ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL

N/A

Manufactured by Lil' Drug Store Products, Inc.

1,275 FDA adverse event reports analyzed

Last updated: 2026-04-15

About ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL

ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Lil' Drug Store Products, Inc.. The most commonly reported adverse reactions for ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL include FATIGUE, NAUSEA, DRUG INEFFECTIVE, DYSPNOEA, HEADACHE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL.

Top Adverse Reactions

FATIGUE49 reports
NAUSEA42 reports
DRUG INEFFECTIVE38 reports
DYSPNOEA36 reports
HEADACHE34 reports
DIARRHOEA33 reports
PAIN27 reports
COUGH26 reports
DIZZINESS26 reports
FEELING ABNORMAL24 reports
CONSTIPATION23 reports
WEIGHT DECREASED23 reports
ARTHRALGIA21 reports
ASTHENIA19 reports
FALL19 reports
DEATH18 reports
MALAISE18 reports
PNEUMONIA18 reports
PRODUCT DOSE OMISSION ISSUE18 reports
SINUSITIS18 reports
VOMITING18 reports
ABDOMINAL PAIN UPPER17 reports
GAIT DISTURBANCE17 reports
NASOPHARYNGITIS17 reports
RASH17 reports
PRURITUS16 reports
PYREXIA16 reports
DECREASED APPETITE15 reports
PAIN IN EXTREMITY15 reports
URINARY TRACT INFECTION15 reports
ABDOMINAL DISCOMFORT14 reports
BRONCHITIS14 reports
OFF LABEL USE14 reports
WEIGHT INCREASED14 reports
ANXIETY13 reports
CHEST PAIN12 reports
ILLNESS12 reports
NEUROPATHY PERIPHERAL12 reports
BACK PAIN11 reports
COVID 1911 reports
DEPRESSION11 reports
HOT FLUSH11 reports
INFLUENZA11 reports
INSOMNIA11 reports
MUSCLE SPASMS11 reports
PERIPHERAL SWELLING11 reports
RHINORRHOEA11 reports
SEASONAL ALLERGY11 reports
TREMOR11 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION10 reports
MEMORY IMPAIRMENT10 reports
SOMNOLENCE10 reports
CHILLS9 reports
FLUSHING9 reports
INFECTION9 reports
MULTIPLE SCLEROSIS RELAPSE9 reports
UPPER RESPIRATORY TRACT INFECTION9 reports
ANAEMIA8 reports
DEHYDRATION8 reports
DERMATITIS CONTACT8 reports
DRUG HYPERSENSITIVITY8 reports
HYPERSENSITIVITY8 reports
MUSCULAR WEAKNESS8 reports
PRODUCT USE ISSUE8 reports
RHEUMATOID ARTHRITIS8 reports
SWELLING8 reports
WHITE BLOOD CELL COUNT DECREASED8 reports
ASTHMA7 reports
CONDITION AGGRAVATED7 reports
ERYTHEMA7 reports
LIMB DISCOMFORT7 reports
PRODUCT QUALITY ISSUE7 reports
SLEEP DISORDER7 reports
VIRAL INFECTION7 reports
ALOPECIA6 reports
BLOOD GLUCOSE INCREASED6 reports
BURNING SENSATION6 reports
CHRONIC OBSTRUCTIVE PULMONARY DISEASE6 reports
CONFUSIONAL STATE6 reports
DYSPEPSIA6 reports
GASTROOESOPHAGEAL REFLUX DISEASE6 reports
HYPERHIDROSIS6 reports
HYPERTENSION6 reports
INFLAMMATION6 reports
INFUSION SITE PAIN6 reports
INJECTION SITE PAIN6 reports
INJURY6 reports
INSURANCE ISSUE6 reports
JOINT SWELLING6 reports
MYALGIA6 reports
MYOCARDIAL INFARCTION6 reports
OEDEMA PERIPHERAL6 reports
PARAESTHESIA6 reports
PRODUCT DOSE OMISSION IN ERROR6 reports
PSORIASIS6 reports
RETCHING6 reports
ARTHRITIS5 reports
BALANCE DISORDER5 reports
BLOOD PRESSURE INCREASED5 reports
CHEST DISCOMFORT5 reports

Report Outcomes

Out of 502 classified reports for ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL:

Serious 48.0%Non-Serious 52.0%

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

Female335 (71.4%)
Male130 (27.7%)
Unknown4 (0.9%)

Reports by Age

Age 6013 reports
Age 5912 reports
Age 6712 reports
Age 6111 reports
Age 5610 reports
Age 7310 reports
Age 7610 reports
Age 529 reports
Age 649 reports
Age 538 reports
Age 668 reports
Age 747 reports
Age 757 reports
Age 787 reports
Age 416 reports
Age 636 reports
Age 696 reports
Age 706 reports
Age 716 reports
Age 555 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 ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL?

This profile reflects 1,275 FDA FAERS reports that mention ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL?

Frequently reported terms in FAERS include FATIGUE, NAUSEA, DRUG INEFFECTIVE, DYSPNOEA, HEADACHE, DIARRHOEA. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL?

Labeling and FAERS entries often list Lil' Drug Store Products, Inc. in connection with ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL. 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.