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Promethazine Side Effects

The most commonly reported side effects of promethazine include nausea, dependence, and fatigue, based on 59,778 FDA adverse event reports from 2004 to 2025. 3.4% of reports found the drug to be ineffective.

Promethazine side effects

Percentages show how often each reaction appears relative to total reports for promethazine.

1
Nausea7.9%4,713
2
Dependence5.9%3,513
3
Fatigue5.4%3,229
4
Pain5.1%3,027
5
Vomiting4.9%2,941
6
Diarrhoea4.5%2,709
7
Chronic Kidney Disease4.3%2,575
8
Headache4.1%2,465
9
Acute Kidney Injury3.4%2,035
10
Drug Ineffective3.4%2,027
11
Anxiety3.3%1,967
12
Dyspnoea3.3%1,955
13
Renal Failure3.2%1,903
14
Death3.0%1,822
15
Nausea3.0%1,807

These are voluntary reports and do not establish that promethazine caused these reactions.

Report severity

76.1%Serious45,496 reports
35.4%Hospitalizations21,167 reports
12.4%Fatal7,403 reports

Seriousness is determined by the reporter, not by OpenClaim.

Promethazine drug interactions

Other drugs that appear in adverse event reports alongside promethazine. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Tramadol-hydrochloride6.6%3,948
2
Codeine6.3%3,759
3
Oxymorphone-hydrochloride5.2%3,096
4
Propoxyphene4.7%2,834
5
Esomeprazole4.4%2,625
6
Omeprazole4.3%2,574
7
Acetaminophen4.1%2,447
8
Oxycodone3.9%2,308
9
Sodium-oxybate3.7%2,209
10
Lenalidomide3.5%2,105
11
Adalimumab3.2%1,935
12
Pantoprazole-sodium3.2%1,932
13
Fentanyl2.7%1,631
14
Ethinyl-estradiol2.6%1,573
15
Lansoprazole2.6%1,571

Taken alongside

1
Acetaminophen29.8%17,803
2
Ondansetron19.9%11,898
3
Albuterol15.8%9,471
4
Oxycodone15.1%9,021
5
Gabapentin14.9%8,898
6
Hydrocodone14.7%8,766
7
Omeprazole14.2%8,507
8
Ergocalciferol13.5%8,054
9
Aspirin13.0%7,789
10
Furosemide12.1%7,221
11
Levothyroxine-sodium12.1%7,212
12
Ibuprofen11.3%6,765
13
Prednisone10.8%6,430
14
Pantoprazole-sodium10.7%6,387
15
Fluticasone10.7%6,371

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports promethazine side effects

65.3% of promethazine adverse event reports involve female patients and 26.7% involve male patients. The largest age group is adult at 74%. These figures reflect who reports side effects, not underlying risk.

Sex

Female65.3%
Male26.7%
Unknown8.0%

Age group

< 20.9%
2–110.8%
12–172.1%
18–6474.4%
65+21.9%

What is promethazine used for

Conditions and purposes for which patients were taking promethazine when the adverse event was reported.

Abdominal DiscomfortAbdominal DistensionAbdominal HerniaAbdominal OperationAbdominal PainAbdominal Pain LowerAbdominal Pain UpperAbnormal BehaviourAbortion Induced ComplicatedAcarodermatitisAccidental ExposureAccidental Exposure To ProductAccidental OverdoseAcneAcute Psychosis

Showing 15 of 716 indications

Promethazine brand names and reporting trend

Promethazine is sold under the brand name Promethazine Vc W/ Codeine.

Brand names

Promethazine Vc W/ Codeine108

Quarterly reports (20042025)

20052010201520202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking promethazine with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.