Common Amitriptyline Side Effects


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

Completed Suicide (96)
Toxicity To Various Agents (72)
Overdose (61)
Cardiac Arrest (56)
Somnolence (48)
Pain (47)
Convulsion (45)
Death (42)
Headache (42)
Anxiety (42)
Vomiting (40)
Confusional State (39)
Intentional Overdose (39)
Dyspnoea (38)
Loss Of Consciousness (37)
Dizziness (37)
Fatigue (35)
Nausea (34)
Coma (33)
Respiratory Arrest (33)

➢ 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.

Amitriptyline Side Effects Reported to FDA



Amitriptyline Side Effect Report#9924072
Serotonin Syndrome, Body Temperature Increased, Mydriasis
This is a report of a 59-year-old male patient (weight: NA) from NL, suffering from the following health symptoms/conditions: pain,infection, who was treated with Amitriptyline Hydrochloride (dosage: 75 Mg, Qd, start time:
Jan 28, 2014), combined with:
  • Linezolid (1 Df, Bid,concentration-2mg/ml)
  • Budesonide (1 Df, Bid)
  • Meropenem (1 Df, Tid)
  • Acenocoumarol (Unk)
  • Fentanyl (Unk, Hs)
  • Midazolam (Concentration-5mg/ml)
  • Acetaminophen (500 Mg, Qid)
  • Zopiclone
and developed a serious reaction and side effect(s): Serotonin Syndrome, Body Temperature Increased, Mydriasis after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Amitriptyline Hydrochloride treatment in male patients, resulting in Serotonin Syndrome side effect. The patient was hospitalized.
Amitriptyline Side Effect Report#9921975
Agitation, Aggression, Condition Aggravated
This report suggests a potential Amitriptyline Agitation side effect(s) that can have serious consequences. A 33-year-old female patient (weight: NA) from GB was diagnosed with the following symptoms/conditions: cystitis interstitial and used Amitriptyline (dosage: Increased To 100ml) starting 2013. After starting Amitriptyline the patient began experiencing various side effects, including: Agitation, Aggression, Condition AggravatedAdditional drugs used concurrently: NA. Although Amitriptyline demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Agitation, may still occur.
Amitriptyline Side Effect Report#9921283
Syncope
This Syncope problem was reported by a pharmacist from US. A 83-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: sleep disorder. On
Jun 16, 1995 this consumer started treatment with Amitriptyline (dosage: NA). The following drugs were being taken at the same time: NA. When using Amitriptyline, the patient experienced the following unwanted symptoms/side effects: SyncopeThe 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 Syncope, may become evident only after a product is in use by the general population.
Amitriptyline Side Effect Report#9916073
Urticaria
This Urticaria side effect was reported by a consumer or non-health professional from US. A 67-year-old female patient (weight:NA) experienced the following symptoms/conditions: cough.The patient was prescribed Amitriptyline (drug dosage: NA), which was initiated on
Dec 03, 2013. Concurrently used drugs: NA..After starting to take Amitriptyline the consumer reported adverse symptoms, such as: UrticariaThese side effects may potentially be related to Amitriptyline.
Amitriptyline Side Effect Report#9904623
Somnolence, Paraesthesia, Dyspnoea
This is a report of a 27-year-old female patient (weight: NA) from GB, suffering from the following health symptoms/conditions: migraine, who was treated with Amitriptyline (dosage: NA, start time: 201312), combined with: NA. and developed a serious reaction and side effect(s): Somnolence, Paraesthesia, Dyspnoea after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Amitriptyline treatment in female patients, resulting in Somnolence side effect.
Amitriptyline Side Effect Report#9894742
Accidental Overdose, Feeling Abnormal, Memory Impairment, Hostility
This report suggests a potential Amitriptyline Hcl Accidental Overdose side effect(s) that can have serious consequences. A 38-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: insomnia and used Amitriptyline Hcl (dosage: NA) starting 2012. After starting Amitriptyline Hcl the patient began experiencing various side effects, including: Accidental Overdose, Feeling Abnormal, Memory Impairment, HostilityAdditional drugs used concurrently: NA. Although Amitriptyline Hcl demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Accidental Overdose, may still occur.
Amitriptyline Side Effect Report#9894608
Hallucination, Hypoaesthesia, Panic Attack, Grip Strength Decreased, Hot Flush, Anxiety
This Hallucination 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: migraine. On
May 01, 2013 this consumer started treatment with Amitriptyline (dosage: 10 Milligram Daily;). The following drugs were being taken at the same time: NA. When using Amitriptyline, the patient experienced the following unwanted symptoms/side effects: Hallucination, Hypoaesthesia, Panic Attack, Grip Strength Decreased, Hot Flush, AnxietyAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Hallucination, may become evident only after a product is in use by the general population.
Amitriptyline Side Effect Report#9890506
Palpitations, Chest Discomfort, Tachycardia
This Palpitations side effect was reported by a pharmacist from US. A 60-year-old male patient (weight:NA) experienced the following symptoms/conditions: peripheral arterial occlusive disease,intermittent claudication.The patient was prescribed Amitriptyline (drug dosage: NA), which was initiated on
Nov 15, 2013. Concurrently used drugs: NA..After starting to take Amitriptyline the consumer reported adverse symptoms, such as: Palpitations, Chest Discomfort, TachycardiaThese side effects may potentially be related to Amitriptyline. The patient was hospitalized.
Amitriptyline Side Effect Report#9885637
Panic Reaction, Agitation, Depressed Mood
This is a report of a female patient (weight: NA) from GB, suffering from the following health symptoms/conditions: NA, who was treated with Amitriptyline (dosage: NA, start time:
Jan 08, 2014), combined with:
  • Hydroxychloroquine Sulfate (watson Laboratories) (200 Mg, Daily)
and developed a serious reaction and side effect(s): Panic Reaction, Agitation, Depressed Mood after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Amitriptyline treatment in female patients, resulting in Panic Reaction side effect.
Amitriptyline Side Effect Report#9868026
Dysphemia, Dysarthria, Dysarthria, Dysarthria
This report suggests a potential Amitriptyline Dysphemia side effect(s) that can have serious consequences. A 53-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Amitriptyline (dosage: NA) starting
Dec 13, 2013. After starting Amitriptyline the patient began experiencing various side effects, including: Dysphemia, Dysarthria, Dysarthria, DysarthriaAdditional drugs used concurrently:
  • Topiramate (^for Years^)
Although Amitriptyline demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Dysphemia, may still occur.
Amitriptyline Side Effect Report#9857077
Depressed Level Of Consciousness, Overdose
This Depressed Level Of Consciousness problem was reported by a health professional from US. A 49-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Amitriptyline Hydrochloride (dosage: 700 Mg, Unk). The following drugs were being taken at the same time:
  • Clonazepam (1000 Mg, Unk)
When using Amitriptyline Hydrochloride, the patient experienced the following unwanted symptoms/side effects: Depressed Level Of Consciousness, OverdoseAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Depressed Level Of Consciousness, may become evident only after a product is in use by the general population.
Amitriptyline Side Effect Report#9828495
Off Label Use
This Off Label Use side effect was reported by a physician from US. A 59-year-old male patient (weight:NA) experienced the following symptoms/conditions: pain.The patient was prescribed Amitriptyline Hydrochloride (drug dosage: 25 Mg, Hs), which was initiated on NS. Concurrently used drugs:
  • Gabapentin
  • Morphine
.After starting to take Amitriptyline Hydrochloride the consumer reported adverse symptoms, such as: Off Label UseThese side effects may potentially be related to Amitriptyline Hydrochloride.
Amitriptyline Side Effect Report#9827474
Toxicity To Various Agents, Brugada Syndrome
This is a report of a 42-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Amitriptyline Hydrochloride (dosage: NA, start time: NS), combined with:
  • Buprenorphine Hydrochloride (+) Naloxone Hydrochloride
  • Fluoxetine
  • Buspirone Hydrochloride
and developed a serious reaction and side effect(s): Toxicity To Various Agents, Brugada Syndrome after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Amitriptyline Hydrochloride treatment in male patients, resulting in Toxicity To Various Agents side effect. The patient was hospitalized.
Amitriptyline Side Effect Report#9782601
Cough, Retching, Lacrimation Increased, Rhinorrhoea, Mucosal Inflammation
This report suggests a potential Amitriptyline Cough side effect(s) that can have serious consequences. A 67-year-old female patient (weight: NA) from GB was diagnosed with the following symptoms/conditions: back pain and used Amitriptyline (dosage: At Night.) starting
Feb 05, 1990. After starting Amitriptyline the patient began experiencing various side effects, including: Cough, Retching, Lacrimation Increased, Rhinorrhoea, Mucosal InflammationAdditional drugs used concurrently: NA. Although Amitriptyline demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Cough, may still occur.
Amitriptyline Side Effect Report#9782034
Glaucoma
This Glaucoma problem was reported by a physician from US. A 60-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Amitriptyline Hydrochloride (dosage: Unk). The following drugs were being taken at the same time: NA. When using Amitriptyline Hydrochloride, the patient experienced the following unwanted symptoms/side effects: GlaucomaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Glaucoma, may become evident only after a product is in use by the general population.
Amitriptyline Side Effect Report#9779843
Cardiac Arrest, Brain Injury, Respiratory Arrest, Cerebrovascular Accident, Neck Pain, Phantom Pain, Arthralgia, Back Pain
This Cardiac Arrest side effect was reported by a consumer or non-health professional from US. A 66-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Amitriptyline (drug dosage: Unk Ukn, Unk), which was initiated on NS. Concurrently used drugs:
  • Lisinopril (Unk Ukn, Unk)
  • Welchol (Unk Ukn, Unk)
  • Dilaudid (19.978 Mg, Daily)
  • Ultram (Unk Ukn, Unk)
  • Protonix (Unk Ukn, Unk)
  • Cymbalta (Unk Ukn, Unk)
  • Neurontin (Unk Ukn, Unk)
  • Norvasc (Unk Ukn, Unk)
.After starting to take Amitriptyline the consumer reported adverse symptoms, such as: Cardiac Arrest, Brain Injury, Respiratory Arrest, Cerebrovascular Accident, Neck Pain, Phantom Pain, Arthralgia, Back PainThese side effects may potentially be related to Amitriptyline.
Amitriptyline Side Effect Report#9767847
Retinopathy
This is a report of a 47-year-old female patient (weight: NA) from Country Not Specified, suffering from the following health symptoms/conditions: NA, who was treated with Amitriptyline Hcl (dosage: NA, start time: NS), combined with:
  • Hydrocodone Bitartrate/acetaminophen (paracetamol, Hydrocodone
  • Diphenhydramine (diphenhydramine Capsules) (diphenhydramine)
  • Meloxicam (meloxicam)
and developed a serious reaction and side effect(s): Retinopathy after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Amitriptyline Hcl treatment in female patients, resulting in Retinopathy side effect.
Amitriptyline Side Effect Report#9745903
Sleep Paralysis
This report suggests a potential Amitriptyline Sleep Paralysis side effect(s) that can have serious consequences. A 16-year-old male patient (weight: NA) from GB was diagnosed with the following symptoms/conditions: pain and used Amitriptyline (dosage: NA) starting NS. After starting Amitriptyline the patient began experiencing various side effects, including: Sleep ParalysisAdditional drugs used concurrently: NA. Although Amitriptyline demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Sleep Paralysis, may still occur.
Amitriptyline Side Effect Report#9745464
Overdose, Depression, Anxiety, Panic Reaction, Suicide Attempt
This Overdose problem was reported by a consumer or non-health professional from US. A male patient (weight: NA) was diagnosed with the following symptoms/conditions: depression,anxiety,panic attack. On
Dec 10, 2011 this consumer started treatment with Amitriptyline (dosage: 100mg, Once Daily, Taken By Mouth). The following drugs were being taken at the same time: NA. When using Amitriptyline, the patient experienced the following unwanted symptoms/side effects: Overdose, Depression, Anxiety, Panic Reaction, Suicide AttemptAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Overdose, may become evident only after a product is in use by the general population.
Amitriptyline Side Effect Report#9739492
Retinopathy
This Retinopathy side effect was reported by a physician from US. A 47-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Amitriptyline (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Meloxicam
  • Procet
  • Diphenhydramine
.After starting to take Amitriptyline the consumer reported adverse symptoms, such as: RetinopathyThese side effects may potentially be related to Amitriptyline.
Amitriptyline Side Effect Report#9733965
Chest Discomfort, Circulatory Collapse, Dry Mouth
This is a report of a 53-year-old female patient (weight: NA) from DE, suffering from the following health symptoms/conditions: fibromyalgia, who was treated with Amitriptyline (dosage: 25, start time:
Jul 23, 2013), combined with:
  • Arcoxia
and developed a serious reaction and side effect(s): Chest Discomfort, Circulatory Collapse, Dry Mouth after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Amitriptyline treatment in female patients, resulting in Chest Discomfort side effect.
Amitriptyline Side Effect Report#9733467
Toxicity To Various Agents, Intentional Overdose
This report suggests a potential Amitriptyline Hydrochloride Toxicity To Various Agents side effect(s) that can have serious consequences. A 10-year-old female patient (weight: NA) from JP was diagnosed with the following symptoms/conditions: schizophreniform disorder,autism spectrum disorder and used Amitriptyline Hydrochloride (dosage: Unk) starting NS. After starting Amitriptyline Hydrochloride the patient began experiencing various side effects, including: Toxicity To Various Agents, Intentional OverdoseAdditional drugs used concurrently: NA. Although Amitriptyline Hydrochloride demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Toxicity To Various Agents, may still occur.
Amitriptyline Side Effect Report#9729084
Retinopathy, Visual Field Defect, Photopsia
This Retinopathy problem was reported by a health professional from US. A 47-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Amitriptyline (dosage: NA). The following drugs were being taken at the same time:
  • Meloxicam
  • Hydrocodone W/paracetamol
  • Diphenhydramine
When using Amitriptyline, the patient experienced the following unwanted symptoms/side effects: Retinopathy, Visual Field Defect, PhotopsiaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Retinopathy, may become evident only after a product is in use by the general population.
Amitriptyline Side Effect Report#9727773
Nausea
This Nausea side effect was reported by a consumer or non-health professional from US. A female patient (weight:NA) experienced the following symptoms/conditions: abdominal pain upper.The patient was prescribed Amitriptyline (drug dosage: NA), which was initiated on NS. Concurrently used drugs: NA..After starting to take Amitriptyline the consumer reported adverse symptoms, such as: NauseaThese side effects may potentially be related to Amitriptyline.
Amitriptyline Side Effect Report#9727771
Suicidal Ideation, Somnolence, Agitation, Irritability
This is a report of a 44-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: depression, who was treated with Amitriptyline (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Suicidal Ideation, Somnolence, Agitation, Irritability after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Amitriptyline treatment in female patients, resulting in Suicidal Ideation side effect.


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The appearance of Amitriptyline 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 Amitriptyline Side Effects for Women?

Women Side Effects Reports
Completed Suicide 57
Toxicity To Various Agents 44
Cardiac Arrest 41
Overdose 40
Pain 39
Somnolence 32
Vomiting 30
Anxiety 29
Headache 28
Nausea 27

What are common Amitriptyline Side Effects for Men?

Men Side Effects Reports
Completed Suicide 29
Toxicity To Various Agents 21
Convulsion 20
Overdose 20
Dyspnoea 17
Confusional State 16
Dizziness 16
Somnolence 16
Agitation 14
Cardiac Arrest 14

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.

    Amitriptyline 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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    How Effective is Amitriptyline for You?

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    Amitriptyline Safety Alerts, Active Ingredients, Usage Information

    NDC 0378-0042
    Type HUMAN PRESCRIPTION DRUG
    Proprietary Name Perphenazine and Amitriptyline Hydrochloride
    Name perphenazine and amitriptyline hydrochloride
    Dosage Form TABLET, FILM COATED
    Route ORAL
    On market since 19881110
    Labeler Mylan Pharmaceuticals Inc.
    Active Ingredient(s) AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE
    Strength(s) 10; 4
    Unit(s) mg/1; mg/1
    Pharma Class Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient],Tricyclic Antidepressant [EPC]

    More About Amitriptyline

    Side Effects reported to FDA: 1323

    Amitriptyline safety alerts: No

    Reported deaths: 196

    Reported hospitalizations: 330

    Latest Amitriptyline clinical trials