This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Mirtazapine and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.
Reports by Event Outcome
All Cases (1317)
Death (324)
Life Threatening Events (111)
Disability (56)
Reports by Reaction Type
Completed Suicide (101),
Neuroleptic Malignant Syndrome (96),
Anxiety (84),
Convulsion (81),
Fall (80),
Toxicity To Various Agents (80),
Confusional State (79),
Dizziness (74),
Depression (72),
Drug Interaction (71),
Headache (71),
Insomnia (71)
Below are a few examples of reports where side effects / adverse reactions may be related to Mirtazapine. For a complete list or a specific selection of reports, please use the links above.
Possible Mirtazapine side effects in 60 year old female
Reported by a consumer/non-health professional from United Kingdom on 2012-08-27
Patient: 60 year old female
Reactions: Pruritus, Chapped Lips, Oropharyngeal Pain, Pyrexia, Tongue Eruption, Hyperhidrosis, Pharyngeal Oedema, Sensation of Foreign Body, Nervousness, Decreased Appetite, Neck Mass, Tremor, Eye Pain, Paraesthesia, Anxiety, Gastrointestinal Disorder, Insomnia, JAW Disorder, Withdrawal Syndrome
Drug(s) suspected as cause:
Mirtazapine
Other drugs received by patient: Sertraline Hydrochloride
Possible Mirtazapine side effects in
Reported by a consumer/non-health professional from United Kingdom on 2012-08-25
Patient:
Reactions: Pruritus, Chapped Lips, Pyrexia, Oropharyngeal Pain, Hyperhidrosis, Pharyngeal Oedema, Tongue Disorder, Decreased Appetite, Nervousness, Neck Mass, Paraesthesia, Eye Pain, Tremor, Anxiety, Insomnia, Gastrointestinal Disorder, JAW Disorder, Withdrawal Syndrome
Drug(s) suspected as cause:
Mirtazapine
Other drugs received by patient: Sertraline Hydrochloride
Possible Mirtazapine side effects in 79 year old male
Reported by a pharmacist from United States on 2012-08-24
Patient: 79 year old male
Reactions: Fatigue, Syncope, Hypotension, Dizziness
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Mirtazapine
Possible Mirtazapine side effects in
Reported by a individual with unspecified qualification from Japan on 2012-08-24
Patient:
Reactions: Liver Disorder
Drug(s) suspected as cause:
Mirtazapine
Dosage: 45 mg, qd
Administration route: Oral
Start date: 2011-10-11
End date: 2011-10-29
Mirtazapine
Dosage: 30 mg, qd
Administration route: Oral
Start date: 2011-10-30
End date: 2011-11-04
Mirtazapine
Dosage: 15 mg, qd
Administration route: Oral
Indication: Depression
Start date: 2011-09-30
End date: 2011-10-02
Mirtazapine
Dosage: 30 mg, qd
Administration route: Oral
Start date: 2011-10-03
End date: 2011-10-10
Other drugs received by patient: Amoxapine; Pravastatin Sodium; Mianserin Hydro.; Quetiapine Fumarate; Amoxapine; Sertraline Hydrochloride; Mianserin Hydro.; Quetiapine Fumarate; Quetiapine Fumarate; Biperiden Hydrochloride TAB; Amoxapine; Amoxapine; Flunitrazepam; Mianserin Hydro.; Phenobarbital TAB; Sertraline Hydrochloride; Magnesium Oxide; Biperiden Hydrochloride TAB; Lithium Carbonate; Pravastatin Sodium; Amoxapine; Phenobarbital TAB; Phenobarbital TAB; Mianserin Hydro.; Mianserin Hydro.; Sertraline Hydrochloride; Sertraline Hydrochloride; Biperiden Hydrochloride TAB
Possible Mirtazapine side effects in 77 year old female
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-24
Patient: 77 year old female, weighing 86.0 kg (189.2 pounds)
Reactions: Dysphagia, Tardive Dyskinesia
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Mirtazapine
Possible Mirtazapine side effects in female
Reported by a lawyer from United States on 2012-08-24
Patient: female
Reactions: Speech Disorder, Cleft LIP and Palate, Foetal Growth Restriction, Foetal Heart Rate Abnormal, Otitis Media Chronic, Gastrooesophageal Reflux Disease
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Bupivacaine HCL
Indication: Foetal Exposure During Pregnancy
Colace
Indication: Foetal Exposure During Pregnancy
Effexor
Indication: Foetal Exposure During Pregnancy
Fentanyl
Indication: Foetal Exposure During Pregnancy
Hydroxyzine
Indication: Foetal Exposure During Pregnancy
Ibuprofen
Indication: Foetal Exposure During Pregnancy
Ibuprofen
Mirtazapine
Indication: Foetal Exposure During Pregnancy
Oxytocin
Indication: Foetal Exposure During Pregnancy
Terbutaline
Indication: Foetal Exposure During Pregnancy
Topamax
Indication: Foetal Exposure During Pregnancy
Trazodone Hydrochloride
Indication: Foetal Exposure During Pregnancy
Zoloft
Indication: Foetal Exposure During Pregnancy
Other drugs received by patient: Multi-Vitamins; Metformin HCL; Risedronate Sodium; Folic Acid; Ferrous Sulfate TAB
Possible Mirtazapine side effects in female
Reported by a lawyer from United States on 2012-08-24
Patient: female
Reactions: Oligohydramnios, Maternal Exposure During Pregnancy, Perineal Laceration, Emotional Disorder, Epilepsy
Drug(s) suspected as cause:
Brethine
Indication: Product Used FOR Unknown Indication
Bupivacaine HCL
Indication: Product Used FOR Unknown Indication
Colace
Indication: Product Used FOR Unknown Indication
Effexor
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Fentanyl
Indication: Product Used FOR Unknown Indication
Hydroxyzine
Dosage: as necessary
Administration route: Oral
Indication: Anxiety
Ibuprofen
Indication: Product Used FOR Unknown Indication
Ibuprofen
Metformin HCL
Administration route: Oral
Indication: Type 2 Diabetes Mellitus
Mirtazapine
Administration route: Oral
Indication: Depression
Oxytocin
Indication: Product Used FOR Unknown Indication
Topamax
Administration route: Oral
Indication: Convulsion
Start date: 2006-09-18
End date: 2006-12-18
Topamax
Administration route: Oral
Indication: Migraine
Start date: 2006-09-18
End date: 2006-12-18
Trazodone Hydrochloride
Administration route: Oral
Indication: Depression
Zoloft
Administration route: Oral
Indication: Antidepressant Therapy
Other drugs received by patient: Folic Acid; Ferrous Sulfate TAB; Risedronate Sodium; Vitamin and Mineral Prenatal Supplement W / Folic Acid CAP
Possible Mirtazapine side effects in male
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-23
Patient: male
Reactions: Irritability, Psychotic Disorder, Paranoia, Paramnesia
Drug(s) suspected as cause:
Mirtazapine
Dosage: 15 mg, unknown
Indication: Product Used FOR Unknown Indication
Start date: 2012-01-04
End date: 2012-01-17
Mirtazapine
Dosage: 30 mg, unknown
Start date: 2012-01-17
Mirtazapine
Dosage: 15 mg, unknown
Possible Mirtazapine side effects in
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-23
Patient:
Reactions: Chromaturia, Faeces Discoloured
Drug(s) suspected as cause:
Mirtazapine
Indication: Depression
Mirtazapine
Dosage: 30 mg, unk
Administration route: Oral
Indication: Anxiety
End date: 2012-07-03
Other drugs received by patient: Doublebase; Quinine Sulfate; Mineral OIL
Possible Mirtazapine side effects in 60 year old female
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-23
Patient: 60 year old female
Reactions: Pruritus, Chapped Lips, Oropharyngeal Pain, Pyrexia, Hyperhidrosis, Sensation of Foreign Body, Pharyngeal Oedema, Tongue Disorder, Decreased Appetite, Nervousness, Eye Pain, Tremor, Paraesthesia, Anxiety, Insomnia, Gastrointestinal Disorder, JAW Disorder, Withdrawal Syndrome
Drug(s) suspected as cause:
Mirtazapine
Other drugs received by patient: Sertraline Hydrochloride
Possible Mirtazapine side effects in 68 year old female
Reported by a physician from United Kingdom on 2012-08-23
Patient: 68 year old female, weighing 55.0 kg (121.0 pounds)
Reactions: Chromaturia, Faeces Discoloured
Drug(s) suspected as cause:
Mirtazapine
Indication: Anxiety
End date: 2012-07-03
Mirtazapine
Indication: Depression
End date: 2012-07-03
Other drugs received by patient: Doublebase; Light Liquid Paraffin; Quinine Sulfate
Possible Mirtazapine side effects in
Reported by a physician from Japan on 2012-08-23
Patient:
Reactions: Completed Suicide
Adverse event resulted in: death
Drug(s) suspected as cause:
Mirtazapine
Dosage: 30 mg, qd
Administration route: Oral
Indication: Depression
Start date: 2012-04-18
End date: 2012-05-02
Trazodone Hydrochloride
Dosage: 75 mg, qd
Administration route: Oral
Indication: Depression
Start date: 2009-11-17
End date: 2012-05-02
Other drugs received by patient: Cloxazolam
Possible Mirtazapine side effects in 49 year old male
Reported by a consumer/non-health professional from France on 2012-08-23
Patient: 49 year old male
Reactions: Cytolytic Hepatitis, Neuroleptic Malignant Syndrome, Drug Withdrawal Syndrome
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Abilify
Dosage: until jul12
Administration route: Oral
Indication: Schizophrenia
Alprazolam
Administration route: Oral
End date: 2012-07-01
Mianserin HCL
End date: 2012-07-01
Mirtazapine
Dosage: formulation: tabs
Administration route: Oral
Possible Mirtazapine side effects in
Reported by a physician from Japan on 2012-08-23
Patient:
Reactions: Convulsion
Drug(s) suspected as cause:
Mirtazapine
Other drugs received by patient: Estazolam; Chlorpromazine HCL; Flunitrazepam
Possible Mirtazapine side effects in 49 year old female
Reported by a physician from United Kingdom on 2012-08-23
Patient: 49 year old female
Reactions: Eosinophil Count Decreased, Scratch, White Blood Cell Count Decreased, Tooth Infection, Off Label Use, Road Traffic Accident, Platelet Count Decreased, Injury, Neutropenia, Toothache, Neutrophil Count Decreased, Infection Susceptibility Increased
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Clozaril
Administration route: Oral
Indication: Schizophrenia
Start date: 2012-01-12
End date: 2012-01-17
Clozaril
Administration route: Oral
Clozaril
Administration route: Oral
Start date: 2006-08-14
End date: 2012-01-09
Clozaril
Administration route: Oral
Mirtazapine
Administration route: Oral
Indication: Depressive Symptom
Start date: 2006-01-01
End date: 2012-01-21
Topiramate
Administration route: Oral
Indication: Psychotic Disorder
Start date: 2007-01-01
End date: 2012-01-21
Topiramate
Administration route: Oral
Indication: Schizophrenia
Start date: 2007-01-01
End date: 2012-01-21
Other drugs received by patient: Amoxicillin; Zopiclone; Quetiapine Fumarate
Possible Mirtazapine side effects in 68 year old female
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-23
Patient: 68 year old female, weighing 55.0 kg (121.0 pounds)
Reactions: Chromaturia, Faeces Discoloured
Drug(s) suspected as cause:
Mirtazapine
Other drugs received by patient: Paraffin, Liquid; Doublebase; Quinine Sulfate
Possible Mirtazapine side effects in
Reported by a pharmacist from United Kingdom on 2012-08-23
Patient:
Reactions: Congestive Cardiomyopathy, Antipsychotic Drug Level Above Therapeutic, Cardiac Failure Congestive
Adverse event resulted in: death
Drug(s) suspected as cause:
Aripiprazole
Dosage: 10 mg, unk
Administration route: Oral
Indication: Schizophrenia
Citalopram Hydrobromide
Dosage: 40 mg, unk
Administration route: Oral
Indication: Depressed Mood
Clozapine
Dosage: 450 mg, unk
Administration route: Oral
Indication: Schizophrenia
Clozaril
Dosage: unk
Administration route: Oral
Start date: 2001-07-01
Clozaril
Dosage: unk
Administration route: Oral
Start date: 1994-12-05
Clozaril
Dosage: 450 mg, unk
Administration route: Oral
Mirtazapine
Dosage: 30 mg, unk
Administration route: Oral
Indication: Depressed Mood
Possible Mirtazapine side effects in 45 year old male
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-23
Patient: 45 year old male, weighing 104.2 kg (229.2 pounds)
Reactions: Congestive Cardiomyopathy, Antipsychotic Drug Level Above Therapeutic, Cardiac Failure Congestive
Adverse event resulted in: death
Drug(s) suspected as cause:
Aripiprazole
Dosage: 10 mg, unknown
Administration route: Oral
Indication: Schizophrenia
Citalopram Hydrobromide
Dosage: 40 mg, unknown
Administration route: Oral
Indication: Depression
Clozaril
Dosage: 450 mg, unknown
Administration route: Oral
Clozaril
Dosage: unk
Administration route: Oral
Indication: Schizophrenia
Start date: 2001-07-01
Clozaril
Dosage: unk
Administration route: Oral
Start date: 1994-12-05
Mirtazapine
Dosage: 30 mg, unknown
Indication: Depressed Mood
Possible Mirtazapine side effects in 79 year old female
Reported by a consumer/non-health professional from United States on 2012-08-22
Patient: 79 year old female
Reactions: Abdominal Pain, Agitation, Pruritus, Restless Legs Syndrome, Orthostatic Hypotension, Disorientation, Pharyngeal Oedema, Dyspepsia, Palpitations, Feeling of Body Temperature Change, Muscle Spasms, Blood Pressure Increased, Nightmare, Nausea, Hypotension, Blood Creatine Increased, Tremor, Anxiety, Heart Rate Decreased, Arthralgia, Diarrhoea
Drug(s) suspected as cause:
Cardura
Dosage: unk
Cartia XT
Dosage: unk
Celebrex
Dosage: unk
Ciprofloxacin HCL
Dosage: unk
Cymbalta
Dosage: unk
Diltiazem
Dosage: unk
Diovan
Dosage: unk
Fentanyl
Dosage: unk
Levaquin
Macrobid
Dosage: unk
Micardis
Dosage: unk
Mirtazapine
Dosage: unk
Naproxen Sodium
Dosage: unk
Norvasc
Dosage: unk
Paxil
Dosage: unk
Prozac
Dosage: unk
Tekturna
Dosage: unk
Tiazac
Dosage: unk
Toprol-XL
Vasotec
Dosage: unk
Wellbutrin XL
Dosage: unk
Zoloft
Dosage: unk
Other drugs received by patient: Effexor XR; Protonix
Possible Mirtazapine side effects in 40 year old male
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-22
Patient: 40 year old male
Reactions: Depressive Symptom, Liver Function Test Abnormal, Hypothyroidism, Extrapyramidal Disorder, Metabolic Syndrome
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Abilify
Dosage: 15 mg, daily
Administration route: Oral
Indication: Bipolar Disorder
Start date: 2008-04-01
Duloxetine Hydrochloride
Dosage: 60 mg, unk
Indication: Bipolar Disorder
Mirtazapine
Dosage: unk
Indication: Depressive Symptom
Mirtazapine
Indication: Extrapyramidal Disorder
Quetiapine
Dosage: unk
Indication: Mood Swings
Risperidone
Dosage: 4 mg, daily
Indication: Mania
Start date: 2008-03-01
Valproate Sodium
Dosage: unk
Indication: Product Used FOR Unknown Indication
Other drugs received by patient: Lithium Carbonate
Possible Mirtazapine side effects in 49 year old female
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-22
Patient: 49 year old female
Reactions: Scratch, White Blood Cell Count Decreased, Eosinophil Count Decreased, Tooth Infection, Off Label Use, Road Traffic Accident, Platelet Count Decreased, Toothache, Neutropenia, Injury
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Clozaril
Dosage: 75 mg, unk
Administration route: Oral
Indication: Schizophrenia
Start date: 2012-01-12
End date: 2012-01-17
Mirtazapine
Dosage: 45 mg, qd
Administration route: Oral
Indication: Depressive Symptom
Start date: 2006-01-01
End date: 2012-01-21
Topiramate
Dosage: 300 mg, qd
Administration route: Oral
Start date: 2007-01-01
End date: 2012-01-21
Other drugs received by patient: Quetiapine Fumarate; Zopiclone; Antibiotics; Amoxicillin
Possible Mirtazapine side effects in 40 year old male
Reported by a physician from France on 2012-08-22
Patient: 40 year old male
Reactions: Liver Function Test Abnormal, Hypothyroidism, Metabolic Syndrome
Drug(s) suspected as cause:
Aripiprazole
Administration route: Oral
Indication: Metabolic Syndrome
Start date: 2008-04-15
Aripiprazole
Indication: Schizoaffective Disorder
Duloxetine Hydrochloride
Dosage: 60 mg daily
Indication: Product Used FOR Unknown Indication
Duloxetine Hydrochloride
Mirtazapine
Indication: Affective Disorder
Quetiapine Fumarate
Indication: Affective Disorder
Risperidone
Dosage: 4 mg daily
Indication: Product Used FOR Unknown Indication
Valproate Sodium
Indication: Product Used FOR Unknown Indication
Start date: 2008-03-01
Other drugs received by patient: Effexor; Lithium Carbonate; Drug Used IN Diabetes
Possible Mirtazapine side effects in
Reported by a physician from Japan on 2012-08-22
Patient:
Reactions: Status Epilepticus
Drug(s) suspected as cause:
Mirtazapine
Other drugs received by patient: Sertraline Hydrochloride; Amitriptyline HCL
Possible Mirtazapine side effects in
Reported by a physician from United Kingdom on 2012-08-22
Patient:
Reactions: NO Adverse Event
Drug(s) suspected as cause:
Aripiprazole
Dosage: 10 mg, unk
Administration route: Oral
Indication: Schizophrenia
Citalopram Hydrobromide
Dosage: 40 mg, unk
Administration route: Oral
Indication: Depression
Clozaril
Dosage: unk
Administration route: Oral
Indication: Schizophrenia
Start date: 1994-12-05
Clozaril
Dosage: unk
Administration route: Oral
Start date: 2001-07-01
Clozaril
Dosage: 450 mg, unk
Administration route: Oral
Mirtazapine
Dosage: 30 mg, unk
Administration route: Oral
Indication: Depression
Possible Mirtazapine side effects in 40 year old male
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-21
Patient: 40 year old male
Reactions: Depressive Symptom, Liver Function Test Abnormal, Hypothyroidism, Extrapyramidal Disorder, Metabolic Syndrome
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Abilify
Dosage: 15 mg, daily
Administration route: Oral
Indication: Bipolar Disorder
Start date: 2008-04-01
Abilify
Indication: Metabolic Syndrome
Duloxetine Hydrochloride
Dosage: 60 mg, unk
Indication: Bipolar Disorder
Mirtazapine
Dosage: unk
Indication: Depressive Symptom
Mirtazapine
Indication: Extrapyramidal Disorder
Quetiapine
Dosage: unk
Indication: Mood Swings
Risperidone
Dosage: 4 mg, daily
Indication: Mania
Start date: 2008-03-01
Valproate Sodium
Dosage: 600 mg, unknown
Indication: Product Used FOR Unknown Indication
Other drugs received by patient: Lithium Carbonate
Possible Mirtazapine side effects in 40 year old male
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-21
Patient: 40 year old male, weighing 105.0 kg (231.0 pounds)
Reactions: Liver Function Test Abnormal, Hypothyroidism, Metabolic Syndrome
Adverse event resulted in: death
Drug(s) suspected as cause:
Abilify
Dosage: 15 mg, qd
Administration route: Oral
Indication: Metabolic Syndrome
Start date: 2008-04-01
Abilify
Indication: Schizoaffective Disorder
Duloxetine Hydrochloride
Dosage: unk
Indication: Product Used FOR Unknown Indication
Mirtazapine
Dosage: unk
Indication: Product Used FOR Unknown Indication
Quetiapine
Dosage: unk
Indication: Product Used FOR Unknown Indication
Risperidone
Dosage: unk
Indication: Product Used FOR Unknown Indication
Valproic Acid
Dosage: unk
Indication: Product Used FOR Unknown Indication
Other drugs received by patient: Effexor; Lithium Carbonate
Possible Mirtazapine side effects in 68 year old female
Reported by a physician from United Kingdom on 2012-08-21
Patient: 68 year old female, weighing 55.0 kg (121.0 pounds)
Reactions: Chromaturia, Faeces Discoloured
Drug(s) suspected as cause:
Mirtazapine
Other drugs received by patient: Paraffin Light Liquid; Quinine Sulfate; Doublebase
Possible Mirtazapine side effects in 60 year old female
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-20
Patient: 60 year old female
Reactions: Pruritus, Chapped Lips, Oropharyngeal Pain, Pyrexia, Hyperhidrosis, Tongue Eruption, Sensation of Foreign Body, Pharyngeal Oedema, Nervousness, Decreased Appetite, Eye Pain, Tremor, Paraesthesia, Anxiety, Insomnia, Gastrointestinal Disorder, JAW Disorder, Withdrawal Syndrome
Drug(s) suspected as cause:
Mirtazapine
Other drugs received by patient: Sertraline Hydrochloride
Possible Mirtazapine side effects in female
Reported by a physician from United Kingdom on 2012-08-20
Patient: female
Reactions: Scratch, Eosinophil Count Decreased, White Blood Cell Count Decreased, Tooth Infection, Road Traffic Accident, Neutropenia, Injury, Toothache, Neutrophil Count Decreased
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Clozaril
Dosage: 650 mg, unk
Administration route: Oral
Indication: Schizophrenia
Start date: 2006-08-14
End date: 2012-01-09
Clozaril
Dosage: 75 mg, unk
Administration route: Oral
Start date: 2012-01-12
End date: 2012-01-17
Mirtazapine
Dosage: 45 mg, unk
Administration route: Oral
Indication: Depressive Symptom
Start date: 2006-01-01
End date: 2012-01-21
Topiramate
Dosage: 300 mg, qd
Administration route: Oral
Indication: Psychotic Disorder
Start date: 2007-01-01
End date: 2012-01-21
Possible Mirtazapine side effects in 84 year old male
Reported by a health professional (non-physician/pharmacist) from Brazil on 2012-08-20
Patient: 84 year old male
Reactions: Haematochezia
Drug(s) suspected as cause:
Exelon
Dosage: 4.6 mg/24hs, one patch
Exelon
Dosage: 4.6 mg/24hs, one patch
Indication: Dementia Alzheimer's Type
Memamtine Hydrochloride
Dosage: 1 df, in the morning and 1df at night
Indication: Dementia Alzheimer's Type
Mirtazapine
Dosage: 30mg, once at night
Indication: Dementia Alzheimer's Type
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