VERAPAMIL HYDROCHLORIDE

85/100 · Critical

Manufactured by Lannett Company, Inc.

Verapamil Hydrochloride Adverse Events: High Serious Reaction Rate

13,321 FDA adverse event reports analyzed

Last updated: 2026-05-12

About VERAPAMIL HYDROCHLORIDE

VERAPAMIL HYDROCHLORIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Lannett Company, Inc.. Based on analysis of 13,321 FDA adverse event reports, VERAPAMIL HYDROCHLORIDE has a safety score of 85 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 VERAPAMIL HYDROCHLORIDE include DYSPNOEA, NAUSEA, DRUG INTERACTION, DIZZINESS, HYPOTENSION. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for VERAPAMIL HYDROCHLORIDE.

AI Safety Analysis

Verapamil Hydrochloride has a safety concern score of 85 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 13,321 adverse event reports for this medication, which is primarily manufactured by Lannett Company, Inc..

The most commonly reported adverse events include Dyspnoea, Nausea, Drug Interaction. Of classified reports, 90.3% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. High incidence of serious reactions such as respiratory issues, cardiovascular events, and drug interactions.

A significant number of reports involve falls and syncope, indicating potential risk of falls and dizziness. Reports of severe gastrointestinal issues like diarrhea and abdominal pain are common.

Patients taking Verapamil Hydrochloride should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Verapamil Hydrochloride can cause significant drug interactions and should be used with caution, especially with other cardiovascular medications. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.

Safety Score: 85/100

Verapamil Hydrochloride received a safety concern score of 85/100 (high concern). This is based on a 90.3% serious event ratio across 4,222 classified reports. The score accounts for 13,321 total adverse event reports and 100 distinct reaction types. This high score reflects a significant proportion of serious adverse events in the reporting data.

Top Adverse Reactions

DYSPNOEA355 reports
NAUSEA341 reports
DRUG INTERACTION316 reports
DIZZINESS286 reports
HYPOTENSION280 reports
FATIGUE271 reports
DIARRHOEA256 reports
COUGH239 reports
ABDOMINAL PAIN238 reports
ASTHENIA238 reports
HEADACHE237 reports
VOMITING237 reports
DRUG INEFFECTIVE236 reports
FALL234 reports
MALAISE227 reports
COMPLETED SUICIDE224 reports
TACHYCARDIA224 reports
PRURITUS223 reports
ARTHRALGIA211 reports
BRADYCARDIA208 reports
OFF LABEL USE206 reports
BLOOD PRESSURE INCREASED204 reports
CARDIO RESPIRATORY ARREST194 reports
PYREXIA193 reports
COMA190 reports
TOXICITY TO VARIOUS AGENTS188 reports
INSOMNIA187 reports
SOMNOLENCE186 reports
SEPSIS184 reports
DECREASED APPETITE171 reports
ALTERED STATE OF CONSCIOUSNESS163 reports
ASCITES159 reports
HAEMORRHAGIC STROKE159 reports
HAEMATEMESIS155 reports
ABDOMINAL PAIN UPPER154 reports
SYNCOPE153 reports
HEAD DISCOMFORT152 reports
MYALGIA151 reports
BLINDNESS150 reports
CHILLS150 reports
EYE PAIN147 reports
OCULAR DISCOMFORT145 reports
AMAUROSIS FUGAX142 reports
HAEMATURIA141 reports
VISION BLURRED140 reports
PRESYNCOPE130 reports
OVERDOSE128 reports
TINNITUS128 reports
GENERALISED OEDEMA127 reports
ATRIAL FIBRILLATION124 reports
PHOTOPHOBIA124 reports
DIPLOPIA120 reports
URINARY TRACT DISORDER120 reports
ACUTE KIDNEY INJURY112 reports
CARDIOGENIC SHOCK110 reports
PNEUMONIA96 reports
INTENTIONAL OVERDOSE95 reports
PAIN93 reports
CARDIAC ARREST86 reports
WEIGHT DECREASED85 reports
RENAL FAILURE84 reports
CONDITION AGGRAVATED83 reports
RESPIRATORY FAILURE80 reports
PRODUCT USE IN UNAPPROVED INDICATION79 reports
HYPERTENSION76 reports
PALPITATIONS72 reports
RASH72 reports
DRUG INEFFECTIVE FOR UNAPPROVED INDICATION71 reports
CHEST PAIN70 reports
CEREBROVASCULAR ACCIDENT69 reports
CARDIAC FAILURE66 reports
DEATH66 reports
MIGRAINE65 reports
RENAL IMPAIRMENT65 reports
OEDEMA PERIPHERAL64 reports
ANAEMIA63 reports
ATRIOVENTRICULAR BLOCK COMPLETE63 reports
SHOCK63 reports
HYPERKALAEMIA62 reports
METABOLIC ACIDOSIS61 reports
PAIN IN EXTREMITY61 reports
BLOOD PRESSURE DECREASED60 reports
CONSTIPATION57 reports
DYSPEPSIA57 reports
DEPRESSION56 reports
ANXIETY55 reports
ELECTROCARDIOGRAM QT PROLONGED54 reports
PRODUCT USE ISSUE54 reports
ANURIA51 reports
ARRHYTHMIA50 reports
CONFUSIONAL STATE48 reports
LACTIC ACIDOSIS48 reports
ACUTE RESPIRATORY DISTRESS SYNDROME46 reports
ABDOMINAL DISCOMFORT45 reports
TREATMENT FAILURE45 reports
GENERAL PHYSICAL HEALTH DETERIORATION44 reports
SUICIDE ATTEMPT44 reports
FEELING ABNORMAL43 reports
GAIT DISTURBANCE43 reports
HEART RATE INCREASED43 reports

Key Safety Signals

  • High rate of serious adverse events (90.3%)
  • Multiple cardiovascular issues including arrhythmias, bradycardia, and heart rate changes
  • Falls and syncope reported frequently, suggesting potential for falls and dizziness

Patient Demographics

Adverse event reports by sex: Female: 2,200, Male: 1,461, Unknown: 24. The most frequently reported age groups are age 71 (127 reports), age 73 (108 reports), age 74 (102 reports). These demographics reflect reporting patterns and may not represent the full patient population.

Report Outcomes

Out of 4,222 classified reports for VERAPAMIL HYDROCHLORIDE:

  • Serious: 3,812 reports (90.3%) — includes hospitalization, disability, life-threatening events, or death
  • Non-Serious: 410 reports (9.7%)
Serious 90.3%Non-Serious 9.7%

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 Breakdown

Reports by Sex

Female2,200 (59.7%)
Male1,461 (39.6%)
Unknown24 (0.7%)

Reports by Age

Age 71127 reports
Age 73108 reports
Age 74102 reports
Age 78101 reports
Age 6888 reports
Age 7285 reports
Age 7784 reports
Age 7983 reports
Age 7075 reports
Age 8075 reports
Age 6672 reports
Age 7571 reports
Age 7671 reports
Age 6369 reports
Age 6568 reports
Age 5065 reports
Age 6263 reports
Age 5862 reports
Age 5758 reports
Age 5958 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Drug Interactions & Warnings

Verapamil Hydrochloride can cause significant drug interactions and should be used with caution, especially with other cardiovascular medications.

What You Should Know

If you are taking Verapamil Hydrochloride, here are important things to know. The most commonly reported side effects include dyspnoea, nausea, drug interaction, dizziness, hypotension. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Monitor patients for signs of cardiovascular issues, especially bradycardia and arrhythmias. Be cautious when combining Verapamil Hydrochloride with other medications to avoid drug interactions. 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 Context

The FDA closely monitors Verapamil Hydrochloride due to its high rate of serious adverse events, particularly in older adults.

Frequently Asked Questions

How many adverse event reports has the FDA received for Verapamil Hydrochloride?

The FDA has received approximately 13,321 adverse event reports associated with Verapamil Hydrochloride. 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.

What are the most commonly reported side effects of Verapamil Hydrochloride?

The most frequently reported adverse events for Verapamil Hydrochloride include Dyspnoea, Nausea, Drug Interaction, Dizziness, Hypotension. By volume, the top reported reactions are: Dyspnoea (355 reports), Nausea (341 reports), Drug Interaction (316 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Verapamil Hydrochloride.

What percentage of Verapamil Hydrochloride adverse event reports are serious?

Out of 4,222 classified reports, 3,812 (90.3%) were classified as serious and 410 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.

Who reports adverse events for Verapamil Hydrochloride (by sex)?

Adverse event reports for Verapamil Hydrochloride break down by patient sex as follows: Female: 2,200, Male: 1,461, Unknown: 24. 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.

What age groups report the most side effects for Verapamil Hydrochloride?

The most frequently reported age groups for Verapamil Hydrochloride adverse events are: age 71: 127 reports, age 73: 108 reports, age 74: 102 reports, age 78: 101 reports, age 68: 88 reports. Age-related reporting patterns can reflect both the demographics of the patient population and potential age-related susceptibility to certain side effects.

Who manufactures Verapamil Hydrochloride?

The primary manufacturer associated with Verapamil Hydrochloride adverse event reports is Lannett Company, Inc.. Multiple manufacturers may produce generic versions of this drug. The manufacturer listed reflects the most frequently reported brand in FDA adverse event data.

What other side effects have been reported for Verapamil Hydrochloride?

Beyond the most common reactions, other reported adverse events for Verapamil Hydrochloride include: Fatigue, Diarrhoea, Cough, Abdominal Pain, Asthenia. Less common side effects can still be clinically significant. Patients should report any unusual symptoms to their healthcare provider.

How do I report a side effect from Verapamil Hydrochloride?

You can report adverse events from Verapamil Hydrochloride 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.

What is Verapamil Hydrochloride's safety score and what does it mean?

Verapamil Hydrochloride has a safety concern score of 85 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 incidence of serious reactions such as respiratory issues, cardiovascular events, and drug interactions.

What are the key safety signals for Verapamil Hydrochloride?

Key safety signals identified in Verapamil Hydrochloride's adverse event data include: High rate of serious adverse events (90.3%). Multiple cardiovascular issues including arrhythmias, bradycardia, and heart rate changes. Falls and syncope reported frequently, suggesting potential for falls and dizziness. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.

Does Verapamil Hydrochloride interact with other drugs?

Verapamil Hydrochloride can cause significant drug interactions and should be used with caution, especially with other cardiovascular medications. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Verapamil Hydrochloride.

What should patients know before taking Verapamil Hydrochloride?

Monitor patients for signs of cardiovascular issues, especially bradycardia and arrhythmias. Be cautious when combining Verapamil Hydrochloride with other medications to avoid drug interactions.

Are Verapamil Hydrochloride side effects well-documented?

Verapamil Hydrochloride has 13,321 adverse event reports on file with the FDA. A significant number of reports involve falls and syncope, indicating potential risk of falls and dizziness. The volume of reports for Verapamil Hydrochloride reflects both the drug's usage level and the vigilance of the reporting community.

What is the FDA's position on Verapamil Hydrochloride?

The FDA closely monitors Verapamil Hydrochloride due to its high rate of serious adverse events, particularly in older adults. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.

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Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.