Drug Safety Information for HYDROCORTISONE (Hydrocortisone)

Safety-related Labeling Changes for CORTEF (HYDROCORTISONE) Rx Drug: FDA Link

Safety-related Labeling Changes for SOLU-CORTEF (HYDROCORTISONE SODIUM SUCCINATE) Rx Drug: FDA Link

Safety-related Labeling Changes for PANDEL (HYDROCORTISONE PROBUTATE) Rx Drug: FDA Link

Adverse Drug Reactions for HYDROCORTISONE* (Hydrocortisone)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with HYDROCORTISONE
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Dyspnoea1061
2Nausea1038
3Fatigue920
4Pyrexia903
5Drug ineffective856
6Diarrhoea851
7Vomiting851
8Headache775
9Pain764
10Asthenia675
11Arthralgia663
12Rash642
13Pneumonia602
14Hypotension580
15Dizziness578
16Infusion related reaction544
17Malaise540
18Fall515
19Abdominal pain501
20Pain in extremity482

* This side effect also appears in "Top 10 Side Effects of HYDROCORTISONE " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking HYDROCORTISONE
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Product used for unknown indication9496
2Premedication3628
3Adrenal insufficiency*1513
4Rheumatoid arthritis1078
5Addison's disease*1006
6Acute lymphocytic leukaemia875
7Rash769
8Hypopituitarism591
9Blood corticotrophin decreased586
10Haemorrhoids577

*Also a top-10 reason in AskaPatient Review Summary.


Types of Adverse Events for HYDROCORTISONE

Total Reports Filed with FDA: 98386


Number of FDA Adverse Event Reports by Patient Age for HYDROCORTISONE

Total Reports Filed with FDA: 98386*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Hydrocortisone (Hi-cor, Glycort, Stie-cort, Eldecort, Cortisporin ointment, Hc (hydrocortisone), Hc #4, Balneol-hc, Tucks hc, Nogenic hc, Aeroseb-hc, Texacort, Epicort, Cortizone 10 plus, Cortizone-10, Cortizone 10, Hydro-rx, Ala-scalp, Penecort, Massengill, Hydrocortone, Equaline anti itch, Formu care anti itch, Good sense anti itch, Hydrocortisone 1, Hydrocortisone plus, Maximum-h, Piyanping antiitch, Refuge hc, Cetacort, Up and up anti itch, Hc #1, H-cort, Hydrocortizone, Cortef, Cortisporin-tc, 1 hydrocortisone, Budpak anti-itch, Healerz for itches, Hydroskin, Hydro skin, Medi-cortisone, Procto-pak, Procure, Rexall anti itch, Anusol, Proctosol-hc, Antibiotic ear, Cicatricure, Cvs cools itch fast, H-releve anti-itch, Quadrydern, Corticool, Nutracort, Hemorrhoidal hc, Locoid c, Proctocream, Proctocream-hc, Acticort, Cort-dome, Ala-cort, Dermarest, Cortisone cream, Cortizone-5, Cortatrigen, Anusert hc-1, Thera, Cortisone, Loesch, Tecnu corticool, Hytone, Caldecort, Efcortelan, Colocort, Alacort, Flexicort, Encort, Balneol, Cortic, Hydrocortisone ac, Hemril-30, Proctocort, Nu-derm tolereen, Cortane-b, Delcort, Scalpicin, Synacort, Proctozone, Cortril, Anusol hc, Hydrocortisone, Beta-hc, Hysone, Dermacort, Cortenema)

Charts are based on 98386 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

Click to go back to search results and HYDROCORTISONE Reviews and Review Summary .

Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.

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