What are the possible side effects of Dicicloverina [Inn-Spanish]?
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:
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fast or slow heartbeats, pounding heartbeats or fluttering in your chest;
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confusion, agitation, hallucinations, unusual thoughts or behavior;
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problems with memory or speech;
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problems with balance or muscle movement;
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diarrhea, severe constipation, or worsening of bowel symptoms;
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trouble swallowing;
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bruising, swelling, or pain where a Dicicloverina [Inn-Spanish] injection was given; or
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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:
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drowsiness, dizziness, weakness, nervousness;
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blurred vision;
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dry mouth; or
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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.
Dicicloverina [Inn-Spanish] side effects (more detail)
Side effects of Dicicloverina [Inn-Spanish] in details
The pattern of adverse effects seen with Dicicloverina [Inn-Spanish] is mostly related to its pharmacological actions at muscarinic receptors. 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 Dicicloverina [Inn-Spanish] hydrochloride include cardiovascular and central nervous system symptoms.
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 Dicicloverina [Inn-Spanish] 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 | Dicicloverina [Inn-Spanish] 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 Dicicloverina [Inn-Spanish] 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 Dicicloverina [Inn-Spanish]. 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 Dicicloverina [Inn-Spanish]. 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 Dicicloverina [Inn-Spanish].
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 Dicicloverina [Inn-Spanish].
What is the most important information I should know about Dicicloverina [Inn-Spanish]?
- Dicicloverina [Inn-Spanish] syrup may cause drowsiness, dizziness, blurred vision, or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use Dicicloverina [Inn-Spanish] syrup with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Check with your doctor before you drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Dicicloverina [Inn-Spanish] syrup; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
- Do not become overheated in hot weather or while you are being active; heatstroke may occur.
- Dicicloverina [Inn-Spanish] syrup may make your eyes more sensitive to sunlight. It may help to wear sunglasses.
- Use Dicicloverina [Inn-Spanish] syrup with caution in the ELDERLY; they may be more sensitive to its effects.
- Dicicloverina [Inn-Spanish] syrup should not be used in CHILDREN younger than 6 months old; safety and effectiveness in these children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of taking Dicicloverina [Inn-Spanish] syrup while you are pregnant. Dicicloverina [Inn-Spanish] syrup is found in breast milk. Do not breast-feed while taking Dicicloverina [Inn-Spanish] syrup.
Dicicloverina [Inn-Spanish] contraindications
This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.
Drinking alcohol can increase certain side effects of Dicicloverina [Inn-Spanish].
Avoid becoming overheated or dehydrated during exercise and in hot weather. Dicicloverina [Inn-Spanish] can decrease your sweating, which can lead to heat stroke in a hot environment.
Stop using Dicicloverina [Inn-Spanish] and call your doctor right away if you have serious side effects such as confusion, hallucinations, unusual thoughts or behavior, fast or uneven heart rate, or if you urinate less than usual or not at all.
There are many other medicines that can interact with Dicicloverina [Inn-Spanish]. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.
References
- DTP/NCI. "Merbentyl: The NCI Development Therapeutics Program (DTP) provides services and resources to the academic and private-sector research communities worldwide to facilitate the discovery and development of new cancer therapeutic agents.". https://dtp.cancer.gov/dtpstandard/s... (accessed September 17, 2018).
- European Chemicals Agency - ECHA. "Dicycloverine: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (accessed September 17, 2018).
- HSDB. "DICYCLOMINE". https://toxnet.nlm.nih.gov/cgi-bin/s... (accessed September 17, 2018).
Reviews
The results of a survey conducted on ndrugs.com for Dicicloverina [Inn-Spanish] are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Dicicloverina [Inn-Spanish]. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.User reports
Consumer reported side effects
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Information checked by Dr. Sachin Kumar, MD Pharmacology
