The Ministry of Food and Drug Safety (MFDS) said that it has added “increase in leukocyte cells” as an adverse effect for two ibuprofen injections – DB Pharm Korea’s Caldolor and Huons’ Amoburofen.
Ibuprofen injection is used for adjuvant therapy or fever when using narcotic analgesics for moderate to severe pain control.
The addition comes after a post-marketing survey conducted on 640 people for six years.
The survey showed 16 patients (2.5 percent) had an unexpected case of adverse effect unrelated to causality. Of these 16 patients, one of the patients (0.16 percent) showed an increase in the number of leukocyte cells in the blood from time to time.
Other adverse effects listed for the drug include nausea, vomiting, and headache, hypokalemia.
The ministry will be accepting all comments regarding the change until Feb. 23.
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