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

Along with its needed effects, nitisinone (the active ingredient contained in Orfadin) 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 nitisinone:

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 side effects of nitisinone 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 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).

Dermatologic

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

Endocrine

Frequency not reported: Hypoglycemia

Gastrointestinal

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

Genitourinary

Frequency not reported: Amenorrhea

Hematologic

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

Hepatic

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

Metabolic

Frequency not reported: High plasma tyrosine levels, dehydration

Musculoskeletal

Frequency not reported: Pathological fracture

Nervous system

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

Ocular

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

Oncologic

Common (1% to 10%): Hepatic neoplasm (8%)

Other

Frequency not reported: Death, cyanosis, thirst, infection, septicemia, otitis

Respiratory

Frequency not reported: Bronchitis, respiratory insufficiency

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