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Elavil (Amitriptyline) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Elavil (Amitriptyline) 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 (67)
Death (5)
Life Threatening Events (1)
Disability (1)

Reports by Reaction Type

Drug Ineffective (14)Drug Hypersensitivity (14)Weight Increased (13)Disturbance in Attention (13)Pain (11)Agitation (10)Rash (10)Fatigue (9)Depression (9)Toxicity To Various Agents (9)Anxiety (9)Insomnia (8)

Below are a few examples of reports where side effects / adverse reactions may be related to Elavil (Amitriptyline). For a complete list or a specific selection of reports, please use the links above.

Possible Elavil side effects in 32 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27

Patient: 32 year old female

Reactions: Asthma, Pulmonary Hypertension, Oesophageal Spasm, Weight Increased, Fibromyalgia, Migraine, Back Pain, Vomiting, Type 2 Diabetes Mellitus, Nausea, Anaemia, Supraventricular Tachycardia, Ataxia, Dysstasia, Temporomandibular Joint Syndrome, Gait Disturbance, Hypertension, Sleep Apnoea Syndrome

Drug(s) suspected as cause:
Lisinopril
    Administration route: Oral

Zomig
    Administration route: Oral

Elavil

Other drugs received by patient: Firocet; Prilocaine Hydrochloride; Lyrica; Vistaril; Compazine; Metformin HCL; Protonix; Oxycodone; Analpram; Lipitor; Calan; Albuterol; Novolog; Aspirin; Lyrica; Lactulose; Ambien; Hydrochlorothiazide; Vitamin D; Remeron; Zanaflex; Magnesium; Lidocaine; Naftin



Possible Elavil side effects in

Reported by a consumer/non-health professional from Japan on 2012-08-23

Patient:

Reactions: Status Epilepticus, Convulsion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Elavil



Possible Elavil side effects in 66 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-21

Patient: 66 year old female

Reactions: Drug Hypersensitivity, Rash

Drug(s) suspected as cause:
Flexeril
    Dosage: unk

Amitriptyline Hydrochloride
    Dosage: unk

Neosporin
    Dosage: unk

Elavil
    Dosage: unk



Possible Elavil side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-15

Patient:

Reactions: Hypoxic-Ischaemic Encephalopathy

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Elavil
    Administration route: Oral

Oxycodone HCL

Trazodone HCL



Possible Elavil side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-14

Patient: female

Reactions: Confusional State, Agitation, Nightmare, Drug Ineffective, Hyperglycaemia, Rash, Toxicity To Various Agents, Convulsion, Tremor, Weight Increased, Bipolar Disorder, Chest Pain

Drug(s) suspected as cause:
Trileptal

Tizanidine Hydrochloride
    Indication: Migraine

Depakote

Darvocet-N 50

Skelaxin

Prozac

Paxil

Lunesta

Beta Blocking Agents

Topamax

Zonegran

Valium
    Indication: Agitation

Reglan

Abilify

Elavil

Zyprexa

Tegretol

Requip

MAO Inhibitors

Remeron

Buspar

Adderall

Erythromycin

Ritalin

Effexor

Sumatriptan

Wellbutrin

Tofranil

Zoloft

Daytrana

Antidepressants

Steroids NOS

Desyrel

Neurontin

Sinequan

Seroquel

Pamelor

Other drugs received by patient: Aspirin; Vitamin B-Complex, Other Combinations; Ensure; Caltrate +D; ONE A DAY



Possible Elavil side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-10

Patient:

Reactions: Hypoxic-Ischaemic Encephalopathy

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Oxycodone HCL

Trazodone HCL

Elavil
    Administration route: Oral



Possible Elavil side effects in

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-08-10

Patient:

Reactions: Status Epilepticus, Convulsion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Elavil



Possible Elavil side effects in 44 year old male

Reported by a consumer/non-health professional from United States on 2012-08-06

Patient: 44 year old male, weighing 74.8 kg (164.7 pounds)

Reactions: Product Quality Issue, Drug Hypersensitivity, Poor Quality Drug Administered

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Elavil



Possible Elavil side effects in

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-08-03

Patient:

Reactions: Status Epilepticus, Convulsion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Elavil



Possible Elavil side effects in 38 year old female

Reported by a physician from United Kingdom on 2012-07-25

Patient: 38 year old female

Reactions: Galactorrhoea, Blood Prolactin Increased, Pituitary Tumour Benign

Drug(s) suspected as cause:
Neurontin
    Indication: Product Used FOR Unknown Indication

Risperidone
    Indication: Depression
    Start date: 2011-09-01

Fosamax
    Indication: Product Used FOR Unknown Indication

Cellcept
    Indication: Product Used FOR Unknown Indication

Synthroid
    Indication: Product Used FOR Unknown Indication

Celexa
    Indication: Product Used FOR Unknown Indication

Plaquenil
    Indication: Product Used FOR Unknown Indication

Prednisone
    Indication: Product Used FOR Unknown Indication

Elavil
    Indication: Product Used FOR Unknown Indication

Zocor
    Indication: Product Used FOR Unknown Indication



Possible Elavil side effects in

Reported by a physician from United States on 2012-07-19

Patient:

Reactions: Extrapyramidal Disorder

Drug(s) suspected as cause:
Elavil



Possible Elavil side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-17

Patient: female, weighing 82.5 kg (181.6 pounds)

Reactions: Thinking Abnormal, Nausea, Drug Ineffective, Disturbance in Attention, Feeling Abnormal, Ulcer

Drug(s) suspected as cause:
Aleve
    Dosage: unk
    Indication: Headache

Elavil
    Dosage: unk
    Indication: Diabetic Neuropathy

Neurontin
    Dosage: unk
    Indication: Diabetic Neuropathy

Humalog
    Dosage: 60units in the morning and 40units in the evening
    Indication: Diabetes Mellitus

Other drugs received by patient: Metformin; Metformin; Celebrex; Simvastatin; Actos



Possible Elavil side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-11

Patient: female

Reactions: Confusional State, Agitation, Nightmare, Drug Ineffective, Hyperglycaemia, Toxicity To Various Agents, Rash, Convulsion, Tremor, Weight Increased, Bipolar Disorder, Chest Pain

Drug(s) suspected as cause:
Tegretol

Requip

Neurontin

Darvocet-N 50

Remeron

Reglan

Depakote

Imitrex

Zonegran

Erythromycin

Ritalin

Sinequan

Elavil

Adderall 5

Wellbutrin

Pamelor

Prozac

Buspar

Lunesta

Trileptal

Topamax

Beta Blocking Agents

Abilify

Valium
    Indication: Agitation

Steroids NOS

Seroquel

MAO Inhibitors

Tofranil

Zoloft

Paxil

Daytrana

Effexor

Skelaxin

Antidepressants

Tizanidine Hydrochloride

Desyrel

Zyprexa

Other drugs received by patient: Vitamin B-Complex, Other Combinations; Caltrate +D; Ensure; ONE A DAY; Aspirin



Possible Elavil side effects in

Reported by a individual with unspecified qualification from United States on 2012-07-09

Patient:

Reactions: Medication Error, Incorrect Dose Administered, Drug Dispensing Error

Drug(s) suspected as cause:
Elavil
    Dosage: oral
    Administration route: Oral

Elavil
    Dosage: oral
    Administration route: Oral



Possible Elavil side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-05

Patient: female

Reactions: Drug Hypersensitivity

Drug(s) suspected as cause:
Trazodone HCL
    Dosage: unk

Elavil
    Dosage: unk

Lyrica
    Dosage: unk

Atarax
    Dosage: unk

Bystolic
    Dosage: unk

Wellbutrin
    Dosage: unk

Lexapro
    Dosage: unk



Possible Elavil side effects in female

Reported by a consumer/non-health professional from United States on 2012-06-13

Patient: female

Reactions: Drug Hypersensitivity

Drug(s) suspected as cause:
Bystolic
    Dosage: unk

Lexapro
    Dosage: unk

Atarax
    Dosage: unk

Trazodone HCL
    Dosage: unk

Elavil
    Dosage: unk

Lyrica
    Dosage: unk

Wellbutrin
    Dosage: unk



Possible Elavil side effects in female

Reported by a consumer/non-health professional from United States on 2012-06-08

Patient: female

Reactions: Agitation, Confusional State, Nightmare, Drug Ineffective, Hyperglycaemia, Rash, Toxicity To Various Agents, Tremor, Convulsion, Weight Increased, Bipolar Disorder, Chest Pain

Drug(s) suspected as cause:
Skelaxin

Elavil

Prozac

Reglan

Tegretol

Depakote

Steroids NOS

Zonegran

MAO Inhibitors

Pamelor

Paxil

Requip

Sinequan

Abilify

Remeron

Tofranil

Buspar

Topamax

Imitrex

Darvocet-N 50

Seroquel

Tizanidine Hydrochloride

Adderall 5

Neurontin

Beta Blocking Agents

Desyrel

Zoloft

Ritalin

Trileptal

Valium
    Indication: Agitation

Lunesta

Daytrana

Erythromycin

Effexor

Antidepressants

Wellbutrin

Zyprexa

Other drugs received by patient: Aspirin; Caltrate +D; ONE A DAY; Vitamin B-Complex, Other Combinations; Ensure



Possible Elavil side effects in female

Reported by a consumer/non-health professional from United States on 2012-06-08

Patient: female

Reactions: Migraine, Intervertebral Disc Disorder, Bipolar Disorder, Drug Hypersensitivity, Depression, Gastrooesophageal Reflux Disease, Convulsion

Drug(s) suspected as cause:
Elavil

Zomig-ZMT
    Administration route: Oral

Other drugs received by patient: Klor-CON M10; Lexapro; Restoril; Adderall 5; Flonase; Hydroxyzine; Lamictal; Lyrica; Singulair; Diovan; Saphris; Protonix



Possible Elavil side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-24

Patient: female

Reactions: Serotonin Syndrome

Drug(s) suspected as cause:
Elavil
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    End date: 2012-01-01

Nucynta ER
    Dosage: twice per day
    Administration route: Oral
    Indication: Analgesic Therapy
    End date: 2012-01-01



Possible Elavil side effects in male

Reported by a consumer/non-health professional from United States on 2012-05-23

Patient: male, weighing 99.8 kg (219.5 pounds)

Reactions: DRY Mouth, Blood Cholesterol Increased, Toxicity To Various Agents

Drug(s) suspected as cause:
Lyrica
    Dosage: 300 mg, 2x/day
    Administration route: Oral
    Indication: Spinal Disorder
    Start date: 2005-01-01
    End date: 2012-03-01

MS Contin
    Dosage: 60 mg, 2x/day
    Indication: Product Used FOR Unknown Indication
    Start date: 2006-01-01

Elavil
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Valium
    Dosage: 10 mg, 3x/day
    Indication: Product Used FOR Unknown Indication

Soma
    Dosage: 350 mg, 3x/day
    Indication: Product Used FOR Unknown Indication

Percocet
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Lyrica
    Dosage: 300 mg, 2x/day
    Start date: 2012-04-01



Possible Elavil side effects in female

Reported by a physician from United States on 2012-05-21

Patient: female

Reactions: Drug Hypersensitivity

Drug(s) suspected as cause:
Elavil
    Dosage: unk

Tofranil
    Dosage: unk

Inderal
    Dosage: unk

Paxil
    Dosage: unk

Remeron
    Dosage: unk

Desyrel
    Dosage: unk

Prozac
    Dosage: unk

Zoloft
    Dosage: unk



Possible Elavil side effects in male

Reported by a consumer/non-health professional from United States on 2012-05-18

Patient: male, weighing 99.8 kg (219.5 pounds)

Reactions: DRY Mouth, Blood Cholesterol Increased, Toxicity To Various Agents

Drug(s) suspected as cause:
MS Contin
    Dosage: 60 mg, bid
    Indication: Product Used FOR Unknown Indication
    Start date: 2006-01-01

Lyrica
    Dosage: 300 mg, bid
    Start date: 2012-04-01

Elavil
    Indication: Product Used FOR Unknown Indication

Valium
    Dosage: 10 mg, tid
    Indication: Product Used FOR Unknown Indication

Lyrica
    Dosage: 300 mg, bid
    Administration route: Oral
    Indication: Spinal Disorder
    Start date: 2005-01-01
    End date: 2012-03-01

Soma
    Dosage: 350 mg, tid
    Indication: Product Used FOR Unknown Indication

Percocet
    Indication: Product Used FOR Unknown Indication



Possible Elavil side effects in male

Reported by a consumer/non-health professional from United States on 2012-05-15

Patient: male, weighing 99.8 kg (219.6 pounds)

Reactions: DRY Mouth, Blood Cholesterol Increased, Toxicity To Various Agents

Drug(s) suspected as cause:
Valium
    Dosage: 10 mg, 3x/day

Soma
    Dosage: 350 mg, 3x/day

Percocet
    Dosage: unk

Lyrica
    Dosage: 300 mg, 2x/day
    Administration route: Oral
    Indication: Spinal Disorder
    Start date: 2005-01-01
    End date: 2012-04-01

Lyrica
    Dosage: 300 mg, 2x/day
    Administration route: Oral
    Start date: 2012-04-01

Elavil
    Dosage: unk

MS Contin
    Dosage: 60 mg, unk



Possible Elavil side effects in male

Reported by a consumer/non-health professional from United States on 2012-05-09

Patient: male, weighing 99.8 kg (219.5 pounds)

Reactions: DRY Mouth, Blood Cholesterol Increased, Toxicity To Various Agents

Drug(s) suspected as cause:
Valium
    Dosage: 10 mg, tid
    Indication: Product Used FOR Unknown Indication

Percocet
    Indication: Product Used FOR Unknown Indication

Lyrica
    Dosage: 300 mg, bid
    Indication: Spinal Disorder
    Start date: 2005-01-01
    End date: 2012-04-01

Elavil
    Indication: Product Used FOR Unknown Indication

MS Contin
    Dosage: 60 mg, unk
    Indication: Product Used FOR Unknown Indication

Lyrica
    Dosage: 300 mg, bid
    Start date: 2012-04-01

Soma
    Dosage: 350 mg, tid
    Indication: Product Used FOR Unknown Indication



Possible Elavil side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-04

Patient: female

Reactions: Serotonin Syndrome

Drug(s) suspected as cause:
Elavil
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    End date: 2012-01-01

Nucynta ER
    Dosage: twice per day
    Administration route: Oral
    Indication: Analgesic Therapy
    End date: 2012-01-01



Possible Elavil side effects in female

Reported by a physician from United States on 2012-05-02

Patient: female

Reactions: Drug Hypersensitivity

Drug(s) suspected as cause:
Penicillin G Potassium
    Dosage: unk

Elavil
    Dosage: unk



Possible Elavil side effects in female

Reported by a lawyer from United States on 2012-05-01

Patient: female, weighing 74.4 kg (163.6 pounds)

Reactions: Agitation, Drug Ineffective, Folliculitis, Bipolar II Disorder, Obesity, Depression, Sinusitis, Arteriosclerosis, Migraine, Libido Decreased, Stress, Seborrhoea, Anxiety, Cholelithiasis, Hysterectomy, Affective Disorder, Insomnia, Withdrawal Syndrome, Memory Impairment, Feeling Abnormal, Respiratory Tract Infection, Salpingo-Oophorectomy Bilateral

Drug(s) suspected as cause:
Zoloft
    Dosage: 50 mg, 1x/day
    Start date: 1999-06-15

Effexor
    Dosage: 75 mg, 1x/day
    Indication: Anxiety
    Start date: 2006-10-17

Zoloft
    Dosage: 25mg, a day for seven days
    Indication: Depression
    Start date: 1999-03-01
    End date: 1999-03-07

Xanax
    Dosage: 0.5 mg, every 8 hours
    Start date: 2002-11-19

Wellbutrin
    Dosage: 200mg, one daily
    Indication: Depression
    Start date: 2004-05-18
    End date: 2004-05-20

Lortab
    Dosage: 7.5/500 one every 6-8 hours as needed
    Indication: Headache
    Start date: 2004-01-01
    End date: 2005-02-02

Zoloft
    Dosage: 50 mg, 2x/day
    Start date: 1999-12-06

Xanax
    Dosage: 0.25 mg, 2x/day
    Indication: Anxiety

Calan
    Dosage: unk
    Indication: Migraine

Wellbutrin
    Dosage: 150 mg, 1x/day
    Indication: Affective Disorder
    Start date: 2004-11-11

Topamax
    Dosage: 25 mg, at night for 17 days
    Start date: 2004-05-04

Midrin
    Dosage: two capsules at start of migraine
    Indication: Migraine
    Start date: 2011-11-11

Excedrin (Migraine)
    Indication: Migraine

Zoloft
    Dosage: 75 mg, 1x/day
    Indication: Adjustment Disorder
    Start date: 1999-06-01

Effexor
    Dosage: 37.5 mg, 1x/day
    Indication: Depression
    Start date: 2006-10-10
    End date: 2006-10-16

Lunesta
    Dosage: unk
    Indication: Sleep Disorder
    Start date: 2009-06-01

Topamax
    Dosage: 25 mg, x7days in the morning
    Start date: 2005-02-16

Mirapex
    Indication: Sleep Disorder

Paxil
    Dosage: 20 mg, 1x/day
    Start date: 1999-01-01

Zoloft
    Dosage: 20 mg, 1x/day for 4 weeks

Zoloft
    Dosage: 100 mg, for 6 months
    Start date: 2004-06-23

Ultram
    Dosage: 50 mg, as needed, every 8 hours
    Indication: Headache
    Start date: 2004-11-17

Wellbutrin
    Dosage: 300 mg, unk
    Start date: 2004-11-17

Zoloft
    Dosage: 50mg, for four weeks
    Indication: Affective Disorder
    Start date: 1999-03-08

Zoloft
    Dosage: 100 mg, 1x/day
    Start date: 1999-07-27

Zoloft
    Dosage: 75 mg, unk
    Start date: 2002-11-19

Zoloft
    Dosage: 50 mg, unk
    Administration route: Oral
    Start date: 2002-05-20

Inderal LA
    Dosage: 60mg 1 at night

Topamax
    Dosage: 25, twice a day for seven days
    Indication: Migraine
    Start date: 2005-02-02

Lortab
    Dosage: 5/500 one every 8 hours as needed
    Start date: 2005-01-18
    End date: 2005-02-02

Cymbalta
    Dosage: 30 mg, 1x/day
    Indication: Insomnia

Paxil
    Dosage: 10 mg, 1x/day
    Administration route: Oral
    Start date: 1999-06-01

Elavil
    Dosage: unk
    Indication: Migraine

Lexapro
    Dosage: 10 mg, unk
    Start date: 2004-06-23

Topamax
    Dosage: 50 mg and 25 mg in the morning for 7 days
    Start date: 2005-02-09

Motrin
    Indication: Migraine

Other drugs received by patient: Ortho-Novum



Possible Elavil side effects in 78 year old female

Reported by a pharmacist from United States on 2012-05-01

Patient: 78 year old female, weighing 80.2 kg (176.4 pounds)

Reactions: Mental Status Changes

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Elavil
    Dosage: 75mg qhs po chronic
    Administration route: Oral
    Indication: Neuralgia

Vesicare
    Dosage: 10mg/5mg qam/qpm po chronic
    Administration route: Oral
    Indication: Bladder Spasm

Other drugs received by patient: Lutein; Toprol-XL; Pravastatin; Calcium +D; Apriso; Vitamin B-12; VIT B6; VIT D3; Fish OIL; Zetia; Potassium Chloride; Diovan; Aspirin; Coenzyme Q10; Norvasc; Gabapentin; Multivitamin; Fenofibrate; Lisinopril



Possible Elavil side effects in female

Reported by a physician from United States on 2012-04-30

Patient: female

Reactions: Drug Hypersensitivity

Drug(s) suspected as cause:
Elavil
    Dosage: unk

Penicillin G Potassium
    Dosage: unk



Possible Elavil side effects in 56 year old female

Reported by a physician from United States on 2012-04-20

Patient: 56 year old female, weighing 64.9 kg (142.7 pounds)

Reactions: Hyperkeratosis, Pruritus, Skin Exfoliation, Morphoea, Pain, Skin Burning Sensation, Skin Hyperpigmentation, Joint Stiffness, Myalgia, Anhedonia, Skin Discolouration, Oedema Peripheral, Depression, Excoriation, Rash Papular, Musculoskeletal Pain, General Physical Health Deterioration, Rash, Skin Hypertrophy, Nephrogenic Systemic Fibrosis, Skin Induration, Skin Oedema, Deformity, Skin Plaque, Skin Tightness, Anxiety, Emotional Distress, Lichen Planus, Arthralgia, Alopecia, Asthenia, Scar, Scleral Disorder

Drug(s) suspected as cause:
Unspecified Gadolinium-Based Contrast Agent
    Indication: Angiogram Cerebral
    Start date: 2008-11-01
    End date: 2008-11-01

Magnevist
    Dosage: 15 ml, once
    Indication: Nuclear Magnetic Resonance Imaging Brain
    Start date: 2005-10-12
    End date: 2005-10-12

Unspecified Gadolinium-Based Contrast Agent
    Indication: Nuclear Magnetic Resonance Imaging

Unspecified Gadolinium-Based Contrast Agent
    Indication: Nuclear Magnetic Resonance Imaging Brain

Elavil

Other drugs received by patient: Prednisone TAB; Vicodin; Advair Diskus 100 / 50; Neurontin; Depakote; Lasix; Atenolol; Flexeril

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