Does HUMAN C1-ESTERASE INHIBITOR Cause Product quality issue? 458 Reports in FDA Database

Q: Does HUMAN C1-ESTERASE INHIBITOR cause Product quality issue?

458 reports of Product quality issue have been filed with the FDA for HUMAN C1-ESTERASE INHIBITOR, representing 3.2% of all HUMAN C1-ESTERASE INHIBITOR adverse event reports.

Q: How dangerous is Product quality issue from HUMAN C1-ESTERASE INHIBITOR?

Of 458 reports, 400 (87.3%) resulted in death and 339 required hospitalization.

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According to the FDA Adverse Event Reporting System (FAERS), 458 reports of Product quality issue have been filed in association with HUMAN C1-ESTERASE INHIBITOR (Cinryze). This represents 3.2% of all adverse event reports for HUMAN C1-ESTERASE INHIBITOR.

458

Reports of Product quality issue with HUMAN C1-ESTERASE INHIBITOR

3.2%

of all HUMAN C1-ESTERASE INHIBITOR reports

400

Deaths

339

Hospitalizations

How Dangerous Is Product quality issue From HUMAN C1-ESTERASE INHIBITOR?

Of the 458 reports, 400 (87.3%) resulted in death, 339 (74.0%) required hospitalization, and 333 (72.7%) were considered life-threatening.

Is Product quality issue Listed in the Official Label?

This adverse event is not currently listed in the official FDA drug label for HUMAN C1-ESTERASE INHIBITOR. However, 458 reports have been filed with the FAERS database.

What Other Side Effects Does HUMAN C1-ESTERASE INHIBITOR Cause?

Hereditary angioedema (5,572) No adverse event (1,660) Off label use (1,614) Drug ineffective (1,426) Intentional product use issue (1,117) Product use in unapproved indication (1,003) Weight increased (897) Maternal exposure during pregnancy (869) Pain (822) Condition aggravated (775)

What Other Drugs Cause Product quality issue?

ETONOGESTREL (4,651) ALBUTEROL (4,466) TIOTROPIUM (3,821) MOMETASONE FUROATE (3,406) LIDOCAINE (3,126) FLUTICASONE\SALMETEROL (2,986) FORMOTEROL\MOMETASONE FUROATE (2,458) FENTANYL (2,450) NICOTINE (1,987) EXENATIDE (1,839)

Which HUMAN C1-ESTERASE INHIBITOR Alternatives Have Lower Product quality issue Risk?

HUMAN C1-ESTERASE INHIBITOR vs HUMAN COAGULATION FACTOR VIII/VON WILLEBRAND FACTOR COMPLEX HUMAN C1-ESTERASE INHIBITOR vs HUMAN CYTOMEGALOVIRUS IMMUNE GLOBULIN HUMAN C1-ESTERASE INHIBITOR vs HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN HUMAN C1-ESTERASE INHIBITOR vs HUMAN IMMUNOGLOBULIN G HUMAN C1-ESTERASE INHIBITOR vs HUMAN IMMUNOGLOBULIN G\HYALURONIDASE

HUMAN C1-ESTERASE INHIBITOR Full Profile All Product quality issue Reports All Drugs Causing Product quality issue HUMAN C1-ESTERASE INHIBITOR Demographics