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Limbitrol DS Side Effects

Generic name: amitriptyline / chlordiazepoxide

Medically reviewed by Drugs.com. Last updated on May 2, 2023.

Note: This document contains side effect information about amitriptyline / chlordiazepoxide. Some dosage forms listed on this page may not apply to the brand name Limbitrol DS.

Applies to amitriptyline / chlordiazepoxide: oral tablet.

Warning

Oral route (Tablet)

Warning: Risks from concomitant use with opioids, abuse, misuse, addition, dependence, withdrawal reactions, and suicidal thoughts and behaviors:Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs for patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation.The use of benzodiazepines, including amitriptyline/chlordiazepoxide, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death. Abuse and misuse of benzodiazepines commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes. Before prescribing amitriptyline / chlordiazepoxide and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction.The continued use of benzodiazepines, including amitriptyline / chlordiazepoxide, may lead to clinically significant physical dependence. The risks of dependence and withdrawal increase with longer treatment duration and higher daily dose. Abrupt discontinuation or rapid dosage reduction of amitriptyline / chlordiazepoxide after continued use may precipitate acute withdrawal reactions, which can be life-threatening. To reduce the risk of withdrawal reactions, use a gradual taper to discontinue amitriptyline / chlordiazepoxide or reduce the dosage.Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors. Amitriptyline / chlordiazepoxide is not approved for use in pediatric patients.

Serious side effects of Limbitrol DS

Along with its needed effects, amitriptyline / chlordiazepoxide 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 amitriptyline / chlordiazepoxide:

Less common

Incidence not known

Get emergency help immediately if any of the following symptoms of overdose occur while taking amitriptyline / chlordiazepoxide:

Symptoms of overdose

Other side effects of Limbitrol DS

Some side effects of amitriptyline / chlordiazepoxide 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:

More common

Less common

For Healthcare Professionals

Applies to amitriptyline / chlordiazepoxide: oral tablet.

General

The most frequently reported side effects included drowsiness, dry mouth, constipation, and blurred vision.[Ref]

Psychiatric

Frequency not reported: Apprehension, confusion, delusions, drug habituation/dependence, dysphoria, euphoria, hallucinations, hypomania, impotence, increased/decreased libido, insomnia, poor concentration, restlessness, vivid dreams, withdrawal symptoms[Ref]

Nervous system

Frequency not reported: Ataxia, convulsions, dizziness, drowsiness, EEG pattern changes, extrapyramidal symptoms, extremity numbness/tingling/paresthesia, headache, incoordination, peculiar taste, stroke, syncope, tremor[Ref]

Gastrointestinal

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

Dermatologic

Frequency not reported: Alopecia, face edema, increased perspiration, photosensitization, pruritus, purpura, skin rash, sweating, urticaria[Ref]

Cardiovascular

Frequency not reported: Arrhythmias, heart block, hypertension, hypotension, myocardial infarction, palpitations, tachycardia[Ref]

Genitourinary

Frequency not reported: Breast enlargement, galactorrhea, minor menstrual abnormalities, testicular swelling, urinary frequency, urinary retention, urinary tract dilation[Ref]

Hematologic

Frequency not reported: Agranulocytosis, bone marrow depression, eosinophilia, granulocytopenia, thrombocytopenia

Metabolic

Frequency not reported: Anorexia, blood sugar level elevation/lowering, weight gain/loss[Ref]

Other

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

Ocular

Frequency not reported: Accommodation disturbance, blurred vision, mydriasis[Ref]

Hepatic

Frequency not reported: Hepatic dysfunction, jaundice[Ref]

Endocrine

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

Musculoskeletal

Frequency not reported: Muscle cramps[Ref]

Respiratory

Frequency not reported: Nasal congestion[Ref]

References

1. Product Information. Amitriptyline-Chlordiazepoxide (amitriptyline-chlordiazepoxide). Mylan Pharmaceuticals Inc. 2017.

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.