MEPREDNISONE: 89 Adverse Event Reports & Safety Profile

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Total FAERS Reports

14 (15.7%)

Deaths Reported

Hospitalizations

As Primary/Secondary Suspect

Life-Threatening

Disabilities

Approved Prior to Jan 1, 1982

FDA Approved

Discontinued

Status

FDA Application: 016053 ·

First Report: 20071208 · Latest Report: 20240101

What Are the Most Common MEPREDNISONE Side Effects?

#1 Most Reported

Foetal exposure during pregnancy

19 reports (21.3%)

#2 Most Reported

Premature baby

17 reports (19.1%)

#3 Most Reported

Oesophageal atresia

16 reports (18.0%)

Side Effect	Reports	% of Total	Deaths	Hosp.
Foetal exposure during pregnancy	19	21.4%	4	0
Premature baby	17	19.1%	3	0
Oesophageal atresia	16	18.0%	4	0
Low birth weight baby	15	16.9%	3	0
Polyhydramnios	11	12.4%	0	0
Foetal growth restriction	9	10.1%	0	0
Atrial septal defect	8	9.0%	0	0
Hemivertebra	8	9.0%	4	0
Caesarean section	7	7.9%	1	0
Facial asymmetry	6	6.7%	0	0
Maternal exposure during pregnancy	6	6.7%	0	0
Tuberculosis	6	6.7%	0	0
Urinary tract infection	6	6.7%	0	5
Anomaly of external ear congenital	5	5.6%	0	0
Apgar score abnormal	5	5.6%	0	0
Cerebral ventricle dilatation	5	5.6%	0	0
Congenital skin dimples	5	5.6%	0	0
Finger deformity	5	5.6%	0	0
Off label use	5	5.6%	1	1
Sepsis	5	5.6%	1	3

Gender: 61.8% female, 38.2% male. Average age: 36.4 years. Most reports from: AR. View detailed demographics →

Year	Reports	Deaths	Hosp.
2007	1	0	1
2011	1	0	0
2013	1	0	1
2014	3	0	3
2016	1	0	0
2017	2	0	1
2018	2	1	1
2019	2	0	1
2020	2	0	1
2022	2	0	1
2024	1	0	1

Indication	Reports
Product used for unknown indication	21
Foetal exposure during pregnancy	7
Immunosuppressant drug therapy	7
Renal transplant	7
Immunosuppression	6
Prophylaxis against transplant rejection	6

Official prescribing information from the FDA-approved drug label.