regimen, these side effects were included only if patients required medical attention or the condition significantly worsened during the study and was not in the frame of the usual clinical course.

Generalized tonic-clonic seizures occurred with and without hyponatremia in patients with epilepsy.

Common (1% to 10%): Headache

Uncommon (0.1% to 1%): Convulsions, dizziness, epilepsy, grand mal convulsion

Frequency not reported: Generalized tonic-clonic seizures, seizures

Common (1% to 10%): Sleep disorder

Uncommon (0.1% to 1%): Confusional state

Common (1% to 10%): Fatigue

Frequency not reported: Pain

Uncommon (0.1% to 1%): Erythematous rash, maculopapular rash, purpura, rash, urticaria

Frequency not reported: Pruritus

Uncommon (0.1% to 1%): Anaphylactic reaction, hypersensitivity

Frequency not reported: Anaphylactoid reaction, anaphylaxis

Frequency not reported: Aspiration