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Surmontil Side Effects

Generic name: trimipramine

Medically reviewed by Drugs.com. Last updated on Apr 28, 2023.

Note: This document contains side effect information about trimipramine. Some dosage forms listed on this page may not apply to the brand name Surmontil.

Applies to trimipramine: oral capsule.

Warning

Oral route (Capsule)

Antidepressants increased the risk of suicidal thinking and behavior in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared with placebo in adults older than 24 years, and there was a reduction in risk with antidepressants compared with placebo in adults aged 65 or older. This risk must be balanced with the clinical need. Monitor patients closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Not approved for use in pediatric patients.

Serious side effects of Surmontil

Along with its needed effects, trimipramine (the active ingredient contained in Surmontil) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking trimipramine:

Incidence not known

Other side effects of Surmontil

Some side effects of trimipramine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known

For Healthcare Professionals

Applies to trimipramine: compounding powder, oral capsule.

General

The most commonly reported side effects were tremors, dizziness, headache, dry mouth, constipation, and nausea.[Ref]

Psychiatric

Frequency not reported: Agitation, anxiety, confusional states (especially the elderly) with hallucinations, disorientation, delusions, exacerbation of psychosis, hypomania, increased or decreased libido, insomnia, irritability, mania, neonatal agitation, neonatal withdrawal symptoms, nightmares, paranoid delusions, restlessness, suicidal behaviors, suicidal ideation, withdrawal symptoms[Ref]

Neonatal agitation and withdrawal symptoms occurred in neonates exposed during the third trimester.

Suicidal behaviors and ideation occurred during or early after treatment.[Ref]

Nervous system

Frequency not reported: Alterations in electroencephalogram (EEG) patterns, ataxia, convulsions, dizziness, drowsiness, extrapyramidal symptoms, extremity paresthesia, headache, incoordination, mydriasis, numbness, peculiar taste, peripheral neuropathy, seizures, tingling, tremor[Ref]

Gastrointestinal

Frequency not reported: Abdominal cramps, black tongue, constipation, diarrhea, dry mouth, epigastric distress, nausea, paralytic ileus, parotid swelling, stomatitis, sublingual adenitis, tongue edema, vomiting[Ref]

Cardiovascular

Frequency not reported: Arrhythmias, cardiac arrhythmia, flushing, heart block, hypertension, hypotension, myocardial infarction, palpitation, postural hypotension, severe hypotension, stroke, tachycardia[Ref]

Genitourinary

Frequency not reported: Breast enlargement, delayed micturition, dilation of the urinary tract, galactorrhea, impotence, interference with sexual function, micturition hesitancy, testicular swelling, urinary frequency, urinary retention[Ref]

Dermatologic

Frequency not reported: Alopecia, excessive perspiration/perspiration, face edema, itching, petechia, photosensitization, skin rashes, sweating, urticaria[Ref]

Other

Frequency not reported: Fatigue, malaise, tinnitus, weakness[Ref]

Hematologic

Frequency not reported: Agranulocytosis, bone marrow depression, eosinophilia, pathological neutrophil depression, purpura, thrombocytopenia[Ref]

Metabolic

Frequency not reported: Anorexia, elevation or depression of blood sugar levels, weight gain or loss[Ref]

Hepatic

Frequency not reported: Altered liver function, cholestatic jaundice, jaundice (simulating obstructive)[Ref]

Ocular

Frequency not reported: Blurred vision, disturbance of accommodation[Ref]

Endocrine

Frequency not reported: Gynecomastia, syndrome of inappropriate antidiuretic hormone (SIADH) secretion[Ref]

Respiratory

Frequency not reported: Neonatal respiratory depression[Ref]

Musculoskeletal

Frequency not reported: Bone fractures[Ref]

References

1. Product Information. Surmontil (trimipramine). Wyeth-Ayerst Laboratories. 2001;PROD.

2. Cerner Multum, Inc. UK Summary of Product Characteristics.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.