The summary view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. The “quick view” table below provides the drug name and sections modified. Click on the drug name to go to the detailed view. The detailed view includes sections and subsections modified, a description of new or modified safety information in the BOXED WARNING, CONTRAINDICATIONS, or WARNINGS sections, and a link to the revised prescribing information.

Key to Label Section Acronyms:

BW=BOXED WARNING, C=CONTRAINDICATIONS, W=WARNINGS, P=PRECAUTIONS, AR=ADVERSE REACTIONS, PPI/MG=PATIENT PACKAGE INSERT/MEDICATION GUIDE

BW

C

W

P

AR

BW

C

W

P

AR

BW

C

W

P

AR

BW

C

W

P

AR

Abilify 

Abilify (aripiprazole) 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg tablets

Abilify (aripiprazole) 1 mg /mL Oral Solution

Abilify Discmelt (aripiprazole)  10 mg and 15 mg Orally Disintegrating Tablets

Abilify (aripiprazole) 9.75 mg / 1.3 mL (7.5 mg /mL) Injection

*labeling for the entire class of antipsychotic drugs

Geodon (ziprasidone) 20 mg, 40 mg, 60 mg, and 80 mg capsules and 20 mg base /mL injection

*labeling for the entire class of antipsychotic drugs

Haldol (haloperidol) 5 mg base /mL injection and Haldol Decanoate (haloperidol) 50 mg base /mL and 100 mg base /mL IM injection

*labeling for the entire class of antipsychotic drugs

Invega (paliperidone) 1.5 mg, 3 mg, 6 mg, and 9 mg Extended-Release tablets

*labeling for the entire class of antipsychotic drugs

Moban (molindone) 5 mg, 10 mg, 25 mg, and 50 mg tablets

*labeling for the entire class of antipsychotic drugs

Navane 

Navane (thiothixene) 1 mg, 2 mg, 5 mg, 10 mg, and 20 mg capsules

Navane (thiothixene) 5mg base /mL  oral concentrate

Navane (thiothixene) 2 mg base/mL and 10 mg base/mL injectable

*labeling for the entire class of antipsychotic drugs

Orap (pimozide) 1 mg and 2 mg tablets

*labeling for the entire class of antipsychotic drugs

Risperdal 

Risperdal (risperidone) 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg tablets

Risperdal (risperidone) 1 mg / mL oral solution 

Risperdal CONSTA (risperidone) 12.5 mg / vial, 25 mg / vial, 37.5 mg / vial, and 50 mg / vial Long-Acting injection 

Risperdal M-TAB (risperidone) 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg Orally Disintegrating tablets

*labeling for the entire class of antipsychotic drugs

BW

C

W

P

AR

BW

C

W

P

AR