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Amitriptyline Side Effects

The most commonly reported side effects of amitriptyline include fatigue, nausea, and pain, based on 102,976 FDA adverse event reports from 2004 to 2025. 6.8% of reports found the drug to be ineffective.

Amitriptyline side effects

Percentages show how often each reaction appears relative to total reports for amitriptyline.

1
Drug Ineffective6.8%7,044
2
Fatigue6.2%6,357
3
Nausea5.9%6,059
4
Pain5.8%5,978
5
Headache5.5%5,675
6
Off Label Use5.4%5,584
7
Diarrhoea4.4%4,579
8
Dizziness4.4%4,508
9
Dyspnoea4.3%4,408
10
Arthralgia3.8%3,910
11
Fall3.6%3,750
12
Toxicity To Various Agents3.6%3,749
13
Malaise3.6%3,728
14
Vomiting3.6%3,665
15
Anxiety3.0%3,105

These are voluntary reports and do not establish that amitriptyline caused these reactions.

Report severity

78.3%Serious80,648 reports
34.2%Hospitalizations35,179 reports
11.9%Fatal12,231 reports

Seriousness is determined by the reporter, not by OpenClaim.

Amitriptyline drug interactions

Other drugs that appear in adverse event reports alongside amitriptyline. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Gabapentin5.1%5,238
2
Pregabalin4.8%4,928
3
Adalimumab4.4%4,581
4
Acetaminophen3.9%4,022
5
Omeprazole3.8%3,921
6
Oxycodone2.8%2,855
7
Tramadol-hydrochloride2.6%2,725
8
Duloxetine-hydrochloride2.6%2,680
9
Topiramate2.5%2,560
10
Esomeprazole2.5%2,560
11
Pantoprazole-sodium2.4%2,485
12
Methotrexate2.3%2,376
13
Etanercept2.2%2,235
14
Quetiapine-fumarate2.2%2,231
15
Venlafaxine2.2%2,220

Taken alongside

1
Acetaminophen19.7%20,301
2
Gabapentin14.9%15,359
3
Omeprazole13.6%14,050
4
Aspirin12.1%12,494
5
Levothyroxine-sodium11.1%11,454
6
Albuterol10.3%10,621
7
Ergocalciferol10.3%10,568
8
Atorvastatin-calcium9.9%10,148
9
Furosemide9.1%9,351
10
Metformin8.0%8,201
11
Prednisone7.4%7,643
12
Amlodipine7.3%7,558
13
Pantoprazole-sodium7.2%7,383
14
Folic-acid7.1%7,267
15
Tramadol-hydrochloride6.8%7,023

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports amitriptyline side effects

66.3% of amitriptyline adverse event reports involve female patients and 26.2% involve male patients. The largest age group is adult at 68%. These figures reflect who reports side effects, not underlying risk.

Sex

Female66.3%
Male26.2%
Unknown7.5%

Age group

< 20.6%
2–110.6%
12–171.4%
18–6468.2%
65+29.2%

What is amitriptyline used for

Conditions and purposes for which patients were taking amitriptyline when the adverse event was reported.

Abdominal AdhesionsAbdominal DiscomfortAbdominal MigraineAbdominal PainAbdominal Pain UpperAbdominal RigidityAbnormal DreamsAbnormal Sleep-related EventAccidental Drug Intake By ChildAccidental ExposureAccidental Exposure To ProductAccidental Exposure To Product By ChildAccidental OverdoseAcetabulum FractureAcne

Showing 15 of 1,246 indications

Amitriptyline brand names and reporting trend

Amitriptyline is sold under the brand name Chlordiazepoxide And Amitriptyline Hydrochloride.

Brand names

Chlordiazepoxide And Amitriptyline Hydrochloride3,115

Quarterly reports (20042025)

20052010201520202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking amitriptyline with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.