Procysbi Side Effects

Generic name: cysteamine

Medically reviewed by Drugs.com. Last updated on Aug 29, 2024.

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

Applies to cysteamine: oral capsule, oral capsule delayed release, oral packet.

Serious side effects of Procysbi

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:

More common side effects

• diarrhea
• drowsiness
• fever
• loss of appetite
• nausea
• skin rash
• stomach pain
• vomiting

Less common side effects

• confusion
• dizziness
• headache
• mental depression
• sore throat
• trembling

Rare side effects

• increased thirst
• seizures
• unusual tiredness or weakness

Incidence not known

• blistering, peeling, or loosening of the skin
• blurred or double vision
• bone lesions
• bulging soft spot on the head of an infant
• change in the ability to see colors, especially blue or yellow
• chills
• continuing ringing or buzzing or other unexplained noise in the ears
• cough
• eye pain
• hearing loss
• itching
• joint or muscle pain
• loss of appetite
• loss of bowel control
• loss of vision
• pain behind the eyes
• pain in the legs
• pain with eye movement
• red skin lesions, often with a purple center
• red, irritated eyes
• reddish purple lines on the arms, face, legs, trunk, or groin
• severe headache
• sores, ulcers, or white spots in the mouth or on the lips

Other side effects of Procysbi

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:

Less common side effects

• breath odor
• constipation
• hives
• redness of the skin
• unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
• weight loss

For healthcare professionals

Applies to cysteamine: oral capsule, oral delayed release capsule, oral granule enteric coated.

General adverse events

The most common adverse events were vomiting, abdominal pain, nausea, anorexia, fever, diarrhea, lethargy, headache, and rash.^[Ref]

Gastrointestinal

• 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^[Ref]

Metabolic

• Very common (10% or more): Anorexia (31%)
• Uncommon (0.1% to 1%): Dehydration^[Ref]

Nervous system

• 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^[Ref]

Other

• Very common (10% or more): Fever (22%)
• Common (1% to 10%): Fatigue, asthenia
• Uncommon (0.1% to 1%): Decreasing hearing^[Ref]

Dermatologic

• 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^[Ref]

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.^[Ref]

Hepatic

• Common (1% to 10%): Abnormal liver function
• Frequency not reported: Elevated alkaline phosphatase^[Ref]

Cardiovascular

• Uncommon (0.1% to 1%): Hypertension^[Ref]

Genitourinary

• Uncommon (0.1% to 1%): Abnormal urine odor^[Ref]

Hematologic

• Uncommon (0.1% to 1%): Leukopenia, anemia^[Ref]

Immunologic

• Uncommon (0.1% to 1%): Anaphylactic reaction^[Ref]

Musculoskeletal

• Uncommon (0.1% to 1%): Joint hyperextension, leg pain, genu valgum, osteopenia, compression fracture, scoliosis
• Postmarketing reports: Molluscoid pseudotumors^[Ref]

Psychiatric

• Uncommon (0.1% to 1%): Nervousness, abnormal thinking, depression, emotional lability, hallucinations, nightmares^[Ref]

Renal

• Uncommon (0.1% to 1%): Nephrotic syndrome, interstitial nephritis, renal failure^[Ref]

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.^[Ref]

Further information

Procysbi 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