Common Mianserin Side Effects


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

Renal Failure Acute (3)
Decreased Appetite (2)
Confusional State (2)
Delirium (2)
Dehydration (2)
Diabetes Mellitus (2)
Somnolence (2)
Suicidal Ideation (2)
Disinhibition (2)
Loss Of Consciousness (1)
Hypomania (1)
Hypercholesterolaemia (1)
Lymphadenopathy (1)
Hyperthermia (1)
Meningioma (1)
Migraine (1)
Myocardial Infarction (1)
Myoclonus (1)
Oedema Peripheral (1)
Lymphocytosis (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.

Mianserin Side Effects Reported to FDA



Mianserin Side Effect Report#9752851
Subdural Haematoma, Cognitive Disorder, Somnolence
This is a report of a 64-year-old female patient (weight: NA) from FR, suffering from the following health symptoms/conditions: NA, who was treated with Mianserine (dosage: NA, start time: NS), combined with:
  • Lasilix
  • Lantus
  • Previscan
  • Tahor
  • Aricept
  • Ebixa
  • Risperdal
  • Tareg
and developed a serious reaction and side effect(s): Subdural Haematoma, Cognitive Disorder, Somnolence after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Mianserine treatment in female patients, resulting in Subdural Haematoma side effect. The patient was hospitalized.
Mianserin Side Effect Report#9099338
Eosinophilia, Lymphocytosis, Hepatocellular Injury, Cholestasis, Rash Morbilliform, Face Oedema, Hyperthermia, Somnolence
This report suggests a potential Mianserin Eosinophilia side effect(s) that can have serious consequences. A 66-year-old female patient (weight: NA) from FR was diagnosed with the following symptoms/conditions: NA and used Mianserin (dosage: 30 Mg, Daily) starting
Nov 09, 2011. After starting Mianserin the patient began experiencing various side effects, including: Eosinophilia, Lymphocytosis, Hepatocellular Injury, Cholestasis, Rash Morbilliform, Face Oedema, Hyperthermia, SomnolenceAdditional drugs used concurrently:
  • Pravastatin (20 Mg, Daily)
  • Lamictal (25 Mg, Daily)
  • Neuleptil (10 Mg, Bid)
  • Diffu K
  • Esidrex
  • Kardegic
  • Loxen
  • Transipeg /00754501/
The patient was hospitalized. Although Mianserin demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Eosinophilia, may still occur.
Mianserin Side Effect Report#8296865-6
Coma, Progressive Multifocal Leukoencephalopathy, Grand Mal Convulsion, Respiratory Arrest
This Coma problem was reported by a health professional from France. A 53-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Jan 01, 2009 this consumer started treatment with Mianserine (dosage: NA). The following drugs were being taken at the same time:
  • Corticosteroid Bolus
  • Tysabri
  • Lorazepam
  • Tysabri
  • Zoplicone
  • Escitalopram
  • Alfuzosin Hcl
When using Mianserine, the patient experienced the following unwanted symptoms/side effects: Coma, Progressive Multifocal Leukoencephalopathy, Grand Mal Convulsion, Respiratory ArrestThe 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 Coma, may become evident only after a product is in use by the general population.
Mianserin Side Effect Report#8260141-8
Overdose, Toxicity To Various Agents
This Overdose side effect was reported by a health professional from Norway. A 64-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Mianserin (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Zolpidem
  • Acetaminophen W/ Codeine
  • Citalopram Hydrobromide
  • Amitriptyline Hcl
  • Nitrazepam
  • Diazepam
.After starting to take Mianserin the consumer reported adverse symptoms, such as: Overdose, Toxicity To Various AgentsThese side effects may potentially be related to Mianserin.
Mianserin Side Effect Report#8234581-7
Depression, Abdominal Rigidity, Flatulence, Dyspepsia, Oedema Peripheral, Migraine, Haemorrhoidal Haemorrhage, Swelling Face, Constipation
This is a report of a 23-year-old female patient (weight: NA) from Denmark, suffering from the following health symptoms/conditions: depression,insomnia, who was treated with Mianserin (mianserin Hydrochloride /00390602/) (dosage: Hs, start time:
Feb 23, 2009), combined with:
  • Imovane (zopiclone) (7.5 Mg;qd)
  • Magnesium Hydroxid
  • Acetaminophen
  • Paroxetine Hydrochloride
  • Truxal (chlorprothixene)
  • Venlafaxine
  • Ibumetin
  • Pamol
and developed a serious reaction and side effect(s): Depression, Abdominal Rigidity, Flatulence, Dyspepsia, Oedema Peripheral, Migraine, Haemorrhoidal Haemorrhage, Swelling Face, Constipation after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Mianserin (mianserin Hydrochloride /00390602/) treatment in female patients, resulting in Depression side effect.
Mianserin Side Effect Report#8136220-2
Sick Sinus Syndrome, Loss Of Consciousness, Sinus Arrest
This report suggests a potential Mianserin Hydrochloride Sick Sinus Syndrome side effect(s) that can have serious consequences. A 81-year-old female patient (weight: NA) from Japan was diagnosed with the following symptoms/conditions: NA and used Mianserin Hydrochloride (dosage: NA) starting NS. After starting Mianserin Hydrochloride the patient began experiencing various side effects, including: Sick Sinus Syndrome, Loss Of Consciousness, Sinus ArrestAdditional drugs used concurrently:
  • Lithium Carbonate (Po)
Although Mianserin Hydrochloride demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Sick Sinus Syndrome, may still occur.
Mianserin Side Effect Report#8076859-6
Dehydration, Renal Failure Acute
This Dehydration problem was reported by a health professional from France. A 87-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Nov 14, 2011 this consumer started treatment with Mianserin Hydrochloride (dosage: NA). The following drugs were being taken at the same time:
  • Acetaminophen (Twice 500mg On Demand)
  • Esidrix
  • Vitamin D
  • Ixprim (acetaminophen (+) Tramadol Hydrochloride)
  • Previscan
  • Cordarone
  • Cozaar
  • Lorazepam
When using Mianserin Hydrochloride, the patient experienced the following unwanted symptoms/side effects: Dehydration, Renal Failure AcuteThe 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 Dehydration, may become evident only after a product is in use by the general population.
Mianserin Side Effect Report#8061651-9
Stupor, Decreased Appetite
This Stupor side effect was reported by a consumer or non-health professional from Japan. A 66-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Mianserin Hcl (drug dosage: Tabs Increased To 60mg), which was initiated on NS. Concurrently used drugs:
  • Abilify (Increased To 6mg And 9mg)
  • Mirtazapine (Tabs Increased To 30mg)
  • Quetiapine Fumarate (Tabs)
.After starting to take Mianserin Hcl the consumer reported adverse symptoms, such as: Stupor, Decreased AppetiteThese side effects may potentially be related to Mianserin Hcl.
Mianserin Side Effect Report#7983811-5
Diabetes Mellitus, Embolism, Arthropathy
This is a report of a 68-year-old male patient (weight: NA) from Switzerland, suffering from the following health symptoms/conditions: depression,multiple sclerosis, who was treated with Mianserin (mianserini Hydrochloridum) (dosage: NA, start time: NS), combined with:
  • Tysabri
  • Venlafaxin (venlafaxinum Ut Venlafaxini Hydrochloridum)
  • Mirtazapine
and developed a serious reaction and side effect(s): Diabetes Mellitus, Embolism, Arthropathy after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Mianserin (mianserini Hydrochloridum) treatment in male patients, resulting in Diabetes Mellitus side effect.
Mianserin Side Effect Report#7889240-7
Head Discomfort
This report suggests a potential Mianserin Hydrochloride Head Discomfort side effect(s) that can have serious consequences. A 64-year-old female patient (weight: NA) from Sweden was diagnosed with the following symptoms/conditions: NA and used Mianserin Hydrochloride (dosage: NA) starting
Apr 01, 2010. After starting Mianserin Hydrochloride the patient began experiencing various side effects, including: Head DiscomfortAdditional drugs used concurrently:
  • Sinemet
  • Zopiclone
The patient was hospitalized. Although Mianserin Hydrochloride demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Head Discomfort, may still occur.
Mianserin Side Effect Report#7730733-0
Urticaria
This Urticaria problem was reported by a physician from France. A male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Jun 20, 2011 this consumer started treatment with Mianserine (dosage: NA). The following drugs were being taken at the same time:
  • Levemir
  • Fungizone
  • Acetaminophen
  • Arixtra
  • Rabeprazole Sodium
When using Mianserine, the patient experienced the following unwanted symptoms/side effects: UrticariaThe 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 Urticaria, may become evident only after a product is in use by the general population.
Mianserin Side Effect Report#7703374-9
Lymphadenopathy, Renal Failure Acute, Confusional State, Hepatic Steatosis, Dehydration
This Lymphadenopathy side effect was reported by a health professional from France. A 60-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Mianserine (drug dosage: NA), which was initiated on
Dec 21, 2009. Concurrently used drugs:
  • Peg-intron
  • Nicardipine Hcl
  • Amitriptyline Hcl
  • Ribavirin
.After starting to take Mianserine the consumer reported adverse symptoms, such as: Lymphadenopathy, Renal Failure Acute, Confusional State, Hepatic Steatosis, DehydrationThese side effects may potentially be related to Mianserine. The patient was hospitalized.
Mianserin Side Effect Report#7603523-7
Meningioma, Blood Pressure Diastolic Increased, Renal Failure Acute, Haematotoxicity, Acute Graft Versus Host Disease, Deep Vein Thrombosis, Hypercholesterolaemia, Glomerulonephritis Minimal Lesion, Cytomegalovirus Infection
This is a report of a 53-year-old male patient (weight: NA) from Portugal, suffering from the following health symptoms/conditions: NA, who was treated with Mianserine (mianserin Hydrochloride) (dosage: NA, start time: NS), combined with:
  • Folate (folic Acid)
  • Prednisolone
  • Bisoprolol (bisoprolol Hemifumarate)
  • Cyclosporine
  • Sulfamehoxazole And Trimethoprim (sulfamethoxazole, Trimethoprim)
  • Acyclovir
  • Magnesium (magnesium)
  • Busulfex (Intravenous)
and developed a serious reaction and side effect(s): Meningioma, Blood Pressure Diastolic Increased, Renal Failure Acute, Haematotoxicity, Acute Graft Versus Host Disease, Deep Vein Thrombosis, Hypercholesterolaemia, Glomerulonephritis Minimal Lesion, Cytomegalovirus Infection after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Mianserine (mianserin Hydrochloride) treatment in male patients, resulting in Meningioma side effect. The patient was hospitalized.
Mianserin Side Effect Report#7523526-0
Confusional State, Fall, Convulsion, Myoclonus, Condition Aggravated
This report suggests a potential Mianserin Confusional State side effect(s) that can have serious consequences. A 76-year-old female patient (weight: NA) from France was diagnosed with the following symptoms/conditions: NA and used Mianserin (dosage: NA) starting NS. After starting Mianserin the patient began experiencing various side effects, including: Confusional State, Fall, Convulsion, Myoclonus, Condition AggravatedAdditional drugs used concurrently:
  • Phenobarbital Tab
  • Amantadine Hcl
  • Carbamazepine
  • Citalopram Hydrobromide
The patient was hospitalized. Although Mianserin demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Confusional State, may still occur.
Mianserin Side Effect Report#7489533-1
Epistaxis, Thrombocytopenia, Gastrointestinal Haemorrhage
This Epistaxis problem was reported by a physician from France. A 61-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Sep 16, 2009 this consumer started treatment with Mianserin (dosage: 1df=one Intake Daily). The following drugs were being taken at the same time:
  • Flolan
  • Lasix (Df=two Intakes A Day)
  • Coumadin (Suspended From 11-apr-2011 To 13-apr-2011.)
  • Atarax (1 Intake Daily)
  • Revatio (1df=three Intakes A Day)
  • Levothyroxine Sodium (1 Scored Tablet One Intake Daily)
  • Lorazepam
  • Tercian
When using Mianserin, the patient experienced the following unwanted symptoms/side effects: Epistaxis, Thrombocytopenia, Gastrointestinal HaemorrhageThe 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 Epistaxis, may become evident only after a product is in use by the general population.
Mianserin Side Effect Report#7419727-2
Myocardial Infarction
This Myocardial Infarction side effect was reported by a physician from France. A 83-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Mianserin (drug dosage: NA), which was initiated on
Dec 03, 2010. Concurrently used drugs:
  • Lasix
  • Rivotril
  • Forteo (20 Ug, Qod)
  • Forteo (20 Ug, Daily (1/d))
  • Foradil
  • Gabapentine
  • Previscan
  • Miflonil
.After starting to take Mianserin the consumer reported adverse symptoms, such as: Myocardial InfarctionThese side effects may potentially be related to Mianserin.
Mianserin Side Effect Report#7398418-0
Acute Myeloid Leukaemia
This is a report of a 40-year-old male patient (weight: NA) from Denmark, suffering from the following health symptoms/conditions: NA, who was treated with Mianserin (dosage: NA, start time: NS), combined with:
  • Olanzapine
  • Clozapine (Clozapine Exposure: 2295 Defined Daily Doses (ddd=300mg))
and developed a serious reaction and side effect(s): Acute Myeloid Leukaemia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Mianserin treatment in male patients, resulting in Acute Myeloid Leukaemia side effect.
Mianserin Side Effect Report#7248518-0
Sleep-related Eating Disorder, Diabetes Mellitus, Delirium, Restless Legs Syndrome
This report suggests a potential Mianserin Hydrochloride Sleep-related Eating Disorder side effect(s) that can have serious consequences. A 44-year-old male patient (weight: NA) from Japan was diagnosed with the following symptoms/conditions: NA and used Mianserin Hydrochloride (dosage: NA) starting
Apr 01, 2007. After starting Mianserin Hydrochloride the patient began experiencing various side effects, including: Sleep-related Eating Disorder, Diabetes Mellitus, Delirium, Restless Legs SyndromeAdditional drugs used concurrently:
  • Pepcid Rpd
  • Amlodipine Besylate
  • Neuleptil
  • Tegretol
  • Akineton Tablets
  • Rivotril
  • Vegetamin B
  • Rohypnol
The patient was hospitalized. Although Mianserin Hydrochloride demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Sleep-related Eating Disorder, may still occur.
Mianserin Side Effect Report#4711991-3
Anterograde Amnesia, Decreased Appetite, Decreased Interest, Delirium, Disinhibition, Hypomania, Sleep Disorder, Suicidal Ideation
This Anterograde Amnesia problem was reported by a consumer or non-health professional from Japan. A 67-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: insomnia. On
Apr 20, 2003 this consumer started treatment with Mianserin (dosage: Daily Dose: 10 Milligram(s)). The following drugs were being taken at the same time: NA. When using Mianserin, the patient experienced the following unwanted symptoms/side effects: Anterograde Amnesia, Decreased Appetite, Decreased Interest, Delirium, Disinhibition, Hypomania, Sleep Disorder, Suicidal IdeationThe 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 Anterograde Amnesia, may become evident only after a product is in use by the general population.
Mianserin Side Effect Report#4693062-8
Amnesia, Disinhibition, Suicidal Ideation
This Amnesia side effect was reported by a consumer or non-health professional from . A 67-year-old female patient (weight:NA) experienced the following symptoms/conditions: insomnia.The patient was prescribed Mianserin (drug dosage: Daily Dose: 10 Milligram(s)), which was initiated on NS. Concurrently used drugs: NA..After starting to take Mianserin the consumer reported adverse symptoms, such as: Amnesia, Disinhibition, Suicidal IdeationThese side effects may potentially be related to Mianserin. The patient was hospitalized.



The appearance of Mianserin 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 Mianserin Side Effects for Women?

Women Side Effects Reports
Confusional State 2
Decreased Appetite 2
Dehydration 2
Disinhibition 2
Renal Failure Acute 2
Somnolence 2
Suicidal Ideation 2
Abdominal Rigidity 1
Amnesia 1
Anterograde Amnesia 1

What are common Mianserin Side Effects for Men?

Men Side Effects Reports
Diabetes Mellitus 2
Acute Graft Versus Host Disease 1
Acute Myeloid Leukaemia 1
Arthropathy 1
Blood Pressure Diastolic Increased 1
Cytomegalovirus Infection 1
Deep Vein Thrombosis 1
Delirium 1
Embolism 1
Glomerulonephritis Minimal Lesion 1

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.

    Mianserin reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
    FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.

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    More About Mianserin

    Side Effects reported to FDA: 20

    Mianserin safety alerts: No

    Reported deaths: 2

    Reported hospitalizations: 6

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