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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\TRAMADOL Cause Product use in unapproved indication? 366 Reports in FDA Database

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According to the FDA Adverse Event Reporting System (FAERS), 366 reports of Product use in unapproved indication have been filed in association with ACETAMINOPHEN\TRAMADOL. This represents 6.6% of all adverse event reports for ACETAMINOPHEN\TRAMADOL.

366
Reports of Product use in unapproved indication with ACETAMINOPHEN\TRAMADOL
6.6%
of all ACETAMINOPHEN\TRAMADOL reports
65
Deaths
102
Hospitalizations

How Dangerous Is Product use in unapproved indication From ACETAMINOPHEN\TRAMADOL?

Of the 366 reports, 65 (17.8%) resulted in death, 102 (27.9%) required hospitalization, and 56 (15.3%) were considered life-threatening.

Is Product use in unapproved indication Listed in the Official Label?

This adverse event is not currently listed in the official FDA drug label for ACETAMINOPHEN\TRAMADOL. However, 366 reports have been filed with the FAERS database.

What Other Side Effects Does ACETAMINOPHEN\TRAMADOL Cause?

Nausea (685) Drug ineffective (662) Vomiting (619) Off label use (570) Pain (407) Malaise (374) Hyperhidrosis (365) Dyspnoea (360) Somnolence (344) Suicide attempt (321)

What Other Drugs Cause Product use in unapproved indication?

DUPILUMAB (33,452) DICLOFENAC (12,197) METHOTREXATE (8,930) PREDNISONE (7,625) RITUXIMAB (7,519) MYCOPHENOLATE MOFETIL (5,910) ACETAMINOPHEN (5,819) CYCLOPHOSPHAMIDE (5,750) RISPERIDONE (5,551) TACROLIMUS (5,057)

Which ACETAMINOPHEN\TRAMADOL Alternatives Have Lower Product use in unapproved indication Risk?

ACETAMINOPHEN\TRAMADOL vs ACETAZOLAMIDE ACETAMINOPHEN\TRAMADOL vs ACETYLCYSTEINE ACETAMINOPHEN\TRAMADOL vs ACETYLLEUCINE ACETAMINOPHEN\TRAMADOL vs ACETYLLEUCINE, L- ACETAMINOPHEN\TRAMADOL vs ACETYLSALICYLIC ACID

Related Pages

ACETAMINOPHEN\TRAMADOL Full Profile All Product use in unapproved indication Reports All Drugs Causing Product use in unapproved indication ACETAMINOPHEN\TRAMADOL Demographics