g Reactions Observed During the Clinical Trial eva luation of PERSERIS
The following list does not include reactions: 1) already listed in previous tables or elsewhere in labeling, 2) which are part of the disease state, 3) for which a drug cause was remote, 4) which were so general as to be uninformative, or 5) which were not considered to have significant clinical implications.
Blood and Lymphatic System Disorders: neutropenia
Ear and Labyrinth Disorders: vertigo
Endocrine Disorders: hyperprolactinemia
Eye Disorders: blepharospasm
Gastrointestinal Disorders: nausea, dyspepsia, vomiting, diarrhea, abdominal pain upper, salivary hypersecretion, hypoesthesia oral, tongue movement disturbance
General Disorders and Administration Site Conditions: injection site reaction (including injection site pain, induration, pruritus, bruising, erythema, inflammation, swelling and irritation) fatigue, edema peripheral, asthenia, chest discomfort
Investigations: blood prolactin increased, blood glucose increased, glycosylated hemoglobin increased, electrocardiogram abnormal, electrocardiogram QT prolonged, blood creatine phosphokinase increased
Metabolism and Nutrition Disorders: diabetes mellitus, decreased appetite
Musculoskeletal, Connective Tissue, and Bone Disorders: arthralgia, muscle twitching, joint stiffness, trismus
Nervous System Disorders: headache, dizziness, tremor, drooling, dyskinesia, lethargy, dystonia, hypoesthesia, oromandibular dystonia, tardive dyskinesia, cogwheel rigidity, dysarthria, balance disorder, parkinsonian rest tremor, parkinsonism, slow speech
Psychiatric Disorders: insomnia, libido decreased, bruxism, restlessness, anorgasmia, loss of libido
Reproductive System and Breast Disorders: erectile dysfunction, galactorrhea, breast tenderness, breast pain, amenorrhea, breast engorgement, ejaculation delayed, ejaculation disorder, gynecomastia, hypomenorrhea, breast discharge, breast enlargement, ejaculation failure, menstruation delayed, menstruation irregular, polymenorrhea
Skin and Subcutaneous Tissue Disorders: night sweats
Vascular Disorders: hypertension, hypotension, orthostatic hypotension
Other Adverse Reactions Observed During the Clinical Trial eva luations of Oral Risperidone
The following is a list of additional ADRs that have been reported during the clinical trial eva luation of oral risperidone, regardless of frequency of occurrence:
Blood and Lymphatic System Disorders: anemia, granulocytopenia
Cardiac Disorders: tachycardia, sinus bradycardia, sinus tachycardia, atrioventricular block first degree, bundle branch block left, bundle branch block right, atrioventricular block
Ear and Labyrinth Disorders: ear pain, tinnitus
Eye Disorders: vision blurred, oculogyration, ocular hyperemia, eye discharge, conjunctivitis, eye rolling, eyelid edema, eye swelling, eyelid margin crusting, dry eye, lacrimation increased, photophobia, glaucoma, visual acuity reduced
Gastrointestinal Disorders: dysphagia, fecaloma, fecal incontinence, gastritis, lip swelling, cheilitis, aptyalism
General Disorders: thirst, gait disturbance, chest pain, influenza-like illness, pitting edema, edema, chills, sluggishness, malaise, face edema, discomfort, generalized edema, drug withdrawal syndrome, peripheral coldness, feeling abnormal
Immune System Disorders: d |
