What are the possible side effects of Omtrik D?
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Symptoms of overdose
Get emergency help immediately if any of the following symptoms of overdose occur:
- Difficulty in speaking
- disorientation
- dizziness
- fainting
- irregular heartbeat
- light-headedness
- loss of balance or muscle control
Check with your doctor immediately if any of the following side effects occur:
Less common
- Loss of balance or muscle control
- swelling of the mouth
- Fast, irregular, pounding, or racing heartbeat or pulse
- swelling of face, hands, lower legs, or feet
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Less common
- Breast milk flowing from the nipple
- dry mouth
- swelling of the breast in the male
- headache
- hives
- hot flashes
- itching of skin
- itching, redness, pain, or swelling of eye
- menstrual irregularities
- pain in the breast
- Change in need to urinate
- change in appetite
- constipation
- diarrhea
- burning, difficult, or painful urination
- difficulty in speaking
- dizziness
- drowsiness
- heartburn
- irritability
- lack or loss of strength
- leg cramps
- mental dullness
- nervousness
- palpitations
- sluggishness
- stomach cramps
- thirst
- tiredness
- weakness
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Side effects of Omtrik D in details
Clinical Trial Data: The safety of Omtrik D was evaluated in 1221 patients with gastroparesis, dyspepsia, gastro-oesophageal reflux disorder (GERD) or other related conditions in 45 clinical trials included in the safety database. All patients were ≥15 years and received at least 1 dose of oral Omtrik D (Omtrik D base). Slightly fewer than one-half (553/1221) of patients were diabetic. The median total daily dose was 80 mg (range 10-160 mg), with 230 patients receiving a dose >80 mg. Median duration of exposure was 56 days (range 1-2248 days).
Adverse drug reactions (ADRs) reported by ≥1% of patients treated with oral Omtrik D in these 45 clinical trials (n=1221) are the following: Psychiatric Disorders: Depression (2.5%), anxiety (1.6%), decreased libido/loss of libido (1.5%).
Nervous System Disorders: Headache (5.6%), somnolence (2.5%), akathisia (1%).
Gastrointestinal Disorders: Diarrhoea (5.2%).
Skin and Subcutaneous Tissue Disorders: Rash (2.8%), pruritus (1.7%).
Reproductive System and Breast Disorders: Breast enlargement/gynaecomastia (5.3%), breast tenderness (4.4%), galactorrhoea (3.3%), amenorrhoea (2.9%), breast pain (2.3%), irregular menstruation (2%), lactation disorder (1.6%).
General Disorders and Administration Site Conditions: Asthenia (1.9%).
ADRs that occurred in <1% of Omtrik D-treated patients in the 45 clinical trials (n=1221) are the following: Immune System Disorders: Hypersensitivity (0.2%).
Skin and Subcutaneous Disorders: Urticaria (0.7%).
Reproductive System and Breast Disorders: Breast discharge (0.8%), breast swelling (0.5%).
Dry mouth has been reported with over-the-counter use of Omtrik D.
Post-Marketing: In addition to the adverse effects reported during clinical studies and previously mentioned, the following adverse drug reactions provided the frequencies according to the following convention: Very common (≥1/10), common (≥1/100 and <1/10); uncommon (≥1/1000 and <1/100); rare (≥1/10,000 and <1/1000); very rare (<1/10,000, including isolated reports).
The following ADRs are presented by frequency category based on spontaneous reporting rates: Immune System Disorders: Very Rare: Anaphylactic reactions (including anaphylactic shock).
Psychiatric Disorders: Very Rare: Agitation, nervousness.
Nervous System Disorders: Very Rare: Extrapyramidal disorder, convulsion.
Cardiac Disorders: Very Rare: Sudden cardiac death*, serious ventricular arrhythmias*.
Skin and Subcutaneous Tissue Disorders: Very Rare: Angioedema.
Renal and Urinary Disorders: Very Rare: Urinary retention.
Investigations: Very Rare: Abnormal liver function test; increased blood prolactin.
Note: *Based on epidemiology data (as follows).
As the hypophysis is outside the blood-brain barrier, Omtrik D may cause an increase in prolactin levels. In rare cases, this hyperprolactinaemia may lead to neuro-endocrinological side effects eg, galactorrhoea, gynaecomastia and amenorrhoea.
Extrapyramidal disorder occurs primarily in neonates and infants.
Other central nervous system-related effects of convulsion and agitation are also reported primarily in infants and children.
An increase in the risk of serious ventricular arrhythmias and sudden cardiac death has been reported in some epidemiology studies. Due to the limitations of these data, risk factors and the exact frequency of these adverse reactions could not be defined.
Omtrik D contraindications
Hypersensitivity to Omtrik D or any ingredient of Omtrik D.
If patients are taking oral ketoconazole, fluconazole, voriconazole, erythromycin, clarithromycin, telithromycin, amiodarone, selective serotonin reuptake inhibitors, HIV protease inhibitors, calcium antagonists which can increase plasma concentrations of Omtrik D, leading to a prolonged QTc interval. These medicines can increase plasma concentrations of Omtrik D leading to a prolonged QTc interval. Patients with long QT syndrome develop a very fast heart rhythm disturbance leading to a sudden loss of consciousness.
Gastrointestinal hemorrhage (bleeding), obstruction, perforation or conditions where gastrointestinal stimulation or movements may be dangerous.
Prolactin-releasing pituitary tumor (prolactinoma).
References
- DTP/NCI. "domperidone: 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. "Domperidone: 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).
- NCIt. "Domperidone: NCI Thesaurus (NCIt) provides reference terminology for many systems. It covers vocabulary for clinical care, translational and basic research, and public information and administrative activities.". https://ncit.nci.nih.gov/ncitbrowser... (accessed September 17, 2018).
Reviews
The results of a survey conducted on ndrugs.com for Omtrik D 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 Omtrik D. 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
