What the label lists and what reports show
Imipramine side effects
Imipramine's FDA label: “Note – In enuretic children treated with imipramine hydrochloride tablets, the most common adverse reactions have been nervousness, sleep disorders, tiredness, and mild gastrointestinal disturbances.” FAERS holds 723 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is dizziness (42 reports).
- Generic listed
- Boxed warning
Check it at the source: the imipramine FDA label on DailyMed (effective August 11, 2026, Leading Pharma, LLC); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsNote – In enuretic children treated with imipramine hydrochloride tablets, the most common adverse reactions have been nervousness, sleep disorders, tiredness, and mild gastrointestinal disturbances.
From the label: adverse reactions, continuedNote – Although the listing which follows includes a few adverse reactions which have not been reported with this specific drug, the pharmacological similarities among the tricyclic antidepressant drugs require that each of the reactions be considered when imipramine hydrochloride tablets, is administered. Cardiovascular: Orthostatic hypotension, hypertension, tachycardia, palpitation, myocardial infarction, arrhythmias, heart block, ECG changes, precipitation of congestive heart failure, stroke. Psychiatric: Confusional states (especially in the elderly) with hallucinations, disorientation, delusions; anxiety, restlessness, agitation; insomnia and nightmares; hypomania; exacerbation of psychosis. Neurological: Numbness, tingling, paresthesias of extremities; incoordination, ataxia, tremors; peripheral neuropathy; extrapyramidal symptoms; seizures, alterations in EEG patterns; tinnitus. Anticholinergic: Dry mouth, and, rarely, associated sublingual adenitis; blurred vision, disturbances of accommodation, mydriasis; constipation, paralytic ileus; urinary retention, delayed micturition, dilation of the urinary tract. Allergic: Skin rash, petechiae, urticaria, itching, photosensitization; edema (general or of face and tongue); drug fever; cross-sensitivity with desipramine. Hematologic: Bone marrow depression including agranulocytosis; eosinophilia; purpura; thrombocytopenia. …
Source: FDA drug label, Leading Pharma, LLC, effective August 11, 2026 (SPL set 490263ce-b4d2-428a-87da-fcd07f85499a), via openFDA; the full label on DailyMed
What do FAERS reports show?
723 reports list imipramine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 56 are coded as a death and 242 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 19 reactions below, 7 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Imipramine: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions