Ostenil Plus Adverse Reactions

Summary of the safety profile: The most commonly reported undesirable effects reported with OSTENIL PLUS are injection site reactions, including pain, effusion, swelling, inflammation, redness and warmth. Application of an ice pack onto the joint for five to ten minutes reduces the incidence of these events.
List of adverse reactions: Adverse reactions associated with OSTENIL PLUS obtained from clinical studies and postmarketing surveillance are listed as follows by body system organ class and frequency: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS: Common: Injection site pain, injection site effusion, injection site swelling, injection site inflammation, injection site redness, injection site warmth.
Description of selected adverse reactions: As with all injectables, adverse reactions may include the risk of infection (see Precautions).
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system.