Orfadin Side Effects

Generic Name: nitisinone

Note: This page contains side effects data for the generic drug nitisinone. It is possible that some of the dosage forms included below may not apply to the brand name Orfadin.

It is possible that some side effects of Orfadin may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to nitisinone: oral capsule

As well as its needed effects, nitisinone (the active ingredient contained in Orfadin) may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking nitisinone, check with your doctor immediately:

More common
  • Bloated abdomen
  • dark-colored urine
  • dull, achy upper abdominal pain
  • general feeling of tiredness or weakness
  • headache
  • light-colored stools
  • loss of appetite
  • unexplained weight loss
  • vomiting
  • yellow eyes or skin
Less common
  • Black, tarry stools
  • blindness
  • blood in urine or stools
  • blisters on skin
  • bloody nose
  • blurred vision
  • change in color vision
  • chest pain or discomfort
  • chills
  • cough
  • darkening of urine
  • decreased vision
  • difficulty seeing at night
  • dry or itching eyes
  • dry skin
  • excessive tearing from eyes
  • eye pain
  • fever
  • fluid-filled skin blisters
  • general feeling of discomfort or illness
  • increased sensitivity of eyes to sunlight
  • irritation or inflammation of the eye
  • itching of the skin
  • painful or difficult urination
  • pinpoint red spots on skin
  • rash with flat lesions or small raised lesions on the skin
  • red, thickened, or scaly skin
  • redness, pain, swelling of eye, eyelid, or inner lining of eyelid burning
  • sensitivity to the sun
  • shortness of breath
  • skin thinness
  • sore throat
  • sores, ulcers, or white spots on lips or in mouth
  • swollen and/or painful glands
  • unusual bleeding or bruising
  • unexplained nosebleed
Rare
  • Agitation
  • anxiety
  • back pain
  • bloody stools
  • bluish color of fingernails, lips, skin, palms, or nail beds
  • change in personality
  • change in vision
  • cold sweats
  • coma
  • confusion
  • cool, pale skin
  • cough producing mucus
  • decreased urination
  • diarrhea
  • difficulty breathing
  • dizziness
  • drowsiness
  • dry mouth
  • earache
  • fainting
  • fast heartbeat
  • feeling full in upper abdomen
  • increase in heart rate
  • increase in body movements
  • increased hunger
  • infection
  • irregular, fast or slow, or shallow breathing
  • irritability
  • lightheadedness
  • mood or mental changes
  • nausea
  • nervousness
  • pain or swelling in arms or legs without any injury
  • pale skin
  • problems with walking or talking
  • rapid breathing
  • redness or swelling in ear
  • seeing things that are not there
  • shakiness
  • skin rash found mostly on mucous membranes such as eyes and mouth
  • stiff neck
  • sunken eyes
  • thirst
  • tightness in chest
  • vomiting of blood or material that looks like coffee grounds
  • wheezing
  • wrinkled skin

Some nitisinone side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

Less common or rare
  • Absent, missed, or irregular menstrual periods
  • burning feeling in chest or stomach
  • hair loss
  • indigestion
  • sleepiness
  • stomach upset
  • stopping of menstrual bleeding
  • tenderness in stomach area
  • thinning of hair
  • tooth discoloration

For Healthcare Professionals

Applies to nitisinone: oral capsule

General

The most common reported side effects included hepatic neoplasm, liver failure, thrombocytopenia, leucopenia, visual system complaints (conjunctivitis, corneal opacity, keratitis, photophobia).[Ref]

Dermatologic

Uncommon (0.1% to 1%): Pruritis (1%), exfoliative dermatitis (1%), dry skin (1%), maculopapular rash (1%), alopecia (1%)[Ref]

Endocrine

Frequency not reported: Hypoglycemia[Ref]

Gastrointestinal

Frequency not reported: Abdominal pain, diarrhea, enanthema, gastritis, gastroenteritis, gastrointestinal hemorrhage, melena, tooth discoloration[Ref]

Genitourinary

Frequency not reported: Amenorrhea[Ref]

Hematologic

Common (1% to 10%): Thrombocytopenia (3%), leucopenia (3%), granulocytopenia (1%), porphyria (1%), epistaxis (1%)[Ref]

Hepatic

Common (1% to 10%): Liver failure (7%)
Frequency not reported: Hepatic function disorder, elevated hepatic enzymes, liver enlargement[Ref]

Metabolic

Frequency not reported: High plasma tyrosine levels, dehydration[Ref]

Musculoskeletal

Frequency not reported: Pathological fracture[Ref]

Nervous system

Frequency not reported: Seizures, brain tumor, encephalopathy, headache, hyperkinesia, nervousness, somnolence[Ref]

Ocular

Common (1% to 10%): Conjunctivitis (2%), corneal opacity (2%), keratitis (2%), photophobia (2%), blepharitis (1%), eye pain (1%), cataracts (1%)[Ref]

Oncologic

Common (1% to 10%): Hepatic neoplasm (8%)[Ref]

Other

Frequency not reported: Death, cyanosis, thirst, infection, septicemia, otitis[Ref]

Respiratory

Frequency not reported: Bronchitis, respiratory insufficiency[Ref]

References

1. "Product Information. Orfadin (nitisinone)." Orphan Pharmaceuticals USA, Inc, Nashville, TN.

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