TABLE 6.

New reports of adverse drug reactions in postmarketing surveillance.

System/organ classification	New adverse reactions
Gastrointestinal disorders	Abnormal feces, gastrointestinal motility disorder, abnormal gastrointestinal sounds
Skin and subcutaneous tissue disorders	Swelling face (4), lip swelling (2), skin swelling (2), photosensitivity reaction, blister
Nervous system disorders	Insomnia (8), oral hypoesthesia (3), hypoesthesia, somnolence
General disorders and administration site conditions	Fever (2), chest discomfort (2), asthenia, chills, thirst, temperature intolerance, pain
Metabolism and nutrition disorders	Decreased appetite (7), hypoglycemia
Musculoskeletal and connective tissue disorders	Muscle weakness (2), joint pain
Immune system disorders	Hypersensitivity reaction (2), anaphylactic shock
Eye disorders	Ocular hyperemia, photophobia, lacrimation increased
Psychiatric disorders	Mental disorder, bruxism, agitation
Renal and urinary disorders	Polyuria
Cardiac disorders	Palpitation
Respiratory, thoracic and mediastinal disorders	Laryngeal edema
Investigations	Blood pressure decreased

^a Except the cases marked (whose occurrence times are indicated in brackets), the rest are single cases.