DOXYLAMINE SUCCINATE

N/A

Manufactured by Chattem, Inc.

7,212 FDA adverse event reports analyzed

Last updated: 2026-04-15

About DOXYLAMINE SUCCINATE

DOXYLAMINE SUCCINATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Chattem, Inc.. The most commonly reported adverse reactions for DOXYLAMINE SUCCINATE include DRUG INEFFECTIVE, SOMNOLENCE, FATIGUE, UNDERDOSE, TOXICITY TO VARIOUS AGENTS. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for DOXYLAMINE SUCCINATE.

Top Adverse Reactions

DRUG INEFFECTIVE995 reports
SOMNOLENCE450 reports
FATIGUE223 reports
UNDERDOSE210 reports
TOXICITY TO VARIOUS AGENTS182 reports
MATERNAL EXPOSURE DURING PREGNANCY181 reports
INSOMNIA177 reports
INCORRECT DOSE ADMINISTERED151 reports
FEELING ABNORMAL143 reports
DIZZINESS134 reports
HEADACHE126 reports
NAUSEA121 reports
OVERDOSE121 reports
EXPOSURE DURING PREGNANCY106 reports
OFF LABEL USE102 reports
THERAPEUTIC PRODUCT EFFECT DECREASED96 reports
DIARRHOEA92 reports
DRUG ABUSE86 reports
ANXIETY78 reports
DRUG EFFECTIVE FOR UNAPPROVED INDICATION78 reports
PAIN77 reports
VOMITING77 reports
DYSPNOEA75 reports
THERAPEUTIC PRODUCT EFFECT INCOMPLETE72 reports
ACUTE KIDNEY INJURY69 reports
ASTHENIA69 reports
DEATH69 reports
FALL67 reports
INTENTIONAL OVERDOSE66 reports
NIGHTMARE65 reports
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS64 reports
COMPLETED SUICIDE60 reports
CONDITION AGGRAVATED60 reports
MALAISE58 reports
COMA55 reports
PNEUMONIA55 reports
TREMOR55 reports
HANGOVER54 reports
CONSTIPATION50 reports
FOETAL EXPOSURE DURING PREGNANCY50 reports
INCORRECT PRODUCT ADMINISTRATION DURATION49 reports
PRURITUS48 reports
INTENTIONAL PRODUCT MISUSE46 reports
ARTHRALGIA45 reports
CHRONIC KIDNEY DISEASE45 reports
POOR QUALITY SLEEP45 reports
ACCIDENTAL OVERDOSE43 reports
PAIN IN EXTREMITY43 reports
ABNORMAL DREAMS42 reports
MYALGIA42 reports
THERAPEUTIC PRODUCT EFFECT DELAYED42 reports
PALPITATIONS41 reports
RASH41 reports
WEIGHT INCREASED41 reports
PYREXIA39 reports
CONFUSIONAL STATE38 reports
THERAPEUTIC PRODUCT EFFECT VARIABLE38 reports
WEIGHT DECREASED38 reports
BACK PAIN37 reports
DRY MOUTH37 reports
MUSCLE SPASMS37 reports
RENAL FAILURE37 reports
ABDOMINAL PAIN UPPER36 reports
DEPRESSION36 reports
DRUG DEPENDENCE36 reports
HYPERHIDROSIS35 reports
VISION BLURRED35 reports
RESTLESS LEGS SYNDROME34 reports
RHABDOMYOLYSIS34 reports
ABDOMINAL DISCOMFORT33 reports
PARAESTHESIA33 reports
POISONING DELIBERATE33 reports
SUICIDE ATTEMPT33 reports
ABDOMINAL PAIN32 reports
ACCIDENTAL EXPOSURE TO PRODUCT BY CHILD32 reports
HYPERSENSITIVITY32 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION32 reports
PRODUCT USE ISSUE32 reports
DRUG EFFECT LESS THAN EXPECTED31 reports
EXPOSURE TO TOXIC AGENT31 reports
HALLUCINATION31 reports
HYPOTENSION31 reports
TACHYCARDIA31 reports
AGITATION30 reports
HEART RATE INCREASED30 reports
MIGRAINE30 reports
NASOPHARYNGITIS30 reports
NO ADVERSE EVENT30 reports
DECREASED APPETITE29 reports
DRUG INTERACTION29 reports
HYPERTENSION29 reports
INTENTIONAL PRODUCT USE ISSUE29 reports
ANAEMIA28 reports
HYPERSOMNIA28 reports
INJECTION SITE PAIN28 reports
PRODUCT USE IN UNAPPROVED INDICATION28 reports
BLOOD PRESSURE INCREASED27 reports
CARDIO RESPIRATORY ARREST27 reports
CHEST PAIN27 reports
HYPOAESTHESIA27 reports

Report Outcomes

Out of 4,474 classified reports for DOXYLAMINE SUCCINATE:

Serious 34.2%Non-Serious 65.8%

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

Female2,050 (65.7%)
Male1,057 (33.9%)
Unknown11 (0.4%)

Reports by Age

Age 6541 reports
Age 3139 reports
Age 5839 reports
Age 7436 reports
Age 4035 reports
Age 2834 reports
Age 3534 reports
Age 5434 reports
Age 5732 reports
Age 7530 reports
Age 2629 reports
Age 5929 reports
Age 7128 reports
Age 2226 reports
Age 3826 reports
Age 3025 reports
Age 3325 reports
Age 4925 reports
Age 5325 reports
Age 5525 reports

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

Frequently Asked Questions

How many FDA adverse event reports are associated with DOXYLAMINE SUCCINATE?

This profile reflects 7,212 FDA FAERS reports that mention DOXYLAMINE SUCCINATE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for DOXYLAMINE SUCCINATE?

Frequently reported terms in FAERS include DRUG INEFFECTIVE, SOMNOLENCE, FATIGUE, UNDERDOSE, TOXICITY TO VARIOUS AGENTS, MATERNAL EXPOSURE DURING PREGNANCY. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures DOXYLAMINE SUCCINATE?

Labeling and FAERS entries often list Chattem, Inc. in connection with DOXYLAMINE SUCCINATE. Always verify the specific product and NDC with your pharmacist.

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.