Prednisolone sodium phosphate adverse event reports that FDA received

Name: Reaction terms in FDA adverse event reports that name Prednisolone sodium phosphate
Creator: Reported Reactions
License: https://creativecommons.org/publicdomain/zero/1.0/

Name type: Generic name
Class: Corticosteroid

What a report is

A report is not proof that the drug was the cause of the event.

FDA says:

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview, section "Responsible use of the data". The site read the page on 2 Oct 2026. The data have the reports that FDA received through 30 Jun 2026.

FDA also says:

There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event. The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.
Source: openFDA, Response of the drug event API (meta.disclaimer). The site read the page on 2 Oct 2026.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

Drug reports received through 30 Jun 2026. Device reports have a separate cutoff, 30 Sep 2026. Why a report count is not a rate.

Reports on file

From April 2004 to June 2026, FDA received 1,727 adverse event reports that name Prednisolone sodium phosphate. In these reports the drug is a suspect or interacting product.

In the same period, 700 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 140 reports in the 12 months to June 2026 and 84 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Of the 1,332,454 drug reports that FDA received in the 12 months to June 2026, 140 (under 0.1%) name Prednisolone sodium phosphate. Reports from other health professionals were 54.1% of the reports that name Prednisolone sodium phosphate and 19.7% of all drug reports.

The number of people who use the product is not in the data. A count is not a rate. A count of reports is not a count of events or of patients, because one event can have more than one report.

There are many instances of duplicative reports and some reports do not contain all the necessary information.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Suspect product

FDA records each drug in a report as suspect, concomitant or interacting. This page counts the reports in which Prednisolone sodium phosphate is suspect or interacting. FDA says:

Any number of the drugs may be marked as suspect if thought to be responsible for one or more of the reactions, but that information is not validated.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Data version

openFDA FAERS release of 29 Oct 2026. Reports received through 30 Jun 2026.

Since the last update

FDA says:

Many factors can influence whether or not an event will be reported, such as the time a product has been marketed and publicity about an event.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The information in these reports cannot be used to estimate the incidence (occurrence rates) of the events reported.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

The latest update of the FDA data, recorded on 28 Oct 2026, changed no count of this page.

In April to June 2026, FDA received 29 reports that name Prednisolone sodium phosphate.
In January to March 2026, FDA received 41.
In April to June 2025, FDA received 20.

April to June 2026 is the latest closed quarter in the data. A closed quarter is a quarter for which the FDA files have most of the reports.

All updates Feed of updates (RSS)

Reaction lookup

These are the reaction terms that the reports record, with the number of reports for each term. Type a term or a plain word to find its count.

What this list leaves out

The table lists the 340 reaction terms that 5 or more reports record. A term with fewer than 5 reports is not in the table.

The site keeps reaction terms for 1,670 of the 1,727 reports (96.7%).

The reports of the other years are not in the counts.

So a count in the table can be lower than the count of FDA.

Find a reaction term

The table shows the first 50 of 340 terms.

Reaction terms in the reports that name Prednisolone sodium phosphate, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 1,727 reports
Drug ineffectivethe medicine did not work as expected	148	8.6%
Treatment failurethe treatment did not work	143	8.3%
Condition aggravatedthe condition being treated got worse	132	7.6%
Off label useused for a purpose or in a way not on the label	131	7.6%
Asthma	114	6.6%
Pyrexiafever	114	6.6%
Rheumatoid arthritisrheumatoid arthritis, an inflammatory joint disease	109	6.3%
Hypersensitivityan allergic-type reaction	100	5.8%
Painpain, site not specified	100	5.8%
Vomitingbeing sick	98	5.7%
Headachehead pain	97	5.6%
Pneumonialung infection	96	5.6%
Drug hypersensitivityan allergic-type reaction (the term names a medicine)	95	5.5%
Hepatitis B reactivation	89	5.2%
Product use issuea problem in how the product was used	89	5.2%
Fatiguetiredness	88	5.1%
Wheezing	85	4.9%
Dyspnoeashortness of breath	83	4.8%
Malaisegeneral feeling of being unwell	78	4.5%
Contraindicated product administered	72	4.2%
Acute hepatic failure	65	3.8%
Psoriasispsoriasis, a skin condition	64	3.7%
Visual acuity reducedreduced sharpness of vision	62	3.6%
Eye pain	61	3.5%
Intraocular pressure increasedraised pressure in the eye	61	3.5%
Oedemaswelling from fluid	60	3.5%
Endophthalmitisinfection inside the eye	58	3.4%
Cough	57	3.3%
Rashskin rash	57	3.3%
Upper respiratory tract infectiona cold or similar infection	56	3.2%
Choroiditis	55	3.2%
Nasopharyngitisa cold	55	3.2%
Uveitis	55	3.2%
Joint swellinga swollen joint	54	3.1%
Drug intolerancethe medicine was not tolerated	53	3.1%
Loss of personal independence in daily activities	51	3%
Thrombocytopenialow platelets	51	3%
Hypertensionhigh blood pressure	49	2.8%
Nauseafeeling sick	48	2.8%
Bursitis	47	2.7%
Exposure during pregnancythe medicine was taken during pregnancy	47	2.7%
General physical health deteriorationgeneral decline in health	47	2.7%
Hepatic enzyme increasedraised liver enzymes	47	2.7%
Hyperhidrosisexcessive sweating	47	2.7%
Infusion related reactiona reaction during or soon after an infusion	46	2.7%
Prescribed overdose	46	2.7%
Arthritis	45	2.6%
Lower limb fracture	45	2.6%
Mobility decreasedreduced ability to move about	45	2.6%
Sepsisa severe body-wide response to infection	45	2.6%

Download all 340 terms of Prednisolone sodium phosphate (CSV)

The counts add to more than 1,727 reports, because one report can record more than one term. FDA says:

No individual drug is connected to any individual reaction. When a report lists multiple drugs and multiple reactions, there is no way to conclude from the data therein that a given drug is responsible for a given reaction.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The CSV file has the same rows and the same limits. Its last row is a note that says so.

MedDRA term

The person who codes a report selects the preferred term that agrees best with the description of the reporter. The words under a term are the plain meaning that this site gives.

Not the label

The FDA-approved label of a product lists its adverse reactions. See the official pages at the end of this page.

Same ingredient, other names

Reporters write a brand name or a generic name. Each name has its own page and its own count.

Names of Prednisolone with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Prednisolone	Generic name	87,806
Prednisolone acetate	Generic name	3,617
Prednisolone sodium phosphate (this page)	Generic name	1,727
Pred Forte	Brand name	703

Sum of the separately reported names: 93,853. A report that names two of these names is in the sum two times. The sum is not the number of reports for the ingredient.

FDA says:

Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Outcomes by year

The table gives the outcomes that the reporters gave, in the terms of FDA.

Outcomes in the reports that name Prednisolone sodium phosphate, by the year of the openFDA file that holds the report

The table continues to the right.

Year of the openFDA file	Reports	Serious	Death	Life-threatening	Hospitalization (initial or prolonged)	Disability or Permanent Damage	Congenital Anomaly/Birth Defect	Other Serious (Important Medical Events)	Not serious
2004	9	8	0	0	5	1	0	2	1
2005	10	9	3	1	1	0	0	5	1
2006	59	58	3	6	18	3	0	42	1
2007	128	126	37	4	44	6	0	55	2
2008	19	13	1	1	5	2	0	7	6
2009	5	3	0	0	1	1	0	1	2
2010	5	3	0	1	3	0	0	2	2
2011	14	11	3	0	8	0	0	4	3
2012	9	7	0	0	2	0	0	6	2
2013	6	4	0	1	3	1	0	3	2
2014	0	0	0	0	0	0	0	0	0
2015	2	1	0	0	0	0	0	1	1
2016	11	10	3	2	3	0	0	7	1
2017	195	195	26	4	57	0	0	144	0
2018	362	362	69	27	99	0	0	213	0
2019	117	112	42	3	29	0	0	65	5
2020	160	80	10	2	12	2	0	65	80
2021	62	56	9	2	6	2	0	48	6
2022	132	127	48	0	61	9	0	115	5
2023	106	102	47	1	63	4	1	72	4
2024	84	81	35	4	39	4	0	58	3
2025	106	98	32	23	30	20	0	95	8
2026	126	122	28	28	36	20	2	119	4

An outcome in a report is not proof that the drug was the cause. The reporter gives the outcome, and FDA does not verify it. FDA says:

The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The six headings with the names of FDA are the outcome terms of FDA. A report can have more than one outcome. The columns Serious and Not serious are the two values of the openFDA field serious. For the value serious, openFDA gives this description:

The adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition
Source: openFDA, Drug adverse event fields (YAML reference). The site read the page on 2 Oct 2026.

The year is the year of the openFDA file that holds the latest version of the report. It is not always the year in which FDA first received the report. The chart of the next section uses the year of first receipt. The latest year is not complete.

Reports by year and month

Reports that name Prednisolone sodium phosphate, by the year in which FDA received them

The column of 2026 has an outline, because the year is not complete. It has the reports that FDA received through June 2026 only.

Show the figures of the chart as a table

Reports that name Prednisolone sodium phosphate, by the year in which FDA received them
Year	Reports
2004	8
2005	11
2006	58
2007	122
2008	22
2009	7
2010	5
2011	16
2012	10
2013	5
2015	2
2016	22
2017	198
2018	369
2019	135
2020	176
2021	61
2022	131
2023	109
2024	81
2025	109
2026	70

Reports that name Prednisolone sodium phosphate, by month, five years to June 2026

FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Why a count moves

A count moves for many reasons. The guide gives FDA's words about them.

Patients and reporters

Age of the patient in the reports that name Prednisolone sodium phosphate
Age	Reports	Share
Under 2	38	2.2%
2 to 11	58	3.4%
12 to 17	51	3%
18 to 44	321	18.6%
45 to 64	400	23.2%
65 to 74	235	13.6%
75 and over	112	6.5%
Age not given	512	29.6%

Sex of the patient in the reports that name Prednisolone sodium phosphate
Sex	Reports	Share
Female	772	44.7%
Male	636	36.8%
Unknown or not given	319	18.5%

Type of reporter in the reports that name Prednisolone sodium phosphate
Reporter	Reports	Share
Physician	454	26.3%
Pharmacist	26	1.5%
Other health professional	934	54.1%
Lawyer	2	0.1%
Consumer or non-health professional	213	12.3%
Not given	98	5.7%

Age and sex are as the report gives them. The reporter is the primary source in the report. 12.2% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Prednisolone sodium phosphate record
Indication as recorded (MedDRA)	Reports	Share
Diffuse large b-cell lymphoma	84	4.9%
Immunosuppression	80	4.6%
Rheumatoid arthritis	71	4.1%
Peripheral t-cell lymphoma unspecified	70	4.1%
Iridocyclitis	51	3%
Systemic lupus erythematosus	46	2.7%

The reporter fills in the indication, and the field is often empty. Each share is of all 1,727 reports.

Pages near this one

Prednisolone same ingredient
Prednisolone acetate same ingredient
Pred Forte same ingredient
Prednisone same class
Pulmicort Flexhaler same class
Pulmicort Respules same class
Prednisolone Sodium Metazoate next in the A to Z list
Prednisolone Unk next in the A to Z list
Prednisolone Acetate 1 0% next in the A to Z list
Prednison next in the A to Z list
Prednisone acetate next in the A to Z list
Prednisolon next in the A to Z list

These links are for navigation. No count selected them. The class page lists each drug of the class.

Official pages

DailyMed labels for Prednisolone sodium phosphateThe labels (prescribing information) that have this name, at the National Library of Medicine.
MedWatch Online Voluntary Reporting FormThe online form of FDA for a voluntary report.
MedWatch: The FDA Safety Information and Adverse Event Reporting ProgramThe page of the FDA program that receives reports about drugs and devices.
FDA Adverse Event Monitoring System (AEMS) Public DashboardThe public dashboard of FDA for adverse event reports on drugs and biologics.

The site checked these addresses on 2 Oct 2026. The links open in a new tab.

Cite this page

Reported Reactions. Prednisolone sodium phosphate: adverse event reports that FDA received. https://reportedreactions.com/drug/prednisolone-sodium-phosphate/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of 29 Oct 2026. Reports received through 30 Jun 2026.

Where the data come from

The counts come from the openFDA Drug Adverse Event (FAERS) bulk files, release of 29 Oct 2026. The files have the reports that FDA received through 30 Jun 2026. A drug name is the name on the report. The site matches it to a brand name or a generic name of the National Drug Code Directory of 2 Nov 2026. A class is the pharmacologic class (EPC) of the FDA label.

A report is in the count when it names Prednisolone sodium phosphate as a suspect or interacting product. The 700 reports that name it only as a concomitant medicine are not in the count. The site does not publish a report narrative, a lot number, a detail of a patient or the identity of a reporter. The record of FDA is the authority. See how the site counts reports, the data sources and the corrections page.

Questions

Do these reports show that Prednisolone sodium phosphate was responsible for the reactions?

No. FDA says:

For any given report, there is no certainty that a suspected drug caused the event.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

A reaction can relate to the condition that the drug treats, to other medicines, or to something else.

Is this the list of reactions on the label of Prednisolone sodium phosphate?

No. It is a count of what people reported to FDA: 1,727 reports from April 2004 to June 2026. The FDA-approved label of a product lists its adverse reactions. The official pages at the end of this page link to the labels.

Who sent these reports?

Other health professional (54.1%), physician (26.3%) and consumer or non-health professional (12.3%). These are the types of reporter for the reports that name this drug.

If a manufacturer receives an adverse event report, it is normally required to send the report to FDA.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

How does a person report an adverse event?

FDA runs MedWatch, a program that takes voluntary reports from health professionals, patients and consumers. The guide on how to report has the links.

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