FDA Adverse Events Reports (FAERS) Summary for SOLU-CORTEF

These tables and charts are based on 6,034 total reports for SOLU-CORTEF (HYDROCORTISONE SODIUM SUCCINATE) received by the FDA Adverse Event Reporting System (FAERS) from 2004 through April 28, 2026.

This FAERS total includes 5,915 pharmaceutical company-submitted and non-U.S. FAERS reports and 119 U.S. consumer or healthcare provider-submitted MedWatch reports. For a separate summary of the 119 U.S. reports filed via the FDA MedWatch voluntary reporting system, view our FDA MedWatch SOLU-CORTEF summary report. (See notes section below for explanation of FDA’s mandatory and voluntary reporting system.)

Top 20 Adverse Effects Associated with SOLU-CORTEF (reported in FAERS Database)

	Side Effect	# of FDA Reports
1	OFF LABEL USE	924
2	INFUSION RELATED REACTION	645
3	NAUSEA	540
4	SHORTNESS OF BREATH	536
5	FEVER	482
6	FATIGUE	452
7	DIARRHEA	442
8	HEADACHE	424
9	JOINT PAIN	413
10	CONDITION AGGRAVATED	402
11	VOMITING	352
12	PAIN	350
13	ITCHING	342
14	PNEUMONIA	322
15	DRUG INEFFECTIVE	308
16	BLOOD PRESSURE INCREASED	307
17	ABDOMINAL PAIN	300
18	INTENTIONAL PRODUCT USE ISSUE	299
19	RASH	286
20	COUGH	273
21	INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION	268
22	MALAISE	266
23	HIVES	260
24	WEIGHT INCREASED	257
25	DIZZINESS	248
26	LOW BLOOD PRESSURE	243
27	WEIGHT DECREASED	242
28	FLUSHING	227
29	SKIN REDNESS	226
30	HIGH BLOOD PRESSURE	221
31	LACK OF STRENGTH AND ENERGY (ASTHENIA)	219
32	BACK PAIN	218
33	PRODUCT USE ISSUE	213
34	CHEST DISCOMFORT	210
35	CHILLS	188
36	BLOOD PRESSURE FLUCTUATION	184
37	ANXIETY	182
38	COMMON COLD	175
39	OXYGEN SATURATION DECREASED	174
40	HEART RATE INCREASED	173
41	SEPSIS	164
42	PLATELET COUNT DECREASED	162
43	ANEMIA	158
44	CHEST PAIN	152
45	FALL	149
46	FEBRILE NEUTROPENIA	146
47	BLOOD PRESSURE DECREASED	143
48	HYPERSENSITIVITY	143
49	COVID-19	142
50	PAIN IN EXTREMITY	141
51	URINARY TRACT INFECTION	140
52	DEATH	132
53	INFECTION	126
54	THROAT PAIN	121
55	SINUSITIS	120
56	DECREASED APPETITE	117
57	ABDOMINAL DISCOMFORT	115
58	INCORRECT DOSE ADMINISTERED	115
59	RAPID HEART RATE (TACHYCARDIA)	114
60	WHITE BLOOD CELL COUNT DECREASED	112
61	ANAPHYLACTIC REACTION	109
62	PRODUCT DOSE OMISSION ISSUE	109
63	THROAT IRRITATION	106
64	CONSTIPATION	105
65	FEELING HOT	104
66	PINS AND NEEDLES	104
67	TREMOR	104
68	MUSCLE SPASMS	100
69	ABDOMINAL PAIN UPPER	99
70	HEART RATE DECREASED	99
71	KIDNEY FAILURE	99
72	INFLUENZA	97
73	SEPTIC SHOCK	97
74	NUMBNESS	95
75	NASAL CONGESTION	95
76	CROHN^S DISEASE	94
77	INSOMNIA	93
78	RESPIRATORY FAILURE	93
79	DEHYDRATION	92
80	THROMBOCYTOPENIA	92
81	BLOOD IN STOOL	91
82	EXCESS SWEATING	91
83	BLOOD CLOTTING DISORDER	89
84	DRUG HYPERSENSITIVITY	88
85	PALPITATIONS	88
86	STRESS	88
87	GENERAL PHYSICAL HEALTH DETERIORATION	87
88	DROWSINESS	87
89	HYPOKALAEMIA	86
90	FEELING ABNORMAL	82
91	MUSCLE PAIN	82
92	NEUTROPHIL COUNT DECREASED	79
93	LOWER LIMBS SWELLING	78
94	SWELLING OF LIMBS	77
95	PLEURAL EFFUSION	77
96	ANAPHYLACTIC SHOCK	76
97	ARTHRITIS	76
98	BRONCHITIS	76
99	DIFFICULTY SWALLOWING	76
100	HAEMOGLOBIN DECREASED	75

Latest Known Outcomes for Reactions Reported for SOLU-CORTEF

	Latest Known Outcome for Reported Reactions	Number of Cases
1	Unknown Outcome	2607
2	Patient recovered	2086
3	Patient has not recovered/symtoms have not resolved	1475
4	Patient is recovering/symptoms resolving	972
5	Patient died	489
6	Patient has recovered but has consequent health issues	71

Search all MedWatch and FAERS by keyword:

SOLU-CORTEF Total Reports

Male	Female	Unknown	Total
2439	2847	748	6,034

Top Countries Reporting

	Country	Number of Reports
1	United States	1696
2	Canada	1436
3	Japan	911
4	Switzerland	70
5	Norway	66
6	Belgium	61
7	Sweden	43
8	Italy	38
9	Taiwan	37
10	South Africa	32

Outcomes for Reports

Serious: 5230
Not Serious: 800
Note: A serious outcome means the adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition.

Top Indications

Adrenocortical insufficiency acute
Inflammation

Top Companies Reporting

PFIZER

Safety-Related FDA Updates

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

Have experience (good or bad) with SOLU-CORTEF? Rate SOLU-CORTEF at Ask a Patient.

For serious adverse events, report them to the FDA by contacting the drug manufacturer or report directly through the MedWatch voluntary reporting form.

Notes

This report, created by AskaPatient.com, is derived from the cases for SOLU-CORTEF reported to the United States Food and Drug Administration (FDA) FDA Safety Information and Adverse Event Reporting System (FAERS) and obtained from Open FDA. Data was last updated with reports received through April 28, 2026.

This summary includes ALL reports where the drug is a "primary OR secondary OR suspected interacting" drug. Typically, reports are filed for the most serious type or "event" and do not represent incidental or minor side effects. The majority of these reports are mandatory reports submitted by pharmaceutical companies, who receive complaints from consumers. The reactions, side effects, or "adverse events," represent up to the 20 most frequently occuring events in the database for a drug related to the event. This report also features counts of latest known outcomes associated with reported side effects, but does not provide the specific outcomes for specific adverse events.

Adverse Event Reports are submitted to the FAERS database by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers). Health care providers such as doctors (voluntary reporting), and patients themselves (voluntary reporting) report to the FDA directly through the MedWatch program. Those MedWatch reports are coded and included in the FAERS database. This report mainly consists of the mandatory reports, because the MedWatch reports are a small percentage (3 - 5%) of total reports. Link to the MedWatch summary report at the top of the page for a summary of the directly reported (voluntary) adverse events for this drug.The number of reports included here might differ somewhat from the number of reports in the downloadable quarterly FAERS reports and in the online FAERS dashboard, due to lags in reporting, drug name differences, duplicates, and other factors. Open FDA states that it only includes the most recent version of a case report. It also adds the disclaimer: "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."

FDA uses the "MedDRA" classification system to describe reported adverse reactions. MedDRA is a standardized medical terminology that facilitates sharing of regulatory information internationally. In some cases, "patient friendly" terms for the layman designated by MedDRA have been substituted for medical jargon. Please contact us with questions or comments about this report.