Risperidone
Product Images NDC 42291-913

Product Visual Gallery

This gallery contains 25 technical images submitted to the FDA as part of the official labeling for Risperidone (NDC 42291-913). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Avkare, these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

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10.1

A data table listing adverse reactions reported in 2% or more of Risperidone-treated adult patients compared to placebo in double-blind, placebo-controlled monotherapy trials for bipolar mania. The table categorizes reactions by system/organ class including eye, gastrointestinal, general, and nervous system disorders, showing percentages of patients reporting each reaction at Risperidone doses of 1 mg to 6 mg per day versus placebo.*

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10.2

A data table listing side effects including Sedation, Akathisia, Tremor, Dizziness, Dystonia, and Lethargy with corresponding numerical values in two columns. The bottom of the table includes footnotes explaining medical terms related to Parkinsonism, Akathisia, Tremor, and Dystonia.*

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11.1

A table listing adverse reactions occurring in 2% or more of risperidone-treated adult patients with bipolar mania from double-blind, placebo-controlled adjunctive therapy trials. It compares the percentage of patients experiencing reactions such as palpitations, dyspepsia, nausea, diarrhea, salivary hypersecretion, chest pain, and urinary tract infection between risperidone plus mood stabilizer and placebo plus mood stabilizer groups.*

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11.2

A data table listing side effects categorized by disorder type, with numeric values indicating frequency or severity. Categories include Parkinsonism, Sedation, Akathisia, Dizziness, Tremor, Lethargy, Psychiatric Disorders (Anxiety), and Respiratory, Thoracic and Mediastinal Disorders (Pharyngolaryngeal pain and Cough). Notes explain definitions of Parkinsonism and Akathisia.*

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12.1

Table showing adverse reactions reported in more than 5% of risperidone-treated pediatric patients with bipolar mania from double-blind, placebo-controlled trials. It details the percentage of patients reporting various reactions such as blurred vision, abdominal pain, nausea, vomiting, diarrhea, dyspepsia, stomach discomfort, and fatigue across different doses of risperidone and placebo.*

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12.2

A data table listing adverse reactions categorized by system organ class for Risperidone. It includes entries and associated values for nervous system disorders (sedation, dizziness, parkinsonism, dystonia, akathisia), psychiatric disorders (anxiety), respiratory disorders (pharyngolaryngeal pain), and skin disorders (rash). Footnotes define parkinsonism, dystonia, and akathisia symptoms.*

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13.1

A table listing adverse reactions reported in pediatric patients treated with Risperidone 0.5 mg/day to 4.0 mg/day compared to placebo in clinical trials for irritability associated with autistic disorder. The table shows reaction categories, specific reactions, and the percentage of patients reporting each reaction for both Risperidone and placebo groups.*

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13.2

A data table presenting adverse event frequency counts related to various disorders and symptoms. It includes categories like Investigations, Metabolism and Nutrition Disorders, Nervous System Disorders, Renal and Urinary Disorders, and Respiratory, Thoracic, and Mediastinal Disorders. The table lists conditions such as increased appetite, sedation, headache, enuresis, and cough with corresponding numerical values.*

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13.3

A section of a data table listing adverse effects related to nasal congestion and skin and subcutaneous tissue disorders, including rash, with numerical values provided in adjacent columns. It also includes a footnote explaining Parkinsonism-related symptoms such as musculoskeletal stiffness and muscle rigidity.*

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14

A data table titled 'Adverse Reactions Associated With Discontinuation in 2 or More Risperidone-Treated Adult Patients in Schizophrenia Trials.' It lists adverse reactions and the percentage of affected patients for three groups: Risperidone 2 mg/day to 8 mg/day (N=366), Risperidone >8 mg/day to 16 mg/day (N=198), and Placebo (N=225). Reported adverse reactions include dizziness, nausea, vomiting, parkinsonism, somnolence, dystonia, agitation, abdominal pain, orthostatic hypotension, and akathisia, with varying incidence percentages across the groups.*

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15

A table presenting adverse reactions associated with discontinuation in 2 or more adult patients treated with Risperidone at 1 mg/day to 6 mg/day in bipolar mania clinical trials compared to placebo. The table lists reactions including Parkinsonism, lethargy, dizziness, and increased alanine and aspartate aminotransferases with corresponding percentages for Risperidone and placebo groups.*

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16

A data table titled Table 16 displaying dose groups for Risperidone (2 mg, 6 mg, 10 mg, 16 mg) and placebo, with corresponding values for Parkinsonism and EPS Incidence percentages for each group.*

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17

A data table titled Table 17 presenting dose groups of Risperidone ranging from 1 mg to 16 mg. The table shows associated values for Parkinsonism and EPS incidence percentages, with Parkinsonism values increasing from 0.6 to 4.1 and EPS incidence from 7% to 20% across the dose groups.*

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8.1

Table presenting adverse reactions occurring in 2% or more of adult patients with schizophrenia treated with Risperidone in double-blind, placebo-controlled trials. The table compares the percentage of patients reporting reactions across three groups: 2 mg to 8 mg per day, greater than 8 mg to 16 mg per day, and placebo, organized by system/organ class and specific adverse reaction.*

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8.2

A partial data table listing adverse events associated with Risperidone, including categories such as General Disorders, Infections and Infestations, Investigations, and Musculoskeletal and Connective Tissue Disorders. The table details specific conditions like fatigue, chest pain, nasopharyngitis, and back pain with corresponding numerical data across columns, presented in a structured format.*

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8.3

A data table presenting adverse events categorized by system disorders including Nervous System Disorders, Psychiatric Disorders, Respiratory, Thoracic and Mediastinal Disorders, and Skin and Subcutaneous Tissue Disorders. The table shows various symptoms such as Parkinsonism, Insomnia, Nasal congestion, and Rash, with corresponding frequency counts under separate columns.*

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8.4

A data table segment displaying vascular disorders related to orthostatic hypotension with corresponding numerical data. Below the table, a detailed note explains various symptoms and conditions associated with Parkinsonism, akathisia, dystonia, and tremor.*

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25 (908 50 0.25mg 500ct)

Risperidone Tablets, USP 0.25 mg label showing the product name with strength prominently displayed. The label states Rx only and a quantity of 500 tablets. Manufactured for AvKARE, Pulaski, TN and by Amneal Pharmaceuticals of NY, LLC, Brookhaven, NY. Storage instructions and dosage advisory are included along with the NDC 42291-908-50 barcode.*

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.5 (909 50 .5mg 500ct)

The label shows Risperidone Tablets, USP 0.5 mg in a bottle containing 500 tablets. It is manufactured for AvKARE, with storage instructions to keep between 20° to 25°C, allowing excursions to 15° to 30°C, and to protect from light and moisture. The label states 'Rx only' and includes manufacturer and packer details.*

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1 (910 50 1mg 500ct)

Risperidone Tablets USP label from AvKARE for 1 mg strength. The label indicates a package size of 500 tablets and includes storage instructions, dosage unit, and manufacturer information. The label features the proprietary name 'risperiDONE' prominently along with a barcode and NDC number 42291-910-50.*

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2 (911 50 2mg 500ct)

Risperidone Tablets, USP 2 mg packaging label showing a bottle label with red and black text. The label states each tablet contains 2 mg of Risperidone, and includes storage and dosage information. It is labeled for Rx only with a count of 500 tablets and manufactured for AvKARE in Pulaski, TN.*

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3 (912 50 3mg 500ct)

Packaging label for Risperidone Tablets, USP 3 mg by AvKARE. The label indicates a quantity of 500 tablets, with storage instructions and dosage information. The label includes the National Drug Code (NDC) 42291-912-50 and manufacturing details for AvKARE and Amneal Pharmaceuticals of NY, LLC.*

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4 (913 50 4mg 500ct)

Label for risperiDONE Tablets, USP 4 mg by AvKARE. The label indicates each tablet contains 4 mg of Risperidone. It shows the package size of 500 tablets, storage instructions, manufacturer information for AvKARE in Pulaski, TN, and Amneal Pharmaceuticals of NY, LLC. The label includes dosage guidance to see the outer carton and a barcode with NDC 42291-913-50.*

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Table 9

Table showing adverse reactions reported in more than 5% of pediatric patients treated with Risperidone compared to placebo in a double-blind trial for schizophrenia. It lists reactions by system or organ class, including gastrointestinal, nervous system, and psychiatric disorders, with percentages for different Risperidone dosing groups and placebo.*

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1 (Risperidone Tablets Usp 1)

Chemical structure of risperidone, an antipsychotic active ingredient. The diagram shows fused six-membered rings, nitrogen atoms incorporated in the ring system, and a fluorinated aromatic substituent, consistent with risperidone's molecular structure.*

* About these descriptions: Image descriptions on this page are generated by automated AI analysis of the product label images from the manufacturer's FDA label submission (SPL). They are provided for reference only and may contain errors or omissions. Always rely on the printed label itself and the official FDA labeling, and consult a pharmacist or healthcare professional with any questions about this product.