83/100 · Critical
Manufactured by CVS Pharmacy
Antacid Adverse Events Show High Seriousness and Diverse Reactions
184,150 FDA adverse event reports analyzed
Last updated: 2026-05-12
ANTACID is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by CVS Pharmacy. Based on analysis of 184,150 FDA adverse event reports, ANTACID has a safety score of 83 out of 100. This score indicates a relatively favorable safety profile, with fewer or less severe adverse events compared to many other tracked medications. The most commonly reported adverse reactions for ANTACID include FATIGUE, NAUSEA, OFF LABEL USE, PAIN, DYSPNOEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ANTACID.
Antacid has a safety concern score of 83 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 184,150 adverse event reports for this medication, which is primarily manufactured by Cvs Pharmacy.
The most commonly reported adverse events include Fatigue, Nausea, Off Label Use. Of classified reports, 83.7% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. The majority of adverse events are serious, with a high percentage of reports involving respiratory and gastrointestinal issues.
A wide range of reactions are reported, indicating potential for diverse side effects. The most common reactions include fatigue, nausea, and pain, suggesting these as primary concerns.
Patients taking Antacid should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Antacids may interact with other medications, and warnings should be followed to avoid potential complications. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Antacid received a safety concern score of 83/100 (high concern). This is based on a 83.7% serious event ratio across 45,522 classified reports. The score accounts for 184,150 total adverse event reports and 100 distinct reaction types. This high score reflects a significant proportion of serious adverse events in the reporting data.
Adverse event reports by sex: Female: 28,540, Male: 13,543, Unknown: 46. The most frequently reported age groups are age 65 (1,156 reports), age 43 (980 reports), age 64 (881 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 45,522 classified reports for ANTACID:
The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.
Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.
Antacids may interact with other medications, and warnings should be followed to avoid potential complications.
If you are taking Antacid, here are important things to know. The most commonly reported side effects include fatigue, nausea, off label use, pain, dyspnoea. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Consult a healthcare provider before using antacids for prolonged periods or if symptoms persist. Be aware of potential interactions with other medications and follow dosage instructions carefully. If you experience a serious adverse reaction, seek emergency medical attention immediately or call 911. You can report side effects to the FDA's MedWatch program at 1-800-FDA-1088.
Regulatory oversight is necessary to ensure the safety of over-the-counter antacids, especially for those with pre-existing conditions.
The FDA has received approximately 184,150 adverse event reports associated with Antacid. These reports come from healthcare professionals, consumers, and manufacturers through the FDA Adverse Event Reporting System (FAERS). Note that the number of reports does not directly indicate the frequency of side effects, as adverse events are voluntarily reported and may be underrepresented.
The most frequently reported adverse events for Antacid include Fatigue, Nausea, Off Label Use, Pain, Dyspnoea. By volume, the top reported reactions are: Fatigue (4,660 reports), Nausea (4,098 reports), Off Label Use (3,962 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Antacid.
Out of 45,522 classified reports, 38,100 (83.7%) were classified as serious and 7,422 as non-serious. The FDA classifies an event as "serious" if it results in death, hospitalization, disability, or other medically significant outcomes. A higher serious-event ratio warrants closer attention but does not necessarily mean the drug is unsafe.
Adverse event reports for Antacid break down by patient sex as follows: Female: 28,540, Male: 13,543, Unknown: 46. This distribution reflects reporting patterns rather than actual risk differences between groups. Reporting rates can be influenced by prescribing patterns, disease demographics, and reporting behavior.
The most frequently reported age groups for Antacid adverse events are: age 65: 1,156 reports, age 43: 980 reports, age 64: 881 reports, age 75: 798 reports, age 71: 786 reports. Age-related reporting patterns can reflect both the demographics of the patient population and potential age-related susceptibility to certain side effects.
The primary manufacturer associated with Antacid adverse event reports is Cvs Pharmacy. Multiple manufacturers may produce generic versions of this drug. The manufacturer listed reflects the most frequently reported brand in FDA adverse event data.
Beyond the most common reactions, other reported adverse events for Antacid include: Diarrhoea, Drug Ineffective, Vomiting, Headache, Pneumonia. Less common side effects can still be clinically significant. Patients should report any unusual symptoms to their healthcare provider.
You can report adverse events from Antacid to the FDA through their MedWatch program at www.fda.gov/medwatch, by calling 1-800-FDA-1088, or by completing Form FDA 3500. Healthcare professionals, consumers, and manufacturers can all submit reports. Reporting helps the FDA monitor drug safety after approval.
Antacid has a safety concern score of 83 out of 100 (high concern). This score is calculated from the ratio of serious to non-serious adverse events, the diversity of reported reactions, and the overall volume of reports relative to usage. The majority of adverse events are serious, with a high percentage of reports involving respiratory and gastrointestinal issues.
Key safety signals identified in Antacid's adverse event data include: High percentage of serious adverse events (83.7%). Respiratory issues like dyspnoea and pneumonia are frequently reported. Gastrointestinal issues such as diarrhoea and vomiting are also common. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Antacids may interact with other medications, and warnings should be followed to avoid potential complications. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Antacid.
Consult a healthcare provider before using antacids for prolonged periods or if symptoms persist. Be aware of potential interactions with other medications and follow dosage instructions carefully.
Antacid has 184,150 adverse event reports on file with the FDA. A wide range of reactions are reported, indicating potential for diverse side effects. The volume of reports for Antacid reflects both the drug's usage level and the vigilance of the reporting community.
Regulatory oversight is necessary to ensure the safety of over-the-counter antacids, especially for those with pre-existing conditions. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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