Common Mirtazapine Side Effects


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

Completed Suicide (237)
Confusional State (206)
Hyponatraemia (180)
Depression (160)
Overdose (148)
Anxiety (147)
Fall (136)
Dizziness (130)
Agitation (130)
Condition Aggravated (123)
Somnolence (117)
Insomnia (113)
Headache (110)
Serotonin Syndrome (109)
Suicidal Ideation (107)
Fatigue (105)
Loss Of Consciousness (104)
Aggression (103)
Convulsion (102)
Suicide Attempt (100)

➢ 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.

Mirtazapine Side Effects Reported to FDA



Mirtazapine Side Effect Report#9998214
Blepharospasm, Aggression, Anger, Violence-related Symptom, Suicidal Ideation
This is a report of a 46-year-old female patient (weight: NA) from GB, suffering from the following health symptoms/conditions: depression, who was treated with Mirtazapine (dosage: NA, start time:
Jan 01, 2014), combined with:
  • Lansoprazole
  • Nasonex
and developed a serious reaction and side effect(s): Blepharospasm, Aggression, Anger, Violence-related Symptom, Suicidal Ideation after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Mirtazapine treatment in female patients, resulting in Blepharospasm side effect.
Mirtazapine Side Effect Report#9995356
Muscle Twitching, Anger, Suicidal Ideation, Aggression, Violence-related Symptom, Eye Disorder
This report suggests a potential Mirtazapine Muscle Twitching side effect(s) that can have serious consequences. A 46-year-old female patient (weight: NA) from GB was diagnosed with the following symptoms/conditions: depression and used Mirtazapine (dosage: NA) starting
Jan 01, 2014. After starting Mirtazapine the patient began experiencing various side effects, including: Muscle Twitching, Anger, Suicidal Ideation, Aggression, Violence-related Symptom, Eye DisorderAdditional drugs used concurrently:
  • Lansoprazole (lansoprazole)
  • Nasonex (mometasone Furoate)
Although Mirtazapine demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Muscle Twitching, may still occur.
Mirtazapine Side Effect Report#9988709
Toxicity To Various Agents, Restlessness, Sedation, Intentional Overdose
This Toxicity To Various Agents problem was reported by a pharmacist from IT. A 36-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: depression. On
Sep 20, 2013 this consumer started treatment with Mirtazapine (mirtazapine) (dosage: 60 Mg, Total, Oral). The following drugs were being taken at the same time:
  • Xanax (alprazolam) (3 Dosage Forms, Total, Oral)
When using Mirtazapine (mirtazapine), the patient experienced the following unwanted symptoms/side effects: Toxicity To Various Agents, Restlessness, Sedation, Intentional OverdoseAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Toxicity To Various Agents, may become evident only after a product is in use by the general population.
Mirtazapine Side Effect Report#9988310
Sopor, Toxicity To Various Agents, Atrioventricular Block, Hypotension
This Sopor side effect was reported by a health professional from IT. A 34-year-old female patient (weight:NA) experienced the following symptoms/conditions: intentional self-injury.The patient was prescribed Mirtazapine (drug dosage: 900 Mg, Once/single), which was initiated on
Jan 21, 2014. Concurrently used drugs:
  • Flecainide (300 Mg, Once/single)
  • Sodium Bicarbonate (60 Meq/l,)
  • Buscofen
  • Sotalol
  • Sertraline
  • Bromazepam
.After starting to take Mirtazapine the consumer reported adverse symptoms, such as: Sopor, Toxicity To Various Agents, Atrioventricular Block, HypotensionThese side effects may potentially be related to Mirtazapine. The patient was hospitalized.
Mirtazapine Side Effect Report#9981220
Anaphylactic Reaction
This is a report of a 89-year-old female patient (weight: NA) from GB, suffering from the following health symptoms/conditions: depression,pain, who was treated with Mirtazapine (dosage: NA, start time:
Feb 04, 2014), combined with:
  • Dihydrocodeine
  • Clopidogrel
  • Lidocaine
  • Nitrofurantoin
  • Paracetamol
  • Simvastatin
and developed a serious reaction and side effect(s): Anaphylactic Reaction after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Mirtazapine treatment in female patients, resulting in Anaphylactic Reaction side effect. The patient was hospitalized.
Mirtazapine Side Effect Report#9981085
Oedema, Diaphragmatic Disorder, Dyspnoea
This report suggests a potential Mirtazapine Oedema side effect(s) that can have serious consequences. A 63-year-old male patient (weight: NA) from GB was diagnosed with the following symptoms/conditions: depression and used Mirtazapine (dosage: NA) starting 201312. After starting Mirtazapine the patient began experiencing various side effects, including: Oedema, Diaphragmatic Disorder, DyspnoeaAdditional drugs used concurrently: NA. Although Mirtazapine demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Oedema, may still occur.
Mirtazapine Side Effect Report#9980892
Hypotension, Tachycardia, Oxygen Saturation Decreased, Coma Scale Abnormal, Rash Erythematous, Rash, Anaphylactic Reaction
This Hypotension problem was reported by a physician from GB. A 89-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: depression. On
Feb 04, 2014 this consumer started treatment with Mirtazapine (mirtazapine) (dosage: NA). The following drugs were being taken at the same time:
  • Dihydrocodeine (dihydrocodeine)
  • Clopidogrel (clopidogrel)
  • Lidocaine (lidocaine)
  • Nitrofurantoin (nitrofurantoin)
  • Paracetamol (paracetamol)
  • Simvastatin (simvastatin)
When using Mirtazapine (mirtazapine), the patient experienced the following unwanted symptoms/side effects: Hypotension, Tachycardia, Oxygen Saturation Decreased, Coma Scale Abnormal, Rash Erythematous, Rash, Anaphylactic ReactionThe 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 Hypotension, may become evident only after a product is in use by the general population.
Mirtazapine Side Effect Report#9980851
Off Label Use, Liver Function Test Abnormal, Dyspnoea, Dizziness, Abdominal Distension, Eating Disorder, Oedema, Abdominal Pain Upper, Malaise
This Off Label Use side effect was reported by a consumer or non-health professional from GB. A 32-year-old female patient (weight:NA) experienced the following symptoms/conditions: personality disorder,depression,off label use.The patient was prescribed Mirtazapine (drug dosage: NA), which was initiated on
Feb 05, 2013. Concurrently used drugs: NA..After starting to take Mirtazapine the consumer reported adverse symptoms, such as: Off Label Use, Liver Function Test Abnormal, Dyspnoea, Dizziness, Abdominal Distension, Eating Disorder, Oedema, Abdominal Pain Upper, MalaiseThese side effects may potentially be related to Mirtazapine.
Mirtazapine Side Effect Report#9980743
Blepharospasm, Anger, Violence-related Symptom, Aggression, Suicidal Ideation
This is a report of a 46-year-old female patient (weight: NA) from GB, suffering from the following health symptoms/conditions: depression, who was treated with Mirtazapine (dosage: 30 Mg, Unk, start time:
Jan 01, 2014), combined with:
  • Lansoprazole
  • Nasonex
and developed a serious reaction and side effect(s): Blepharospasm, Anger, Violence-related Symptom, Aggression, Suicidal Ideation after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Mirtazapine treatment in female patients, resulting in Blepharospasm side effect.
Mirtazapine Side Effect Report#9972852
Malaise, Asthenia, Anaemia
This report suggests a potential Mirtazapine Malaise side effect(s) that can have serious consequences. A 13-year-old female patient (weight: NA) from IT was diagnosed with the following symptoms/conditions: NA and used Mirtazapine (dosage: 90 Mg, Once/single) starting
Oct 09, 2012. After starting Mirtazapine the patient began experiencing various side effects, including: Malaise, Asthenia, AnaemiaAdditional drugs used concurrently: NA.The patient was hospitalized. Although Mirtazapine demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Malaise, may still occur.
Mirtazapine Side Effect Report#9970303
Blepharospasm, Anger, Violence-related Symptom, Aggression, Suicidal Ideation
This Blepharospasm problem was reported by a consumer or non-health professional from GB. A 46-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: depression. On
Jan 01, 2014 this consumer started treatment with Mirtazapine (dosage: 30 Mg, Unk). The following drugs were being taken at the same time:
  • Nasonex (Unk)
  • Lansoprazole
When using Mirtazapine, the patient experienced the following unwanted symptoms/side effects: Blepharospasm, Anger, Violence-related Symptom, Aggression, Suicidal IdeationAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Blepharospasm, may become evident only after a product is in use by the general population.
Mirtazapine Side Effect Report#9967693
Diaphragmatic Disorder, Dyspnoea, Oedema
This Diaphragmatic Disorder side effect was reported by a health professional from GB. A 63-year-old male patient (weight:NA) experienced the following symptoms/conditions: depression.The patient was prescribed Mirtazapine (drug dosage: NA), which was initiated on 201312. Concurrently used drugs: NA..After starting to take Mirtazapine the consumer reported adverse symptoms, such as: Diaphragmatic Disorder, Dyspnoea, OedemaThese side effects may potentially be related to Mirtazapine.
Mirtazapine Side Effect Report#9967677
Liver Function Test Abnormal, Dyspnoea, Dizziness, Abdominal Distension, Oedema, Abdominal Pain Upper, Abnormal Weight Gain, Eating Disorder
This is a report of a 32-year-old female patient (weight: NA) from GB, suffering from the following health symptoms/conditions: depression, who was treated with Mirtazapine (dosage: NA, start time:
Feb 05, 2013), combined with: NA. and developed a serious reaction and side effect(s): Liver Function Test Abnormal, Dyspnoea, Dizziness, Abdominal Distension, Oedema, Abdominal Pain Upper, Abnormal Weight Gain, Eating Disorder after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Mirtazapine treatment in female patients, resulting in Liver Function Test Abnormal side effect.
Mirtazapine Side Effect Report#9964661
Liver Function Test Abnormal, Dyspnoea, Dizziness, Abdominal Distension, Oedema, Abdominal Pain Upper, Abnormal Weight Gain, Eating Disorder, Malaise
This report suggests a potential Mirtazapine Liver Function Test Abnormal side effect(s) that can have serious consequences. A 32-year-old female patient (weight: NA) from GB was diagnosed with the following symptoms/conditions: depression and used Mirtazapine (dosage: NA) starting
Feb 05, 2013. After starting Mirtazapine the patient began experiencing various side effects, including: Liver Function Test Abnormal, Dyspnoea, Dizziness, Abdominal Distension, Oedema, Abdominal Pain Upper, Abnormal Weight Gain, Eating Disorder, MalaiseAdditional drugs used concurrently: NA. Although Mirtazapine demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Liver Function Test Abnormal, may still occur.
Mirtazapine Side Effect Report#9958591
Pancytopenia, Cough, Pyrexia, Influenza Like Illness
This Pancytopenia problem was reported by a health professional from US. A 58-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: schizoaffective disorder. On NS this consumer started treatment with Mirtazapine Tablets (dosage: NA). The following drugs were being taken at the same time:
  • Divalproex Sodium
  • Olanzapine
  • Clonazepam
  • Risperidone
When using Mirtazapine Tablets, the patient experienced the following unwanted symptoms/side effects: Pancytopenia, Cough, Pyrexia, Influenza Like IllnessThe 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 Pancytopenia, may become evident only after a product is in use by the general population.
Mirtazapine Side Effect Report#9955354
Shared Psychotic Disorder, Mania, Tachyphrenia, Suicidal Ideation, Suicidal Behaviour, Abnormal Behaviour, Dysarthria, Dyspraxia, Psychomotor Retardation
This Shared Psychotic Disorder side effect was reported by a consumer or non-health professional from GB. A 31-year-old female patient (weight:NA) experienced the following symptoms/conditions: depression.The patient was prescribed Mirtazapine (drug dosage: 15 Mg (only Took 3 Doses As Directed)), which was initiated on 2008. Concurrently used drugs:
  • Sertraline Hcl (200 Mg, Unk)
  • Sertraline Hcl (150 Mg, Unk)
  • Sertraline Hcl (100 Mg, Unk)
  • Sertraline Hcl (50 Mg, Unk)
  • Zinc (Unk)
.After starting to take Mirtazapine the consumer reported adverse symptoms, such as: Shared Psychotic Disorder, Mania, Tachyphrenia, Suicidal Ideation, Suicidal Behaviour, Abnormal Behaviour, Dysarthria, Dyspraxia, Psychomotor RetardationThese side effects may potentially be related to Mirtazapine.
Mirtazapine Side Effect Report#9953394
Dyspnoea, Diaphragmatic Disorder, Oedema
This is a report of a 63-year-old male patient (weight: NA) from GB, suffering from the following health symptoms/conditions: depression, who was treated with Mirtazapine (dosage: 15 Mg, Unk, start time: 201312), combined with: NA. and developed a serious reaction and side effect(s): Dyspnoea, Diaphragmatic Disorder, Oedema after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Mirtazapine treatment in male patients, resulting in Dyspnoea side effect.
Mirtazapine Side Effect Report#9952085
Priapism
This report suggests a potential Mirtazapine Priapism side effect(s) that can have serious consequences. A 47-year-old male patient (weight: NA) from GB was diagnosed with the following symptoms/conditions: bipolar disorder,depression and used Mirtazapine (dosage: 30 Mg, Once A Night (1/1 Days)) starting
Sep 03, 2012. After starting Mirtazapine the patient began experiencing various side effects, including: PriapismAdditional drugs used concurrently: NA.The patient was hospitalized. Although Mirtazapine demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Priapism, may still occur.
Mirtazapine Side Effect Report#9949485
Petit Mal Epilepsy, Self-injurious Ideation, Activities Of Daily Living Impaired, Apraxia, Vision Blurred, Dyspraxia, Fear, Feeling Hot, Frustration
This Petit Mal Epilepsy problem was reported by a physician from GB. A 31-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: depression. On 2008 this consumer started treatment with Mirtazapine (dosage: 3 Total). The following drugs were being taken at the same time:
  • Sertraline Hydrochloride (Unk)
When using Mirtazapine, the patient experienced the following unwanted symptoms/side effects: Petit Mal Epilepsy, Self-injurious Ideation, Activities Of Daily Living Impaired, Apraxia, Vision Blurred, Dyspraxia, Fear, Feeling Hot, FrustrationAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Petit Mal Epilepsy, may become evident only after a product is in use by the general population.
Mirtazapine Side Effect Report#9940875
Heart Rate Increased, Pyrexia, Asthenia, Hyperhidrosis, Pyrexia, Oral Herpes, Thirst, Dysuria, Balance Disorder
This Heart Rate Increased side effect was reported by a consumer or non-health professional from SE. A 53-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Mirtazapine Teva (drug dosage: NA), which was initiated on NS. Concurrently used drugs: NA..After starting to take Mirtazapine Teva the consumer reported adverse symptoms, such as: Heart Rate Increased, Pyrexia, Asthenia, Hyperhidrosis, Pyrexia, Oral Herpes, Thirst, Dysuria, Balance DisorderThese side effects may potentially be related to Mirtazapine Teva.
Mirtazapine Side Effect Report#9937229
Liver Function Test Abnormal, Dyspnoea, Abdominal Distension, Abdominal Pain Upper, Eating Disorder, Dizziness, Oedema, Abnormal Weight Gain
This is a report of a 32-year-old female patient (weight: NA) from GB, suffering from the following health symptoms/conditions: depression, who was treated with Mirtazapine (dosage: 30 Mg, Unk, start time:
Feb 05, 2013), combined with: NA. and developed a serious reaction and side effect(s): Liver Function Test Abnormal, Dyspnoea, Abdominal Distension, Abdominal Pain Upper, Eating Disorder, Dizziness, Oedema, Abnormal Weight Gain after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Mirtazapine treatment in female patients, resulting in Liver Function Test Abnormal side effect.
Mirtazapine Side Effect Report#9937224
Diaphragmatic Disorder, Dyspnoea, Oedema
This report suggests a potential Mirtazapine Diaphragmatic Disorder side effect(s) that can have serious consequences. A 63-year-old male patient (weight: NA) from GB was diagnosed with the following symptoms/conditions: depression and used Mirtazapine (dosage: 15 Mg, Unk) starting 201312. After starting Mirtazapine the patient began experiencing various side effects, including: Diaphragmatic Disorder, Dyspnoea, OedemaAdditional drugs used concurrently: NA. Although Mirtazapine demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Diaphragmatic Disorder, may still occur.
Mirtazapine Side Effect Report#9931155
Abnormal Weight Gain, Abdominal Distension, Eating Disorder, Dyspnoea, Abdominal Pain Upper, Dizziness, Liver Function Test Abnormal, Oedema
This Abnormal Weight Gain problem was reported by a consumer or non-health professional from GB. A 32-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: personality disorder,depression,off label use. On
Feb 05, 2013 this consumer started treatment with Mirtazapine (dosage: 30 Mg, Unk). The following drugs were being taken at the same time: NA. When using Mirtazapine, the patient experienced the following unwanted symptoms/side effects: Abnormal Weight Gain, Abdominal Distension, Eating Disorder, Dyspnoea, Abdominal Pain Upper, Dizziness, Liver Function Test Abnormal, OedemaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Abnormal Weight Gain, may become evident only after a product is in use by the general population.
Mirtazapine Side Effect Report#9931075
Anaphylactic Reaction
This Anaphylactic Reaction side effect was reported by a physician from GB. A 89-year-old female patient (weight:NA) experienced the following symptoms/conditions: depression,pain.The patient was prescribed Mirtazapine (drug dosage: 15 Mg, Unk), which was initiated on
Feb 04, 2014. Concurrently used drugs:
  • Dihydrocodeine (30 Mg, Unk)
  • Clopidogrel
  • Lidocaine
  • Nitrofurantoin
  • Acetaminophen
  • Simvastatin
.After starting to take Mirtazapine the consumer reported adverse symptoms, such as: Anaphylactic ReactionThese side effects may potentially be related to Mirtazapine. The patient was hospitalized.
Mirtazapine Side Effect Report#9928131
Pulmonary Oedema, Gait Disturbance, Dysarthria, Dysphagia, Condition Aggravated, Aphasia, Bedridden, Jc Virus Infection
This is a report of a 51-year-old male patient (weight: NA) from IT, suffering from the following health symptoms/conditions: jc virus infection, who was treated with Mirtazapine (dosage: NA, start time: NS), combined with:
  • Mefloquine
  • Ritonavir (ritonavir)
  • Raltegravir (raltegravir)
  • Enfuvirtide (enfuviritde)
  • Emtricitabine /tenovir (emtricitabine W/tenfovir)
  • Methylprednisolone (methylprednisolone)
and developed a serious reaction and side effect(s): Pulmonary Oedema, Gait Disturbance, Dysarthria, Dysphagia, Condition Aggravated, Aphasia, Bedridden, Jc Virus Infection after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Mirtazapine treatment in male patients, resulting in Pulmonary Oedema side effect.


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The appearance of Mirtazapine 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 Mirtazapine Side Effects for Women?

Women Side Effects Reports
Hyponatraemia 124
Completed Suicide 100
Confusional State 94
Depression 93
Overdose 83
Fall 82
Anxiety 76
Dizziness 76
Condition Aggravated 72
Fatigue 71

What are common Mirtazapine Side Effects for Men?

Men Side Effects Reports
Confusional State 111
Completed Suicide 104
Agitation 71
Anxiety 69
Depression 65
Overdose 61
Somnolence 60
Aggression 59
Fall 54
Hyponatraemia 54

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.

    Mirtazapine 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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    Mirtazapine Safety Alerts, Active Ingredients, Usage Information

    NDC 0093-7206
    Type HUMAN PRESCRIPTION DRUG
    Proprietary Name Mirtazapine
    Name Mirtazapine
    Dosage Form TABLET, FILM COATED
    Route ORAL
    On market since 20030129
    Labeler Teva Pharmaceuticals USA Inc