Common Valdoxan Side Effects


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

Somnolence (5)
Suicide Attempt (4)
Impulsive Behaviour (3)
Intentional Overdose (3)
Tremor (3)
Depression (3)
Hyperhidrosis (3)
Electrocardiogram Abnormal (2)
Fatigue (2)
Disturbance In Attention (2)
Abdominal Pain (2)
Hypertension (2)
Suicidal Ideation (2)
Stress (2)
Vertigo (2)
Vomiting (2)
Malaise (2)
Urinary Retention (1)
Completed Suicide (1)
Weight Decreased (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.

Valdoxan Side Effects Reported to FDA



Valdoxan Side Effect Report#8412397-6
Completed Suicide, Depression
This is a report of a 53-year-old male patient (weight: NA) from France, suffering from the following health symptoms/conditions: NA, who was treated with Valdoxan (dosage: NA, start time:
Aug 18, 2011), combined with:
  • Olanzapine (300 Mg, Every 2 Weeks)
and developed a serious reaction and side effect(s): Completed Suicide, Depression after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Valdoxan treatment in male patients, resulting in Completed Suicide side effect.
Valdoxan Side Effect Report#8386788-6
Electrocardiogram Abnormal
This report suggests a potential Valdoxan Electrocardiogram Abnormal side effect(s) that can have serious consequences. A 35-year-old male patient (weight: NA) from was diagnosed with the following symptoms/conditions: NA and used Valdoxan (dosage: 25 Mg (25 Mg, 1 In 1 D),) starting NS. After starting Valdoxan the patient began experiencing various side effects, including: Electrocardiogram AbnormalAdditional drugs used concurrently:
  • Tetrabenzine (12.5 Mg (12.5 Mg, 1 In 1 D),)
  • Risperidone (2 Mg (2 Mg, 1 In 1 D), Oral)
  • Alcohol (ethanol)
  • Cocaine (cocaine)
  • Methadone Hcl (80 Mg (80 Mg, 1 In 1 D),)
  • Diclofenac Sodium (150 Mg (50 Mg, 3 In 1 D),)
  • Amphetamine Sulfate
  • Lansoprazole (60 Mg (30 Mg, 2 In 1 D),)
The patient was hospitalized. Although Valdoxan demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Electrocardiogram Abnormal, may still occur.
Valdoxan Side Effect Report#8380785-2
Abortion Spontaneous, Pregnancy On Oral Contraceptive
This Abortion Spontaneous problem was reported by a health professional from Netherlands. A 22-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: depression. On
Feb 19, 2012 this consumer started treatment with Valdoxan (dosage: 25 Mg, Unk). The following drugs were being taken at the same time:
  • Doxycycline
  • Omeprazole (Unk)
  • Yaz (1 Df, Qd)
When using Valdoxan, the patient experienced the following unwanted symptoms/side effects: Abortion Spontaneous, Pregnancy On Oral ContraceptiveAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Abortion Spontaneous, may become evident only after a product is in use by the general population.
Valdoxan Side Effect Report#8353024-6
Oesophageal Atresia
This Oesophageal Atresia side effect was reported by a consumer or non-health professional from Germany. A male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Valdoxan (drug dosage: NA), which was initiated on
Oct 14, 2009. Concurrently used drugs:
  • Folic Acid
  • Morphine Sulfate (Also Orally)
  • Hydroxyurea
  • Melperone Hcl (1df:3x1 Tablet)
  • Haldol
  • Omeprazole
  • Meperidine Hcl
.After starting to take Valdoxan the consumer reported adverse symptoms, such as: Oesophageal AtresiaThese side effects may potentially be related to Valdoxan.
Valdoxan Side Effect Report#8270581-9
Extrapyramidal Disorder, Serotonin Syndrome
This is a report of a 43-year-old female patient (weight: NA) from France, suffering from the following health symptoms/conditions: depression, who was treated with Valdoxan (dosage: NA, start time:
Jan 17, 2012), combined with: NA. and developed a serious reaction and side effect(s): Extrapyramidal Disorder, Serotonin Syndrome after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Valdoxan treatment in female patients, resulting in Extrapyramidal Disorder side effect. The patient was hospitalized.
Valdoxan Side Effect Report#8188572-5
Somnolence, Suicide Attempt
This report suggests a potential Valdoxan Somnolence side effect(s) that can have serious consequences. A 54-year-old male patient (weight: NA) from France was diagnosed with the following symptoms/conditions: NA and used Valdoxan (dosage: 50 Mg, Qd) starting
Feb 16, 2012. After starting Valdoxan the patient began experiencing various side effects, including: Somnolence, Suicide AttemptAdditional drugs used concurrently: NA.The patient was hospitalized. Although Valdoxan demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Somnolence, may still occur.
Valdoxan Side Effect Report#8188571-3
Suicide Attempt, Fatigue, Stress, Somnolence
This Suicide Attempt problem was reported by a health professional from Germany. A 40-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Feb 06, 2012 this consumer started treatment with Valdoxan (dosage: 25 Mg, Qd). The following drugs were being taken at the same time:
  • Mirtazapine (5 Df, Once/single)
  • Opipramol (350-400 Mg, Once/single)
When using Valdoxan, the patient experienced the following unwanted symptoms/side effects: Suicide Attempt, Fatigue, Stress, SomnolenceThe 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 Suicide Attempt, may become evident only after a product is in use by the general population.
Valdoxan Side Effect Report#8174756-9
Vertigo, Discomfort, Asthenia
This Vertigo side effect was reported by a consumer or non-health professional from France. A 31-year-old female patient (weight:NA) experienced the following symptoms/conditions: depression,anxiety.The patient was prescribed Valdoxan (drug dosage: 25 Mg, Qd), which was initiated on
Dec 01, 2011. Concurrently used drugs:
  • Seroquel
  • Alprazolam (0.5 Mg, Bid)
.After starting to take Valdoxan the consumer reported adverse symptoms, such as: Vertigo, Discomfort, AstheniaThese side effects may potentially be related to Valdoxan.
Valdoxan Side Effect Report#8158796-1
Stress, Fatigue, Somnolence
This is a report of a 40-year-old female patient (weight: NA) from Germany, suffering from the following health symptoms/conditions: NA, who was treated with Valdoxan (dosage: 500 Mg, Once/single, start time:
Feb 06, 2012), combined with:
  • Mirtazapine (5 Df, Once/single)
  • Opipramol (350-400 Mg, Once/single)
and developed a serious reaction and side effect(s): Stress, Fatigue, Somnolence after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Valdoxan treatment in female patients, resulting in Stress side effect. The patient was hospitalized.
Valdoxan Side Effect Report#8077653-2
Muscular Weakness, Nausea, Decreased Appetite, Headache, Thinking Abnormal, Insomnia, Vertigo, Morbid Thoughts
This report suggests a potential Valdoxan Muscular Weakness side effect(s) that can have serious consequences. A 61-year-old female patient (weight: NA) from France was diagnosed with the following symptoms/conditions: NA and used Valdoxan (dosage: 25 Mg, Qd) starting
Dec 27, 2011. After starting Valdoxan the patient began experiencing various side effects, including: Muscular Weakness, Nausea, Decreased Appetite, Headache, Thinking Abnormal, Insomnia, Vertigo, Morbid ThoughtsAdditional drugs used concurrently: NA. Although Valdoxan demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Muscular Weakness, may still occur.
Valdoxan Side Effect Report#7996462-3
Chronic Obstructive Pulmonary Disease, Spinal Disorder, Oedema, Coronary Artery Disease, Skin Ulcer, Psychiatric Symptom, Psychotic Disorder, Depression
This Chronic Obstructive Pulmonary Disease problem was reported by a physician from Germany. A female patient (weight: NA) was diagnosed with the following symptoms/conditions: depression,diabetes mellitus,hypertension. On
Jun 01, 2011 this consumer started treatment with Valdoxan (dosage: 25 Mg/day). The following drugs were being taken at the same time:
  • Glimepiride (3 Mg/day)
  • Moxonidine (0.4 Mg/day)
  • Hydrochlorothiazide (25 Mg/day)
  • Delix Plus (1 Df, Qd)
  • Insuman Comb (40 Iu/day)
  • Calcium Channel Blockers (Unk)
  • Escitalopram (10 Mg/day)
  • Amlodipine (Unk)
When using Valdoxan, the patient experienced the following unwanted symptoms/side effects: Chronic Obstructive Pulmonary Disease, Spinal Disorder, Oedema, Coronary Artery Disease, Skin Ulcer, Psychiatric Symptom, Psychotic Disorder, DepressionThe 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 Chronic Obstructive Pulmonary Disease, may become evident only after a product is in use by the general population.
Valdoxan Side Effect Report#7800418-0
Abdominal Pain, Hypotension, Syncope
This Abdominal Pain side effect was reported by a physician from . A 81-year-old female patient (weight:NA) experienced the following symptoms/conditions: major depression.The patient was prescribed Valdoxan (drug dosage: 25 Mg (25 Mg,1 In 1 D),oral), which was initiated on
Sep 20, 2010. Concurrently used drugs:
  • Olanzapine (Oral)
  • Zolpidem
  • Mirtazapine (Oral)
  • Aspirin
  • Lorazapem (lorazepam)
  • Simvastatin
  • Levothyroxine Sodium
  • Ramipril
.After starting to take Valdoxan the consumer reported adverse symptoms, such as: Abdominal Pain, Hypotension, SyncopeThese side effects may potentially be related to Valdoxan.
Valdoxan Side Effect Report#7763465-3
Feeding Disorder, Hypertriglyceridaemia
This is a report of a 45-year-old female patient (weight: NA) from France, suffering from the following health symptoms/conditions: depression, who was treated with Valdoxan (dosage: 25 Mg, 1x/day, start time:
Mar 01, 2011), combined with:
  • Zoloft (25 Mg, 1x/day)
  • Propranolol (80 Mg, 2x/day)
and developed a serious reaction and side effect(s): Feeding Disorder, Hypertriglyceridaemia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Valdoxan treatment in female patients, resulting in Feeding Disorder side effect.
Valdoxan Side Effect Report#7721728-1
Epilepsy
This report suggests a potential Valdoxan Epilepsy side effect(s) that can have serious consequences. A male patient (weight: NA) from Germany was diagnosed with the following symptoms/conditions: depression,epilepsy and used Valdoxan (dosage: 25mg Per Day) starting
Jul 31, 2010. After starting Valdoxan the patient began experiencing various side effects, including: EpilepsyAdditional drugs used concurrently:
  • Lamictal (50mg Twice Per Day)
Although Valdoxan demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Epilepsy, may still occur.
Valdoxan Side Effect Report#7660006-6
Sarcoidosis, Granulomatous Liver Disease
This Sarcoidosis problem was reported by a consumer or non-health professional from France. A 40-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Aug 01, 2010 this consumer started treatment with Valdoxan (dosage: NA). The following drugs were being taken at the same time:
  • Imovane
  • Nicotine (1df=5 Nicotine Lozenges)
  • Abilify
  • Lithium Carbonate
  • Acetaminophen
  • Levothyroxine Sodium
  • Tramadol Hcl
When using Valdoxan, the patient experienced the following unwanted symptoms/side effects: Sarcoidosis, Granulomatous Liver DiseaseAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Sarcoidosis, may become evident only after a product is in use by the general population.
Valdoxan Side Effect Report#7659192-3
Hyperhidrosis, Tremor, Hypertension, Palpitations, Restlessness, Impulsive Behaviour, Cognitive Disorder
This Hyperhidrosis side effect was reported by a consumer or non-health professional from Denmark. A 53-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Valdoxan (drug dosage: 25 Mg, Unk), which was initiated on NS. Concurrently used drugs:
  • Sertraline Hydrochloride (100mg, Daily)
  • Abilify (2.5 Mg, Unk)
.After starting to take Valdoxan the consumer reported adverse symptoms, such as: Hyperhidrosis, Tremor, Hypertension, Palpitations, Restlessness, Impulsive Behaviour, Cognitive DisorderThese side effects may potentially be related to Valdoxan.
Valdoxan Side Effect Report#7658476-2
Grand Mal Convulsion, Complicated Fracture
This is a report of a 37-year-old male patient (weight: NA) from Germany, suffering from the following health symptoms/conditions: NA, who was treated with Valdoxan (agomelatine) (dosage: NA, start time:
Jan 01, 2011), combined with:
  • Risperdal Consta
  • Abilify
and developed a serious reaction and side effect(s): Grand Mal Convulsion, Complicated Fracture after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Valdoxan (agomelatine) treatment in male patients, resulting in Grand Mal Convulsion side effect.
Valdoxan Side Effect Report#7626973-1
Impulsive Behaviour, Hyperhidrosis, Tremor, Disturbance In Attention
This report suggests a potential Valdoxan Impulsive Behaviour side effect(s) that can have serious consequences. A 53-year-old female patient (weight: NA) from Denmark was diagnosed with the following symptoms/conditions: NA and used Valdoxan (dosage: 25 Mg, Unk) starting NS. After starting Valdoxan the patient began experiencing various side effects, including: Impulsive Behaviour, Hyperhidrosis, Tremor, Disturbance In AttentionAdditional drugs used concurrently:
  • Sertraline Hydrochloride (100 Mg, Unk)
  • Sertraline Hydrochloride (50 Mg, Unk)
  • Abilify
Although Valdoxan demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Impulsive Behaviour, may still occur.
Valdoxan Side Effect Report#7605700-8
Hyperhidrosis, Impulsive Behaviour, Tremor, Disturbance In Attention, Hypertension
This Hyperhidrosis problem was reported by a consumer or non-health professional from Denmark. A 53-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Valdoxan (dosage: 25 Mg, Unk). The following drugs were being taken at the same time:
  • Sertraline Hydrochloride (100mg, Daily)
  • Abilify (2.5 Mg, Unk)
When using Valdoxan, the patient experienced the following unwanted symptoms/side effects: Hyperhidrosis, Impulsive Behaviour, Tremor, Disturbance In Attention, HypertensionAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Hyperhidrosis, may become evident only after a product is in use by the general population.
Valdoxan Side Effect Report#7591036-0
Weight Decreased, Liver Function Test Abnormal, Blood Cholesterol Increased, Chest Pain
This Weight Decreased side effect was reported by a consumer or non-health professional from Brazil. A female patient (weight:NA) experienced the following symptoms/conditions: depression,schizophrenia.The patient was prescribed Valdoxan (drug dosage: NA), which was initiated on
Jan 01, 2007. Concurrently used drugs:
  • Geodon
  • Lisador (Unk)
  • Plantaben (Unk)
  • Neozine (Unk)
  • Spironolactone (100 Mg, Unk)
  • Omeprazole (40 Mg, Unk)
  • Paroxetine (20 Mg, Unk)
  • Clonazepam (2 Mg, Unk)
.After starting to take Valdoxan the consumer reported adverse symptoms, such as: Weight Decreased, Liver Function Test Abnormal, Blood Cholesterol Increased, Chest PainThese side effects may potentially be related to Valdoxan.
Valdoxan Side Effect Report#7483613-2
Abdominal Pain, Urinary Retention, Social Avoidant Behaviour, Depression, Anxiety, Bladder Dilatation
This is a report of a 39-year-old female patient (weight: NA) from Denmark, suffering from the following health symptoms/conditions: NA, who was treated with Valdoxan (agomelatin) (tablets) (agomelatin) (dosage: NA, start time:
Jan 31, 2011), combined with:
  • Tercian (cyamemazine)(tab Ets)(cyamemazine)
  • Abilify (5 Mg (5 Mg, 1 In 1 D) ,oral)
  • Noctran (noctran) (tablets) (noctran)
  • Escitalopram (20 Mg (20 Mg, 1 In 1 D),oral)
  • Imovane (zopiclone)(tabl.ets)(zopiclone)
  • Xanax (alprazolam)(tablets)(alprazolam)
and developed a serious reaction and side effect(s): Abdominal Pain, Urinary Retention, Social Avoidant Behaviour, Depression, Anxiety, Bladder Dilatation after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Valdoxan (agomelatin) (tablets) (agomelatin) treatment in female patients, resulting in Abdominal Pain side effect. The patient was hospitalized.
Valdoxan Side Effect Report#7073937-5
Electrocardiogram Abnormal
This report suggests a potential Valdoxan Electrocardiogram Abnormal side effect(s) that can have serious consequences. A 35-year-old male patient (weight: NA) from France was diagnosed with the following symptoms/conditions: NA and used Valdoxan (dosage: 25 Mg, Qd) starting
Jul 14, 2010. After starting Valdoxan the patient began experiencing various side effects, including: Electrocardiogram AbnormalAdditional drugs used concurrently:
  • Diclofenac Sodium (50 Mg, Tid)
  • Alcohol (Unk)
  • Amfetamine (Unk)
  • Cocaine (Unk)
  • Lansoprazole (30 Mg, Bid)
  • Methadone (80 Mg, Qd)
  • Risperdal Consta (50 Mg, Once Every 2 Weeks)
  • Risperdal Consta (50 Mg, Once Every 2 Weeks)
The patient was hospitalized. Although Valdoxan demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Electrocardiogram Abnormal, may still occur.
Valdoxan Side Effect Report#6909571-4
Intentional Overdose, Malaise, Somnolence, Suicidal Ideation, Suicide Attempt, Vomiting
This Intentional Overdose problem was reported by a consumer or non-health professional from France. A 25-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: depression. On
Jun 02, 2010 this consumer started treatment with Valdoxan (dosage: 25 Mg, Unk). The following drugs were being taken at the same time: NA. When using Valdoxan, the patient experienced the following unwanted symptoms/side effects: Intentional Overdose, Malaise, Somnolence, Suicidal Ideation, Suicide Attempt, 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 Intentional Overdose, may become evident only after a product is in use by the general population.
Valdoxan Side Effect Report#6895207-8
Intentional Overdose, Suicide Attempt
This Intentional Overdose side effect was reported by a physician from France. A 33-year-old female patient (weight:NA) experienced the following symptoms/conditions: depression,insomnia.The patient was prescribed Valdoxan (drug dosage: 25 Mg, Qd), which was initiated on
May 01, 2010. Concurrently used drugs:
  • Clozapine (Unk)
  • Fluanxol
.After starting to take Valdoxan the consumer reported adverse symptoms, such as: Intentional Overdose, Suicide AttemptThese side effects may potentially be related to Valdoxan. The patient was hospitalized.
Valdoxan Side Effect Report#6771264-4
Intentional Overdose, Malaise, Somnolence, Suicidal Ideation, Vomiting
This is a report of a 25-year-old female patient (weight: NA) from France, suffering from the following health symptoms/conditions: depression, who was treated with Valdoxan (dosage: 25 Mg, Unk, start time:
Jun 02, 2010), combined with: NA. and developed a serious reaction and side effect(s): Intentional Overdose, Malaise, Somnolence, Suicidal Ideation, Vomiting after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Valdoxan treatment in female patients, resulting in Intentional Overdose side effect. The patient was hospitalized.



The appearance of Valdoxan 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 Valdoxan Side Effects for Women?

Women Side Effects Reports
Somnolence 4
Hyperhidrosis 3
Impulsive Behaviour 3
Intentional Overdose 3
Suicide Attempt 3
Tremor 3
Abdominal Pain 2
Depression 2
Disturbance In Attention 2
Fatigue 2

What are common Valdoxan Side Effects for Men?

Men Side Effects Reports
Electrocardiogram Abnormal 2
Completed Suicide 1
Complicated Fracture 1
Depression 1
Epilepsy 1
Grand Mal Convulsion 1
Oesophageal Atresia 1
Somnolence 1
Suicide Attempt 1

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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:

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  • 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.

    Valdoxan 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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    Valdoxan Safety Alerts, Active Ingredients, Usage Information

    More About Valdoxan

    Side Effects reported to FDA: 25

    Valdoxan safety alerts: No

    Reported deaths: 1

    Reported hospitalizations: 10

    Latest Valdoxan clinical trials