Medication Guide App

Label Changes for:

Invega (paliperidone) extended-release tablets

March 2010

Changes have been made to the ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – March 2010

ADVERSE REACTIONS

Commonly-Observed Adverse Reactions in Double-Blind, Placebo- Controlled Clinical Trials – Schizoaffective Disorder
  • Table 2 Updated
  • Extrapyramidal symptoms includes the terms bradykinesia, drooling, dyskinesia, dystonia, hypertonia, muscle rigidity, muscle twitching, oculogyration, parkinsonian gait, parkinsonism, restlessness, and tremor. Somnolence includes the terms sedation and somnolence.
Other Adverse Reactions Observed During Premarketing Evaluation of Invega

The following also includes additional adverse reactions reported at any frequency by Invega-treated subjects who participated in other clinical studies

  • Cardiac disorders: bundle branch block left,
  • Endocrine disorders: hyperprolactinemia
  • Gastrointestinal disorders: flatulence
  • General disorders: edema peripheral
  • Infections and infestations: urinary tract infection
  • Investigations: electrocardiogram abnormal
  • Musculoskeletal and connective tissue disorders: arthralgia, pain in extremity
  • Nervous system disorders: cerebrovascular accident, convulsion, transient ischemic attack, additional extrapyramidal symptoms
    (cogwheel rigidity, muscle spasms, musculoskeletal pain, torticollis, trismus)
  • Psychiatric disorders: agitation
  • Reproductive system and breast disorders: breast tenderness, retrograde ejaculation
  • Respiratory, thoracic and mediastinal disorders: nasal congestion, pneumonia aspiration
  • Skin and subcutaneous tissue disorders: pruritus, rash, rash papular
Postmarketing Experience
  • angioedema, swollen tongue. tardive dyskinesia, urinary incontinence, urinary retention
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