IMIPRAMINE HYDROCHLORIDE

N/A

Manufactured by Key Therapeutics

1,335 FDA adverse event reports analyzed

Last updated: 2026-04-15

About IMIPRAMINE HYDROCHLORIDE

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

Top Adverse Reactions

OFF LABEL USE37 reports
DIZZINESS35 reports
DRUG INEFFECTIVE35 reports
FATIGUE30 reports
HYPERTENSION29 reports
ANXIETY28 reports
DEPRESSION28 reports
DYSPNOEA28 reports
HALLUCINATION, AUDITORY28 reports
PSYCHOTIC DISORDER28 reports
HEADACHE27 reports
DRUG INTERACTION25 reports
NAUSEA25 reports
PARANOIA25 reports
ARTHRALGIA24 reports
PNEUMONIA21 reports
ASTHENIA20 reports
URINARY TRACT INFECTION20 reports
COLITIS19 reports
COLITIS ULCERATIVE19 reports
FALL19 reports
INSOMNIA19 reports
FEELING ABNORMAL18 reports
RECTAL HAEMORRHAGE17 reports
DECREASED ACTIVITY16 reports
FREQUENT BOWEL MOVEMENTS16 reports
NASOPHARYNGITIS16 reports
BACK PAIN15 reports
HYPOAESTHESIA15 reports
PRODUCT DOSE OMISSION ISSUE15 reports
SOMNOLENCE15 reports
TREMOR14 reports
WEIGHT INCREASED14 reports
CHEST PAIN13 reports
MUSCLE SPASMS13 reports
NEUROPATHY PERIPHERAL13 reports
PYREXIA13 reports
SLEEP APNOEA SYNDROME13 reports
ABDOMINAL PAIN UPPER12 reports
DIARRHOEA12 reports
MYOCARDIAL INFARCTION12 reports
PAIN12 reports
SYNCOPE12 reports
WEIGHT DECREASED12 reports
BALANCE DISORDER11 reports
CEREBROVASCULAR ACCIDENT11 reports
DYSPEPSIA11 reports
MALAISE11 reports
PALPITATIONS11 reports
TOXICITY TO VARIOUS AGENTS11 reports
VOMITING11 reports
COUGH10 reports
GASTROOESOPHAGEAL REFLUX DISEASE10 reports
ILLNESS10 reports
MUSCULOSKELETAL STIFFNESS10 reports
PRODUCT SUBSTITUTION ISSUE10 reports
RASH10 reports
BLOOD PRESSURE INCREASED9 reports
CONDITION AGGRAVATED9 reports
CORONARY ARTERY DISEASE9 reports
DEPRESSED LEVEL OF CONSCIOUSNESS9 reports
HYPERHIDROSIS9 reports
HYPERSENSITIVITY9 reports
HYPOTENSION9 reports
NEURALGIA9 reports
OVERDOSE9 reports
ANAEMIA8 reports
CARDIAC DISORDER8 reports
CONSTIPATION8 reports
DEATH8 reports
DRY MOUTH8 reports
HEART RATE INCREASED8 reports
INFECTION8 reports
NEPHROLITHIASIS8 reports
NEUROLEPTIC MALIGNANT SYNDROME8 reports
SINUSITIS8 reports
ABDOMINAL DISCOMFORT7 reports
ARTHROPATHY7 reports
BLOOD CHOLESTEROL INCREASED7 reports
COMPLETED SUICIDE7 reports
CONFUSIONAL STATE7 reports
COVID 197 reports
DYSURIA7 reports
GAIT DISTURBANCE7 reports
HYPERLIPIDAEMIA7 reports
INFLUENZA7 reports
LETHARGY7 reports
PAIN IN EXTREMITY7 reports
PRURITUS7 reports
SUICIDAL IDEATION7 reports
THROMBOSIS7 reports
UPPER RESPIRATORY TRACT INFECTION7 reports
ANGER6 reports
ARRHYTHMIA6 reports
ARTHRITIS6 reports
CARDIAC FAILURE CONGESTIVE6 reports
CARPAL TUNNEL SYNDROME6 reports
CHEST DISCOMFORT6 reports
CHRONIC KIDNEY DISEASE6 reports
DRUG HYPERSENSITIVITY6 reports

Report Outcomes

Out of 537 classified reports for IMIPRAMINE HYDROCHLORIDE:

Serious 72.3%Non-Serious 27.7%

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

Female346 (68.4%)
Male159 (31.4%)
Unknown1 (0.2%)

Reports by Age

Age 5421 reports
Age 7321 reports
Age 5718 reports
Age 6413 reports
Age 6512 reports
Age 5610 reports
Age 559 reports
Age 689 reports
Age 759 reports
Age 158 reports
Age 628 reports
Age 668 reports
Age 678 reports
Age 708 reports
Age 768 reports
Age 446 reports
Age 636 reports
Age 696 reports
Age 746 reports
Age 836 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 IMIPRAMINE HYDROCHLORIDE?

This profile reflects 1,335 FDA FAERS reports that mention IMIPRAMINE HYDROCHLORIDE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for IMIPRAMINE HYDROCHLORIDE?

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

Who manufactures IMIPRAMINE HYDROCHLORIDE?

Labeling and FAERS entries often list Key Therapeutics in connection with IMIPRAMINE 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.