Bentyl

Bentyl Side Effects Center

Pharmacy Editor: Eni Williams, PharmD, PhD

Bentyl (dicyclomine) is a medication that belongs to the drug class called anticholinergics. Bentyl is available as a generic drug, and is prescribed for irritable bowel syndrome (IBS). Common side effects of Bentyl include dry mouth, blurred vision, confusion, agitation, increased heart rate, constipation, difficulty urinating, headache, nervousness, drowsiness, weakness, dizziness, flushing, nausea, vomiting, rash, and bloating.

The usual doses of Bentyl range from from 20 - 40 mg given 4 times daily. Drug interactions include Benadryl (diphenhydramine), Tavist (clemastine), Phenergan (promethazine), Mellaril (thioridazine), Elavil, Endep (amitriptyline), Flexeril (cyclobenzaprine) and Norpace (disopyramide). 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.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Bentyl in Detail - Patient Information: Side Effects

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

Stop using dicyclomine and call your doctor at once if you have a serious side effect such as:

  • severe constipation, bloating, or stomach pain;
  • worsening of diarrhea or other irritable bowel symptoms;
  • feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin
  • confusion, hallucinations, unusual thoughts or behavior; or
  • pounding heartbeats or fluttering in your chest.

Less serious side effects may include:

  • drowsiness, dizziness, weakness, nervousness;
  • blurred vision;
  • dry mouth, stuffy nose; or
  • mild constipation.

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) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Bentyl Overview - Patient Information: Side Effects

SIDE EFFECTS: Dizziness, drowsiness, lightheadedness, weakness, blurred vision, dry eyes, dry mouth, nausea, constipation, and abdominal bloating may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To relieve dry mouth, suck (sugarless) hard candy or ice chips, chew (sugarless) gum, drink water, or use a saliva substitute. To relieve dry eyes, consult your pharmacist for artificial tears or other eye lubricants.

To prevent constipation, eat a diet adequate in fiber, drink plenty of water, and exercise. Consult your pharmacist for help in selecting a laxative (such as a stimulant type with stool softener).

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: decreased sweating, dry/hot/flushed skin, fast/irregular heartbeat, loss of coordination, slurred speech, mental/mood changes (such as confusion, hallucinations, agitation, nervousness, unusual excitement), eye pain, vision changes, difficulty urinating, decreased sexual ability.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Bentyl (Dicyclomine)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Bentyl FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The pattern of adverse effects seen with dicylomine 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 Inadvertent 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) »

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Bentyl - User Reviews

Bentyl User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Bentyl sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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