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

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Abdominal Pain, Colitis Ischaemic, Necrotising Colitis, Vomiting (5708228-5)
on Apr 14, 2008 Male from FRANCE , 48 years of age, was treated with Moditen. Directly after, patient experienced the unwanted or unexpected Moditen side effects: abdominal pain, colitis ischaemic, necrotising colitis, vomiting. Moditen dosage: N/A.
Associated medications used:
  • Tiapridal
  • Lepticur
  • Nozinan
  • Anticholinergic Agent
Patient was hospitalized.

Abdominal Pain, Colitis Ischaemic, Vomiting (5707308-8)
Patient was taking Moditen. Patient felt the following Moditen side effects: abdominal pain, colitis ischaemic, vomiting on Apr 14, 2008 from FRANCE Additional patient health information: Male , 48 years of age, . Moditen dosage: N/A.
Multiple prescriptions taken:
  • Tiapridal
  • Lepticur
  • Nozinan
  • Anticholinergic Agent
Patient was hospitalized.

Hyponatraemia, Malaise, Nausea, Polydipsia, Vomiting (5505111-5)
Adverse event was reported on Oct 30, 2007 by a Male taking Moditen Tabs (Dosage: N/A) was diagnosed with
  • delusional disorder, persecutory type
and. Location: FRANCE , 60 years of age, After Moditen was administered, patient encountered several Moditen side effects: hyponatraemia, malaise, nausea, polydipsia, vomiting. Patient was hospitalized.

Abnormal Behaviour, Amnesia, Apraxia, Confabulation, Delirium, Disorientation, Dysarthria, Gait Disturbance, Mental Disorder (5477934-2)
on Oct 02, 2007 Male from CROATIA (local name: Hrvatska) , 38 years of age, weighting 136.7 lb, was diagnosed with
  • somatoform disorder
and was treated with Moditen. Directly after, patient experienced the unwanted or unexpected Moditen side effects: abnormal behaviour, amnesia, apraxia, confabulation, delirium, disorientation, dysarthria, gait disturbance, mental disorder. Moditen dosage: 2.5 Mg/day.
Associated medications used:
  • Amyzol (75 Mg/day)
  • Normabel (diazepam)
  • Ladiomil
  • Cerson
  • Leponex (100 Mg/day)
Patient was hospitalized.


Abdominal Pain, Colitis Ischaemic, Vomiting (5203610-7)
on Dec 19, 2006 Male from FRANCE , 48 years of age, was treated with Moditen. Patient felt the following Moditen side effects: abdominal pain, colitis ischaemic, vomiting. Moditen dosage: N/A.
Multiple prescriptions taken:
  • Tiapridal
  • Lepticur
  • Nozinan
  • Anticholinergic Agent
Patient was hospitalized.

Neutropenia, Platelet Count Decreased, Thrombocytopenia (5139642-7)
Patient was taking Moditen (fluphenazine Hcl). After Moditen was administered, patient encountered several Moditen side effects: neutropenia, platelet count decreased, thrombocytopenia on Oct 11, 2006 from FRANCE Additional patient health information: Male , 32 years of age, was diagnosed with
  • bipolar disorder
and. Moditen (fluphenazine Hcl) dosage: 25 Milligram, Oral.
Multiple concurrent drugs taken:
  • Revia (50 Milligram, Oral)
  • Depakote (250mg)
  • Doliprane (acetaminophen)
  • Paroxetine Hcl
  • Risperdal
Patient was hospitalized.

Coma, Respiratory Depression, Somnolence, Tachycardia (5128926-4)
Adverse event was reported on Aug 29, 2006 by a Male taking Moditen (Dosage: N/A) . Location: FRANCE , 75 years of age, Directly after, patient experienced the unwanted or unexpected Moditen side effects: coma, respiratory depression, somnolence, tachycardia.
Associated medications used:
  • Tercian (1 Dosage Form = 40 Mg/ml)
  • Rivotril (1 Dosage Form = 2.5 Mg/ml)
Patient was hospitalized.

Coma, Respiratory Depression, Somnolence, Tachycardia (5098666-9)
on Aug 29, 2006 Male from FRANCE , 75 years of age, was treated with Moditen Tabs 100 Mg. Patient felt the following Moditen side effects: coma, respiratory depression, somnolence, tachycardia. Moditen Tabs 100 Mg dosage: N/A.
Multiple prescriptions taken:
  • Tercian (1 Dosage Form = 40 Mg/ml)
  • Rivotril (1 Dosage Form = 2.5 Mg/ml)
Patient was hospitalized.

Circulatory Collapse, Hypotension, Urinary Tract Infection (5096433-3)
on Mar 18, 2005 Female from UNITED KINGDOM , 80 years of age, was treated with Moditen Depot. After Moditen was administered, patient encountered several Moditen side effects: circulatory collapse, hypotension, urinary tract infection. Moditen Depot dosage: N/A.
Multiple concurrent drugs taken:
  • Risperdal
Patient was hospitalized.

Hypertension, Urinary Tract Infection (4864473-2)
Patient was taking Moditen Depot. Directly after, patient experienced the unwanted or unexpected Moditen side effects: hypertension, urinary tract infection on Jul 22, 2005 from UNITED STATES Additional patient health information: Female , 80 years of age, . Moditen Depot dosage: N/A.
Associated medications used:
  • Risperdal (The Dose Of Risperdal Was Decreased To 1 Mg Daily In The Evening.)
Patient was hospitalized.

Hypotension, Urinary Tract Infection (4864453-7)
Adverse event was reported on Mar 18, 2005 by a Female taking Moditen Depot (Dosage: N/A) . Location: UNITED KINGDOM , 80 years of age, Patient felt the following Moditen side effects: hypotension, urinary tract infection.
Multiple prescriptions taken:
  • Risperdal
Patient was hospitalized.

Agranulocytosis, Haematotoxicity, Mental Disorder (4590620-6)
on Feb 18, 2005 Male from , 62 years of age, was treated with Moditen Tabs. After Moditen was administered, patient encountered several Moditen side effects: agranulocytosis, haematotoxicity, mental disorder. Moditen Tabs dosage: N/A.
Multiple concurrent drugs taken:
  • Parkinane
  • Xeloda
Patient was hospitalized.

Hyponatraemia, Malaise, Parkinson's Disease, Tardive Dyskinesia (4588470-X)
on Feb 14, 2005 Female from , 68 years of age, was diagnosed with
  • psychotic disorder
and was treated with Moditen. Directly after, patient experienced the unwanted or unexpected Moditen side effects: hyponatraemia, malaise, parkinson's disease, tardive dyskinesia. Moditen dosage: N/A. Patient was hospitalized.

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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.

Moditen Information

More About Moditen

Side Effects reported to FDA: 13. View Moditen Adverse Reports

Moditen safety alerts: No

Reported deaths: 3

Reported hospitalizations: 6

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