ACETAMINOPHEN AND CODEINE PHOSPHATE

N/A

Manufactured by Aurolife Pharma, LLC

3,182 FDA adverse event reports analyzed

Last updated: 2026-04-15

About ACETAMINOPHEN AND CODEINE PHOSPHATE

ACETAMINOPHEN AND CODEINE PHOSPHATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Aurolife Pharma, LLC. The most commonly reported adverse reactions for ACETAMINOPHEN AND CODEINE PHOSPHATE include DYSPNOEA, COMPLETED SUICIDE, DRUG INTERACTION, NAUSEA, VOMITING. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ACETAMINOPHEN AND CODEINE PHOSPHATE.

Top Adverse Reactions

DYSPNOEA106 reports
COMPLETED SUICIDE99 reports
DRUG INTERACTION77 reports
NAUSEA72 reports
VOMITING69 reports
MALAISE68 reports
DIZZINESS67 reports
ABDOMINAL PAIN62 reports
HEADACHE57 reports
RASH57 reports
GASTROINTESTINAL HAEMORRHAGE48 reports
HAEMOGLOBIN DECREASED48 reports
OEDEMA PERIPHERAL48 reports
HYPOTENSION47 reports
MYOCARDIAL INFARCTION46 reports
ASTHENIA45 reports
DIARRHOEA45 reports
PAIN43 reports
RENAL FAILURE ACUTE43 reports
CONFUSIONAL STATE41 reports
FATIGUE41 reports
LIVER FUNCTION TEST ABNORMAL39 reports
PNEUMONIA39 reports
ARTHRALGIA38 reports
MYALGIA37 reports
NEUTROPENIA37 reports
PRURITUS37 reports
PYREXIA37 reports
CHEST PAIN36 reports
DEPRESSION35 reports
OVERDOSE34 reports
RENAL FAILURE34 reports
ANAEMIA33 reports
SOMNOLENCE33 reports
ATRIAL FIBRILLATION31 reports
FALL31 reports
HYPERTENSION31 reports
RHABDOMYOLYSIS31 reports
ALANINE AMINOTRANSFERASE INCREASED30 reports
BACK PAIN30 reports
DRUG TOXICITY30 reports
PAIN IN EXTREMITY30 reports
CARDIAC ARREST29 reports
CONSTIPATION29 reports
DEATH29 reports
HAEMATEMESIS29 reports
CARDIAC FAILURE28 reports
DRUG INEFFECTIVE28 reports
DEHYDRATION27 reports
GAIT DISTURBANCE27 reports
CARDIO RESPIRATORY ARREST26 reports
CEREBROVASCULAR ACCIDENT26 reports
MEDICATION ERROR26 reports
MULTIPLE DRUG OVERDOSE INTENTIONAL26 reports
TREMOR26 reports
ABDOMINAL PAIN UPPER25 reports
ERYTHEMA25 reports
GENERAL PHYSICAL HEALTH DETERIORATION25 reports
INTERNATIONAL NORMALISED RATIO INCREASED25 reports
CONDITION AGGRAVATED23 reports
DECREASED APPETITE23 reports
LOSS OF CONSCIOUSNESS23 reports
ANAPHYLACTIC REACTION22 reports
DEPRESSED LEVEL OF CONSCIOUSNESS22 reports
DRUG ABUSE22 reports
PANCREATITIS22 reports
PARAESTHESIA22 reports
HYPERHIDROSIS21 reports
SEPSIS21 reports
EPISTAXIS20 reports
HALLUCINATION20 reports
LOWER RESPIRATORY TRACT INFECTION20 reports
PALPITATIONS20 reports
ACUTE MYOCARDIAL INFARCTION19 reports
ANXIETY19 reports
CONVULSION19 reports
HYPERKALAEMIA19 reports
INFECTION19 reports
LETHARGY19 reports
POISONING19 reports
URINARY TRACT INFECTION19 reports
ABDOMINAL DISTENSION18 reports
ASPARTATE AMINOTRANSFERASE INCREASED18 reports
BLOOD CREATINE PHOSPHOKINASE INCREASED18 reports
MELAENA18 reports
MULTIPLE DRUG OVERDOSE18 reports
NEUTROPENIC SEPSIS18 reports
URTICARIA18 reports
WEIGHT DECREASED18 reports
AGITATION17 reports
AMNESIA17 reports
HEPATIC FAILURE17 reports
HYPERSENSITIVITY17 reports
HYPONATRAEMIA17 reports
IRRITABILITY17 reports
JAUNDICE17 reports
PULMONARY EMBOLISM17 reports
PULMONARY FIBROSIS17 reports
RENAL IMPAIRMENT17 reports
RESPIRATORY ARREST17 reports

Report Outcomes

Out of 1,889 classified reports for ACETAMINOPHEN AND CODEINE PHOSPHATE:

Serious 97.6%Non-Serious 2.4%

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

Female1,030 (58.0%)
Male737 (41.5%)
Unknown10 (0.6%)

Reports by Age

Age 6345 reports
Age 5043 reports
Age 6439 reports
Age 4337 reports
Age 6036 reports
Age 6836 reports
Age 5832 reports
Age 6532 reports
Age 5231 reports
Age 7431 reports
Age 6930 reports
Age 7229 reports
Age 7928 reports
Age 5427 reports
Age 5527 reports
Age 7127 reports
Age 5926 reports
Age 6226 reports
Age 6726 reports
Age 7625 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 AND CODEINE PHOSPHATE?

This profile reflects 3,182 FDA FAERS reports that mention ACETAMINOPHEN AND CODEINE PHOSPHATE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for ACETAMINOPHEN AND CODEINE PHOSPHATE?

Frequently reported terms in FAERS include DYSPNOEA, COMPLETED SUICIDE, DRUG INTERACTION, NAUSEA, VOMITING, MALAISE. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures ACETAMINOPHEN AND CODEINE PHOSPHATE?

Labeling and FAERS entries often list Aurolife Pharma, LLC in connection with ACETAMINOPHEN AND CODEINE PHOSPHATE. 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.