openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Adverse reactions sections page 1 of 1 · 2 matching rows.
adverse reactions
ADVERSE REACTIONS The safety of IT PRIALT administered as a continuous infusion has been evaluated in 1254 patients participating in acute and severe chronic pain trials. The duration of treatment has ranged from a one-hour IT infusion to treatment lasting for more than 7.5 years. The mean duration of treatment was 193 days with 173 patients (14%) treated for at least 1 year. The average final dose was 17.6 mcg/day (0.73 mcg/hr). The most frequently reported adverse events (≥25%) in the 1254 patients (662 patient years) in clinical trials were dizziness, nausea, confusional state and nystagmus. Serious adverse events and discontinuation of PRIALT for adverse events are less frequent when the drug is slowly titrated over 21 days than with a faster titration schedule. (see CLINICAL TRIALS and DOSAGE and ADMINISTRATION .) Table 2 summarizes the treatment-emergent adverse events with a frequency of 5% or greater in the PRIALT-treated group from the one placebo-controlled trial using the slow titration schedule in patients with severe chronic pain. All events reported during the initial placebo-controlled period of the studies (21 days in the slow titration schedule) are tabulated, regardless of relationship to PRIALT. Table 2. Incidence of Treatment-Emergent Adverse Events in Slow Titration Placebo-Controlled Trial by Percent (Events That Occurred in ≥ 5% of Patients and More Commonly with PRIALT than with Placebo) MedDRA System Organ Class PRIALT Placebo MedDRA Preferred term N=112 N=108 Percentage of Patients Any AE 93 82 Ear and Labyrinth Disorders Vertigo 7 0 Eye Disorders Vision Blurred 12 3 Gastrointestinal Disorders Diarrhea NOS 18 15 Nausea 40 29 Vomitting NOS 16 14 General Disorders and Administration Site Conditions Asthenia 18 6 Gait Abnormal 14 2 Pyrexia 5 3 Rigors 7 5 Infections and Infestations Sinusitis NOS 5 2 Metabolism and Nutrition Disorders Anorexia 6 2 Musculoskeletal and Connective Tissue Disorders Muscle Spasms 6 4 Pain in Limb 5 2 Nervous System Disorders Amnesia 8 0 Ataxia 14 1 Dizziness 46 13 Dysarthria 7 0 Dysgeusia 5 5 Headache 13 11 Memory Impairment 7 1 Nystagmus NOS 8 0 Somnolence 17 10 Tremor 7 3 Psychiatric Disorders Anxiety 8 3 Confusional State 15 5 Insomnia 6 9 Renal and Urinary Disorders Urinary Retention 9 0 Skin and Subcutaneous Disorders Pruritis 7 7 Sweating Increased 5 6 The following adverse events assessed as related to PRIALT have been reported in 2% or greater of patients participating in the clinical studies (MedDRA preferred terms, by system organ class): EAR AND LABYRINTH DISORDERS: vertigo; EYE DISORDERS: diplopia, vision blurred, visual disturbance NOS; GASTROINTESTINAL DISORDERS: abdominal pain NOS, constipation, diarrhea NOS, dry mouth, nausea, nausea aggravated, vomiting NOS; GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS: asthenia, fall, fatigue, gait abnormal, lethargy, edema peripheral, pain NOS, pyrexia, rigors; INVESTIGATIONS: blood creatine phosphokinase increased; METABOLISM AND NUTRITION DISORDERS: anorexia, appetite decreased NOS; MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS: muscle cramp, muscle spasms, muscle weakness NOS, myalgia, pain in limb; NERVOUS SYSTEM DISORDERS: amnesia, aphasia, areflexia, ataxia, balance impaired NOS, burning sensation NOS, coordination abnormal NOS, disturbance in attention, dizziness, dizziness postural, dysarthria, dysgeusia, headache, hypoaesthesia, memory impairment, mental impairment NOS, nystagmus NOS, paraesthesia, sedation, somnolence, speech disorder, tremor; PSYCHIATRIC DISORDERS: agitation, anxiety, cognitive disorder NOS, confusional state, depression, depression aggravated, disorientation, hallucination NOS, hallucination auditory, hallucination visual, insomnia, irritability, mood disorder NOS, nervousness, paranoia; RENAL AND URINARY DISORDERS: dysuria, urinary hesitation, urinary retention; SKIN AND SUBCUTANEOUS TISSUE DISORDERS: pruritus, sweating increased; VASCULAR DISORDERS: hypotension NOS, orthostatic hypotension. At less than 2%, the following medically important events were assessed by the clinical investigators as related to PRIALT: acute renal failure, atrial fibrillation, cerebrovascular accident, sepsis, meningitis, psychotic disorder, suicidal ideation, respiratory distress, rhabdomyolysis, electrocardiogram abnormal, stupor, loss of consciousness, incoherent, clonic convulsion and grand mal convulsion. Rare instances of fatal pneumonia aspiration and suicide attempt were reported (<1%).