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Antipsychotics Side Effects and Adverse Effects reported to US Food and Drug Administration (FDA)

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Fall, Haemorrhage Intracranial (8473851-4)
on Jan 26, 2012 Female from UNITED STATES , 54 years of age, was diagnosed with
  • schizoaffective disorder
and was treated with Antipsychotics. Directly after, patient experienced the unwanted or unexpected Antipsychotics side effects: fall, haemorrhage intracranial. Antipsychotics dosage: N/A.
Associated medications used:
  • Clozapine
  • Clozapine
Patient was hospitalized.

Osteonecrosis Of Jaw, Toothache (8473291-8)
Patient was taking Antipsychotics. Patient felt the following Antipsychotics side effects: osteonecrosis of jaw, toothache on Jun 25, 2012 from GREECE Additional patient health information: Female , 70 years of age, . Antipsychotics dosage: N/A.
Multiple prescriptions taken:
  • Prolia (60 Mg, Q6mo)


Psychotic Disorder (8425966-4)
Adverse event was reported on May 31, 2012 by a Female taking Antipsychotics (Dosage: Received Depot) . Location: UNITED KINGDOM , 59 years of age, After Antipsychotics was administered, patient encountered several Antipsychotics side effects: psychotic disorder.
Multiple concurrent drugs taken:
  • Ethambutol Hydrochloride
  • Isoniazid
  • Rifampicin
  • Tricyclic Antidepressants
  • Pyrazinamide


Dysphoria, Aggression, Hallucination, Auditory, Disinhibition, Psychotic Disorder, Persecutory Delusion, Treatment Noncompliance (8310476-5)
on Apr 13, 2012 Male from NETHERLANDS , 42 years of age, was diagnosed with
  • psychotic disorder
and was treated with Antipsychotics. Directly after, patient experienced the unwanted or unexpected Antipsychotics side effects: dysphoria, aggression, hallucination, auditory, disinhibition, psychotic disorder, persecutory delusion, treatment noncompliance. Antipsychotics dosage: N/A.
Associated medications used:
  • Cannabis
  • Methylphenidate Hcl
  • Methylphenidate Hcl
  • Cocaine
  • Methylphenidate Hcl
Patient was hospitalized.


White Blood Cell Count Decreased, Acute Psychosis, Somatic Hallucination, Neutrophil Count Decreased, Psychotic Disorder, Hallucination, Auditory, Blood Disorder, Influenza Like Illness, Euphoric Mood (8303807-3)
on Apr 11, 2012 Male from UNITED KINGDOM , 51 years of age, was treated with Antipsychotics. Patient felt the following Antipsychotics side effects: white blood cell count decreased, acute psychosis, somatic hallucination, neutrophil count decreased, psychotic disorder, hallucination, auditory, blood disorder, influenza like illness, euphoric mood. Antipsychotics dosage: N/A.
Multiple prescriptions taken:
  • Clozapine (225 Mg, Daily)
  • Aripiprazole
  • Amisulpride
  • Clozapine


Intentional Overdose (8152617-9)
Patient was taking Antipsychotics. After Antipsychotics was administered, patient encountered several Antipsychotics side effects: intentional overdose on Feb 14, 2012 from UNITED STATES Additional patient health information: Female , weighting 134.0 lb, . Antipsychotics dosage: N/A.
Multiple concurrent drugs taken:
  • Tylenol Pm (Daily Dose Text: ^7 -8 Bottles^)
  • Benadryl
  • Benadryl (Daily Dose Text: 2 Bottles)
Patient was hospitalized.

Hepatitis C, Abdominal Pain Upper, Pancreatitis, Diabetes Mellitus (8102482-0)
Adverse event was reported on Jan 23, 2012 by a Male taking Antipsychotics (Dosage: N/A) . Location: UNITED STATES , weighting 140.0 lb, Directly after, patient experienced the unwanted or unexpected Antipsychotics side effects: hepatitis c, abdominal pain upper, pancreatitis, diabetes mellitus.
Associated medications used:
  • Clozaril
  • Zyprexa (20 Mg, Unk)
  • Seroquel


Skin Discolouration, Pain In Extremity, Thrombophlebitis Superficial, Oedema Peripheral (8075356-1)
on Jan 19, 2012 Female from UNITED STATES , 31 years of age, was treated with Antipsychotics. Patient felt the following Antipsychotics side effects: skin discolouration, pain in extremity, thrombophlebitis superficial, oedema peripheral. Antipsychotics dosage: N/A.
Multiple prescriptions taken:
  • Zoloft
  • Yaz


Gastrointestinal Haemorrhage (7933338-1)
on Nov 08, 2011 Male from UNITED STATES , 59 years of age, was treated with Antipsychotics. After Antipsychotics was administered, patient encountered several Antipsychotics side effects: gastrointestinal haemorrhage. Antipsychotics dosage: N/A.
Multiple concurrent drugs taken:
  • Nuedexta (1 Cap, Qd)
  • Nuedexta (1 Cap, Qd)
  • Depakote
  • Ativan
  • Seroquel
Patient was hospitalized.

White Blood Cell Count Increased, Quality Of Life Decreased, Neutrophil Count Increased, Malaise, Neutropenia (7682184-5)
Patient was taking Antipsychotics. Directly after, patient experienced the unwanted or unexpected Antipsychotics side effects: white blood cell count increased, quality of life decreased, neutrophil count increased, malaise, neutropenia on Aug 10, 2011 from UNITED KINGDOM Additional patient health information: Male , 26 years of age, . Antipsychotics dosage: N/A.
Associated medications used:
  • Clozapine (300 Mg, Qd)
  • Neupogen


Neutropenia, White Blood Cell Count Increased, Malaise, Quality Of Life Decreased, Neutrophil Count Increased (7668298-4)
Adverse event was reported on Aug 01, 2011 by a Male taking Antipsychotics (Dosage: N/A) . Location: UNITED KINGDOM , 26 years of age, Patient felt the following Antipsychotics side effects: neutropenia, white blood cell count increased, malaise, quality of life decreased, neutrophil count increased.
Multiple prescriptions taken:
  • Neupogen
  • Clozapine (Unk)


Coma, Hypotension, Toxicity To Various Agents, Oxygen Saturation Decreased (7647976-7)
on Jul 21, 2011 Female from UNITED STATES , 57 years of age, was treated with Antipsychotics. After Antipsychotics was administered, patient encountered several Antipsychotics side effects: coma, hypotension, toxicity to various agents, oxygen saturation decreased. Antipsychotics dosage: N/A.
Multiple concurrent drugs taken:
  • Anticonvulsant
  • Anti-anxiety
  • Carbamazepine


Quality Of Life Decreased, Malaise, Neutrophil Count Increased, Neutropenia, White Blood Cell Count Increased (7515693-X)
on May 25, 2011 Male from UNITED KINGDOM , 26 years of age, was treated with Antipsychotics. Directly after, patient experienced the unwanted or unexpected Antipsychotics side effects: quality of life decreased, malaise, neutrophil count increased, neutropenia, white blood cell count increased. Antipsychotics dosage: N/A.
Associated medications used:
  • Clozaril (Unk)
  • Neupogen


Fall, Off Label Use, Cerebrovascular Accident (7469131-6)
Patient was taking Antipsychotics. Patient felt the following Antipsychotics side effects: fall, off label use, cerebrovascular accident on Apr 26, 2011 from CANADA Additional patient health information: Female , 81 years of age, . Antipsychotics dosage: N/A.
Multiple prescriptions taken:
  • Olanzapine


Overdose, Respiratory Arrest, Convulsion (7457015-9)
Adverse event was reported on Apr 19, 2011 by a Male taking Antipsychotics (Dosage: N/A) . Location: UNITED STATES , 50 years of age, After Antipsychotics was administered, patient encountered several Antipsychotics side effects: overdose, respiratory arrest, convulsion.
Multiple concurrent drugs taken:
  • Ultram (Took 5 At Once)
Patient was hospitalized.

Hallucination, Auditory, Extrapyramidal Disorder, Abnormal Behaviour (7358598-X)
on Jan 25, 2011 Male from UNITED KINGDOM , 28 years of age, was diagnosed with
  • psychotic disorder
and was treated with Antipsychotics. Directly after, patient experienced the unwanted or unexpected Antipsychotics side effects: hallucination, auditory, extrapyramidal disorder, abnormal behaviour. Antipsychotics dosage: N/A.
Associated medications used:
  • Amisulpride
  • Tacrolimus
  • Clozapine
  • Mycophenolate Mofetil


Completed Suicide (7334333-6)
on Jan 25, 2011 Female from UNITED STATES , 50 years of age, was treated with Antipsychotics. Patient felt the following Antipsychotics side effects: completed suicide. Antipsychotics dosage: N/A.
Multiple prescriptions taken:
  • Hydrocodone/acetaminophen
  • Warfarin
  • Methamphetamine
  • Alprazolam


Hypotension, Shock, Vasoplegia Syndrome, Coma Scale Abnormal, Toxicity To Various Agents (7319972-0)
Patient was taking Antipsychotics. After Antipsychotics was administered, patient encountered several Antipsychotics side effects: hypotension, shock, vasoplegia syndrome, coma scale abnormal, toxicity to various agents on Feb 24, 2011 from FRANCE Additional patient health information: Male , 44 years of age, . Antipsychotics dosage: N/A.
Multiple concurrent drugs taken:
  • Amlor (20 Tabs In Single Intake)
  • Rasilez (1 Packet Of 20 Tabs In Single Intake)
  • Benzodiazepines
Patient was hospitalized.

Extrapyramidal Disorder, No Therapeutic Response, Abnormal Behaviour, Hallucination, Auditory (7298167-3)
Adverse event was reported on Jan 25, 2011 by a Male taking Antipsychotics (antipsychotics) (Dosage: N/A) . Location: UNITED KINGDOM , 28 years of age, Directly after, patient experienced the unwanted or unexpected Antipsychotics side effects: extrapyramidal disorder, no therapeutic response, abnormal behaviour, hallucination, auditory.
Associated medications used:
  • Amisulpride (amisulpride)
  • Clozapine
  • Mycophenolate Mofetil
  • Tacrolimus


Pancytopenia (6341444-0)
on Aug 26, 2009 Male from JAPAN , 38 years of age, was treated with Antipsychotics. Patient felt the following Antipsychotics side effects: pancytopenia. Antipsychotics dosage: Unk.
Multiple prescriptions taken:
  • Depromel (Unk)
  • Seroquel (Unk)
  • Myslee (Unk)
Patient was hospitalized.

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It is very important to keep track of all side effects and discuss them with your doctor. If you think you may have a medical emergency, call your doctor or 911 immediately.

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Most drugs have a large list of nonsevere or mild adverse effects which do not rule out continued usage. These effects depend on individual sensitivity, and can include nausea, dizziness, diarrhea, malaise, vomiting, headache, dermatitis, dry mouth, etc. Check commonly reported side effects . These can be considered a form of pseudo-allergic reaction, as not all users experience these effects; many users experience none at all.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

Antipsychotics Information

More About Antipsychotics

Side Effects reported to FDA: 20. View Antipsychotics Adverse Reports

Antipsychotics safety alerts: 2008

Reported deaths: 4

Reported hospitalizations: 7

Antipsychotics, Conventional and Atypical

Audience: Neuropsychiatric and geriatrics healthcare professionals

[Posted 06/16/2008] FDA notified healthcare professionals that both conventional and atypical antipsychotics are associated with an increased risk of mortality in elderly patients treated for dementia-related psychosis. In April 2005, FDA notified healthcare professionals that patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death. Since issuing that notification, FDA has reviewed additional information that indicates the risk is also associated with conventional antipsychotics. Antipsychotics are not indicated for the treatment of dementia-related psychosis. The prescribing information for all antipsychotic drugs will now include the same information about this risk in a BOXED WARNING and the WARNINGS section.

[June 16, 2008 - Information for Healthcare Professionals - FDA]
[June 16, 2008 - News Release - FDA]

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