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Mirtazapine Side Effects

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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#9922785
Tenderness, Oedema Peripheral, Oedema
This is a report of a 48-year-old female patient (weight: NA) from AU, suffering from the following health symptoms/conditions: NA, who was treated with Mirtazapine Ga (dosage: 15 Mg, Daily, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Tenderness, Oedema Peripheral, Oedema after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Mirtazapine Ga treatment in female patients, resulting in Tenderness side effect. The patient was hospitalized.
Mirtazapine Side Effect Report#9917751
Toxicity To Various Agents, Vascular Calcification, Arteriosclerosis Coronary Artery, Intentional Self-injury
This report suggests a potential Mirtazapine Toxicity To Various Agents side effect(s) that can have serious consequences. A 68-year-old male patient (weight: NA) from AU was diagnosed with the following symptoms/conditions: NA and used Mirtazapine (dosage: NA) starting NS. After starting Mirtazapine the patient began experiencing various side effects, including: Toxicity To Various Agents, Vascular Calcification, Arteriosclerosis Coronary Artery, Intentional Self-injuryAdditional drugs used concurrently:
  • Duloxetine Hydrochloride
  • Paroxetine Hydrochloride
  • Zolpidem Tartrate
Although Mirtazapine demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Toxicity To Various Agents, may still occur.
Mirtazapine Side Effect Report#9915710
Abnormal Dreams, Middle Insomnia, Hyperhidrosis, Dyspnoea, Feeling Abnormal, Fear, Vision Blurred
This Abnormal Dreams problem was reported by a consumer or non-health professional from US. A 79-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: sleep disorder. On
Jan 28, 2014 this consumer started treatment with Mirtazapine (dosage: 15 Mg?1 Tablet At Bedtime?1 Per Day?mouth). The following drugs were being taken at the same time:
  • Atenolol
  • Hydrochlorotheze
  • Atorvastatin
  • L Thyroxine
  • Zyrtec
When using Mirtazapine, the patient experienced the following unwanted symptoms/side effects: Abnormal Dreams, Middle Insomnia, Hyperhidrosis, Dyspnoea, Feeling Abnormal, Fear, Vision BlurredAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Abnormal Dreams, may become evident only after a product is in use by the general population.
Mirtazapine Side Effect Report#9914048
Toxicity To Various Agents, Exposure Via Ingestion
This Toxicity To Various Agents side effect was reported by a pharmacist from US. A 41-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Mirtazapine (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Naproxen
  • Semisodium Valproate
  • Tramadol
.After starting to take Mirtazapine the consumer reported adverse symptoms, such as: Toxicity To Various Agents, Exposure Via IngestionThese side effects may potentially be related to Mirtazapine.
Mirtazapine Side Effect Report#9913875
Completed Suicide
This is a report of a 60-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Mirtazapine (dosage: NA, start time: NS), combined with:
  • Carbon Monoxide
and developed a serious reaction and side effect(s): Completed Suicide after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Mirtazapine treatment in male patients, resulting in Completed Suicide side effect.
Mirtazapine Side Effect Report#9913590
Completed Suicide, Toxicity To Various Agents
This report suggests a potential Mirtazapine (mirtazapine) Completed Suicide side effect(s) that can have serious consequences. A 78-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Mirtazapine (mirtazapine) (dosage: NA) starting NS. After starting Mirtazapine (mirtazapine) the patient began experiencing various side effects, including: Completed Suicide, Toxicity To Various AgentsAdditional drugs used concurrently:
  • Acetaminophen/oxycodone
  • Lorazepam
Although Mirtazapine (mirtazapine) demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Completed Suicide, may still occur.
Mirtazapine Side Effect Report#9913570
Toxicity To Various Agents, Exposure Via Ingestion, Completed Suicide, Respiratory Arrest, Cardiac Arrest
This Toxicity To Various Agents problem was reported by a pharmacist from US. A 30-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Mirtazapine (mirtazapine) (dosage: NA). The following drugs were being taken at the same time:
  • Bupropion (bupropion)
  • Ziprasidone
  • Benztropine
When using Mirtazapine (mirtazapine), the patient experienced the following unwanted symptoms/side effects: Toxicity To Various Agents, Exposure Via Ingestion, Completed Suicide, Respiratory Arrest, Cardiac ArrestAlthough 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#9913402
Completed Suicide, Exposure Via Ingestion, Toxicity To Various Agents
This Completed Suicide side effect was reported by a pharmacist from US. A 34-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Mirtazapine (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Carvedilol
  • Topiramate (topiramate)
  • Clopidogrel (clopidogrel)
  • Simvastatin (simvastatin)
  • Alprazolam (alprazolam)
  • Hydrocodone+paracetamol (vicodin)
  • Propranolol (propranolol)
  • Lurasidone
.After starting to take Mirtazapine the consumer reported adverse symptoms, such as: Completed Suicide, Exposure Via Ingestion, Toxicity To Various AgentsThese side effects may potentially be related to Mirtazapine.
Mirtazapine Side Effect Report#9913224
Completed Suicide
This is a report of a 27-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Mirtazapine (dosage: NA, start time: NS), combined with:
  • Hydroxyzine (hydroxyzine)
  • Chlordiazepoxide (chlordiazepoxide) (chlordiazepoxide)
  • Clonazepam (clonazepam) (clonazepam)
  • Phenobarbital (phenobarbital)
  • Atomoxetine (atomoxetine)
and developed a serious reaction and side effect(s): Completed Suicide after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Mirtazapine treatment in male patients, resulting in Completed Suicide side effect.
Mirtazapine Side Effect Report#9912907
Crohn^s Disease, Pancytopenia
This report suggests a potential Mirtazapine (mirtazapine) Crohn^s Disease side effect(s) that can have serious consequences. A 31-year-old female patient (weight: NA) from GB was diagnosed with the following symptoms/conditions: NA and used Mirtazapine (mirtazapine) (dosage: 30 Mg, 1 In 1 D) starting NS. After starting Mirtazapine (mirtazapine) the patient began experiencing various side effects, including: Crohn^s Disease, PancytopeniaAdditional drugs used concurrently:
  • Cyclizine
  • Fentanyl
  • Ferrous Fumarate
  • Fluconazole
  • Lansoprazole
  • Norethisterone
  • Nystatin
  • Oramorph
The patient was hospitalized. Although Mirtazapine (mirtazapine) demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Crohn^s Disease, may still occur.
Mirtazapine Side Effect Report#9911744
Memory Impairment, Disorientation, Insomnia
This Memory Impairment problem was reported by a consumer or non-health professional from BR. A 70-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: depression,anxiety,headache. On 201401 this consumer started treatment with Mirtazapine Sandoz (dosage: 30 Mg, Qd). The following drugs were being taken at the same time: NA. When using Mirtazapine Sandoz, the patient experienced the following unwanted symptoms/side effects: Memory Impairment, Disorientation, InsomniaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Memory Impairment, may become evident only after a product is in use by the general population.
Mirtazapine Side Effect Report#9908177
Toxicity To Various Agents, Exposure Via Ingestion
This Toxicity To Various Agents side effect was reported by a pharmacist from US. A 62-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Mirtazapine (mirtazapine) (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Methadone (methadone) (Oral)
  • Tramadol (tramadol)
  • Doxepin (doxepin) (doxepin)
  • Clonazepam (clonazepam) (clonazepam)
  • Ethanol
.After starting to take Mirtazapine (mirtazapine) the consumer reported adverse symptoms, such as: Toxicity To Various Agents, Exposure Via IngestionThese side effects may potentially be related to Mirtazapine (mirtazapine).
Mirtazapine Side Effect Report#9908125
Toxicity To Various Agents, Exposure Via Ingestion
This is a report of a 51-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Mirtazapine (dosage: NA, start time: NS), combined with:
  • Cyclobenzaprine (cyclobenzaprine)
  • Hydrocodone Paracetamol
  • Zolpidem (zolpidem)
  • Morphine
and developed a serious reaction and side effect(s): Toxicity To Various Agents, Exposure Via Ingestion after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Mirtazapine treatment in female patients, resulting in Toxicity To Various Agents side effect.
Mirtazapine Side Effect Report#9907603
Aggression
This report suggests a potential Mirtazapine Aggression side effect(s) that can have serious consequences. A 40-year-old male patient (weight: NA) from GB was diagnosed with the following symptoms/conditions: NA and used Mirtazapine (dosage: Unk) starting
Dec 11, 2013. After starting Mirtazapine the patient began experiencing various side effects, including: AggressionAdditional drugs used concurrently:
  • Citalopram (Unk)
  • Doxycycline (Unk)
  • Doxycycline (Unk)
  • Venlafaxine Hydrochloride (Unk)
Although Mirtazapine demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Aggression, may still occur.
Mirtazapine Side Effect Report#9907301
Pancytopenia, Crohn^s Disease
This Pancytopenia problem was reported by a pharmacist from GB. A 31-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Mirtazapine (dosage: NA). The following drugs were being taken at the same time:
  • Fentanyl
  • Lansoprazole
  • Ferrous Fumarate
  • Nystatin
  • Fluconazole
  • Cyclizine
  • Paracetamol
  • Norethisterone
When using Mirtazapine, the patient experienced the following unwanted symptoms/side effects: Pancytopenia, Crohn^s DiseaseThe 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#9907289
Pancytopenia, Crohn^s Disease
This Pancytopenia side effect was reported by a pharmacist from GB. A 31-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Mirtazapine (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Fentanyl
  • Lansoprazole (Orodispersible Tablet)
  • Ferrous Fumarate (140mg/5ml)
  • Nystatin (100,000 Units/ml)
  • Fluconazole
  • Cyclizine (50mg/1ml)
  • Paracetamol
  • Norethisterone
.After starting to take Mirtazapine the consumer reported adverse symptoms, such as: Pancytopenia, Crohn^s DiseaseThese side effects may potentially be related to Mirtazapine. The patient was hospitalized.
Mirtazapine Side Effect Report#9902839
Crohn^s Disease, Pancytopenia
This is a report of a 31-year-old female patient (weight: NA) from GB, suffering from the following health symptoms/conditions: NA, who was treated with Mirtazapine (dosage: 30 Mg, Qd, start time: NS), combined with:
  • Fentanyl (50 Ug, Qh)
  • Lansoprazole (30 Mg, Qd)
  • Ferrous Fumarate (280 Mg, Bid)
  • Nystatin (1 Ml, Qid)
  • Fluconazole (50 Mg, Qd)
  • Cyclizine (50 Mg, Tid)
  • Paracetamol (1 G, Qid)
  • Norethisterone (5 Mg, Tid)
and developed a serious reaction and side effect(s): Crohn^s Disease, Pancytopenia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Mirtazapine treatment in female patients, resulting in Crohn^s Disease side effect. The patient was hospitalized.
Mirtazapine Side Effect Report#9893339
Bezoar, Overdose, Somnolence, Tachycardia, Disturbance In Attention
This report suggests a potential Mirtazapine Bezoar side effect(s) that can have serious consequences. A 26-year-old female patient (weight: NA) from CH was diagnosed with the following symptoms/conditions: NA and used Mirtazapine (dosage: Unk) starting NS. After starting Mirtazapine the patient began experiencing various side effects, including: Bezoar, Overdose, Somnolence, Tachycardia, Disturbance In AttentionAdditional drugs used concurrently:
  • Lorazepam (Unk)
  • Seroquel Xr
The patient was hospitalized. Although Mirtazapine demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Bezoar, may still occur.
Mirtazapine Side Effect Report#9891919
Toxicity To Various Agents, Exposure Via Ingestion
This Toxicity To Various Agents problem was reported by a pharmacist from US. A 44-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Mirtazapine (mirtazapine) (dosage: NA). The following drugs were being taken at the same time:
  • Fentanyl (fentanyl)
  • Amitriptyline (amitriptyline)
  • Ethanol
When using Mirtazapine (mirtazapine), the patient experienced the following unwanted symptoms/side effects: Toxicity To Various Agents, Exposure Via IngestionAlthough 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#9890719
Foetal Exposure During Pregnancy, Foetal Exposure During Pregnancy, Cardiac Murmur, Atrial Septal Defect, Pulmonary Valve Stenosis
This Foetal Exposure During Pregnancy side effect was reported by a health professional from DE. A female patient (weight:NA) experienced the following symptoms/conditions: sleep disorder.The patient was prescribed Mirtazapine (drug dosage: 7.5 Mg, 1 D, Transplacental), which was initiated on
May 09, 2012. Concurrently used drugs:
  • Folio ( Folio)
.After starting to take Mirtazapine the consumer reported adverse symptoms, such as: Foetal Exposure During Pregnancy, Foetal Exposure During Pregnancy, Cardiac Murmur, Atrial Septal Defect, Pulmonary Valve StenosisThese side effects may potentially be related to Mirtazapine.
Mirtazapine Side Effect Report#9889624
Condition Aggravated, Restless Legs Syndrome
This is a report of a 47-year-old male patient (weight: NA) from GB, suffering from the following health symptoms/conditions: NA, who was treated with Mirtazapine (dosage: NA, start time:
Oct 07, 2013), combined with:
  • Fluoxetine
  • Ranitidine
and developed a serious reaction and side effect(s): Condition Aggravated, Restless Legs Syndrome after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Mirtazapine treatment in male patients, resulting in Condition Aggravated side effect.
Mirtazapine Side Effect Report#9886895
Psychotic Disorder
This report suggests a potential Mirtazapine Psychotic Disorder side effect(s) that can have serious consequences. A 36-year-old male patient (weight: NA) from NL was diagnosed with the following symptoms/conditions: tension and used Mirtazapine (dosage: 1 Times Per 1 Days 45 Mg) starting 201307. After starting Mirtazapine the patient began experiencing various side effects, including: Psychotic DisorderAdditional drugs used concurrently:
  • Lorazepam (1times Per 1 Days 1 Df)
The patient was hospitalized. Although Mirtazapine demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Psychotic Disorder, may still occur.
Mirtazapine Side Effect Report#9885918
Restless Legs Syndrome, Condition Aggravated
This Restless Legs Syndrome problem was reported by a physician from GB. A 47-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Jan 17, 2014 this consumer started treatment with Mirtazapine (mirtazapine) (dosage: NA). The following drugs were being taken at the same time:
  • Fluoxetine (fluoxetine)
  • Ranitidine (ranitidine)
When using Mirtazapine (mirtazapine), the patient experienced the following unwanted symptoms/side effects: Restless Legs Syndrome, Condition AggravatedAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Restless Legs Syndrome, may become evident only after a product is in use by the general population.
Mirtazapine Side Effect Report#9880885
Tremor, Neurological Symptom
This Tremor side effect was reported by a health professional from IT. A 59-year-old female patient (weight:NA) experienced the following symptoms/conditions: parkinson^s disease.The patient was prescribed Mirtazapine (drug dosage: NA), which was initiated on
Sep 12, 2012. Concurrently used drugs:
  • Valium - 5mg/ml Gocce Orali, Soluzione - Roche S.p.a. (5 Gtt Total,solution)
  • Tavor
.After starting to take Mirtazapine the consumer reported adverse symptoms, such as: Tremor, Neurological SymptomThese side effects may potentially be related to Mirtazapine. The patient was hospitalized.
Mirtazapine Side Effect Report#9877923
Crohn^s Disease, Pancytopenia
This is a report of a 31-year-old female patient (weight: NA) from GB, suffering from the following health symptoms/conditions: NA, who was treated with Mirtazapine (dosage: 30 Mg, Qd, start time: NS), combined with:
  • Cyclizine (50 Mg, Tid)
  • Fentanyl (50 Microgram, 1/1 Hours)
  • Ferrous Fumarate (280 Mg, Bid)
  • Fluconazole (50 Mg, Qd)
  • Lansoprazole (30 Mg, Qd)
  • Norethindrone (5 Mg, Tid)
  • Nystatin (1 Ml, Qid)
  • Oramorph (2.5 Mg, 1 / 2 Hours)
and developed a serious reaction and side effect(s): Crohn^s Disease, Pancytopenia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Mirtazapine treatment in female patients, resulting in Crohn^s Disease side effect. The patient was hospitalized.


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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 EffectsReports
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 EffectsReports
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

    NDC0093-7206
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NameMirtazapine
    NameMirtazapine
    Dosage FormTABLET, FILM COATED
    RouteORAL
    On market since20030129
    LabelerTeva Pharmaceuticals USA Inc
    Active Ingredient(s)MIRTAZAPINE
    Strength(s)15
    Unit(s)mg/1
    Pharma Class

    Mirtazapine Dosage, Warnings, Usage.

    Side Effects reported to FDA: 4068

    Mirtazapine safety alerts: 2005

    Reported deaths: 613

    Reported hospitalizations: 1511

    Latest Mirtazapine clinical trials