Last Updated on November 26, 2025 by Bilal Hasdemir

Patients often look to trusted medical sources for clear answers about procedures like epidural steroid injections. They want to know about their safety and if they are approved.

Epidural steroid injections are a common way to manage pain. But, the FDA says using steroids in these injections is off-label.

This means steroids are FDA-approved, but not for epidural injections. This raises concerns about possible risks and complications.

Key Takeaways

• Epidural steroid injections are a widely used pain management procedure.
• The use of steroids in epidural injections is considered off-label by the FDA.
• Patients should be aware of the possible risks and complications with epidural steroid injections.
• It’s important to understand the regulatory status of epidural steroid injections for making informed decisions.
• Patients should talk to their healthcare provider about the benefits and risks of epidural steroid injections.

Understanding Epidural Injections and Their Uses

Epidural injections, like epidural steroid injections, are getting more attention in medicine. They help with spinal pain. These injections go into the space around the spinal cord and nerves, helping with different spinal issues.

What Are Epidural Injections?

Epidural injections put medicine right into the epidural space. This space is filled with fat and is between the bone and the sac around the spinal cord and nerves. The medicine used is a corticosteroid to reduce swelling and a local anesthetic to numb the area.

“Epidural steroid injections are used a lot to treat pain from nerve problems,” say doctors. The corticosteroid in these injections helps lessen swelling and irritation of the spinal nerves, which helps with pain.

Common Types of Epidural Procedures

There are a few kinds of epidural injections:

• Interlaminar Epidural Steroid Injections: These are given between the vertebrae’s laminae.
• Transforaminal Epidural Steroid Injections: This method involves injecting through the foramen where the nerve root exits the spinal canal.
• Caudal Epidural Injections: These are done through the sacral hiatus, an opening at the lower end of the sacrum.

Medical Conditions Treated with Epidural Injections

Epidural steroid injections are mainly for treating radiculopathy, or pain from nerve irritation or compression. They can help with:

• Disc herniation
• Degenerative disc disease
• Spinal stenosis
• Spondylolisthesis

Knowing about the different epidural injections and their uses helps patients make better choices. It’s key to talk to a healthcare professional to find the best treatment.

Are Epidurals FDA Approved? The Regulatory Status Explained

Epidural steroid injections are used to treat back pain, but the FDA approval question is complex. The FDA approval process for these injections is detailed and nuanced.

FDA Approval Process for Medical Procedures

The FDA checks if treatments and devices are safe and work well. They do this through tests and clinical trials. A treatment must pass these tests to get FDA approval.

The FDA checks treatments in several steps:

• Preclinical testing to check safety and effectiveness
• Clinical trials to test in humans
• New Drug Application (NDA) submission
• FDA review of the NDA
• Post-marketing surveillance

The Off-Label Use Concept in Medicine

Off-label use means using a treatment for a purpose not listed on its FDA approval. Doctors often use treatments this way, based on their experience. This is common in medicine.

For epidural steroid injections, the corticosteroids are FDA approved for other uses. But using them in epidural injections is off-label. This is important for understanding their regulatory status.

Current Regulatory Status of Epidural Steroid Injections

The corticosteroids in epidural injections are FDA approved, but not for this use. This means the medications are approved, but their use in epidural injections is not. It’s considered off-label.

The table below shows the regulatory status of epidural steroid injections:

Medication/Device	FDA Approval Status	Use in Epidural Injections
Corticosteroids (e.g., triamcinolone, betamethasone)	FDA approved for various conditions	Off-label use
Epidural steroid injections	Not FDA approved as a procedure	Commonly used off-label

It’s key for patients and doctors to know the regulatory status of epidural steroid injections. This helps make informed decisions about their use.

Medications Used in Epidural Injections

Epidural injections work well because of the medicines used. It’s key to know what these medicines are and how they help. Corticosteroids, strong anti-inflammatory agents, are often used in these injections.

Common Corticosteroids Used in Epidural Procedures

Corticosteroids are the main medicines in epidural injections. They cut down inflammation and swelling around the spinal nerves. This helps ease pain. Triamcinolone, betamethasone, and dexamethasone are common ones used. Each is picked based on the condition and the patient’s history.

Dexamethasone Injection for Back Pain

Dexamethasone is a corticosteroid sometimes used for back pain in epidural injections. It has strong anti-inflammatory effects. Dexamethasone injection for back pain is tried when other treatments don’t work. But, it’s not FDA-approved for this use.

FDA Approval Status of These Medications

The FDA approval status of these medicines is very important. Corticosteroids like dexamethasone are FDA-approved for many uses. But, their use in epidural injections is often off-label. This means they’re used based on doctor’s judgment, not FDA approval for that specific use.

Knowing the FDA approval status helps patients make better choices. It’s also key for doctors to talk about the benefits and risks of these medicines in epidural injections.

The Efficacy of Epidural Steroid Injections

It’s important to know how well epidural steroid injections work. These injections are used to treat pain from different spinal problems. They can offer quick relief but may not last long.

Short-Term Pain Relief Benefits

Epidural steroid injections can help a lot of people feel better quickly. The steroids in these injections reduce swelling around the spinal nerves. This helps to lessen pain.

Many studies show that these injections can improve how well people can move and feel less pain in the short term.

Long-Term Effectiveness Concerns

Even though they work well at first, the lasting effects of these injections are not clear. Some research points out that the pain relief might not last long. How well they work can depend on the condition being treated, how often they are used, and how each person reacts.

What the Clinical Research Shows

Studies on epidural steroid injections have given mixed results. Some say they can really help with pain and improve life quality for a while. But, other studies have raised doubts about their long-term benefits and risks.

To really understand how well these injections work, we need to look at all the research together. They might be a good choice for some patients with specific spinal issues. But, it’s key to think about the good and bad sides and talk to a doctor before deciding.

Common Side Effects of Epidural Injections

Epidural injections can help with back pain but come with risks and side effects. It’s important for patients to know about the possible complications.

Mild to Moderate Side Effects

Some people might feel temporary discomfort, headache, or nausea after the injection. These symptoms usually go away quickly. But, some might face more serious side effects that need medical help.

Common mild side effects include:

• Temporary pain or discomfort at the injection site
• Headache
• Nausea
• Dizziness

Severe Back Pain After Epidural Steroid Injection

Some might feel severe back pain after the injection. This could be because of the injection or the condition being treated. The FDA warns about serious neurologic problems with these injections.

It’s important for patients to watch their symptoms and get help if the pain gets worse or doesn’t go away.

Symptom	Possible Causes	Recommended Action
Severe back pain	Injection technique, underlying condition	Consult a healthcare provider
Tingling in leg	Nerve irritation, steroid effect	Monitor symptoms, seek medical help if persistent
Numbness after cortisone shot	Nerve damage, steroid effect	Seek immediate medical attention

Tingling in Leg After Epidural Steroid Injection

Some might feel tingling in their leg after the injection. This could be from nerve irritation or the steroid. It’s key to watch these symptoms and talk to a doctor if they don’t go away or get worse.

Numbness After Cortisone Shot

Numbness after a cortisone shot is a serious sign that needs quick medical attention. It could mean nerve damage or other serious issues. Patients should be careful with their symptoms and tell their doctor about any unusual feelings.

Knowing the possible side effects of epidural injections helps patients make better choices about their treatment.

Serious Complications and Risks of Epidural Procedures

Epidural steroid injections can be helpful for some, but they also come with serious risks. These procedures are used to relieve pain but can cause significant side effects.

Leg Weakness After Epidural Steroid Injection

Leg weakness is a serious side effect of epidural steroid injections. This happens when the injection affects the nerves around the spine. Some people experience weakness in one or both legs, which can last a while or even be permanent.

A study in the Journal of Neurosurgery: Spine found that leg weakness can happen after these injections. The exact reason is not always known, but it’s thought to be due to the steroid’s effect on nerves.

Severe Headache After Steroid Injection

Severe headaches can also occur after epidural steroid injections. These headaches might come from the dural puncture during the procedure or a reaction to the steroid. In some cases, these headaches can be very bad and need more medical help.

“The occurrence of severe headache after epidural steroid injection is a recognized complication, and its management requires prompt medical attention to rule out other causes such as infection or nerve damage.” – Spine Specialist

Severe Leg Pain After Epidural Injection

Some people feel severe leg pain after an epidural injection. This pain can come from nerve irritation or damage during the procedure. It’s important for patients to tell their healthcare provider about any severe or ongoing pain.

Complication	Possible Cause	Management
Leg Weakness	Nerve damage or corticosteroid effect	Physical therapy, pain management
Severe Headache	Dural puncture or steroid reaction	Rest, hydration, pain management
Severe Leg Pain	Nerve irritation or damage	Pain management, possible nerve blocks

Rare but Severe Complications: Paralysis and Stroke

Rarely, epidural steroid injections can lead to severe complications like paralysis or stroke. These outcomes are very rare but can greatly affect a patient’s life.

It’s important for patients to talk about their individual risks and any worries with their healthcare provider before getting an epidural steroid injection.

The Dark Side of Epidural Steroid Injections: What Patients Should Know

Epidural steroid injections are often seen as safe. But, there are hidden dangers patients should know. They can help with back pain, but it’s important to understand the risks.

Epidural Injection Dangers Often Not Discussed

Many patients don’t know about the risks of epidural steroid injections. Risks include nerve damage, infection, and adrenal suppression. These can greatly affect a patient’s life.

Are ESI Injections Safe? Examining the Evidence

Studies on epidural steroid injections show mixed results. Some say they’re safe when used right. Others worry about long-term safety. It’s key to consider both sides.

• Short-term relief vs. long-term risks
• Potential for dependency on steroid injections
• Impact on bone density and osteoporosis risk

Long-Term Health Concerns

Using epidural steroid injections often can harm health over time. Repeated steroid use can cause osteoporosis, cataracts, and glaucoma. Talk to your doctor about your risks.

Regulatory Warnings and Medical Alerts

In 2014, the FDA warned about using these injections too often. They said it could lead to serious problems. Know these warnings and talk to your doctor.

In summary, while epidural steroid injections can help with back pain, it’s vital to know the risks. By understanding the dark side, patients can make better choices about their treatment.

Location-Specific Risks: Are Neck Injections Safe?

When thinking about epidural steroid injections, knowing the risks by location is key. These injections are given in different spine areas. Each area has its own risks and things to consider.

Cervical Spinal Steroid Injections Side Effects

Cervical injections treat neck pain and cervical spine issues. But, they can harm the carotid or vertebral artery. There’s also a risk of spinal cord injury. It’s important for patients to know these risks before getting cervical injections.

Risk	Description
Carotid or Vertebral Artery Damage	Potential injury to the arteries supplying blood to the brain
Spinal Cord Injury	Risk of damage to the spinal cord during the injection procedure

Side Effects of Cervical Epidural Injections

Cervical epidural injections can cause side effects. These include temporary increase in pain, numbness or tingling in the arms or hands, and infection. These effects are usually short-lived but can worry patients.

Lumbar Epidural Injection Risks

Lumbar injections treat lower back pain and sciatica. Risks include durals tear, infection, and nerve damage. It’s important for patients to understand these risks before treatment.

Are Back Injections Safe? Thoracic Considerations

Thoracic injections treat mid-back pain. They are generally safe but carry risks like spinal cord injury and pneumothorax (collapsed lung). The thoracic spine’s anatomy makes injections here more challenging.

In conclusion, epidural steroid injections can help with back pain. But, it’s vital to know the risks based on the injection location. Patients should talk to their healthcare provider about their specific risks and benefits to make an informed choice.

Conclusion: Making Informed Decisions About Epidural Treatments

Patients thinking about epidural steroid injections for pain relief need to know a few things. They should understand the FDA approval status, the risks, and the benefits. Knowing these details is key to making smart choices about epidural treatments.

Epidural injections help with back pain and inflammation. They can offer quick relief, but it’s important to think about long-term effects and possible side effects. These can include severe back pain or numbness.

Patients should talk to their healthcare provider about their own risks and benefits. They should think about where the injection will be and their medical history. Being well-informed helps patients make choices that are right for them.

FAQ

Reference

• U.S. Food & Drug Administration. (2024, October 25). Update: Do Not Use BioZorb Marker Implantable Radiographic Marker Devices: FDA Safety Communication. U.S. Department of Health & Human Services. https://www.fda.gov/medical-devices/safety-communications/update-do-not-use-biozorb-marker-implantable-radiographic-marker-devices-fda-safety-communication