ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE

N/A

Manufactured by Rite Aid Corporation

171 FDA adverse event reports analyzed

Last updated: 2026-04-15

About ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE

ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Rite Aid Corporation. The most commonly reported adverse reactions for ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE include COVID-19, FOREIGN BODY IN THROAT, SURGERY, ANXIETY, CHOKING. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE.

Top Adverse Reactions

COVID 196 reports
FOREIGN BODY IN THROAT5 reports
SURGERY5 reports
ANXIETY4 reports
CHOKING4 reports
FATIGUE4 reports
INSOMNIA4 reports
MALAISE4 reports
NASOPHARYNGITIS4 reports
DECREASED APPETITE3 reports
DISEASE RECURRENCE3 reports
DRUG INEFFECTIVE3 reports
FOREIGN BODY IN RESPIRATORY TRACT3 reports
NAUSEA3 reports
OSTEOPOROSIS3 reports
PRODUCT ADMINISTRATION INTERRUPTED3 reports
SOMNOLENCE3 reports
WEIGHT DECREASED3 reports
ABDOMINAL DISCOMFORT2 reports
COUGH2 reports
DEHYDRATION2 reports
DEPRESSION2 reports
DIARRHOEA2 reports
DIZZINESS2 reports
GASTRIC BYPASS2 reports
HEADACHE2 reports
HOSPITALISATION2 reports
HYPERSENSITIVITY2 reports
HYPERTENSION2 reports
ILLNESS2 reports
PANIC ATTACK2 reports
PRODUCT DOSE OMISSION ISSUE2 reports
RASH GENERALISED2 reports
RESTLESS LEGS SYNDROME2 reports
SEIZURE2 reports
TREMOR2 reports
UNDERDOSE2 reports
URINARY TRACT INFECTION2 reports
VISION BLURRED2 reports
VOMITING2 reports
ABORTION INFECTED1 reports
ABORTION SPONTANEOUS1 reports
ACTIVITIES OF DAILY LIVING IMPAIRED1 reports
ACUTE SINUSITIS1 reports
AFFECTIVE DISORDER1 reports
AGITATION1 reports
ALOPECIA1 reports
ANAL FISSURE1 reports
ANHEDONIA1 reports
ANTICOAGULATION DRUG LEVEL INCREASED1 reports
APPLICATION SITE PAIN1 reports
APPLICATION SITE SWELLING1 reports
ARTHRITIS1 reports
ASTHENIA1 reports
BACK PAIN1 reports
BIPOLAR DISORDER1 reports
BLINDNESS1 reports
BLINDNESS UNILATERAL1 reports
BLOOD GLUCOSE DECREASED1 reports
BLOOD GLUCOSE INCREASED1 reports
BLOOD TESTOSTERONE DECREASED1 reports
BONE PAIN1 reports
CANDIDA INFECTION1 reports
CATAPLEXY1 reports
CHEST DISCOMFORT1 reports
CLAUSTROPHOBIA1 reports
CONDITION AGGRAVATED1 reports
DENTAL OPERATION1 reports
DERMATITIS1 reports
DEVICE DIFFICULT TO USE1 reports
DISEASE PROGRESSION1 reports
DISORIENTATION1 reports
DRY SKIN1 reports
DYSGEUSIA1 reports
DYSKINESIA1 reports
DYSPHONIA1 reports
DYSPNOEA1 reports
DYSURIA1 reports
EMOTIONAL DISORDER1 reports
ENDOCARDITIS STAPHYLOCOCCAL1 reports
ERYTHEMA1 reports
EUPHORIC MOOD1 reports
EXPOSURE DURING PREGNANCY1 reports
EYE INFECTION1 reports
EYE PAIN1 reports
FEELING ABNORMAL1 reports
FOOT FRACTURE1 reports
FUNGAL INFECTION1 reports
GLUCOSE TOLERANCE IMPAIRED1 reports
HAEMOGLOBIN INCREASED1 reports
HEAD DISCOMFORT1 reports
HIATUS HERNIA1 reports
HOMICIDAL IDEATION1 reports
HYPERHIDROSIS1 reports
HYPOTENSION1 reports
HYPOXIA1 reports
INFLUENZA1 reports
INFUSION SITE BRUISING1 reports
INJURY1 reports
INTENTIONAL DOSE OMISSION1 reports

Report Outcomes

Out of 55 classified reports for ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE:

Serious 60.0%Non-Serious 40.0%

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

Female35 (66.0%)
Male18 (34.0%)

Reports by Age

Age 593 reports
Age 502 reports
Age 572 reports
Age 732 reports
Age 01 reports
Age 51 reports
Age 151 reports
Age 181 reports
Age 201 reports
Age 221 reports
Age 281 reports
Age 301 reports
Age 331 reports
Age 351 reports
Age 371 reports
Age 381 reports
Age 401 reports
Age 431 reports
Age 441 reports
Age 491 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, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE?

This profile reflects 171 FDA FAERS reports that mention ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE?

Frequently reported terms in FAERS include COVID-19, FOREIGN BODY IN THROAT, SURGERY, ANXIETY, CHOKING, FATIGUE. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE?

Labeling and FAERS entries often list Rite Aid Corporation in connection with ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE. 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.