82/100 · Critical
Manufactured by Pfizer Laboratories Div Pfizer Inc
Nifedipine Adverse Events: High Seriousness and Diverse Reactions
86,569 FDA adverse event reports analyzed
Last updated: 2026-05-12
NIFEDIPINE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Pfizer Laboratories Div Pfizer Inc. Based on analysis of 86,569 FDA adverse event reports, NIFEDIPINE has a safety score of 82 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 NIFEDIPINE include DRUG INEFFECTIVE, DYSPNOEA, FATIGUE, DIARRHOEA, NAUSEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for NIFEDIPINE.
Nifedipine has a safety concern score of 82 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 86,569 adverse event reports for this medication, which is primarily manufactured by Pfizer Laboratories Div Pfizer Inc.
The most commonly reported adverse events include Drug Ineffective, Dyspnoea, Fatigue. Of classified reports, 77.4% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. High percentage of serious adverse events (77.4%) indicates significant safety concerns.
Diverse range of reactions, including cardiovascular, respiratory, and gastrointestinal issues. Frequent reports of hypotension and renal impairment suggest potential safety risks.
Patients taking Nifedipine should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Nifedipine can cause hypotension and renal impairment, which may interact with other drugs affecting blood pressure and kidney function. Warnings are issued for drug interactions and caution is advised. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Nifedipine received a safety concern score of 82/100 (high concern). This is based on a 77.4% serious event ratio across 45,396 classified reports. The score accounts for 86,569 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: 23,902, Male: 17,677, Unknown: 98. The most frequently reported age groups are age 72 (842 reports), age 68 (841 reports), age 67 (826 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 45,396 classified reports for NIFEDIPINE:
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.
Nifedipine can cause hypotension and renal impairment, which may interact with other drugs affecting blood pressure and kidney function. Warnings are issued for drug interactions and caution is advised.
If you are taking Nifedipine, here are important things to know. The most commonly reported side effects include drug ineffective, dyspnoea, fatigue, diarrhoea, nausea. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Monitor blood pressure and renal function regularly, especially in elderly patients. Be cautious when combining nifedipine with other antihypertensive or nephrotoxic medications. 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.
The FDA closely monitors nifedipine's safety profile, and regulatory actions may be taken based on ongoing safety data. Patients should report any adverse events to their healthcare provider.
The FDA has received approximately 86,569 adverse event reports associated with Nifedipine. 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 Nifedipine include Drug Ineffective, Dyspnoea, Fatigue, Diarrhoea, Nausea. By volume, the top reported reactions are: Drug Ineffective (2,507 reports), Dyspnoea (2,431 reports), Fatigue (2,304 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Nifedipine.
Out of 45,396 classified reports, 35,139 (77.4%) were classified as serious and 10,257 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 Nifedipine break down by patient sex as follows: Female: 23,902, Male: 17,677, Unknown: 98. 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 Nifedipine adverse events are: age 72: 842 reports, age 68: 841 reports, age 67: 826 reports, age 74: 812 reports, age 70: 805 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 Nifedipine adverse event reports is Pfizer Laboratories Div Pfizer Inc. 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 Nifedipine include: Off Label Use, Headache, Dizziness, Hypertension, Pain. 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 Nifedipine 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.
Nifedipine has a safety concern score of 82 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. High percentage of serious adverse events (77.4%) indicates significant safety concerns.
Key safety signals identified in Nifedipine's adverse event data include: High number of serious adverse events (35,139 out of 45,396, 77.4%).. Multiple cardiovascular issues reported, including heart failure and arrhythmias.. Renal impairment and acute kidney injury are common, indicating potential nephrotoxicity.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Nifedipine can cause hypotension and renal impairment, which may interact with other drugs affecting blood pressure and kidney function. Warnings are issued for drug interactions and caution is advised. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Nifedipine.
Monitor blood pressure and renal function regularly, especially in elderly patients. Be cautious when combining nifedipine with other antihypertensive or nephrotoxic medications.
Nifedipine has 86,569 adverse event reports on file with the FDA. Diverse range of reactions, including cardiovascular, respiratory, and gastrointestinal issues. The volume of reports for Nifedipine reflects both the drug's usage level and the vigilance of the reporting community.
The FDA closely monitors nifedipine's safety profile, and regulatory actions may be taken based on ongoing safety data. Patients should report any adverse events to their healthcare provider. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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