75/100 · Elevated
Manufactured by Hikma Pharmaceuticals USA Inc.
Promethazine Hydrochloride Adverse Events Show High Serious Reaction Rate
46,898 FDA adverse event reports analyzed
Last updated: 2026-05-12
PROMETHAZINE HYDROCHLORIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Hikma Pharmaceuticals USA Inc.. Based on analysis of 46,898 FDA adverse event reports, PROMETHAZINE HYDROCHLORIDE has a safety score of 75 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 PROMETHAZINE HYDROCHLORIDE include NAUSEA, VOMITING, PAIN, FATIGUE, DIARRHOEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for PROMETHAZINE HYDROCHLORIDE.
Promethazine Hydrochloride has a safety concern score of 75 out of 100, placing it in the elevated concern category based on analysis of FDA adverse event data. The FDA has received approximately 46,898 adverse event reports for this medication, which is primarily manufactured by Hikma Pharmaceuticals Usa Inc..
The most commonly reported adverse events include Nausea, Vomiting, Pain. Of classified reports, 72.5% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Nausea and vomiting are the most common adverse reactions, with a significant number of serious events reported.
The drug is associated with a range of serious conditions including pneumonia, renal failure, and sepsis. There is a notable increase in reports of falls and confusion, indicating potential cognitive side effects. Drug interactions and off-label use are common, suggesting a need for careful monitoring.
Patients taking Promethazine Hydrochloride should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Promethazine Hydrochloride can cause dizziness, confusion, and falls, which may interact with other sedatives or antipsychotics. Patients should avoid driving or operating machinery. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Promethazine Hydrochloride received a safety concern score of 75/100 (elevated concern). This is based on a 72.5% serious event ratio across 17,959 classified reports. The score accounts for 46,898 total adverse event reports and 100 distinct reaction types. This elevated score indicates a notable proportion of serious adverse events and warrants careful monitoring.
Adverse event reports by sex: Female: 12,676, Male: 4,126, Unknown: 35. The most frequently reported age groups are age 56 (307 reports), age 51 (294 reports), age 55 (292 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 17,959 classified reports for PROMETHAZINE HYDROCHLORIDE:
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.
Promethazine Hydrochloride can cause dizziness, confusion, and falls, which may interact with other sedatives or antipsychotics. Patients should avoid driving or operating machinery.
If you are taking Promethazine Hydrochloride, here are important things to know. The most commonly reported side effects include nausea, vomiting, pain, fatigue, diarrhoea. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Patients should report any serious adverse events to their healthcare provider immediately. Follow prescribed dosages and avoid combining with other sedatives or antipsychotics without medical advice. 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 continues to monitor Promethazine Hydrochloride for safety, and updates are regularly issued based on new data.
The FDA has received approximately 46,898 adverse event reports associated with Promethazine 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.
The most frequently reported adverse events for Promethazine Hydrochloride include Nausea, Vomiting, Pain, Fatigue, Diarrhoea. By volume, the top reported reactions are: Nausea (2,528 reports), Vomiting (1,733 reports), Pain (1,451 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Promethazine Hydrochloride.
Out of 17,959 classified reports, 13,026 (72.5%) were classified as serious and 4,933 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 Promethazine Hydrochloride break down by patient sex as follows: Female: 12,676, Male: 4,126, Unknown: 35. 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 Promethazine Hydrochloride adverse events are: age 56: 307 reports, age 51: 294 reports, age 55: 292 reports, age 54: 287 reports, age 50: 283 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 Promethazine Hydrochloride adverse event reports is Hikma Pharmaceuticals Usa 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 Promethazine Hydrochloride include: Headache, Dyspnoea, Anxiety, Drug Ineffective, Asthenia. 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 Promethazine 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.
Promethazine Hydrochloride has a safety concern score of 75 out of 100 (elevated 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. Nausea and vomiting are the most common adverse reactions, with a significant number of serious events reported.
Key safety signals identified in Promethazine Hydrochloride's adverse event data include: High rate of serious adverse events (72.5%). Multiple serious conditions reported, including pneumonia, renal failure, and sepsis. Falls and confusion are common, indicating potential cognitive impairment. Off-label use and drug interactions are frequent. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Promethazine Hydrochloride can cause dizziness, confusion, and falls, which may interact with other sedatives or antipsychotics. Patients should avoid driving or operating machinery. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Promethazine Hydrochloride.
Patients should report any serious adverse events to their healthcare provider immediately. Follow prescribed dosages and avoid combining with other sedatives or antipsychotics without medical advice.
Promethazine Hydrochloride has 46,898 adverse event reports on file with the FDA. The drug is associated with a range of serious conditions including pneumonia, renal failure, and sepsis. The volume of reports for Promethazine Hydrochloride reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor Promethazine Hydrochloride for safety, and updates are regularly issued based on new data. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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