NORTRIPTYLINE HYDROCHLORIDE

N/A

Manufactured by SpecGx LLC

23,339 FDA adverse event reports analyzed

Last updated: 2026-04-15

About NORTRIPTYLINE HYDROCHLORIDE

NORTRIPTYLINE HYDROCHLORIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by SpecGx LLC. The most commonly reported adverse reactions for NORTRIPTYLINE HYDROCHLORIDE include DRUG INEFFECTIVE, OFF LABEL USE, PAIN, HEADACHE, FATIGUE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for NORTRIPTYLINE HYDROCHLORIDE.

Top Adverse Reactions

DRUG INEFFECTIVE777 reports
OFF LABEL USE705 reports
PAIN695 reports
HEADACHE680 reports
FATIGUE594 reports
NAUSEA514 reports
HYPERHIDROSIS485 reports
HYPERSENSITIVITY460 reports
DRUG HYPERSENSITIVITY430 reports
HYPERTENSION396 reports
CONSTIPATION394 reports
RHEUMATOID ARTHRITIS388 reports
HEPATIC ENZYME INCREASED383 reports
OVERDOSE374 reports
BACK PAIN365 reports
JOINT SWELLING361 reports
IMMUNODEFICIENCY358 reports
UPPER RESPIRATORY TRACT INFECTION351 reports
DRUG INTOLERANCE348 reports
PRODUCT USE ISSUE344 reports
FOOD ALLERGY342 reports
ASTHMA340 reports
PYREXIA337 reports
RASH335 reports
SOMNOLENCE323 reports
EXPOSURE DURING PREGNANCY322 reports
RASH ERYTHEMATOUS307 reports
INFUSION RELATED REACTION306 reports
PRESCRIBED OVERDOSE304 reports
INTENTIONAL PRODUCT MISUSE288 reports
FLUID RETENTION273 reports
TREATMENT FAILURE270 reports
ERYTHEMA268 reports
DIARRHOEA264 reports
INFECTION263 reports
THROMBOCYTOPENIA263 reports
CONTRAINDICATED PRODUCT ADMINISTERED262 reports
GASTROOESOPHAGEAL REFLUX DISEASE256 reports
TEMPERATURE REGULATION DISORDER249 reports
PRODUCT USE IN UNAPPROVED INDICATION247 reports
DIZZINESS246 reports
BURSITIS245 reports
COELIAC DISEASE230 reports
PSORIASIS228 reports
FALL224 reports
PAIN IN EXTREMITY222 reports
COMA212 reports
COMPLETED SUICIDE204 reports
PNEUMONIA ASPIRATION204 reports
DEPRESSION202 reports
ANXIETY200 reports
ARTHRALGIA190 reports
INSOMNIA188 reports
FOETAL DEATH182 reports
MALAISE179 reports
DYSPNOEA172 reports
VOMITING163 reports
ASTHENIA162 reports
MIGRAINE157 reports
GAIT DISTURBANCE153 reports
TOXICITY TO VARIOUS AGENTS151 reports
WEIGHT INCREASED149 reports
CONDITION AGGRAVATED147 reports
WEIGHT DECREASED140 reports
HYPOTENSION138 reports
TREMOR134 reports
PRODUCT DOSE OMISSION ISSUE126 reports
SLEEP DISORDER126 reports
SUICIDAL IDEATION125 reports
PRURITUS124 reports
OSTEOARTHRITIS121 reports
URINARY TRACT INFECTION120 reports
NIGHTMARE117 reports
SEDATION117 reports
HYPOAESTHESIA110 reports
FEELING ABNORMAL109 reports
PNEUMONIA108 reports
NEPHROLITHIASIS107 reports
GASTROINTESTINAL DISORDER104 reports
NEUROPATHY PERIPHERAL104 reports
DEATH100 reports
OSTEOPENIA96 reports
MEMORY IMPAIRMENT94 reports
MUSCLE SPASMS94 reports
ABDOMINAL PAIN92 reports
CHEST PAIN91 reports
MUSCULOSKELETAL STIFFNESS91 reports
DRY EYE89 reports
BLOOD PRESSURE INCREASED84 reports
DYSPHAGIA84 reports
COUGH83 reports
PARAESTHESIA81 reports
MYOCARDIAL INFARCTION79 reports
CONFUSIONAL STATE77 reports
MUSCULAR WEAKNESS77 reports
ABDOMINAL PAIN UPPER75 reports
COVID 1975 reports
SINUSITIS73 reports
RENAL IMPAIRMENT72 reports
MYALGIA71 reports

Report Outcomes

Out of 5,497 classified reports for NORTRIPTYLINE HYDROCHLORIDE:

Serious 71.4%Non-Serious 28.6%

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

Female3,666 (75.4%)
Male1,180 (24.3%)
Unknown14 (0.3%)

Reports by Age

Age 58194 reports
Age 64169 reports
Age 53153 reports
Age 36118 reports
Age 5776 reports
Age 6275 reports
Age 4874 reports
Age 5670 reports
Age 6070 reports
Age 7267 reports
Age 5965 reports
Age 5464 reports
Age 5163 reports
Age 6662 reports
Age 4461 reports
Age 6361 reports
Age 5060 reports
Age 6559 reports
Age 5558 reports
Age 6158 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 NORTRIPTYLINE HYDROCHLORIDE?

This profile reflects 23,339 FDA FAERS reports that mention NORTRIPTYLINE HYDROCHLORIDE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for NORTRIPTYLINE HYDROCHLORIDE?

Frequently reported terms in FAERS include DRUG INEFFECTIVE, OFF LABEL USE, PAIN, HEADACHE, FATIGUE, NAUSEA. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures NORTRIPTYLINE HYDROCHLORIDE?

Labeling and FAERS entries often list SpecGx LLC in connection with NORTRIPTYLINE 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.