AMITRIPTYLINE HYDROCHLORIDE

N/A

Manufactured by Advagen Pharma Ltd

56,602 FDA adverse event reports analyzed

Last updated: 2026-04-14

About AMITRIPTYLINE HYDROCHLORIDE

AMITRIPTYLINE HYDROCHLORIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Advagen Pharma Ltd. The most commonly reported adverse reactions for AMITRIPTYLINE HYDROCHLORIDE include PAIN, NAUSEA, HEADACHE, FATIGUE, DYSPNOEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for AMITRIPTYLINE HYDROCHLORIDE.

Top Adverse Reactions

PAIN1,565 reports
NAUSEA1,432 reports
HEADACHE1,379 reports
FATIGUE1,370 reports
DYSPNOEA1,340 reports
DIZZINESS1,152 reports
DIARRHOEA1,086 reports
MALAISE1,030 reports
FALL1,014 reports
VOMITING982 reports
OFF LABEL USE979 reports
ARTHRALGIA922 reports
COGNITIVE DISORDER921 reports
DRUG INEFFECTIVE870 reports
ANXIETY818 reports
PRURITUS806 reports
INSOMNIA779 reports
HYPOTENSION770 reports
CONSTIPATION768 reports
PYREXIA765 reports
BACK PAIN719 reports
TOXICITY TO VARIOUS AGENTS719 reports
CHEST PAIN700 reports
FEELING ABNORMAL682 reports
HYPERHIDROSIS669 reports
MIGRAINE652 reports
PERIPHERAL SWELLING640 reports
RASH633 reports
BALANCE DISORDER620 reports
PALPITATIONS600 reports
INFUSION SITE PAIN591 reports
ABDOMINAL PAIN UPPER581 reports
VISUAL IMPAIRMENT577 reports
COVID 19562 reports
MYOCARDIAL INFARCTION548 reports
TACHYCARDIA545 reports
HALLUCINATION540 reports
ABDOMINAL DISCOMFORT538 reports
PAIN IN EXTREMITY532 reports
SEDATION526 reports
MEMORY IMPAIRMENT521 reports
MUSCULAR WEAKNESS517 reports
ORTHOSTATIC HYPOTENSION514 reports
DEPRESSED LEVEL OF CONSCIOUSNESS512 reports
MOBILITY DECREASED511 reports
HEART RATE INCREASED502 reports
DRUG INTERACTION499 reports
LIP SWELLING485 reports
DISTURBANCE IN ATTENTION482 reports
DEHYDRATION477 reports
TINNITUS469 reports
DEPRESSION455 reports
ANGIOEDEMA449 reports
AMNESIA446 reports
ALOPECIA443 reports
ASTHENIA441 reports
BLOOD CALCIUM DECREASED435 reports
BLOOD GLUCOSE INCREASED434 reports
INTENTIONAL PRODUCT MISUSE434 reports
CREATININE RENAL CLEARANCE DECREASED433 reports
SEDATION COMPLICATION425 reports
SOMNOLENCE424 reports
PNEUMONIA420 reports
DRY SKIN408 reports
TRANSIENT ISCHAEMIC ATTACK407 reports
CONFUSIONAL STATE397 reports
MUSCLE TWITCHING397 reports
HYPERTENSION395 reports
BLINDNESS392 reports
DIPLOPIA388 reports
ABDOMINAL PAIN381 reports
COUGH371 reports
VENTRICULAR TACHYCARDIA370 reports
VASCULITIS369 reports
EYE PRURITUS368 reports
FACIAL PAIN368 reports
INFUSION SITE ERYTHEMA366 reports
PERICARDITIS366 reports
WEIGHT DECREASED363 reports
ATRIAL TACHYCARDIA361 reports
ANOSMIA360 reports
PAIN OF SKIN356 reports
SUBARACHNOID HAEMORRHAGE356 reports
CARDIOSPASM354 reports
TENSION HEADACHE354 reports
PRURITUS GENITAL350 reports
CAROTID ARTERY OCCLUSION348 reports
PALMOPLANTAR KERATODERMA346 reports
SLEEP TERROR346 reports
INTENTIONAL PRODUCT USE ISSUE340 reports
PRODUCT DOSE OMISSION ISSUE337 reports
PRODUCT USE IN UNAPPROVED INDICATION328 reports
CONDITION AGGRAVATED324 reports
WEIGHT INCREASED318 reports
PARAESTHESIA292 reports
ACUTE KIDNEY INJURY286 reports
MYALGIA283 reports
RASH PAPULAR276 reports
DECREASED APPETITE266 reports
COMPLETED SUICIDE265 reports

Report Outcomes

Out of 16,373 classified reports for AMITRIPTYLINE HYDROCHLORIDE:

Serious 81.1%Non-Serious 18.9%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Female10,710 (71.0%)
Male4,365 (28.9%)
Unknown10 (0.1%)

Reports by Age

Age 77575 reports
Age 58337 reports
Age 55325 reports
Age 65302 reports
Age 53283 reports
Age 63281 reports
Age 61280 reports
Age 67271 reports
Age 59264 reports
Age 44254 reports
Age 64253 reports
Age 50251 reports
Age 60240 reports
Age 57239 reports
Age 68238 reports
Age 69238 reports
Age 70236 reports
Age 62235 reports
Age 54234 reports
Age 51213 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with AMITRIPTYLINE HYDROCHLORIDE?

This profile reflects 56,602 FDA FAERS reports that mention AMITRIPTYLINE HYDROCHLORIDE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for AMITRIPTYLINE HYDROCHLORIDE?

Frequently reported terms in FAERS include PAIN, NAUSEA, HEADACHE, FATIGUE, DYSPNOEA, DIZZINESS. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures AMITRIPTYLINE HYDROCHLORIDE?

Labeling and FAERS entries often list Advagen Pharma Ltd in connection with AMITRIPTYLINE HYDROCHLORIDE. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.