Applies to fosdenopterin: intravenous powder for solution.
Serious side effects of Fosdenopterin
Along with its needed effects, fosdenopterin 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 or nurse immediately if any of the following side effects occur while taking fosdenopterin:
More common
- Chills
- cold flu-like symptoms
- cough or hoarseness
- fever
- increased sensitivity of the skin to sunlight
- itching
- redness or other discoloration of the skin
- severe sunburn
- skin rash
Less common
- Agitation
- body aches or pain
- chest pain or tightness
- cough
- diarrhea
- earache
- ear congestion
- headache
- loss of appetite
- loss of voice
- nausea
- pale skin
- rash with flat lesions or small raised lesions on the skin
- redness or swelling in the ear
- runny or stuffy nose
- seizures
- sneezing
- sore throat
- stomach pain
- swelling of the eye
- trouble breathing
- unusual bleeding or bruising
- unusual tiredness or weakness
- vomiting
Other side effects of Fosdenopterin
Some side effects of fosdenopterin 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:
More common
- Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
For Healthcare Professionals
Applies to fosdenopterin: intravenous powder for injection.
General
Adverse reactions were assessed in 9 patients; the most reported reaction was catheter-related complications which were reported in 8 patients. Phototoxicity was reported in animals and patients are advised to avoid exposure to sunlight and use sun protection when that is not possible.[Ref]
Local
Catheter-related complications included complication associated with device, catheter site abscess, catheter site discharge, catheter site extravasation, catheter site pain, catheter site infection, catheter site inflammation, device dislocation, device leakage, device occlusion, and vascular device infection. Catheter-related complications occurred in 8 of 9 patients evaluated for adverse-reactions.
Very common (10% or more): Catheter-related complications (89%)
Respiratory
Very common (10% or more): Pneumonia (44%), coughing/sneezing (44%), upper viral respiratory infection (33%), lower respiratory tract infection (22%), viral tonsillitis (22%)
Nervous system
Very common (10% or more): Seizure (22%)
Dermatologic
Very common (10% or more): Rash maculo-papular (22%)
Frequency not reported: fungal skin infection, eczema
Gastrointestinal
One patient dies of necrotizing enterocolitis.
Very common (10% or more): Vomiting (44%), gastroenteritis (33%), diarrhea (33%), abdominal pain (22%), oropharyngeal pain (22%)
Frequency not reported: Fatal necrotizing enterocolitis, oral candidiasis
Immunologic
Very common (10% or more): Viral infection (56%), bacteremia (33%), influenza (22%)
Frequency not reported: Sepsis, varicella
Ocular
Very common (10% or more): Eye swelling (22%)
Psychiatric
Very common (10% or more): Agitation (22%)
Hematologic
Very common (10% or more): Anemia (22%)
Other
Very common (10% or more): Pyrexia (78%), otitis media (44%)
