Bentyl Side Effects
Generic Name: dicyclomine
Please note - some side effects for Bentyl may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
Side Effects of Bentyl - for the Consumer
Bentyl
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Bentyl:
Seek medical attention right away if any of these SEVERE side effects occur when using Bentyl:Blurred vision; constipation; decreased sweating; difficulty sleeping; dizziness; drowsiness; dry mouth; headache; lightheadedness; loss of taste; nausea; nervousness.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); agitation; confusion; diarrhea; difficulty focusing your eyes; difficulty moving; difficulty speaking; difficulty urinating; disorientation; exaggerated sense of well-being; fainting; hallucinations; pounding in the chest; rapid heartbeat; short-term memory loss; unusual weakness; vomiting.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
Bentyl Capsules
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Bentyl Capsules:
Seek medical attention right away if any of these SEVERE side effects occur when using Bentyl Capsules:Blurred vision; constipation; decreased sweating; difficulty sleeping; dizziness; drowsiness; dry mouth; headache; lightheadedness; loss of taste; nausea; nervousness.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); agitation; confusion; diarrhea; difficulty focusing your eyes; difficulty moving; difficulty speaking; difficulty urinating; disorientation; exaggerated sense of well-being; fainting; hallucinations; pounding in the chest, rapid heartbeat; short-term memory loss; unusual weakness; vomiting.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
Bentyl Syrup
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Bentyl Syrup:
Seek medical attention right away if any of these SEVERE side effects occur when using Bentyl Syrup:Blurred vision; constipation; decreased sweating; difficulty sleeping; dizziness; drowsiness; dry mouth; headache; lightheadedness; loss of taste; nausea; nervousness.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); agitation; confusion; diarrhea; difficulty focusing your eyes; difficulty moving; difficulty speaking; difficulty urinating; disorientation; exaggerated sense of well-being; fainting; hallucinations; pounding in the chest; rapid heartbeat; short-term memory loss; unusual weakness; vomiting.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch .
TopBentyl Side Effects - for the Professional
Bentyl
The pattern of adverse effects seen with dicyclomine is mostly related to its pharmacological actions at muscarinic receptors [see Clinical Pharmacology (12)]. They are a consequence of the inhibitory effect on muscarinic receptors within the autonomic nervous system. These effects are dose-related and are usually reversible when treatment is discontinued.
The most serious adverse reactions reported with dicyclomine hydrochloride include cardiovascular and central nervous system symptoms [see Warnings and Precautions (5.2,5.3)].
Clinical Studies Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The data described below reflect the exposure in controlled clinical trials involving over 100 patients treated for functional bowel/irritable bowel syndrome with dicyclomine hydrochloride at initial doses of 160 mg daily (40 mg four times a day)
In these trials most of the side effects were typically anticholinergic in nature and were reported by 61% of the patients. Table 1 presents adverse reactions (MedDRA 13.0 preferred terms) by decreasing order of frequency in a side-by-side comparison with placebo.
Table 1: Adverse reactions experienced in controlled clinical trials with decreasing order of frequency
| MedDRA Preferred Term | Dicyclomine Hydrochloride (40 mg four times a day) % | Placebo % |
| Dry Mouth |
33 |
5 |
| Dizziness |
40 |
5 |
| Vision blurred |
27 |
2 |
| Nausea |
14 |
6 |
| Somnolence |
9 |
1 |
| Asthenia |
7 |
1 |
| Nervousness |
6 |
2 |
Postmarketing Experience
The following adverse reactions, presented by system organ class in alphabetical order, have been identified during post approval use of Bentyl. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their freqeuncy or establish a casual relationship to drug exposure.
- Cardiac disorders: palpitations, tachyarrhythmias
- Eye disorders: cycloplegia, mydriasis, vision blurred
- Gastrointestinal disorders: abdominal distension, abdominal pain, constipation, dry mouth, dyspepsia, nausea, vomiting
- General disorders and administration site conditions: fatigue, malaise
- Immune System Disorders: drug hypersensitivity including face oedema, angioedema, anaphylactic shock
- Nervous system disorders: dizziness, headache, hallucinations insomnia, somnolence, syncope
- Psychiatric disorders: confusional state, nervousness
- Reproductive system and breast disorders: suppressed lactation
- Respiratory, thoracid and mediastinal disorders: dyspnoea, nasal congestion
- Skin and subcutaneous tissue disorder: dermatitis allergic, erythema, rash
Adverse Reactions Reported with Similar Drugs with Anticholinergic/Antispasmodic Action
Gastrointestinal: anorexia,
Central Nervous System: tingling, numbness, dyskinesia, speech disturbance, insomnia
Peripheral Nervous System: With overdosage, a curare-like action may occur (i.e., neuromuscular blockade leading to muscular weakness and possible paralysis).
Ophthalmologic: diplopia, increased ocular tension
Dermatologic/Allergic: urticaria, itching, and other dermal manifestations;
Genitourinary: urinary hesitancy, urinary retention in patients with prostatic hypertrophy
Cardiovascular: hypertension
Respiratory: apnea
Other: decreased sweating, sneezing, throat congestion, impotence. With the injectable form, there may be temporary sensation of light-headedness. Some local irritation and focal coagulation necrosis may occur following the intramuscular injection of Bentyl.
Side Effects by Body System - for Healthcare Professionals
Dermatologic
Dermatologic side effects commonly observed have included inhibition of exocrine sweat glands. This is usually not clinically significant except when perspiration becomes a major factor in body temperature control.
Gastrointestinal
Gastrointestinal side effects have been reported the most frequently. These have included the anticholinergic effects of dry mouth and mucous membranes. Other reported side effects have included delayed gastric emptying time, reduced gastric acid secretion, nausea, constipation, and gastroesophageal reflux.
Cardiovascular
Cardiovascular side effects have included tachycardia and palpitations from muscarinic blockade.
General
General side effects have included dicyclomine toxicity (anticholinergic side effects) which often presents with fever, tachycardia, agitation, and dry skin/mucous membranes.
Genitourinary
Genitourinary side effects have frequently included urinary retention as a result of the anticholinergic effects on the urinary sphincter and dose-related, and impotence in male patients.
Nervous system
Nervous system side effects have included lethargy and somnolence. Higher doses may be associated with mental confusion and/or excitement. The elderly appear to be more prone to the anticholinergic effects of dicyclomine on the CNS.
Ocular
Ocular side effects due to the anticholinergic activity of dicyclomine have included inhibition of the iris sphincter muscle (possibly resulting in mydriasis), follicular conjunctivitis, and inhibition of the ciliary muscle (which can produce blurred vision). All muscarinic antagonists can precipitate glaucoma.
Hypersensitivity
Hypersensitivity side effects have been reported rarely. These have included urticaria, pruritus, edema, hypotension, abdominal pain, tachypnea, and nausea and vomiting.
TopMore Bentyl resources
- Bentyl Prescribing Information (FDA)
- Bentyl MedFacts Consumer Leaflet (Wolters Kluwer)
- Bentyl Concise Consumer Information (Cerner Multum)
- Bentyl Monograph (AHFS DI)
- Dicyclomine Prescribing Information (FDA)
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