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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 ISOTRETINOIN Cause Cleft palate? 19 Reports in FDA Database

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According to the FDA Adverse Event Reporting System (FAERS), 19 reports of Cleft palate have been filed in association with ISOTRETINOIN (Amnesteem). This represents 0.1% of all adverse event reports for ISOTRETINOIN.

19
Reports of Cleft palate with ISOTRETINOIN
0.1%
of all ISOTRETINOIN reports
1
Deaths
3
Hospitalizations

How Dangerous Is Cleft palate From ISOTRETINOIN?

Of the 19 reports, 1 (5.3%) resulted in death, 3 (15.8%) required hospitalization.

Is Cleft palate Listed in the Official Label?

This adverse event is not currently listed in the official FDA drug label for ISOTRETINOIN. However, 19 reports have been filed with the FAERS database.

What Other Side Effects Does ISOTRETINOIN Cause?

Depression (2,985) Exposure during pregnancy (1,825) Off label use (1,731) Headache (1,693) Dry skin (1,688) Product dose omission issue (1,673) Arthralgia (1,616) Mood altered (1,367) Adverse drug reaction (1,269) Suicidal ideation (1,120)

What Other Drugs Cause Cleft palate?

ONDANSETRON (165) LEVETIRACETAM (90) LAMOTRIGINE (84) PAROXETINE (77) FLUOXETINE (58) PREDNISONE (45) SERTRALINE (44) VALPROATE (41) VALPROIC ACID (38) FUROSEMIDE (35)

Which ISOTRETINOIN Alternatives Have Lower Cleft palate Risk?

ISOTRETINOIN vs ISRADIPINE ISOTRETINOIN vs ISTRADEFYLLINE ISOTRETINOIN vs ITACITINIB ISOTRETINOIN vs ITRACONAZOLE ISOTRETINOIN vs ITRACONAZOLE\SODIUM

Related Pages

ISOTRETINOIN Full Profile All Cleft palate Reports All Drugs Causing Cleft palate ISOTRETINOIN Demographics