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Ludiomil (Maprotiline) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Ludiomil (Maprotiline) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (10)
Life Threatening Events (2)
Disability (1)

Reports by Reaction Type

Thirst (5)Wrist Fracture (4)Saliva Altered (4)Hallucination (4)Nightmare (3)Hallucination, Visual (2)Confusional State (1)Pyrexia (1)Erythema (1)Fall (1)Intentional Self-Injury (1)Finger Hypoplasia (1)

Possible Ludiomil side effects in male

Reported by a health professional (non-physician/pharmacist) from Denmark on 2012-08-20

Patient: male

Reactions: Disinhibition

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Escitalopram
    Indication: Major Depression
    Start date: 2011-11-03

Alcohol

Ludiomil
    Dosage: 75 mg
    Administration route: Oral
    Indication: Major Depression
    Start date: 2011-11-25

Victan
    Administration route: Oral
    Indication: Major Depression
    Start date: 2011-11-25



Possible Ludiomil side effects in male

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-07-23

Patient: male, weighing 70.0 kg (154.0 pounds)

Reactions: Pruritus, Skin Exfoliation, Urticaria, Pyrexia, Erythema, Human Herpes Virus 6 Serology Positive, Gamma-Glutamyltransferase Increased, C-Reactive Protein Increased, Oedema, Blood Glucose Increased, Blister, White Blood Cell Count Increased, Blood Alkaline Phosphatase Increased, Rash Generalised, Cytomegalovirus Test Positive, Blood Lactate Dehydrogenase Increased, Lymphocyte Stimulation Test Positive, Drug Rash With Eosinophilia and Systemic Symptoms, Pigmentation Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tegretol
    Dosage: 200 mg, unk
    Administration route: Oral
    Indication: Nerve Injury
    Start date: 2007-08-07
    End date: 2007-08-27

Diovan
    Dosage: 20 mg, daily
    Administration route: Oral
    Indication: Hypertension
    Start date: 2007-07-22
    End date: 2007-08-27

Ludiomil
    Dosage: 10 mg, daily
    Administration route: Oral
    Indication: Nerve Injury
    Start date: 2007-08-15
    End date: 2007-08-27

Lipitor
    Dosage: 10 mg, daily
    Administration route: Oral
    Indication: Hyperlipidaemia
    Start date: 2007-08-26
    End date: 2007-08-27

PL Gran.
    Dosage: 3 g/ day
    Administration route: Oral
    Start date: 2007-08-28
    End date: 2007-08-29

Mexitil
    Dosage: 300 mg, daily
    Administration route: Oral
    Indication: Nerve Injury
    Start date: 2007-07-20
    End date: 2007-08-27

PL Gran.
    Dosage: 3 mg
    Administration route: Oral
    Indication: Nasopharyngitis
    Start date: 2007-08-22
    End date: 2007-08-24

Metformin HCL
    Dosage: 500 mg, daily
    Administration route: Oral
    Indication: Diabetes Mellitus
    Start date: 2007-08-10
    End date: 2007-08-27

Other drugs received by patient: Humalog; Humacart-N; Zantac



Possible Ludiomil side effects in 64 year old female

Reported by a physician from Japan on 2012-04-10

Patient: 64 year old female

Reactions: Drug Ineffective, Hallucination, Visual, Conversion Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ludiomil
    Dosage: 35 mg, qd
    Administration route: Oral
    Start date: 2008-04-08

Ludiomil
    Dosage: 10 mg, qd
    Administration route: Oral
    Start date: 2008-04-15
    End date: 2008-04-18

Ludiomil
    Dosage: 75 mg, qd
    Administration route: Oral
    Start date: 2008-02-21

Ludiomil
    Dosage: 100 mg, divided into 100mg and 25mg
    Administration route: Oral
    Start date: 2008-03-06

Ludiomil
    Dosage: 85 mg, divided into 25mg and 60mg
    Administration route: Oral
    Start date: 2008-05-25

Ludiomil
    Dosage: 60 mg, divided into 50mg and 10mg
    Administration route: Oral
    Start date: 2008-04-01

Ludiomil
    Dosage: 25 mg, qd
    Administration route: Oral
    Start date: 2008-04-12

Ludiomil
    Dosage: 25 mg, daily
    Administration route: Oral
    Indication: Depression
    Start date: 2008-02-04

Ludiomil
    Dosage: 50 mg, qd
    Administration route: Oral
    Start date: 2008-02-13

Ludiomil
    Dosage: 75 mg, divided into 25mg and 50mg
    Administration route: Oral
    Start date: 2008-05-28

Ludiomil
    Dosage: 50 mg, qd
    Administration route: Oral
    Start date: 2008-04-05

Other drugs received by patient: Mucosta; Levothyroxine Sodium; Desyrel



Possible Ludiomil side effects in female

Reported by a pharmacist from Japan on 2012-04-02

Patient: female, weighing 42.0 kg (92.4 pounds)

Reactions: Wrist Fracture, Drug Interaction, Thirst, Hallucination, Fall

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ludiomil
    Dosage: 10 mg
    Administration route: Oral
    Indication: Depression
    Start date: 2011-10-21

Neodopasol
    Dosage: 500 mg
    Administration route: Oral
    Indication: Parkinson's Disease
    Start date: 2011-10-21

Pramipexole Dihydrochloride
    Dosage: 0.125 mg
    Administration route: Oral
    Indication: Parkinson's Disease
    Start date: 2011-10-21
    End date: 2011-12-22

Comtan
    Dosage: 500 mg
    Administration route: Oral
    Indication: Parkinson's Disease
    Start date: 2011-12-20

Other drugs received by patient: Aricept; Magmitt; Loxonin; Depas; Motilium; Lansoprazole; LAC-B; Selbex



Possible Ludiomil side effects in male

Reported by a physician from Germany on 2012-03-16

Patient: male

Reactions: Confusional State, Restlessness, Hyponatraemia, Thirst, Intentional Self-Injury, Pallor, Delirium, Somnolence, Suicide Attempt, Inappropriate Antidiuretic Hormone Secretion, Depressed Mood, Cold Sweat, Tension

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Risperdal
    Administration route: Oral
    Indication: Delusion
    Start date: 2012-01-26
    End date: 2012-01-26

Anafranil
    Administration route: Oral
    Indication: Depression
    Start date: 2011-11-15
    End date: 2012-01-26

Risperdal
    Administration route: Oral
    Start date: 2012-01-19

Risperdal
    Administration route: Oral
    Indication: Depressive Delusion
    Start date: 2012-01-26
    End date: 2012-01-26

Risperdal
    Administration route: Oral
    Start date: 2012-01-19

Ludiomil
    Administration route: Oral
    Indication: Depression
    Start date: 2011-11-15
    End date: 2012-01-26

Other drugs received by patient: Seroquel; Seroquel; Seroquel; Lorazepam



Possible Ludiomil side effects in female

Reported by a pharmacist from Japan on 2012-03-08

Patient: female, weighing 42.0 kg (92.4 pounds)

Reactions: Nightmare, Wrist Fracture, Saliva Altered, Thirst, Hallucination

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Neodopasol (Levodopa_benserazide Hydrochloride)
    Administration route: Oral
    Indication: Parkinson's Disease
    Start date: 2011-12-20

Pramipexole Dihydrochloride
    Dosage: 0.125 mg
    Administration route: Oral
    Indication: Parkinson's Disease
    Start date: 2011-12-20

Ludiomil
    Administration route: Oral
    Indication: Depression
    Start date: 2011-12-20

Other drugs received by patient: Comtan; Selbex; Motilium; Magmitt; Depas; Lansoprazole; LAC-B; Aricept; Loxonin



Possible Ludiomil side effects in female

Reported by a pharmacist from Japan on 2012-02-29

Patient: female, weighing 42.0 kg (92.4 pounds)

Reactions: Nightmare, Wrist Fracture, Saliva Altered, Thirst, Hallucination

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Pramipexole Dihydrochloride
    Dosage: 0.125 mg
    Administration route: Oral
    Indication: Parkinson's Disease
    Start date: 2011-12-20

Ludiomil
    Administration route: Oral
    Indication: Depression
    Start date: 2011-12-20

Neodopasol (Levodopa_benserazide Hydrochloride)
    Administration route: Oral
    Indication: Parkinson's Disease
    Start date: 2011-12-20

Other drugs received by patient: Comtan; LAC-B; Lansoprazole; Loxonin; Selbex; Aricept; Depas; Motilium; Magmitt



Possible Ludiomil side effects in female

Reported by a pharmacist from Japan on 2012-02-28

Patient: female, weighing 42.0 kg (92.4 pounds)

Reactions: Nightmare, Wrist Fracture, Saliva Altered, Thirst, Hallucination

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ludiomil
    Administration route: Oral
    Indication: Depression
    Start date: 2011-12-20

Pramipexole Dihydrochloride
    Dosage: 0.125 mg
    Administration route: Oral
    Indication: Parkinson's Disease
    Start date: 2011-12-20

Neodopasol
    Administration route: Oral
    Indication: Parkinson's Disease
    Start date: 2011-12-20

Other drugs received by patient: Loxonin; Aricept; Lansoprazole; Motilium; Comtan; LAC-B; Magmitt; Depas; Selbex



Possible Ludiomil side effects in 72 year old female

Reported by a pharmacist from Japan on 2012-02-24

Patient: 72 year old female, weighing 42.0 kg (92.4 pounds)

Reactions: Hospitalisation, Hallucination, Visual, Saliva Altered

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Depas

Neodopasol (Levodopa_benserazide Hydrochloride)
    Administration route: Oral
    Indication: Parkinson's Disease

Pramipexole Dihydrochloride
    Dosage: 1.5 mg
    Administration route: Oral
    Indication: Parkinson's Disease
    Start date: 2011-01-01
    End date: 2012-01-01

Ludiomil
    Administration route: Oral
    Indication: Depression

Aricept
    Dosage: 5 mg

Other drugs received by patient: Yoku-KAN-SAN; Comtan; LAC-B; Motilium; Lansoprazole; Loxonin; Selbex



Possible Ludiomil side effects in male

Reported by a physician from Japan on 2011-12-16

Patient: male, weighing 2.6 kg (5.7 pounds)

Reactions: Finger Hypoplasia

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Sertraline Hydrochloride

Ludiomil

Zolpidem

Fluvoxamine Maleate

Doral

Zyprexa

Nitrazepam

Silece

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