OpenClaim

Pramoxine Side Effects

The most commonly reported side effects of pramoxine include off label use, product quality issue, and chronic kidney disease, based on 1,287 FDA adverse event reports from 2004 to 2025. 7.1% of reports found the drug to be ineffective.

Pramoxine side effects

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

1
Off Label Use13.4%172
2
Product Quality Issue8.4%108
3
Drug Ineffective7.1%91
4
Chronic Kidney Disease6.7%86
5
Pain5.1%65
6
Diarrhoea4.7%60
7
Fatigue4.2%54
8
Renal Failure4.2%54
9
Device Delivery System Issue4.2%54
10
Acute Kidney Injury4.0%51
11
Nausea3.8%49
12
Dyspnoea3.8%49
13
Product Leakage3.4%44
14
Rash3.1%40
15
Pruritus3.0%38

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

Report severity

52.0%Serious669 reports
25.9%Hospitalizations333 reports
6.8%Fatal87 reports

Seriousness is determined by the reporter, not by OpenClaim.

Pramoxine drug interactions

Other drugs that appear in adverse event reports alongside pramoxine. 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
Hydrocortisone35.7%459
2
Esomeprazole7.1%91
3
Omeprazole5.1%66
4
Pantoprazole-sodium4.4%57
5
Adalimumab4.0%52
6
Infliximab3.3%43
7
Lansoprazole3.0%38
8
Prednisone2.6%34
9
Lenalidomide2.5%32
10
Sodium-oxybate2.3%30
11
Oxycodone2.1%27
12
Vedolizumab1.9%24
13
Amoxicillin1.7%22
14
Fluticasone1.7%22
15
Rivaroxaban1.7%22

Taken alongside

1
Hydrocortisone39.7%511
2
Acetaminophen21.9%282
3
Ergocalciferol15.9%204
4
Aspirin13.8%178
5
Prednisone12.0%154
6
Ondansetron11.6%149
7
Fluticasone11.3%146
8
Albuterol11.2%144
9
Omeprazole10.6%136
10
Furosemide9.7%125
11
Gabapentin9.6%124
12
Atorvastatin-calcium9.2%119
13
Oxycodone9.1%117
14
Ibuprofen8.9%115
15
Hydrocodone8.8%113

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 pramoxine side effects

55.2% of pramoxine adverse event reports involve female patients and 41.3% involve male patients. The largest age group is adult at 60%. These figures reflect who reports side effects, not underlying risk.

Sex

Female55.2%
Male41.3%
Unknown3.5%

Age group

< 20.2%
2–111.1%
12–171.3%
18–6460.1%
65+37.3%

What is pramoxine used for

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

AcneAlopeciaAnal FissureAnal InflammationAnal PruritusAnal RashAnorectal DiscomfortAntibiotic TherapyArthropod BiteAuricular SwellingAbdominal Pain UpperAnal CancerAnal FissureAnal PruritusAnorectal Discomfort

Showing 15 of 122 indications

Pramoxine brand names and reporting trend

Pramoxine is sold under the brand name Hydrocortisone Acetate 1% And Pramoxine Hydrochloride 1%.

Brand names

Hydrocortisone Acetate 1% And Pramoxine Hydrochloride 1%413

Quarterly reports (20042025)

20052010201520202025

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

Taking pramoxine with another medication?

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