Risperidone

Risperidone

Risperidone Recall

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Questions & Answers

Side Effects & Adverse Reactions

There is currently no warning information available for this product. We apologize for any inconvenience.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

1.1 Schizophrenia

Risperidone tablets are indicated for the treatment of schizophrenia. Efficacy was established in 4 short-term trials in adults, 2 short-term trials in adolescents (ages 13 to 17 years), and one long-term maintenance trial in adults [see Clinical Studies (14.1)].

1.2 Bipolar Mania

Monotherapy

Risperidone tablets are indicated for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder. Efficacy was established in 2 short-term trials in adults and one short-term trial in children and adolescents (ages 10 to 17 years)[see Clinical Studies (14.2)]

Adjunctive Therapy

Risperidone tablets adjunctive therapy with lithium or valproate is indicated for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder. Efficacy was established in one short-term trial in adults [see Clinical Studies (14.3)].

1.3 Irritability Associated with Autistic Disorder

Risperidone tablets are indicated for the treatment of irritability associated with autistic disorder, including symptoms of aggression towards others, deliberate self-injuriousness, temper tantrums, and quickly changing moods. Efficacy was established in 3 short-term trials in children and adolescents (ages 5 to 17 years)  [see Clinical Studies (14.4)].

History

There is currently no drug history available for this drug.

Other Information

Risperidone tablets USP contain risperidone USP, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2- benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.49. The structural formula is:

structure

Risperidone USP is a white to slightly beige powder. It is practically insoluble in water, freely soluble in methylene chloride, and soluble in methanol and 0.1 N HCl.

Risperidone tablets USP are for oral administration and available in 0.25 mg (orange), 0.5 mg (orange), 1 mg (white), 2 mg (yellow), 3 mg (orange), and 4 mg (brown) strengths. Risperidone tablets contain the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, propylene glycol (except 1mg), sodium lauryl sulphate, sodium starch glycolate and polyethylene glycol (1mg). Tablets of 0.25 mg, 0.5 mg, 2 mg, 3 mg, and 4 mg also contain talc and titanium dioxide. 0.25 mg, 0.5 mg, and 3 mg tablets contain FD&C Yellow # 6 aluminum lake, the 2 mg tablets contain yellow iron oxide; the 4 mg tablets contain iron oxide red.

Risperidone Manufacturers


  • Proficient Rx Lp
    Risperidone Tablet [Proficient Rx Lp]
  • Remedyrepack Inc.
    Risperidone Tablet [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Risperidone Tablet [Remedyrepack Inc. ]
  • Proficient Rx Lp
    Risperidone Tablet, Film Coated [Proficient Rx Lp]
  • Remedyrepack Inc.
    Risperidone Tablet [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Risperidone Tablet [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Risperidone Tablet [Remedyrepack Inc. ]
  • Direct Rx
    Risperidone Tablet, Film Coated [Direct Rx]
  • State Of Florida Doh Central Pharmacy
    Risperidone Tablet [State Of Florida Doh Central Pharmacy]
  • State Of Florida Doh Central Pharmacy
    Risperidone Tablet, Film Coated [State Of Florida Doh Central Pharmacy]
  • Proficient Rx Lp
    Risperidone Tablet [Proficient Rx Lp]
  • Torrent Pharmaceuticals Limited
    Risperidone Tablet [Torrent Pharmaceuticals Limited]
  • Sandoz Inc
    Risperidone Tablet, Orally Disintegrating [Sandoz Inc]
  • West-ward Pharmaceutical Corp
    Risperidone Tablet [West-ward Pharmaceutical Corp]
  • State Of Florida Doh Central Pharmacy
    Risperidone Tablet [State Of Florida Doh Central Pharmacy]
  • State Of Florida Doh Central Pharmacy
    Risperidone Tablet, Film Coated [State Of Florida Doh Central Pharmacy]
  • Ratiopharm Inc
    Risperidone (Risperidone) Tablet, Coated [Ratiopharm Inc]
  • State Of Florida Doh Central Pharmacy
    Risperidone Tablet, Film Coated [State Of Florida Doh Central Pharmacy]
  • Contract Pharmacy Services-pa
    Risperidone Tablet [Contract Pharmacy Services-pa]
  • Pd-rx Pharmaceuticals, Inc.
    Risperidone Tablet [Pd-rx Pharmaceuticals, Inc.]
  • Contract Pharmacy Services-pa
    Risperidone Tablet, Film Coated [Contract Pharmacy Services-pa]
  • Cobalt Laboratories
    Risperidone Tablet, Film Coated [Cobalt Laboratories]
  • Remedyrepack Inc.
    Risperidone (Risperidone) Tablet [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Risperidone (Risperidone) Tablet [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Risperidone (Risperidone) Tablet [Remedyrepack Inc. ]
  • Cardinal Health
    Risperidone Tablet, Film Coated [Cardinal Health]
  • Gen-source Rx
    Risperidone Tablet, Film Coated [Gen-source Rx]
  • Physicians Total Care, Inc
    Risperidone Tablet [Physicians Total Care, Inc]
  • Hikma Pharmaceutical
    Risperidone Tablet [Hikma Pharmaceutical]
  • Cardinal Health
    Risperidone Tablet, Film Coated [Cardinal Health]
  • Stat Rx Usa Llc
    Risperidone Tablet [Stat Rx Usa Llc]
  • Rebel Distributors Corp
    Risperidone Tablet [Rebel Distributors Corp]
  • H.j. Harkins Company, Inc.
    Risperidone Tablet [H.j. Harkins Company, Inc.]
  • Cadila Healthcare Limited
    Risperidone Tablet, Film Coated [Cadila Healthcare Limited]
  • Aurolife Pharma Llc
    Risperidone Tablet, Film Coated [Aurolife Pharma Llc]
  • Breckenridge Pharmaceutical, Inc.
    Risperidone Tablet [Breckenridge Pharmaceutical, Inc.]
  • Par Pharmaceutical Companies, Inc.
    Risperidone Tablet, Orally Disintegrating [Par Pharmaceutical Companies, Inc.]
  • Mylan Institutional Inc.
    Risperidone Tablet, Film Coated [Mylan Institutional Inc.]
  • Mylan Institutional Inc.
    Risperidone Tablet, Orally Disintegrating [Mylan Institutional Inc.]
  • Wockhardt Limited
    Risperidone Tablet, Film Coated [Wockhardt Limited]
  • Wockhardt Usa Llc
    Risperidone Tablet, Film Coated [Wockhardt Usa Llc]
  • Jubilant Cadista Pharmaceuticals Inc.
    Risperidone (Risperidone) Tablet, Orally Disintegrating [Jubilant Cadista Pharmaceuticals Inc.]
  • Cadila Healthcare Limited
    Risperidone Tablet, Orally Disintegrating [Cadila Healthcare Limited]
  • Bryant Ranch Prepack
    Risperidone Tablet, Film Coated [Bryant Ranch Prepack]
  • Bryant Ranch Prepack
    Risperidone Tablet, Film Coated [Bryant Ranch Prepack]
  • Bryant Ranch Prepack
    Risperidone Tablet, Film Coated [Bryant Ranch Prepack]
  • Bryant Ranch Prepack
    Risperidone Tablet, Film Coated [Bryant Ranch Prepack]
  • Bryant Ranch Prepack
    Risperidone Tablet, Film Coated [Bryant Ranch Prepack]
  • Bryant Ranch Prepack
    Risperidone Tablet, Film Coated [Bryant Ranch Prepack]
  • Dr. Reddy’s Laboratories Limited
    Risperidone Tablet, Film Coated [Dr. Reddy’s Laboratories Limited]
  • Remedyrepack Inc.
    Risperidone Tablet, Film Coated [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Risperidone Tablet, Film Coated [Remedyrepack Inc. ]
  • Sun Pharmaceutical Industries Limited
    Risperidone Tablet, Orally Disintegrating [Sun Pharmaceutical Industries Limited ]
  • Remedyrepack Inc.
    Risperidone Tablet, Film Coated [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Risperidone Tablet, Film Coated [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Risperidone Tablet, Film Coated [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Risperidone Tablet [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Risperidone Tablet, Film Coated [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Risperidone Tablet, Film Coated [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Risperidone Tablet, Film Coated [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Risperidone Tablet, Film Coated [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Risperidone Tablet, Film Coated [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Risperidone Tablet, Film Coated [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Risperidone Tablet [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Risperidone Tablet, Film Coated [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Risperidone Tablet [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Risperidone Tablet, Film Coated [Remedyrepack Inc. ]
  • Mckesson Contract Packaging
    Risperidone Tablet, Film Coated [Mckesson Contract Packaging]
  • Cardinal Health
    Risperidone Tablet, Film Coated [Cardinal Health]
  • Remedyrepack Inc.
    Risperidone Tablet, Film Coated [Remedyrepack Inc. ]
  • Lake Erie Medical Dba Quality Care Products Llc
    Risperidone Tablet, Film Coated [Lake Erie Medical Dba Quality Care Products Llc]
  • Cardinal Health
    Risperidone Tablet, Film Coated [Cardinal Health]
  • Dr. Reddy’s Laboratories Limited
    Risperidone Tablet, Orally Disintegrating [Dr. Reddy’s Laboratories Limited]
  • Major Pharmaceuticals
    Risperidone Tablet, Film Coated [Major Pharmaceuticals]
  • Major Pharmaceuticals
    Risperidone Tablet [Major Pharmaceuticals]
  • Ncs Healthcare Of Ky, Inc Dba Vangard Labs
    Risperidone Tablet, Film Coated [Ncs Healthcare Of Ky, Inc Dba Vangard Labs]
  • Mckesson Packaging Services A Business Unit Of Mckesson Corporation
    Risperidone Tablet, Film Coated [Mckesson Packaging Services A Business Unit Of Mckesson Corporation]
  • American Health Packaging
    Risperidone Tablet, Film Coated [American Health Packaging]
  • Aidarex Pharmaceuticals Llc
    Risperidone Tablet [Aidarex Pharmaceuticals Llc]
  • Caraco Pharmaceutical Laboratories, Ltd.
    Risperidone Tablet [Caraco Pharmaceutical Laboratories, Ltd.]
  • Unit Dose Services
    Risperidone Tablet [Unit Dose Services]
  • State Of Florida Doh Central Pharmacy
    Risperidone Tablet, Film Coated [State Of Florida Doh Central Pharmacy]
  • State Of Florida Doh Central Pharmacy
    Risperidone Tablet, Film Coated [State Of Florida Doh Central Pharmacy]