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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