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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

Does ACETAMINOPHEN\CAFFEINE\CODEINE Cause Systemic lupus erythematosus? 68 Reports in FDA Database

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According to the FDA Adverse Event Reporting System (FAERS), 68 reports of Systemic lupus erythematosus have been filed in association with ACETAMINOPHEN\CAFFEINE\CODEINE. This represents 19.2% of all adverse event reports for ACETAMINOPHEN\CAFFEINE\CODEINE.

68
Reports of Systemic lupus erythematosus with ACETAMINOPHEN\CAFFEINE\CODEINE
19.2%
of all ACETAMINOPHEN\CAFFEINE\CODEINE reports
52
Deaths
53
Hospitalizations

How Dangerous Is Systemic lupus erythematosus From ACETAMINOPHEN\CAFFEINE\CODEINE?

Of the 68 reports, 52 (76.5%) resulted in death, 53 (77.9%) required hospitalization, and 53 (77.9%) were considered life-threatening.

Is Systemic lupus erythematosus Listed in the Official Label?

This adverse event is not currently listed in the official FDA drug label for ACETAMINOPHEN\CAFFEINE\CODEINE. However, 68 reports have been filed with the FAERS database.

What Other Side Effects Does ACETAMINOPHEN\CAFFEINE\CODEINE Cause?

Fatigue (107) Dyspnoea (97) Arthralgia (96) Infusion related reaction (90) Dizziness (87)