Soliris (eculizumab) is a brand-name injection that’s prescribed for certain autoimmune conditions. As with other drugs, Soliris can cause side effects, such as hair loss.
Soliris has a boxed warning. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). For details, see the “Side effect specifics” section.
Soliris can cause certain side effects, some of which are more common than others. These side effects may be temporary, lasting a few days to weeks. However, if the side effects last longer than that, bother you, or become severe, be sure to talk with your doctor or pharmacist.
Below are just a few of the more common side effects reported by people who took Soliris in clinical trials. These side effects can vary depending on the condition being treated.
More common side effects reported in people receiving Soliris for paroxysmal nocturnal hemoglobinuria (PNH) include:
- headache
- back pain
- common cold
- nausea
More common side effects reported in people receiving Soliris for atypical hemolytic uremic syndrome (aHUS) include:
- headache
- diarrhea
- upper respiratory infection
- abdominal pain
- vomiting
More common side effects reported in people receiving Soliris for neuromyelitis optica spectrum disorder (NMOSD) include:
- upper respiratory infection
- common cold
- diarrhea
- back pain
- dizziness
More common side effects reported in people receiving Soliris for generalized myasthenia gravis (gMG) include musculoskeletal pain (pain in the muscles, joints, bones, or surrounding tissue).
Mild side effects can occur with Soliris use. This list doesn’t include all possible mild side effects of the drug. For more information, you can refer to Soliris’ prescribing information.
Mild side effects that have been reported with Soliris include:
- headache
- upper respiratory infections
- musculoskeletal or back pain
- nausea and vomiting
- abdominal pain
- diarrhea
- dizziness
- fatigue
- urinary tract infection (UTI)
- swelling in the lower legs and feet
These side effects may be temporary, lasting a few days to weeks. However, if the side effects last longer than that, bother you, or become severe, be sure to talk with your doctor or pharmacist.
Note: After the FDA approves a drug, it tracks and reviews side effects of the medication. If you develop a side effect while receiving Soliris and want to tell the FDA about it, visit MedWatch.
Soliris may cause serious side effects. The list below may not include all possible serious side effects of the drug. For more information, you can refer to Soliris’s prescribing information.
If you develop serious side effects while receiving Soliris, call your doctor right away. If the side effects seem life threatening or you think you’re having a medical emergency, immediately call 911 or your local emergency number.
Serious side effects that have been reported and their symptoms include:
- high blood pressure, which typically doesn’t produce symptoms. In rare or severe cases, it may cause:
- trouble sleeping
- anxiety
- sweating
- headaches
- nosebleeds
- serious infections, such as meningitis, pneumonia, and gonorrhea, which may cause symptoms such as:
- reactions to the infusion*
- serious meningococcal infections*†
* For more information about this side effect, see “Side effect specifics.”
† Soliris has a boxed warning for this side effect. This is the most serious warning from the FDA. For more information about this side effect, see “Side effect specifics.”
ALLERGIC REACTIONFor some people, Soliris can cause an allergic reaction.
But it’s not clear whether this side effect occurred in the drug’s studies.
In general, symptoms of allergic reaction can be mild or serious.
Ways to manage
For mild allergic reaction symptoms, such as a mild rash, call your doctor right away. They may recommend treatments to help manage your symptoms. They’ll also let you know whether you should keep receiving the medication.
For severe allergic reaction symptoms, such as swelling or trouble breathing, call 911 or your local emergency number right away. These symptoms require immediate medical care because they can become life threatening. If you’ve had a serious allergic reaction to Soliris, your doctor may recommend taking a different medication instead.
Soliris may cause several side effects. Here are some frequently asked questions about the drug’s side effects and their answers.
Does Soliris cause long-term side effects?
Yes, in some cases, Soliris may cause long-term side effects. These can last for a while after you’ve stopped receiving the drug.
Examples of long-term side effects reported with Soliris include:
- hemolysis (breakdown of your red blood cells) if you were receiving Soliris for PNH
- thrombotic microangiopathy (irregular blood clotting) if you were receiving Soliris for atypical hemolytic uremic syndrome (aHUS)
- serious meningococcal infections*
Talk with your doctor to learn more about these side effects and how to manage them. Ask your doctor for more information about how long these side effects of Soliris may last.
*Soliris has a boxed warning for this side effect. This is the most serious warning from the FDA. For more information about this side effect, see “Side effect specifics.”
Can Soliris cause hair loss?
It’s possible. In studies, hair loss was reported in people receiving Soliris for neuromyelitis optica spectrum disorder (NMOSD). However, it wasn’t reported in those who received Soliris for other conditions.
If you have concerns about hair loss with Soliris, talk with your doctor.
Can Soliris cause weight gain?
It’s not likely. Weight gain wasn’t reported in studies of Soliris. However, this doesn’t mean it cannot happen or won’t be reported in the future.
If you’re experiencing weight gain while receiving Soliris, talk with your doctor. They can help determine the cause and whether you should continue Soliris treatment.
Learn more about some of the side effects that Soliris may cause. To find out how often side effects occurred in clinical trials, see the prescribing information for Soliris.
Serious meningococcal infections
Soliris has a boxed warning for the risk of serious meningococcal infections. A boxed warning is the most serious warning from the FDA.
Soliris can raise the risk of serious and life threatening infections caused by a bacteria called Neisseria meningitidis. These include meningitis, pneumonia, and gonorrhea. These infections can be fatal if not recognized and treated early.
Due to this risk, Soliris is only available through the Soliris Risk Evaluation and Mitigation Strategy (REMS) program. This is a program that ensures you’re up to date with all meningococcal vaccinations at least 2 weeks before starting Soliris.
Although vaccinations lower the risk, there’s still a chance you can develop a serious meningococcal infection during treatment or for several weeks after. So if you develop any signs or symptoms of an infection, get medical help right away. Symptoms may include:
- chest pain
- shortness of breath
- fever
- white, green, or yellow discharge from your genitals
- itching around the anus
- pain during bowel movements
- painful or swollen testicles
What you can do
At least 2 weeks before starting Soliris, be sure you’re up to date with all vaccinations, especially meningococcal vaccinations. If you develop signs or symptoms of an infection during treatment, call your doctor or get medical help right away. Meningococcal infections can go from mild to life threatening quickly, so it’s important that you get medical care right away.
Infusion-related reactions
Soliris is given through an intravenous (IV) infusion, which is an injection given into your vein over time. In studies, infusion reactions occurred, including serious allergic reactions. Symptoms may include:
- difficulty breathing
- swelling of lips, face, tongue, or throat
- chest pain
- lightheadedness or fainting
What you can do
If you develop an infusion-related reaction, your doctor will likely pause your Soliris infusion and recommend treatment for your symptoms. If needed, they might stop Soliris treatment entirely and discuss alternative medications that are safer for you.
Below is important information you should consider before receiving Soliris.
Soliris has a boxed warning. A boxed warning is the most serious warning from the FDA. For details, see the “Side effect specifics” section.
Other precautions
Before starting Soliris, discuss your health history with your doctor. Soliris may not be right for you if you have certain medical conditions or other factors affecting your health. Be sure to talk with your doctor if any of the following apply to you:
- weakened immune system
- active or current infection
- low white blood cell count
- previous allergic reaction to this or a similar drug
- pregnancy
- breastfeeding
Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.
