Summary
More frequently reported side effects include: suicidal tendencies. Continue reading for a comprehensive list of adverse effects.
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
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
- Blurred vision or other changes in vision
- confusion
- constipation
- difficulty in urinating
- dizziness or lightheadedness
- eye pain
- fainting
- irregular heartbeat
- irritability
- mental depression
- nervousness
- seeing, hearing, or feeling things that are not there
- shakiness
- talking, feeling, and acting with excitement
- trouble in sleeping
Incidence not known
- Actions that are out of control
- chest pain or discomfort
- decreased interest in sexual intercourse
- false or unusual sense of well-being
- fast, slow, or irregular heartbeat
- inability to have or keep an erection
- increased in sexual ability, desire, drive, or performance
- increased interest in sexual intercourse
- increased sensitivity to sunlight
- loss in sexual ability, desire, drive, or performance
- pain or discomfort in the arms, jaw, back or neck
- redness or other discoloration of skin
- severe sunburn
- shakiness and unsteady walk
- skin rash
- sore throat and fever
- sweating
- swelling of the breasts or breast soreness in males
- swelling of the testicles
- swelling or inflammation of the mouth
- unexpected or excess milk flow from breasts
- unsteadiness, trembling, or other problems with muscle control or coordination
Get emergency help immediately if any of the following symptoms of overdose occur while taking amitriptyline / chlordiazepoxide:
Symptoms of overdose
- Agitation
- changes in patterns and rhythms of speech
- confusion
- disorientation
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- hallucinations
- headache
- loss of consciousness
- loss of strength or energy
- mood or other mental changes
- seizures
- shakiness and unsteady walk
- slurred speech
- trouble breathing
- trouble sleeping
- trouble speaking
- unsteadiness, trembling, or other problems with muscle control or coordination
- unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
- unusual excitement, nervousness, restlessness, or irritability
Other side effects
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
- Bloating
- clumsiness or unsteadiness
- dryness of mouth or unpleasant taste
- weight gain
Less common
- Diarrhea
- nausea or vomiting
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]
