Note: This document contains side effect information about cysteamine. Some of the dosage forms listed on this page may not apply to the brand name Procysbi.
Common side effects of Procysbi include: lethargy, vomiting, and anorexia. Other side effects include: skin rash. See below for a comprehensive list of adverse effects.
Applies to cysteamine: oral capsule, oral capsule delayed release
Along with its needed effects, cysteamine (the active ingredient contained in Procysbi) 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 cysteamine:
Incidence not known
Some side effects of cysteamine 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:
Applies to cysteamine: oral capsule, oral delayed release capsule
The most common adverse events were vomiting, abdominal pain, nausea, anorexia, fever, diarrhea, lethargy, headache, and rash.
Very common (10% or more): Vomiting (35%), diarrhea (16%)
Common (1% to 10%): Nausea, bad breath, abdominal pain, dyspepsia
Uncommon (0.1% to 1%): Gastrointestinal ulceration and bleeding, constipation, gastroenteritis, duodenitis
Very common (10% or more): Anorexia (31%)
Uncommon (0.1% to 1%): Dehydration
Very common (10% or more): Lethargy (11%)
Common (1% to 10%): Dizziness, headache, encephalopathy
Uncommon (0.1% to 1%): Somnolence, seizures, convulsions, ataxia, confusion, tremor, hyperkinesia, jitteriness
Postmarketing reports: Benign intracranial hypertension with papilledema
Very common (10% or more): Fever (22%)
Common (1% to 10%): Fatigue, asthenia
Uncommon (0.1% to 1%): Decreasing hearing
Common (1% to 10%): Rash, skin odor
Uncommon (0.1% to 1%): Hair color changes, skin fragility (molluscoid pseudomotor on elbows)
Frequency not reported: Urticaria
Postmarketing reports: Skin lesions, skin striae, skin fragility
Cases of Ehlers-Danlos like syndrome and vascular disorders on elbows have been reported in children chronically treated with high doses of different cysteamine preparations. In cases where histopathological examination of the skin was performed, the results suggested angioendotheliomatosis.
Common (1% to 10%): Abnormal liver function
Frequency not reported: Elevated alkaline phosphatase
Uncommon (0.1% to 1%): Hypertension
Uncommon (0.1% to 1%): Abnormal urine odor
Uncommon (0.1% to 1%): Leukopenia, anemia
Uncommon (0.1% to 1%): Anaphylactic reaction
Uncommon (0.1% to 1%): Joint hyperextension, leg pain, genu valgum, osteopenia, compression fracture, scoliosis
Postmarketing reports: Molluscoid pseudotumors
Uncommon (0.1% to 1%): Nervousness, abnormal thinking, depression, emotional lability, hallucinations, nightmares
Uncommon (0.1% to 1%): Nephrotic syndrome, interstitial nephritis, renal failure
Cases of nephrotic syndrome have been reported within 6 months of starting therapy with progressive recovery after treatment discontinuation. In some cases, histology showed a membranous glomerulonephritis of the renal allograft and hypersensitivity interstitial nephritis.
Medically reviewed by BestRx Medical Team Last updated on 1/1/2020.
Source: Drugs.com Procysbi