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Modiodal Side Effects

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Common Modiodal Side Effects


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

Depression (5)
Nausea (4)
Fatigue (4)
Amnesia (4)
Asthenia (4)
Chorioretinitis (3)
Aggression (3)
Anxiety (3)
Suicide Attempt (3)
Headache (3)
Gait Disturbance (3)
Cataplexy (2)
Arthralgia (2)
Enuresis (2)
Bone Pain (2)
Motor Dysfunction (2)
Visual Impairment (2)
Palpitations (2)
Fracture (2)
Memory Impairment (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.

Modiodal Side Effects Reported to FDA



Modiodal Side Effect Report#9684840
Aggression, Crying, Headache, Nausea, Palpitations, Paranoia, Visual Impairment, Morbid Thoughts
This is a report of a 31-year-old female patient (weight: NA) from SE, suffering from the following health symptoms/conditions: hypersomnia, who was treated with Modiodal (dosage: 100 Mg, start time:
Oct 16, 2013), combined with: NA. and developed a serious reaction and side effect(s): Aggression, Crying, Headache, Nausea, Palpitations, Paranoia, Visual Impairment, Morbid Thoughts after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Modiodal treatment in female patients, resulting in Aggression side effect. The patient was hospitalized.
Modiodal Side Effect Report#9554154
Eosinophilia, Transaminases Increased, Hepatitis Toxic
This report suggests a potential Modiodal 40 Mg Eosinophilia side effect(s) that can have serious consequences. A 36-year-old female patient (weight: NA) from SE was diagnosed with the following symptoms/conditions: NA and used Modiodal 40 Mg (dosage: NA) starting
Mar 01, 2012. After starting Modiodal 40 Mg the patient began experiencing various side effects, including: Eosinophilia, Transaminases Increased, Hepatitis ToxicAdditional drugs used concurrently:
  • Folacin 5 Mg
  • Zopiklon Mylan
Although Modiodal 40 Mg demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Eosinophilia, may still occur.
Modiodal Side Effect Report#9549702
Anaphylactic Reaction
This Anaphylactic Reaction problem was reported by a physician from JP. A 22-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: narcolepsy,cataplexy. On
Jul 16, 2008 this consumer started treatment with Modiodal (dosage: 300 Milligram Daily;). The following drugs were being taken at the same time: NA. When using Modiodal, the patient experienced the following unwanted symptoms/side effects: Anaphylactic ReactionAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Anaphylactic Reaction, may become evident only after a product is in use by the general population.
Modiodal Side Effect Report#9549696
Rash
This Rash side effect was reported by a health professional from FR. A 59-year-old male patient (weight:NA) experienced the following symptoms/conditions: narcolepsy,tonsillitis,bipolar disorder.The patient was prescribed Modiodal 100 Mg (drug dosage: NA), which was initiated on
Mar 06, 2013. Concurrently used drugs:
  • Paracetamol
  • Tegretol
  • Laroxyl
  • Rulid
  • Helcidine
  • Pivalone
  • Pariet
  • Aerius
.After starting to take Modiodal 100 Mg the consumer reported adverse symptoms, such as: RashThese side effects may potentially be related to Modiodal 100 Mg. The patient was hospitalized.
Modiodal Side Effect Report#9451212
Palpitations, Nausea, Asthenia, Suicide Attempt, Intentional Overdose
This is a report of a 21-year-old female patient (weight: NA) from JP, suffering from the following health symptoms/conditions: narcolepsy,suicide attempt, who was treated with Modiodal Tablets 100mg (dosage: 200 Milligram Daily;, start time:
Jun 25, 2013), combined with: NA. and developed a serious reaction and side effect(s): Palpitations, Nausea, Asthenia, Suicide Attempt, Intentional Overdose after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Modiodal Tablets 100mg treatment in female patients, resulting in Palpitations side effect. The patient was hospitalized.
Modiodal Side Effect Report#9367052
Mouth Ulceration, Genital Ulceration, Raynaud^s Phenomenon, Sjogren^s Syndrome, Urinary Retention
This report suggests a potential Modiodal Mouth Ulceration side effect(s) that can have serious consequences. A 27-year-old female patient (weight: NA) from FR was diagnosed with the following symptoms/conditions: narcolepsy and used Modiodal (dosage: 200 Milligram Daily;) starting 2007. After starting Modiodal the patient began experiencing various side effects, including: Mouth Ulceration, Genital Ulceration, Raynaud^s Phenomenon, Sjogren^s Syndrome, Urinary RetentionAdditional drugs used concurrently:
  • Lyrica
The patient was hospitalized. Although Modiodal demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Mouth Ulceration, may still occur.
Modiodal Side Effect Report#9303362
Overdose, Suicide Attempt, Hallucination, Delusion, Rhabdomyolysis, Carbon Monoxide Poisoning, Depression, Feeling Abnormal, Hepatic Steatosis
This Overdose problem was reported by a physician from JP. A 19-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: narcolepsy,suicide attempt. On
Jan 22, 2013 this consumer started treatment with Modiodal Tablets 100mg (dosage: 200 Milligram Daily;). The following drugs were being taken at the same time: NA. When using Modiodal Tablets 100mg, the patient experienced the following unwanted symptoms/side effects: Overdose, Suicide Attempt, Hallucination, Delusion, Rhabdomyolysis, Carbon Monoxide Poisoning, Depression, Feeling Abnormal, Hepatic SteatosisThe 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 Overdose, may become evident only after a product is in use by the general population.
Modiodal Side Effect Report#9202216
Cognitive Disorder, Fatigue, Fibromyalgia, Vertigo, Feeling Drunk, Hyperhidrosis, Derealisation
This Cognitive Disorder side effect was reported by a physician from FR. A male patient (weight:NA) experienced the following symptoms/conditions: sleep apnoea syndrome,somnolence.The patient was prescribed Modiodal (drug dosage: 400 Milligram Daily; Morning And Noon), which was initiated on 200406. Concurrently used drugs: NA..After starting to take Modiodal the consumer reported adverse symptoms, such as: Cognitive Disorder, Fatigue, Fibromyalgia, Vertigo, Feeling Drunk, Hyperhidrosis, DerealisationThese side effects may potentially be related to Modiodal.
Modiodal Side Effect Report#9186452
Breast Cancer, Malaise, Head Injury, Haematoma, Ligament Sprain, Off Label Use, Underdose, Amnesia, Blood Pressure Abnormal
This is a report of a 26-year-old female patient (weight: NA) from FR, suffering from the following health symptoms/conditions: insomnia,breast cancer, who was treated with Modiodal (dosage: 100 Milligram Daily;, start time: 199907), combined with: NA. and developed a serious reaction and side effect(s): Breast Cancer, Malaise, Head Injury, Haematoma, Ligament Sprain, Off Label Use, Underdose, Amnesia, Blood Pressure Abnormal after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Modiodal treatment in female patients, resulting in Breast Cancer side effect. The patient was hospitalized.
Modiodal Side Effect Report#9029869
Ventricular Tachycardia, Fatigue
This report suggests a potential Modiodal Ventricular Tachycardia side effect(s) that can have serious consequences. A male patient (weight: NA) from IS was diagnosed with the following symptoms/conditions: fatigue and used Modiodal (dosage: 1-1x2) starting
Feb 10, 2010. After starting Modiodal the patient began experiencing various side effects, including: Ventricular Tachycardia, FatigueAdditional drugs used concurrently:
  • Tysabri (Has Received 35 Infusions So Far.)
  • Esomeprazole
  • Ranomax
The patient was hospitalized. Although Modiodal demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Ventricular Tachycardia, may still occur.
Modiodal Side Effect Report#8888945
Activation Syndrome
This Activation Syndrome problem was reported by a physician from JP. A 18-year-old patient (weight: NA) was diagnosed with the following symptoms/conditions: narcolepsy. On NS this consumer started treatment with Modiodal (dosage: 100 Milligram Daily;). The following drugs were being taken at the same time:
  • Cymbalta (20 Milligram Daily;)
When using Modiodal, the patient experienced the following unwanted symptoms/side effects: Activation SyndromeAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Activation Syndrome, may become evident only after a product is in use by the general population.
Modiodal Side Effect Report#8799017
Neutropenia, Pancytopenia
This Neutropenia side effect was reported by a physician from SE. A 69-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Modiodal (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Enalapril
  • Levemir
  • Omeprazole
  • Cozaar
  • Januvia 100 Mg
  • Behepan
  • Citodon
  • Alvedon Forte
.After starting to take Modiodal the consumer reported adverse symptoms, such as: Neutropenia, PancytopeniaThese side effects may potentially be related to Modiodal. The patient was hospitalized.
Modiodal Side Effect Report#8766530
Illusion
This is a report of a 25-year-old female patient (weight: NA) from JP, suffering from the following health symptoms/conditions: narcolepsy, who was treated with Modiodal (dosage: 200 Milligram Daily;, start time:
Jul 06, 2012), combined with: NA. and developed a serious reaction and side effect(s): Illusion after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Modiodal treatment in female patients, resulting in Illusion side effect.
Modiodal Side Effect Report#5942347-3
Somnolence, Suicide Attempt
This report suggests a potential Modiodal Somnolence side effect(s) that can have serious consequences. A 16-year-old female patient (weight: NA) from Japan was diagnosed with the following symptoms/conditions: narcolepsy and used Modiodal (dosage: 200 Mg Divided Into Two Doses Oral) starting
Jul 25, 2008. After starting Modiodal the patient began experiencing various side effects, including: Somnolence, Suicide AttemptAdditional drugs used concurrently: NA.The patient was hospitalized. Although Modiodal demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Somnolence, may still occur.
Modiodal Side Effect Report#5808010-4
Visual Impairment
This Visual Impairment problem was reported by a physician from France. A 18-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: narcolepsy. On
Jan 01, 2007 this consumer started treatment with Modiodal (dosage: Oral). The following drugs were being taken at the same time: NA. When using Modiodal, the patient experienced the following unwanted symptoms/side effects: Visual ImpairmentAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Visual Impairment, may become evident only after a product is in use by the general population.
Modiodal Side Effect Report#5753926-0
Acute Myocardial Infarction, Cardiac Failure, Cardiomegaly, Discomfort, Tachycardia
This Acute Myocardial Infarction side effect was reported by a physician from Denmark. A 49-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Modiodal (drug dosage: 100 Mg, Oral), which was initiated on
Feb 06, 2008. Concurrently used drugs:
  • Noritren (250 Mg, Oral)
  • Noritren (350 Mg, Oral)
  • Noritren (300 Mg, Oral)
  • Viagra
.After starting to take Modiodal the consumer reported adverse symptoms, such as: Acute Myocardial Infarction, Cardiac Failure, Cardiomegaly, Discomfort, TachycardiaThese side effects may potentially be related to Modiodal. The patient was hospitalized.
Modiodal Side Effect Report#5746788-9
Fracture
This is a report of a 67-year-old female patient (weight: NA) from Japan, suffering from the following health symptoms/conditions: narcolepsy, who was treated with Modiodal (dosage: 200 Mg Qd Oral, start time:
Jun 29, 2007), combined with: NA. and developed a serious reaction and side effect(s): Fracture after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Modiodal treatment in female patients, resulting in Fracture side effect. The patient was hospitalized.
Modiodal Side Effect Report#5736870-4
Chorioretinitis
This report suggests a potential Modiodal Chorioretinitis side effect(s) that can have serious consequences. A 36-year-old male patient (weight: NA) from France was diagnosed with the following symptoms/conditions: narcolepsy and used Modiodal (dosage: Oral) starting NS. After starting Modiodal the patient began experiencing various side effects, including: ChorioretinitisAdditional drugs used concurrently:
  • Anafranil
Although Modiodal demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Chorioretinitis, may still occur.
Modiodal Side Effect Report#5711793-5
Aggression, Arthralgia, Asthenia, Bone Pain, Cataplexy, Conversion Disorder, Depression, Enuresis, Fatigue
This Aggression problem was reported by a health professional from France. A 36-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: narcolepsy,sleep disorder. On
Jan 01, 2008 this consumer started treatment with Modiodal (dosage: Oral). The following drugs were being taken at the same time:
  • Xyrem (4.5 G Qd; Oral)
  • Xyrem (6 G Qd; Oral)
  • Xyrem (5.25 G Qd; Oral)
  • Xyrem (6 G Qd; Oral)
  • Xyrem (4.5 G Qd; Oral)
  • Xyrem (4.25 G Qd; Oral)
  • Xyrem (2.5 G Bid; Oral)
  • Xyrem (2.75 G Bid; Oral)
When using Modiodal, the patient experienced the following unwanted symptoms/side effects: Aggression, Arthralgia, Asthenia, Bone Pain, Cataplexy, Conversion Disorder, Depression, Enuresis, FatigueAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Aggression, may become evident only after a product is in use by the general population.
Modiodal Side Effect Report#5705338-3
Headache, Liver Disorder, Nausea
This Headache side effect was reported by a physician from Japan. A 25-year-old female patient (weight:NA) experienced the following symptoms/conditions: narcolepsy.The patient was prescribed Modiodal (drug dosage: 200 Mg Qd Oral), which was initiated on
Oct 12, 2007. Concurrently used drugs: NA..After starting to take Modiodal the consumer reported adverse symptoms, such as: Headache, Liver Disorder, NauseaThese side effects may potentially be related to Modiodal.
Modiodal Side Effect Report#5698475-3
Fracture
This is a report of a 67-year-old female patient (weight: NA) from Japan, suffering from the following health symptoms/conditions: narcolepsy, who was treated with Modiodal (dosage: 200 Mg Qd Oral, start time:
Jun 29, 2007), combined with: NA. and developed a serious reaction and side effect(s): Fracture after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Modiodal treatment in female patients, resulting in Fracture side effect. The patient was hospitalized.
Modiodal Side Effect Report#5698366-8
Anxiety, Extrasystoles, Hypertension, Nervousness
This report suggests a potential Modiodal Anxiety side effect(s) that can have serious consequences. A 41-year-old female patient (weight: NA) from Spain was diagnosed with the following symptoms/conditions: narcolepsy and used Modiodal (dosage: 100 Mg Qd Oral) starting
Oct 09, 2007. After starting Modiodal the patient began experiencing various side effects, including: Anxiety, Extrasystoles, Hypertension, NervousnessAdditional drugs used concurrently:
  • Ibuprofen
  • Tonopan
  • Lexatin
  • Torecan
Although Modiodal demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Anxiety, may still occur.
Modiodal Side Effect Report#5670051-8
Amnesia, Asthenia, Cerebral Infarction, Condition Aggravated, Dysstasia, Gait Disturbance, Thrombosis
This Amnesia problem was reported by a physician from Japan. A 72-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: narcolepsy. On
Sep 03, 2007 this consumer started treatment with Modiodal (dosage: 150 Mg Qd Oral). The following drugs were being taken at the same time:
  • Anafranil
  • Lendormin
  • Rivotril
When using Modiodal, the patient experienced the following unwanted symptoms/side effects: Amnesia, Asthenia, Cerebral Infarction, Condition Aggravated, Dysstasia, Gait Disturbance, ThrombosisAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Amnesia, may become evident only after a product is in use by the general population.
Modiodal Side Effect Report#5632891-0
Ankle Fracture
This Ankle Fracture side effect was reported by a health professional from Japan. A 68-year-old female patient (weight:NA) experienced the following symptoms/conditions: narcolepsy.The patient was prescribed Modiodal (drug dosage: 200 Mg Qd Oral), which was initiated on NS. Concurrently used drugs: NA..After starting to take Modiodal the consumer reported adverse symptoms, such as: Ankle FractureThese side effects may potentially be related to Modiodal. The patient was hospitalized.
Modiodal Side Effect Report#5588247-2
Amnesia, Gait Disturbance
This is a report of a 72-year-old male patient (weight: NA) from Japan, suffering from the following health symptoms/conditions: narcolepsy, who was treated with Modiodal (dosage: 150 Mg Qd Oral, start time:
Sep 03, 2007), combined with:
  • Anafranil
  • Lendormin
  • Rivotril
and developed a serious reaction and side effect(s): Amnesia, Gait Disturbance after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Modiodal treatment in male patients, resulting in Amnesia side effect.


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The appearance of Modiodal 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 Modiodal Side Effects for Women?

Women Side EffectsReports
Depression 4
Nausea 4
Aggression 3
Anxiety 3
Asthenia 3
Headache 3
Arthralgia 2
Bone Pain 2
Cataplexy 2
Enuresis 2

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.

    Modiodal 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 Modiodal

    Side Effects reported to FDA: 40

    Modiodal safety alerts: No

    Reported deaths: 1

    Reported hospitalizations: 16

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