System Organ Adverse Reaction by Frequency Class Very common Common Uncommon Not (cannot 1/10 1/100 to <1/10 1/1000 to <1/100 be estimated from ≥ ≥ ≥ available data) Immune system Hypersensitivity disorders Anorexia Metabolism and nutrition disorders Decreased appetite Psychiatric Depression disorders Paranoia Confusional state Disorientation Mental status changes Anxiety Euphoric mood Dysphoria Emotional lability Disturbance in attention Nervous system Dizziness Amnesia disorders Headache Parosmia Somnolence Dysgeusia Tremor Lethargy Hypoasthesia Insomnia Sleep disorder Vision blurred Eye disorders Cardiac disorders Tachycardia Bradycardia Vascular disorders Hypotension Respiratory, Dyspnoea Oropharyngeal pain thoracic and Throat tightness mediastinal disorders Gastrointestinal Nausea Stomatitis Mouth ulceration Swollen tongue* disorders Vomiting Gingival ulceration Constipation Lip ulceration Dry mouth Impaired gastric emptying Abdominal pain Dyspepsia Stomach discomfort Tongue disorder Aphthous stomatitis
System Organ Class Adverse Reaction by Frequency Very common ≥ 1/10 Common ≥ 1/100 to <1/10 Uncommon ≥ 1/1000 to <1/100 Not (cannot be estimated from available data) Immune system disorders Hypersensitivity Metabolism and nutrition disorders Anorexia Decreased appetite Psychiatric disorders Depression Paranoia Confusional state Disorientation Mental status changes Anxiety Euphoric mood Dysphoria Emotional lability Disturbance in attention Nervous system disorders Dizziness Headache Somnolence Amnesia Parosmia Dysgeusia Tremor Lethargy Hypoasthesia Insomnia Sleep disorder Eye disorders Vision blurred Cardiac disorders Tachycardia Bradycardia Vascular disorders Hypotension Respiratory, thoracic and mediastinal disorders Dyspnoea Oropharyngeal pain Throat tightness Gastrointestinal disorders Nausea Stomatitis Vomiting Constipation Dry mouth Mouth ulceration Gingival ulceration Lip ulceration Impaired gastric emptying Abdominal pain Dyspepsia Stomach discomfort Tongue disorder Aphthous stomatitis Swollen tongue*
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