DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Bentyl (Dicyclomine Hydrochloride) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

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 (5.2,5.3) ].

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.



REPORTS OF SUSPECTED BENTYL SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Bentyl. The information is not vetted and should not be considered as verified clinical evidence.

Possible Bentyl side effects / adverse reactions in 77 year old female

Reported by a consumer/non-health professional from United States on 2012-01-17

Patient: 77 year old female

Reactions: Dyspnoea, Sinus Disorder, Cough

Suspect drug(s):
Protonix
    Dosage: unk

Prinivil
    Dosage: unk

Xanax
    Dosage: unk

Bentyl
    Dosage: unk

Lovaza
    Dosage: unk

Carafate
    Dosage: unk

Remeron
    Dosage: unk



Possible Bentyl side effects / adverse reactions in 27 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-03-07

Patient: 27 year old female

Reactions: Anxiety, Chest Discomfort, Urticaria

Suspect drug(s):
Amitiza
    Dosage: 8 mcg, bid, oral
    Administration route: Oral
    Indication: Irritable Bowel Syndrome
    Start date: 2012-02-20
    End date: 2012-02-22

Bentyl
    Dosage: 20 mg, bid
    End date: 2012-02-22



Possible Bentyl side effects / adverse reactions in 83 year old female

Reported by a consumer/non-health professional from United States on 2012-03-29

Patient: 83 year old female weighing 60.8 kg (133.7 pounds)

Reactions: Malaise, Drug Ineffective, Pain, Dizziness

Suspect drug(s):
Bentyl
    Administration route: Oral
    Indication: Abdominal Pain
    Start date: 2011-01-01
    End date: 2011-02-08

Bentyl
    Administration route: Oral
    Start date: 2011-02-09

Fentanyl-100
    Dosage: qod
    Indication: Spinal Column Stenosis
    Start date: 2011-01-21
    End date: 2011-02-05

Fentanyl-100
    Dosage: qod
    Indication: Back Pain
    Start date: 2011-01-21
    End date: 2011-02-05

Other drugs received by patient: Advair Diskus 100/50; Levaquin; M.v.i.



See index of all Bentyl side effect reports >>

Drug label data at the top of this Page last updated: 2013-06-18

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2015