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Moditen Side Effects

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Common Moditen Side Effects


The most commonly reported Moditen side effects (click to view or check a box to report):

Vomiting (4)
Urinary Tract Infection (3)
Coma (3)
Abdominal Pain (3)
Colitis Ischaemic (3)
Hypotension (2)
Hyponatraemia (2)
Mental Disorder (2)
Malaise (2)
Tachycardia (2)
Somnolence (2)
Respiratory Depression (2)
Parkinson's Disease (1)
Polydipsia (1)
Neutropenia (1)
Platelet Count Decreased (1)
Nausea (1)
Haematotoxicity (1)
Hypertension (1)
Necrotising Colitis (1)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Moditen Side Effects Reported to FDA



Moditen Side Effect Report#8921302
Coma, Convulsion
This is a report of a 40-year-old male patient (weight: NA) from IT, suffering from the following health symptoms/conditions: schizophrenia, who was treated with Moditen (dosage: NA, start time:
Sep 25, 2012), combined with:
  • Abilify
  • Entumine
and developed a serious reaction and side effect(s): Coma, Convulsion after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Moditen treatment in male patients, resulting in Coma side effect. The patient was hospitalized.
Moditen Side Effect Report#5708228-5
Abdominal Pain, Colitis Ischaemic, Necrotising Colitis, Vomiting
This report suggests a potential Moditen Abdominal Pain side effect(s) that can have serious consequences. A 48-year-old male patient (weight: NA) from France was diagnosed with the following symptoms/conditions: NA and used Moditen (dosage: NA) starting
Jun 15, 1981. After starting Moditen the patient began experiencing various side effects, including: Abdominal Pain, Colitis Ischaemic, Necrotising Colitis, VomitingAdditional drugs used concurrently:
  • Tiapridal
  • Lepticur
  • Nozinan
  • Anticholinergic Agent
The patient was hospitalized. Although Moditen demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Abdominal Pain, may still occur.
Moditen Side Effect Report#5707308-8
Abdominal Pain, Colitis Ischaemic, Vomiting
This Abdominal Pain problem was reported by a health professional from France. A 48-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Jun 15, 1981 this consumer started treatment with Moditen (dosage: NA). The following drugs were being taken at the same time:
  • Tiapridal
  • Lepticur
  • Nozinan
  • Anticholinergic Agent
When using Moditen, the patient experienced the following unwanted symptoms/side effects: Abdominal Pain, Colitis Ischaemic, VomitingThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Abdominal Pain, may become evident only after a product is in use by the general population.
Moditen Side Effect Report#5505111-5
Hyponatraemia, Malaise, Nausea, Polydipsia, Vomiting
This Hyponatraemia side effect was reported by a health professional from France. A 60-year-old male patient (weight:NA) experienced the following symptoms/conditions: delusional disorder, persecutory type.The patient was prescribed Moditen Tabs (drug dosage: NA), which was initiated on
Sep 18, 2007. Concurrently used drugs: NA..After starting to take Moditen Tabs the consumer reported adverse symptoms, such as: Hyponatraemia, Malaise, Nausea, Polydipsia, VomitingThese side effects may potentially be related to Moditen Tabs. The patient was hospitalized.
Moditen Side Effect Report#5477934-2
Abnormal Behaviour, Amnesia, Apraxia, Confabulation, Delirium, Disorientation, Dysarthria, Gait Disturbance, Mental Disorder
This is a report of a 38-year-old male patient (weight: NA) from Croatia (local Name: Hrvatska), suffering from the following health symptoms/conditions: somatoform disorder, who was treated with Moditen (dosage: 2.5 Mg/day, start time:
Mar 30, 2007), combined with:
  • Amyzol (75 Mg/day)
  • Normabel (diazepam)
  • Ladiomil
  • Cerson
  • Leponex (100 Mg/day)
and developed a serious reaction and side effect(s): Abnormal Behaviour, Amnesia, Apraxia, Confabulation, Delirium, Disorientation, Dysarthria, Gait Disturbance, Mental Disorder after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Moditen treatment in male patients, resulting in Abnormal Behaviour side effect. The patient was hospitalized.
Moditen Side Effect Report#5203610-7
Abdominal Pain, Colitis Ischaemic, Vomiting
This report suggests a potential Moditen Abdominal Pain side effect(s) that can have serious consequences. A 48-year-old male patient (weight: NA) from France was diagnosed with the following symptoms/conditions: NA and used Moditen (dosage: NA) starting
Jun 15, 1981. After starting Moditen the patient began experiencing various side effects, including: Abdominal Pain, Colitis Ischaemic, VomitingAdditional drugs used concurrently:
  • Tiapridal
  • Lepticur
  • Nozinan
  • Anticholinergic Agent
The patient was hospitalized. Although Moditen demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Abdominal Pain, may still occur.
Moditen Side Effect Report#5139642-7
Neutropenia, Platelet Count Decreased, Thrombocytopenia
This Neutropenia problem was reported by a health professional from France. A 32-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: bipolar disorder. On NS this consumer started treatment with Moditen (fluphenazine Hcl) (dosage: 25 Milligram, Oral). The following drugs were being taken at the same time:
  • Revia (50 Milligram, Oral)
  • Depakote (250mg)
  • Doliprane (acetaminophen)
  • Paroxetine Hcl
  • Risperdal
When using Moditen (fluphenazine Hcl), the patient experienced the following unwanted symptoms/side effects: Neutropenia, Platelet Count Decreased, ThrombocytopeniaThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Neutropenia, may become evident only after a product is in use by the general population.
Moditen Side Effect Report#5128926-4
Coma, Respiratory Depression, Somnolence, Tachycardia
This Coma side effect was reported by a health professional from France. A 75-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Moditen (drug dosage: NA), which was initiated on
Jun 11, 2006. Concurrently used drugs:
  • Tercian (1 Dosage Form = 40 Mg/ml)
  • Rivotril (1 Dosage Form = 2.5 Mg/ml)
.After starting to take Moditen the consumer reported adverse symptoms, such as: Coma, Respiratory Depression, Somnolence, TachycardiaThese side effects may potentially be related to Moditen. The patient was hospitalized.
Moditen Side Effect Report#5098666-9
Coma, Respiratory Depression, Somnolence, Tachycardia
This is a report of a 75-year-old male patient (weight: NA) from France, suffering from the following health symptoms/conditions: NA, who was treated with Moditen Tabs 100 Mg (dosage: NA, start time:
Jun 11, 2006), combined with:
  • Tercian (1 Dosage Form = 40 Mg/ml)
  • Rivotril (1 Dosage Form = 2.5 Mg/ml)
and developed a serious reaction and side effect(s): Coma, Respiratory Depression, Somnolence, Tachycardia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Moditen Tabs 100 Mg treatment in male patients, resulting in Coma side effect. The patient was hospitalized.
Moditen Side Effect Report#5096433-3
Circulatory Collapse, Hypotension, Urinary Tract Infection
This report suggests a potential Moditen Depot Circulatory Collapse side effect(s) that can have serious consequences. A 80-year-old female patient (weight: NA) from United Kingdom was diagnosed with the following symptoms/conditions: NA and used Moditen Depot (dosage: NA) starting NS. After starting Moditen Depot the patient began experiencing various side effects, including: Circulatory Collapse, Hypotension, Urinary Tract InfectionAdditional drugs used concurrently:
  • Risperdal
The patient was hospitalized. Although Moditen Depot demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Circulatory Collapse, may still occur.
Moditen Side Effect Report#4864473-2
Hypertension, Urinary Tract Infection
This Hypertension problem was reported by a health professional from United States. A 80-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Moditen Depot (dosage: NA). The following drugs were being taken at the same time:
  • Risperdal (The Dose Of Risperdal Was Decreased To 1 Mg Daily In The Evening.)
When using Moditen Depot, the patient experienced the following unwanted symptoms/side effects: Hypertension, Urinary Tract InfectionThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Hypertension, may become evident only after a product is in use by the general population.
Moditen Side Effect Report#4864453-7
Hypotension, Urinary Tract Infection
This Hypotension side effect was reported by a health professional from United Kingdom. A 80-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Moditen Depot (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Risperdal
.After starting to take Moditen Depot the consumer reported adverse symptoms, such as: Hypotension, Urinary Tract InfectionThese side effects may potentially be related to Moditen Depot. The patient was hospitalized.
Moditen Side Effect Report#4590620-6
Agranulocytosis, Haematotoxicity, Mental Disorder
This is a report of a 62-year-old male patient (weight: NA) from , suffering from the following health symptoms/conditions: NA, who was treated with Moditen Tabs (dosage: NA, start time:
May 13, 2004), combined with:
  • Parkinane
  • Xeloda
and developed a serious reaction and side effect(s): Agranulocytosis, Haematotoxicity, Mental Disorder after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Moditen Tabs treatment in male patients, resulting in Agranulocytosis side effect. The patient was hospitalized.
Moditen Side Effect Report#4588470-X
Hyponatraemia, Malaise, Parkinson's Disease, Tardive Dyskinesia
This report suggests a potential Moditen Hyponatraemia side effect(s) that can have serious consequences. A 68-year-old female patient (weight: NA) from was diagnosed with the following symptoms/conditions: psychotic disorder and used Moditen (dosage: NA) starting
Dec 09, 2004. After starting Moditen the patient began experiencing various side effects, including: Hyponatraemia, Malaise, Parkinson's Disease, Tardive DyskinesiaAdditional drugs used concurrently: NA.The patient was hospitalized. Although Moditen demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Hyponatraemia, may still occur.



The appearance of Moditen on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.


What are common Moditen Side Effects for Women?

Women Side EffectsReports
Urinary Tract Infection 3
Hypotension 2
Circulatory Collapse 1
Hypertension 1
Hyponatraemia 1
Malaise 1
Parkinson's Disease 1
Tardive Dyskinesia 1

What are common Moditen Side Effects for Men?

Men Side EffectsReports
Vomiting 4
Abdominal Pain 3
Colitis Ischaemic 3
Coma 3
Mental Disorder 2
Respiratory Depression 2
Somnolence 2
Tachycardia 2
Abnormal Behaviour 1
Agranulocytosis 1

Track Your Side Effects

Note Your Observations

It is really important to keep track of your health symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:
    Side Effects Scale Date & Time Other Medicine(s) or Treatment(s)
    Scale: 1 = very mild to 10 = very bad

    Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

    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 reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
    FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.

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    More About Moditen

    Side Effects reported to FDA: 14

    Moditen safety alerts: No

    Reported deaths: 3

    Reported hospitalizations: 7

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