Flucloxacillin and oesophageal complaints
The Netherlands Pharmacovigilance Centre Lareb received 22 reports of oesophageal complaints associated with the use of flucloxacillin. The complaints varied from oesophageal pain, a burning feeling in the oesophagus to oesophagitis.
Flucloxacillin is indicated for the treatment of respiratory infections and infections of the skin and soft tissue. Oesophageal complaints are not mentioned in the Dutch Summary of Product Characteristics of flucloxacillin. Based on the received reports, it seems that flucloxacillin itself causes the complaints and not an excipient. Some patients took stomach protectors to treat their oesophageal complaints.
Lareb informed the Dutch Medicines Evaluation Board about these reports. The Dutch Medicines Evaluation Board will discuss this association within the European regulatory network.