Drug Safety-related Labeling Changes (SrLC)

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Drug Safety-related Labeling Changes (SrLC) Database

ANDA	Abbreviated New Drug Application
BLA	Biologics License Application
CDER	Center for Drug Evaluation and Research
MG	Medication Guide
NDA	New Drug Application
PCI	Patient Counseling Information
PI	Patient Information
PLR	Physician Labeling Rule
PLLR	Pregnancy and Lactation Labeling Rule
Italics	For the most part, italics indicate an FDA comment such as: Additions and/or revisions underlined These italics usually appear at the beginning of the section. In some cases, italics may be an inherent part of the label, and will most often appear in the body of the section.
Underlines	Any text that is underlined indicates text that has been added or revised. There are exceptions where underlining occurs in a section subtitle or heading. This is the case when there is just one word underlined in the body of the text.

Sections

BW	Box Warning
WP	Warnings and Precautions all in one section (PLR-format) Warnings as one section (pre-PLR format) Precautions as one section (pre-PLR format)
AR	Adverse Reactions (in pre-PLR format, this may be a subheading under precautions).
DI	Drug Interactions (in pre-PLR format, this may be a subheading under precautions).
USP	Use in Specific Populations (Inclusive on one or more of the following: Pregnancy; Lactation (PLLR- format); Nursing Mothers (pre-PLLR format); Females and Males of Reproductive Potential (PLLR format only); Pediatric Use, Geriatric Use, Renal Impairment, Hepatic Impairment, Sex, Race (these last six may be a subheading of precautions if label in pre-PLLR format.
PCI/PI/MG	Patient Counseling Information (PLR format only) - summarizes the information that a health care provider should convey to a patient (or caregiver when applicable) when a counseling discussion is taking place (e.g., a physician prescribing a drug during an office visit, a nurse providing discharge instructions at a hospital, or a pharmacist conveying information at a pharmacy). Patient Information - FDA approved patient labeling. Medication Guide - paper handouts that come with many prescription medicines. The guides address issues that are specific to particular drugs and drug classes, and they contain FDA-approved information that can help patients avoid serious adverse events.

Only NDAs and CDER regulated BLAs are included in this database. ANDAs are not included.

Applications that remain active, even if the product has been discontinued, undergo safety-related labeling changes.

SOLU-MEDROL (NDA-011856)

(METHYLPREDNISOLONE SODIUM SUCCINATE)

Safety-related Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER)

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11/04/2025 (SUPPL-143)

Approved Drug Label (PDF)

6 Adverse Reactions

Additions and/or revisions underlined:

The following adverse reactions have been reported with SOLU-MEDROL or other corticosteroids:

…

Vascular: Flushing.

…

06/05/2024 (SUPPL-144)

Approved Drug Label (PDF)

5 Warnings and Precautions

WARNINGS

Additions and/or revisions underlined:

…

Cardio-renal

…

There have been cases reported in which concomitant use of amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure (see CONTRAINDICATIONS and PRECAUTIONS, Drug Interactions, Amphotericin B injection and potassium-depleting agents).

…

Immunosuppression and Increased Risk of Infection

Corticosteroids, including SOLU-MEDROL, suppress the immune system and increase the risk of infection with any pathogen, including viral, bacterial, fungal, protozoan, or helminthic pathogens. Corticosteroids can:

Reduce resistance to new infections
Exacerbate existing infections
Increase the risk of disseminated infections
Increase the risk of reactivation or exacerbation of latent infections
Mask some signs of infection
Corticosteroid-associated infections can be mild but can be severe and at times fatal. The rate of infectious complications increases with increasing corticosteroid dosages.
…
Monitor for the development of infection and consider SOLU-MEDROL withdrawal or dosage reduction as needed.
Tuberculosis
If SOLU-MEDROL is used to treat a condition in patients with latent tuberculosis or tuberculin reactivity, reactivation of the disease may occur. Closely monitor such patients for reactivation. During prolonged SOLU-MEDROL therapy, patients with latent tuberculosis or tuberculin reactivity should receive chemoprophylaxis.
Varicella Zoster and Measles Viral Infections
Varicella and measles can have a serious or even fatal course in non-immune patients taking corticosteroids, including SOLU-MEDROL. In corticosteroid-treated patients who have not had these diseases or are non-immune, particular care should be taken to avoid exposure to varicella and measles:
If a SOLU-MEDROL-treated patient is exposed to varicella, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated. If varicella develops, treatment with antiviral agents may be considered.
If a SOLU-MEDROL-treated patient is exposed to measles, prophylaxis with immunoglobulin (IG) may be indicated.
Hepatitis B Virus Reactivation
Hepatitis B virus reactivation can occur in patients who are hepatitis B carriers treated with immunosuppressive dosages of corticosteroids, including SOLU-MEDROL. Reactivation can also occur infrequently in corticosteroid-treated patients who appear to have resolved hepatitis B infection.
Screen patients for hepatitis B infection before initiating immunosuppressive
(e.g., prolonged) treatment with SOLU-MEDROL. For patients who show evidence of hepatitis B infection, recommend consultation with physicians with expertise in managing hepatitis B regarding monitoring and consideration for hepatitis B antiviral therapy.
Fungal Infections
Corticosteroids, including SOLU-MEDROL, may exacerbate systemic fungal infections; therefore, avoid SOLU-MEDROL use in the presence of such infections unless
SOLU-MEDROL is needed to control drug reactions. For patients on chronic SOLU-MEDROL therapy who develop systemic fungal infections, SOLU-MEDROL withdrawal or dosage reduction is recommended.

Amebiasis
Corticosteroids, including SOLU-MEDROL, may activate latent amebiasis. Therefore, it is recommended that latent amebiasis or active amebiasis be ruled out before initiating SOLU-MEDROL in patients who have spent time in the tropics or patients with unexplained diarrhea.
…
Cerebral Malaria
Avoid corticosteroids, including SOLU-MEDROL, in patients with cerebral malaria.

…

12/20/2023 (SUPPL-141)

Approved Drug Label (PDF)

5 Warnings and Precautions

PRECAUTIONS

Additions and/or revisions underlined:

…

Tumor Lysis Syndrome

In post marketing experience, tumor lysis syndrome (TLS) has been reported in patients with malignancies, including hematological malignancies and solid tumors, following the use of systemic corticosteroids alone or in combination with other chemotherapeutic agents. Patients at high risk of TLS, such as patients with tumors that have a high proliferative rate, high tumor burden and high sensitivity to cytotoxic agents, should be monitored closely and appropriate precautions should be taken.

05/27/2021 (SUPPL-136)

Approved Drug Label (PDF)

8 Use in Specific Populations

(Additions and/or revisions underlined)

Pediatric Use

The adverse effects of corticosteroids in pediatric patients are similar to those in adults (see ADVERSE REACTIONS). Like adults, pediatric patients should be carefully observed with frequent measurements of blood pressure, weight, height, intraocular pressure, and clinical evaluation for the presence of infection, psychosocial disturbances, thromboembolism, peptic ulcers, cataracts, and osteoporosis. Pediatric patients who are treated with corticosteroids by any route, including systemically administered corticosteroids, may experience a decrease in their growth velocity. This negative impact of corticosteroids on growth has been observed at low systemic doses and in the absence of laboratory evidence of HPA axis suppression (i.e., cosyntropin stimulation and basal cortisol plasma levels). Growth velocity may therefore be a more sensitive indicator of systemic corticosteroid exposure in pediatric patients than some commonly used tests of HPA axis function. The linear growth of pediatric patients treated with corticosteroids should be monitored, and the potential growth effects of prolonged treatment should be weighed against clinical benefits obtained and the availability of treatment alternatives. In order to minimize the potential growth effects of corticosteroids, pediatric patients should be titrated to the lowest effective dose.

Hypertrophic cardiomyopathy may develop after administration of methylprednisolone to prematurely born infants, therefore appropriate diagnostic evaluation and monitoring of cardiac function and structure should be performed.

07/24/2018 (SUPPL-133)

Approved Drug Label (PDF)

5 Warnings and Precautions

PRECAUTIONS

Newly added information:

Cardio-renal

Caution is required in patients with systemic sclerosis because an increased incidence of

scleroderma renal crisis has been observed with corticosteroids, including methylprednisolone.

03/28/2018 (SUPPL-131)

Approved Drug Label (PDF)

4 Contraindications

(Additions and/or revisions are underlined)

SOLU-MEDROL Sterile Powder is contraindicated:

in systemic fungal infections and patients with known hypersensitivity to the product and its constituents. The SOLU-MEDROL 40 mg presentation includes lactose monohydrate produced from cow’s milk. This presentation is therefore contraindicated in patients with a known or suspected hypersensitivity to cow’s milk or its components or other dairy products because it may contain trace amounts of milk ingredients.

5 Warnings and Precautions

WARNINGS

General

(Additions and/or revisions are underlined)

In patients receiving the 40 mg presentation of SOLU-MEDROL during the treatment for acute allergic conditions and where these symptoms worsen or any new allergic symptoms occur, consideration should be given to the potential for hypersensitivity reactions to cow’s milk ingredients. If appropriate, administration of SOLU-MEDROL should be stopped, and the patient’s condition should be treated accordingly. Alternative treatments, including the use of corticosteroid formulations that do not contain ingredients produced from cow’s milk, should be considered for acute allergy management, where appropriate.

09/08/2016 (SUPPL-124)

Approved Drug Label (PDF)

6 Adverse Reactions

Blood and lymphatic system disorders: Leukocytosis (addition)

09/08/2016 (SUPPL-126)

Approved Drug Label (PDF)

5 Warnings and Precautions

Drug-Induced Liver Injury

Rarely, high doses of cyclically pulsed intravenous methylprednisolone (usually for the treatment of exacerbations of multiple sclerosis at doses of 1 gram/day) can induce a toxic form of acute hepatitis. The time to onset of this form of steroid-induced liver injury can be several weeks or longer. Resolution has been observed after discontinuation of treatment. However, serious liver injury can occur, sometimes resulting in acute liver failure and death. Discontinue intravenous methylprednisolone if toxic hepatitis occurs. Since recurrence has occurred after re-challenge, avoid use of high dose intravenous methylprednisolone in patients with a history of toxic hepatitis caused by methylprednisolone.

6 Adverse Reactions

Hepatobiliary: Hepatitis (addition)