What are the possible side effects of Ultac?
Stop using Ultac and get emergency medical help if you have any of these signs of an allergic reaction to Ultac: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop taking Ultac and call your doctor at once if you have a serious side effect such as:
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chest pain, fever, feeling short of breath, coughing up green or yellow mucus;
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easy bruising or bleeding, unusual weakness;
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fast or slow heart rate;
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problems with your vision;
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fever, sore throat, and headache with a severe blistering, peeling, and red skin rash; or
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nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
Less serious Ultac side effects may include:
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headache (may be severe);
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drowsiness, dizziness;
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sleep problems (insomnia);
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decreased sex drive, impotence, or difficulty having an orgasm; or
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swollen or tender breasts (in men);
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nausea, vomiting, stomach pain; or
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diarrhea or 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.
Side effects of Ultac in details
The following have been reported as events in clinical trials or in the routine management of patients treated with Ultac Tablets, USP. The relationship to therapy with Ultac Tablets, USP has been unclear in many cases. Headache, sometimes severe, seems to be related to administration of Ultac Tablets, USP.
Central Nervous System: Rarely, malaise, dizziness, somnolence, insomnia, and vertigo. Rare cases of reversible mental confusion, agitation, depression, and hallucinations have been reported, predominantly in severely ill elderly patients. Rare cases of reversible blurred vision suggestive of a change in accommodation have been reported. Rare reports of reversible involuntary motor disturbances have been received.
Cardiovascular: As with other H2-blockers, rare reports of arrhythmias such as tachycardia, bradycardia, atrioventricular block, and premature ventricular beats.
Gastrointestinal: Constipation, diarrhea, nausea/vomiting, abdominal discomfort/pain, and rare reports of pancreatitis.
Hepatic: There have been occasional reports of hepatocellular, cholestatic, or mixed hepatitis, with or without jaundice. In such circumstances, Ultac should be immediately discontinued. These events are usually reversible, but in rare circumstances death has occurred. Rare cases of hepatic failure have also been reported. In normal volunteers, SGPT values were increased to at least twice the pretreatment levels in 6 of 12 subjects receiving 100 mg four times daily intravenously for 7 days, and in 4 of 24 subjects receiving 50 mg four times daily intravenously for 5 days.
Musculoskeletal: Rare reports of arthralgias and myalgias.
Hematologic: Blood count changes (leukopenia, granulocytopenia, and thrombocytopenia) have occurred in a few patients. These were usually reversible. Rare cases of agranulocytosis, pancytopenia, sometimes with marrow hypoplasia, and aplastic anemia and exceedingly rare cases of acquired immune hemolytic anemia have been reported.
Endocrine: Controlled studies in animals and man have shown no stimulation of any pituitary hormone by Ultac Tablets, USP and no antiandrogenic activity, and cimetidine-induced gynecomastia and impotence in hypersecretory patients have resolved when Ultac Tablets, USP have been substituted. However, occasional cases of gynecomastia, impotence, and loss of libido have been reported in male patients receiving Ultac Tablets, USP, but the incidence did not differ from that in the general population.
Rare cases of breast symptoms and conditions, including galactorrhea and gynecomastia, have been reported in both males and females.
Integumentary: Rash, including rare cases of erythema multiforme. Rare cases of alopecia and vasculitis.
Respiratory: A large epidemiological study suggested an increased risk of developing pneumonia in current users of histamine-2-receptor antagonists (H2RAs) compared to patients who had stopped H2RA treatment, with an observed adjusted relative risk of 1.63 (95% CI, 1.07 to 2.48). However, a causal relationship between use of H2RAs and pneumonia has not been established.
Other: Rare cases of hypersensitiviy reactions (e.g., bronchospasm, fever, rash, eosinophilia), anaphylaxis, angioneurotic edema, acute interstitial nephritis, and small increases in serum creatinine.
What is the most important information I should know about Ultac?
- Ultac tablets may rarely cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Ultac tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Do NOT take more than the recommended dose or use for longer than 14 days without checking with your doctor.
- If your stomach pain does not get better or if it gets worse, check with your doctor.
- Ultac tablets may interfere with certain lab tests, including urine protein tests. Be sure your doctor and lab personnel know you are taking Ultac tablets.
- Ultac tablets should not be used in CHILDREN younger than 12 years old without first checking with the child's doctor; 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 using Ultac tablets while you are pregnant. Ultac tablets is found in breast milk. If you are or will be breast-feeding while you use Ultac tablets, check with your doctor. Discuss any possible risks to your baby.
Ultac contraindications
Hypersensitivity to Ultac or any component of the formulation
OTC labeling: When used for self-medication (OTC), do not use if trouble or pain when swallowing food, vomiting with blood, or bloody or black stools, allergic to Ultac or other acid reducers. Do not use with other acid reducers. Do not use 150 mg tablet with kidney disease without medical advice.
Documentation of allergenic cross-reactivity for histamine H antagonists is limited. However, because of similarities in chemical structure and/or pharmacologic actions, the possibility of cross-sensitivity cannot be ruled out with certainty.
References
- DTP/NCI. "ranitidine: 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. "Ranitidine: 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. "RANITIDINE". https://toxnet.nlm.nih.gov/cgi-bin/s... (accessed September 17, 2018).
Reviews
The results of a survey conducted on ndrugs.com for Ultac 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 Ultac. 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