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Prednisolone Side Effects

The most commonly reported side effects of prednisolone include off label use, pyrexia, and dyspnoea, based on 192,314 FDA adverse event reports from 2004 to 2025. 6.7% of reports found the drug to be ineffective.

Prednisolone side effects

Percentages show how often each reaction appears relative to total reports for prednisolone.

1
Off Label Use8.0%15,457
2
Drug Ineffective6.7%12,796
3
Pyrexia3.7%7,197
4
Dyspnoea3.3%6,265
5
Diarrhoea3.2%6,148
6
Pneumonia3.1%5,984
7
Condition Aggravated2.8%5,419
8
Fatigue2.7%5,145
9
Product Use In Unapproved Indication2.7%5,102
10
Nausea2.6%5,005
11
Headache2.4%4,632
12
Vomiting2.4%4,587
13
Rash2.1%4,070
14
Pain2.1%4,039
15
Arthralgia2.1%4,010

These are voluntary reports and do not establish that prednisolone caused these reactions.

Report severity

92.7%Serious178,329 reports
44.1%Hospitalizations84,851 reports
15.4%Fatal29,523 reports

Seriousness is determined by the reporter, not by OpenClaim.

Prednisolone drug interactions

Other drugs that appear in adverse event reports alongside prednisolone. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Rituximab10.2%19,679
2
Tacrolimus10.2%19,651
3
Cyclophosphamide9.9%18,978
4
Mycophenolate9.8%18,865
5
Methotrexate9.0%17,389
6
Vincristine-sulfate8.3%16,039
7
Doxorubicin-hydrochloride7.3%14,089
8
Adalimumab5.3%10,197
9
Methylprednisolone5.2%10,033
10
Cyclosporine5.2%9,998
11
Infliximab4.2%8,082
12
Azathioprine3.9%7,431
13
Etanercept3.4%6,461
14
Dexamethasone3.3%6,416
15
Tocilizumab3.1%5,892

Taken alongside

1
Acetaminophen7.6%14,707
2
Omeprazole6.9%13,231
3
Methotrexate5.8%11,122
4
Aspirin5.8%11,067
5
Folic-acid5.3%10,207
6
Albuterol5.1%9,826
7
Pantoprazole-sodium5.0%9,560
8
Amlodipine4.9%9,385
9
Furosemide4.8%9,144
10
Atorvastatin-calcium4.2%8,147
11
Lansoprazole4.2%8,048
12
Levothyroxine-sodium4.1%7,965
13
Ergocalciferol3.2%6,140
14
Methylprednisolone3.2%6,067
15
Mycophenolate3.1%5,928

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports prednisolone side effects

48.0% of prednisolone adverse event reports involve female patients and 41.0% involve male patients. The largest age group is adult at 52%. These figures reflect who reports side effects, not underlying risk.

Sex

Female48.0%
Male41.0%
Unknown11.0%

Age group

< 22.2%
2–114.4%
12–173.0%
18–6452.3%
65+38.1%

What is prednisolone used for

Conditions and purposes for which patients were taking prednisolone when the adverse event was reported.

1p36 Deletion Syndrome21-hydroxylase Deficiency5q Minus SyndromeAbdominal DiscomfortAbdominal DistensionAbdominal PainAbnormal Sensation In EyeAbo IncompatibilityAbo IncompatibilityAbortion SpontaneousAbscessAcanthamoeba InfectionAcanthamoeba KeratitisAcneAcne Conglobata

Showing 15 of 4,595 indications

Prednisolone brand names and reporting trend

Prednisolone is sold under several brand names including Prelone, Sulphrin, Inflamase Forte.

Brand names

Prelone255,567
Sulphrin9,099
Inflamase Forte3,320
Prednisolone Tebutate1

Quarterly reports (20042025)

20052010201520202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking prednisolone with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.