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Doxylamine Side Effects

The most commonly reported side effects of doxylamine include toxicity to various agents, somnolence, and drug abuse, based on 7,657 FDA adverse event reports from 2004 to 2025. 14.8% of reports found the drug to be ineffective.

Doxylamine side effects

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

1
Drug Ineffective14.8%1,130
2
Toxicity To Various Agents8.4%646
3
Somnolence7.6%580
4
Drug Abuse5.9%455
5
Completed Suicide4.3%328
6
Maternal Exposure During Pregnancy4.0%304
7
Fatigue3.9%297
8
Overdose3.0%233
9
Death3.0%230
10
Nausea3.0%228
11
Underdose2.9%222
12
Exposure During Pregnancy2.8%218
13
Insomnia2.7%210
14
Off Label Use2.6%202
15
Headache2.5%195

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

Report severity

53.3%Serious4,083 reports
16.5%Hospitalizations1,267 reports
21.4%Fatal1,637 reports

Seriousness is determined by the reporter, not by OpenClaim.

Doxylamine drug interactions

Other drugs that appear in adverse event reports alongside doxylamine. 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
Acetaminophen9.2%703
2
Diphenhydramine6.6%502
3
Pyridoxine5.0%381
4
Dextromethorphan4.9%377
5
Diazepam4.5%348
6
Oxycodone4.5%342
7
Ibuprofen4.3%326
8
Alprazolam4.2%321
9
Citalopram-hydrobromide3.4%262
10
Tramadol-hydrochloride2.9%224
11
Zolpidem-tartrate2.8%218
12
Hydrocodone2.7%205
13
Fluoxetine-hydrochloride2.5%194
14
Alcohol2.5%192
15
Methadone-hydrochloride2.5%188

Taken alongside

1
Acetaminophen7.6%585
2
Ergocalciferol5.6%432
3
Aspirin4.9%378
4
Pyridoxine3.7%282
5
Diphenhydramine3.3%250
6
Omeprazole3.3%250
7
Levothyroxine-sodium3.2%246
8
Ibuprofen3.1%236
9
Ondansetron3.1%234
10
Albuterol2.8%214
11
Oxycodone2.3%178
12
Fluticasone2.3%174
13
Atorvastatin-calcium2.3%174
14
Prednisone2.2%169
15
Pantoprazole-sodium2.1%162

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 doxylamine side effects

49.9% of doxylamine adverse event reports involve female patients and 27.3% involve male patients. The largest age group is adult at 79%. These figures reflect who reports side effects, not underlying risk.

Sex

Female49.9%
Male27.3%
Unknown22.8%

Age group

< 22.9%
2–111.1%
12–171.9%
18–6478.6%
65+15.4%

What is doxylamine used for

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

Abdominal PainAbnormal FaecesAccidental ExposureAccidental Exposure To ProductAccidental Exposure To Product By ChildAccidental OverdoseAcneAntiallergic TherapyAntidepressant TherapyAnxietyAppetite DisorderAbnormal BehaviourAccident At HomeAccidental Exposure To ProductAccidental Exposure To Product By Child

Showing 15 of 181 indications

Doxylamine brand names and reporting trend

Doxylamine is sold under the brand name Doxylamine Succinate.

Brand names

Doxylamine Succinate4,573

Quarterly reports (20042025)

20052010201520202025

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

Taking doxylamine with another medication?

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