Adverse reactions were reported in 13 of 2,872 patients (0.45%).
(At the end of the re-examination period).
Clinically significant adverse reactions (incidence unknown)
Anaphylactoid reaction
Anaphylactoid reaction such as decrease in blood pressure or dyspnea, may occur. Patients should be carefully observed. In the event of such symptoms, Mecobalamin should be discontinued immediately, and appropriate measures taken.
Other adverse reactions
| <0.1% | Incidence unknown | |
| Hypersensitivity (note) | Rash | |
| Others | Headache and hot sensation | Diaphoresis and pain/induration at the site of intramuscular injection |
Note: The incidence of adverse reactions includes post marketing surveillance.
| Reporting of suspected adverse drug reactions |
| Please contact: |
| HI-Eisai Pharmaceutical, Inc. |
| +63 2 88875837 / +63 2 88875160 / +63 9088672236 |
| Or Report to FDA Philippines: www.fda.gov.ph |
