Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
ADVERSE REACTIONS Allergic reactions have been reported following the use of oral and parenteral folate.
xxix Mild transient diarrhea, polycythemia vera, itching, transitory exanthema, and the feeling of swelling of the entire body have been associated with methylcobalamin.
xxx Allergic reactions, acne, skin reactions, photosensitivity, nausea, vomiting, abdominal pain, loss of appetite, paresthesia, somnolence, nausea, and headaches have been associated with pyridoxal-5’-phosphate.
xxxi Call your medical practitioner about side effects.
You may report side effects to the FDA at 1-800- FDA-1088 or call Key Therapeutics, LLC.
at 888-981-8337.
WARNINGS/PRECAUTIONS: Caution is recommended in patients with a family history of bipolar illness.
Mood elevation is possible in this population.
Caution is also recommended in patients taking anticonvulsant medications as folate may interfere with anticonvulsant medication, and may lower seizure threshold.
Furthermore, it has been reported that anticonvulsant medications interfere with folate metabolism, but the exact action is unclear;
therefore caution is recommended with patients in this therapeutic group.
Like all medications, Accentrate Pnv can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: