Bentyl

Last updated on RxList: 5/19/2020
Bentyl Side Effects Center

Pharmacy Editor: Omudhome Ogbru, PharmD

What Is Bentyl?

Bentyl (dicyclomine) is an anticholinergics prescribed for irritable bowel syndrome (IBS). Bentyl is available as a generic drug.

What Are Side Effects of Bentyl?

Common side effects of Bentyl include

Dosage for Bentyl

The usual doses of Bentyl range from from 20 - 40 mg given 4 times daily.

What Drugs, Substances, or Supplements Interact with Bentyl?

Drug interactions include Benadryl (diphenhydramine), Tavist (clemastine), Phenergan (promethazine), Mellaril (thioridazine), Elavil, Endep (amitriptyline), Flexeril (cyclobenzaprine) and Norpace (disopyramide).

Bentyl During Pregnancy and Breastfeeding

Bentyl has not been adequately studied in pregnant women and it is excreted in breast milk therefore, it should not be used in nursing mothers.

Additional Information

Our Bentyl Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

SLIDESHOW

Digestive Disorders: Common Misconceptions See Slideshow
Bentyl Consumer Information

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Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • fast or slow heartbeats, pounding heartbeats or fluttering in your chest;
  • confusion, agitation, hallucinations, unusual thoughts or behavior;
  • problems with memory or speech;
  • problems with balance or muscle movement;
  • diarrhea, severe constipation, or worsening of bowel symptoms;
  • trouble swallowing;
  • bruising, swelling, or pain where a dicyclomine injection was given; or
  • dehydration --dizziness, confusion, feeling very thirsty, less urination or sweating.

Confusion and mood or behavior changes may be more likely in older adults.

Common side effects may include:

  • drowsiness, dizziness, weakness, nervousness;
  • blurred vision;
  • dry mouth; or
  • nausea.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Bentyl (Dicyclomine)

QUESTION

What is irritable bowel syndrome or IBS? See Answer
Bentyl Professional Information

SIDE EFFECTS

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The pattern of adverse effects seen with dicyclomine is mostly related to its pharmacological actions at muscarinic receptors [see CLINICAL PHARMACOLOGY]. 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].

Clinical Trials 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 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

Nine percent (9%) of patients were discontinued from BENTYL because of one or more of these side effects (compared with 2% in the placebo group). In 41% of the patients with side effects, side effects disappeared or were tolerated at the 160 mg daily dose without reduction. A dose reduction from 160 mg daily to an average daily dose of 90 mg was required in 46% of the patients with side effects who then continued to experience a favorable clinical response; their side effects either disappeared or were tolerated.

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 frequency or establish a causal 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 edema, angioedema, anaphylactic shock
  • Nervous system disorders: dizziness, headache, somnolence, syncope
  • Psychiatric disorders: As with the other anti-cholinergic drugs, cases of delirium or symptoms of delirium such as amnesia (or transient global amnesia), agitation, confusional state, delusion, disorientation, hallucination (including visual hallucination) as well as mania, mood altered and pseudodementia, have been reported with the use of Dicyclomine. Nervousness and insomnia have also been reported.
  • Reproductive system and breast disorders: suppressed lactation
  • Respiratory, thoracic and mediastinal disorders: dyspnoea, nasal congestion
  • Skin and subcutaneous tissue disorder: dermatitis allergic, erythema, rash

Cases of thrombosis, thrombophlebitis and injection site reactions such as local pain, edema, skin color change and even reflex sympathetic dystrophy syndrome have been reported following inadverent IV injection of BENTYL.

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.

Read the entire FDA prescribing information for Bentyl (Dicyclomine)

© Bentyl Patient Information is supplied by Cerner Multum, Inc. and Bentyl Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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