Applies to citric acid/magnesium oxide/sodium picosulfate: oral solution.

Serious side effects

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

Other side effects

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

For Healthcare Professionals

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

General

The most commonly reported side effects included headache, nausea, vomiting, and proctalgia.^[Ref]

Renal

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.^[Ref]

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

Common (1% to 10%): High creatinine^[Ref]

Cardiovascular

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

Uncommon (0.1% to 1%): Orthostatic hypotension

Frequency not reported: Cardiac arrhythmias^[Ref]

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).^[Ref]

Metabolic

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), dehydration, serious fluid and electrolyte abnormalities^[Ref]

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.^[Ref]

Gastrointestinal

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, diarrhea, ileal ulcers. fecal incontinence

Rare (0.01% to 0.1%): Anal incontinence

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

Postmarketing reports: Severe diarrhea^[Ref]

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.^[Ref]

Nervous system

Generalized tonic-clonic seizures occurred with and without hyponatremia in patients with epilepsy.^[Ref]

Common (1% to 10%): Headache

Uncommon (0.1% to 1%): Convulsions, decreased/loss of consciousness, dizziness, epilepsy, generalized tonic-clonic seizures, grand mal convulsion, seizures, syncope

Rare (0.01% to 0.1%): Presyncope^[Ref]

Psychiatric

Common (1% to 10%): Sleep disorder

Uncommon (0.1% to 1%): Confusional state, disorientation

Frequency not reported: Sleep disturbance^[Ref]

Other

Common (1% to 10%): Fatigue

Frequency not reported: Pain^[Ref]

Dermatologic

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

Frequency not reported: Pruritus^[Ref]

Hypersensitivity

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

Frequency not reported: Anaphylactoid reaction, anaphylaxis^[Ref]

Respiratory

Frequency not reported: Aspiration