It may affect kidney health. Copyright 2023 IBM Watson Health. It is very important that your doctor check your progress closely while you are receiving this medicine to make sure that it is working properly. A propensity scorematched observational study of remdesivir in patients with COVID-19 and severe kidney disease. It is suitable for adults and children who are 28 days or older and weigh at least 6.6 pounds, or 3 kilograms. For this medicine, the following should be considered: Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Indication. Doctors do not recommend it for individuals with kidney failure. Call your doctor for medical advice about side effects. Remdesivir may cause several side effects. What next for remdesivir? We comply with the HONcode standard for trustworthy health information. Blood and urine tests may be needed to check for unwanted effects. COVID-19 Treatment Guidelines. Guidance for Industry, Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act (Revision 1). Mechanism of SARS-CoV-2 polymerase stalling by remdesivir. [Ref], In studies in healthy subjects, increases in ALT, AST, or both in those who received this drug were grade 1 (10%) or grade 2 (4%). National Institutes of Health. This site complies with the HONcode standard for trustworthy health information: verify here. Doctors may consider adjusting doses of certain antibiotics before prescribing them to people with renal failure. Using alcohol or tobacco with certain medicines may also cause interactions to occur. National Institutes of Health. Few side effects "Fortunately, we found that remdesivir does not lead to more serious unwanted side effects than standard treatment," says Dr. Benjamin Speich, joint first author of the study. Relatively common but manageable side effects are nausea and elevated liver enzymes. Tachycardia (an abnormally fast heart rate) However, its not always clear if this effect on liver enzymes is due to remdesivir, COVID-19 itself, or both. In an open-label cohort of 61 COVID-19 patients from the USA, Canada, Europe and Japan, 60% reported adverse events. By tweaking the drug molecule's structure, scientists may be. Ideally, you should receive it within a week of developing symptoms for it to be most effective. There are things you can do to help cope with them: Headache Feeling sick or being sick (nausea or vomiting) Serious side effects Tell your doctor or contact 111 now if you feel that your heart is beating slower than normal. Veklury [package insert]. Acute kidney injury associated with remdesivir: A comprehensive pharmacovigilance analysis of COVID-19 reports in FAERS. Remdesivir, steroids are spiking blood sugar levels, . Mild-to-moderate infusion reactions are also possible. Veklury (remdesivir)." vision changes or damage to your retina caused by an anti-malaria medication; heart disease, heart rhythm disorder (such as long QT syndrome ); diabetes; a stomach disorder; an allergy to quinine; liver or kidney disease; psoriasis; alcoholism; porphyria (a genetic enzyme disorder that causes symptoms affecting the skin or nervous system); or FDA-approved remdesivir is administered intravenously as an aqueous solution and remdesivir has limited aqueous solubility. As a consequence of being mostly ineffective, WHO recommends against the use of remdesivir in Covid-19 patients. other information we have about you. Two studies have now revealed how remdesivir blocks SARS-CoV-2 at the molecular level. Since the outbreak of the COVID-19 pandemic, researchers and medical practitioners have made a massive effort to find effective treatments for the illness. Another plus: Remdesivir has fewer drug interactions than Paxlovid. Gilead Sciences (2020): 2. Please seek medical advice before starting, changing or terminating any medical treatment. In these cases, your doctor may want to change the dose, or other precautions may be necessary. [Ref], Sinus bradycardia generally normalized within 4 days after the last dose of this drug without additional intervention. www.sciencedaily.com/releases/2023/02/230221180127.htm (accessed February 28, 2023). Severe infusion reactions may include angioedema (severe facial swelling) and difficulty breathing. Page last reviewed: 18 May 2022 If youre experiencing nausea or other side effects that are annoying or intolerable, make sure to talk to your healthcare provider. Nausea. FDA is concerned that compounders may have difficulty identifying an appropriate solubilizing agent and sourcing one of sufficient quality. Last medically reviewed on August 29, 2022. Mayo Clinic on Incontinence - Mayo Clinic Press, NEW The Essential Diabetes Book - Mayo Clinic Press, NEW Ending the Opioid Crisis - Mayo Clinic Press, FREE Mayo Clinic Diet Assessment - Mayo Clinic Press, Mayo Clinic Health Letter - FREE book - Mayo Clinic Press. Dizziness. Stay informed and get prescription saving tips and more from GoodRx Health. These medications include: A person should discuss the potential side effects of any drug with a doctor before taking them. Remdesivir was the first antiviral agent approved for treatment of COVID-19, first in the USA in 2020 and later in Europe. The authors highlighted the significant association between remdesivir and acute kidney injury and urged the need for more studies into its safety. The presence of other medical problems may affect the use of this medicine. information is beneficial, we may combine your email and website usage information with But if you do, they usually happen within 1 hour of your infusion. You may report side effects to the FDA at 1-800-FDA-1088. People with kidney issues should avoid using remdesivir. If you experience any worrisome or bothersome side effects like these after you leave the clinic or hospital, make sure to contact your healthcare provider. Remdesivir is an antiviral medication that targets the RNA in viruses to prevent replication. Gilead Sciences, Inc. (2022). Prothrombin time. Based on interim results from studying more than 5000 participants, the international study concluded that remdesivir "had little or no effect on hospitalized patients with Covid-19, as indicated by overall mortality, initiation of ventilation, and duration of hospital stay.". In the hospital, a person takes remdesivir intravenously through a vein, in a procedure that takes 30120 minutes. Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps. Remdesivir has potential side-effects on the kidneys, according to data Gilead shared with the European Medicines Agency, which is assessing its possible toxicity. The blood reports may show an increase in the levels of liver enzymes. dark-colored urine difficulty swallowing fast heartbeat fever flushing headache hives, itching light-colored stools nausea and vomiting puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue stomach pain, continuing trouble breathing unusual tiredness or weakness yellow eyes or skin Less common Seizures The BMJ article implies that the story of remdesivir is another scandal waiting to happen. In this Special Feature, we look at the data on COVID-19 cases and mortality, broken down by sex, insofar as these data were made available. a light-headed feeling, like you might pass out; Common side effects may include: abnormal liver function tests; or. Other medications may be effective for treating infections and carry a reduced risk of adverse effects on the kidneys. Medically reviewed by Drugs.com. If you experience any serious symptoms, as described below, make sure to seek medical attention right away. Summary on compassionate use for remdesivir Gilead. Portions of this document last updated: Feb. 01, 2023. Shark from Jurassic Period Highly Evolved. There are things you can do to help cope with them: Make sure you rest and drink plenty of fluids. One of remdesivir's flaws is its (possibly toxic) high dosage over a short timeframe, which contributes to adverse side effects. Learn more. In remdesivir's case, that's the virus' genetic material, RNA. Remdesivir (Veklury). Several studies suggested this medication may increase the risk of kidney injury, while a few highlight its overall safety and effectiveness in treating viral infections, including the infection that leads to COVID-19. Avoid food, drinks, or other things that have strong odors. As with any medication, Paxlovid and molnupiravir have risks of more serious side effects. Itll depend on your body weight, symptoms, and other health conditions you may have. Retrieved from. Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. Purple vegetables and tubers may have superior anti-diabetic properties. Common side effects of remdesivir include nausea and reactions associated with infusion, such as pain, bleeding, bruising, soreness, and swelling at the injection site. Dizziness. Check out these best-sellers and special offers on books and newsletters from Mayo Clinic Press. So despite being expensive and ineffective at treating Covid, remdesivir's true value could be to help researchers create more effective medicines. You may opt-out of email communications at any time by clicking on You'll soon start receiving the latest Mayo Clinic health information you requested in your inbox. According to Ardis, the side effects were: 22% of all 53 that had COVID-19 experienced these four lethal side effects, multiple organ failure, acute kidney failure, septic shock and hypotension . Remdesivir is an antiviral medicine that works against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). This ingredient can build up in your kidneys and cause harm if theyre not working efficiently enough. Side Effects of Remdesivir Include Possible Liver Damage & Nausea Getty A doctor and nurses wear protective, suits, masks, goggles, and gloves as they perform the morning medical checks inside. The agency reminds health care providers that compounded drugs are not FDA-approved and are not evaluated by FDA for safety, effectiveness or quality. This is to check if you have early signs of side effects. Other antiviral medications may help treat COVID-19 and be safer for the kidneys. University of Basel. Some of the most common known side effects from remdesivir are: 10 Diarrhea Abnormal liver function (as assessed by blood tests) Rash Kidney problems Low blood pressure Nausea and vomiting The following side effects and drug interactions that can occur with ivermectin are signs of ivermectin toxicity, according to the CDC: Abdominal pain, nausea, vomiting, and diarrhea. The effects of remdesivir on vaccinated people and people who have recovered from COVID-19 and the question of how cost-effective remdesivir is remain to be clarified in future studies. https://www.nejm.org/doi/full/10.1056/nejmoa2007764, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7907730/, https://pubmed.ncbi.nlm.nih.gov/33340409/, https://jasn.asnjournals.org/content/32/2/518, https://bmjopen.bmj.com/content/12/3/e048502, https://www.covid19treatmentguidelines.nih.gov/therapies/antiviral-therapy/remdesivir/, https://medlineplus.gov/druginfo/meds/a620033.html, https://www.frontiersin.org/articles/10.3389/fphar.2022.692828/full, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8446775/, Skipping breakfast and fasting may compromise the immune system. 1998-2023 Mayo Foundation for Medical Education and Research (MFMER). (n.d.). Separately, the FDA issued. It hasnt been linked to too many side effects, but specific risks vary by person and situation. In this group, remdesivir lowered mortality during the four-week observation period by roughly two percent, leading to 20 fewer deaths per 1,000 patients. Opinions expressed by Forbes Contributors are their own. Tell your doctor if any of these symptoms are severe or do not go away: nausea pain, bleeding, bruising of the skin, soreness, or swelling near the place where the medication was injected Some side effects can be serious. "Product Information. One of remdesivir's flaws is its (possibly toxic) high dosage over a short timeframe, which contributes to adverse side effects. In addition to whats mentioned above, rare but serious side effects are also possible. What are the side effects? Common side effects of remdesivir may include: nausea; or abnormal liver function tests. Information is for End User's use only and may not be sold, redistributed or otherwise used for commercial purposes. These common side effects of remdesivir happen in up to 1 in 10 people. The effects may be increased because of slower removal of the medicine from the body. It slows down an enzyme (protein) that the virus needs in order to make copies of itself. Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. When viruses like SARS-CoV-2 are no longer able to replicate inside your cells, they begin to die off. These liver effects are usually mild, asymptomatic, and go away on their own. These concerns are further heightened because patients who are prescribed remdesivir require hospitalization and may be critically ill. FDA cautions against compounding remdesivir drug products under section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Medical News Today has strict sourcing guidelines and draws only from peer-reviewed studies, academic research institutions, and medical journals and associations. All rights reserved. Data sources include IBM Watson Micromedex (updated 5 Feb 2023), Cerner Multum (updated 22 Feb 2023), ASHP (updated 12 Feb 2023) and others. - Rash. "Mayo," "Mayo Clinic," "MayoClinic.org," "Mayo Clinic Healthy Living," and the triple-shield Mayo Clinic logo are trademarks of Mayo Foundation for Medical Education and Research. Check with your doctor or nurse immediately if any of the following side effects occur: Some side effects may occur that usually do not need medical attention. Research shows that the treatment reduces the risk of people landing in the hospital or dying from COVID-19 by 87%. Remdesivir was one of the first medications approved for treatment of COVID-19. . Food and Drug Administration. What's weird about remdesivir is that it hasn't been held to the same standards as other drug candidates. Remdesivir: Adverse Reaction: Prolonged Prothrombin Time; Drug (Remdesivir) Placebo . Remdesivir, an anti-viral prodrug originally developed to treat Ebola virus disease, has shown broad spectrum activity against the Coronavirus family. By signing up, I agree to GoodRx's Terms and Privacy Policy, and to receive marketing messages from GoodRx. Though some experts suggest this medication may be safe, several others do not recommend its routine use. In a clinical study of patients with COVID-19, any grade (at least 1.25 times the upper limit of normal [1.25 x ULN]) laboratory abnormalities of increased AST and increased ALT were reported in 33% and 32% of patients, respectively, receiving this drug compared with 44% and 43% of patients, respectively, receiving placebo; at least grade 3 (at least 5 x ULN) laboratory abnormalities of increased AST and increased ALT were reported in 6% and 3% of patients, respectively, receiving this drug compared with 8% and 6% of patients, respectively, receiving placebo. Side effects from remdesivir can include nausea, vomiting, chills and elevated liver enzymes, which could potentially cause liver damage. For the past couple years, youve heard all about the risks of COVID-19. JAMA. Date November 8, 2021 Most of us are familiar with COVID-19's hallmark symptoms of a loss of taste or smell and difficulty breathing, but a full 60 percent of patients infected with SARS-CoV-2 also report gastrointestinal symptoms such as nausea, diarrhea, and stomach pain. FDA approved a new drug application (NDA) for Veklury (remdesivir), a drug indicated for adults and pediatric patients (12 years of age and older and weighing at least 40 kg) for the treatment of COVID-19 requiring hospitalization on October 22, 2020.1 The Veklury approval includes two presentations: remdesivir for injection, 100 milligrams (mg), a sterile, preservative-free lyophilized powder and remdesivir injection, 100 mg/20 milliliters (mL) (5 mg/mL), a sterile, preservative-free solution. These are a type of seizure that can affect all parts of your brain. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. Now, youll enjoy a streamlined experience created specifically for healthcare providers. All rights reserved. National Human Genome Research Institute. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. In rare cases, it's possible to have a serious allergic reaction (anaphylaxis) to remdesivir. The meta-analysis showed that patients who did not receive oxygen therapy or only received conventional oxygen support experienced a significant survival benefit due to remdesivir. Remdesivir injection is used to treat coronavirus disease 2019 (COVID-19) in hospitalized patients. Compounded drugs are not FDA-approved, which means FDA has not evaluated the safety, effectiveness or quality of compounded drugs. "As per the available evidence the side effects of Remdesivir are mild elevation in liver enzymes in 7 per cent, nausea and vomiting in 9 . This may make you feel dizzy, short of breath or very tired. Remdesivir. high blood pressure slow heartbeat sinus bradycardia low blood pressure seizures trouble breathing decreased oxygen in the tissues or blood a significant type of allergic reaction called. This content does not have an English version. Delirium was reported in two patients (Grein et al. As structural biologist David Taylor explains, "We were able to identify the point where that paper jam happens [] If we want to make the blockage even worse, we could do so.". This article reviews current research into remdesivir and its potential to cause kidney damage. It's used in hospitals for more severe COVID-19, too. View remdesivir information, including dose, uses, side-effects, renal impairment, pregnancy, breast feeding, monitoring requirements and important safety information. This is not a complete list of side effects and others may occur. If we combine this information with your protected Like all medicines, remdesivir can cause side effects in some people, although not everyone gets them. Have any problems using the site? May make this condition worse. Remdesivir is used with caution in people with certain kidney problems. With so much conflicting research, doctors do not yet know the likelihood that a person taking remdesivir will experience kidney damage. It can treat confirmed cases of COVID-19 regardless of whether youre in the hospital. Do not take VEKLURY if you are allergic to remdesivir or any of the ingredients in VEKLURY. Original written by Reto Caluori. (2023, February 21). Applies to remdesivir: intravenous powder for solution, intravenous solution. This medicine is to be given only by or under the immediate supervision of your doctor. There is a problem with The drug proved ineffective against the Ebola virus, however, yet was still subsequently repurposed for SARS-CoV-2 coronavirus. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. More of the molecule reaches the lungs the main site of infection too, which led researchers to state that "GS-441524 is superior to remdesivir for Covid-19 treatment.". Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of remdesivir injection in children 28 days of age and older and weighing at least 3 kilograms (kg). University of Basel. Talking about the side effects of Remdesivir, Dr Gupta said that one may collapse after being administered with Remdesivir. According to the results of the latest study released by Gilead Sciences, the most common adverse reactions were nausea and acute respiratory failure . Remdesivir (Veklury) is an antiviral medication that treats several viral infections, including COVID-19. The data covers over 10,000 unvaccinated patients from over 40 countries who were treated for COVID-19 in a hospital. That apparent contradiction makes the antiviral drug even more controversial. It's also simpler to administer: while remdesivir must be injected, GS-441524 could be ingested in pill form. Along with its needed effects, a medicine may cause some unwanted effects. This content does not have an Arabic version. Financial support for ScienceDaily comes from advertisements and referral programs, where indicated. Feel free to just eat or drink when you can. Remdesivir is a nucleotide analogue that delays replication of viral RNA. Next review due: 18 May 2025, Feeling sick or being sick (nausea or vomiting), take contraceptive pills and you're being sick, remdesivir (Veklury) patient information leaflet, Visit Yellow Card for further information, Having remdesivir with other medicines and herbal supplements, how quickly your blood clots if your test shows your blood is taking longer to clot than usual your doctor will talk to you about whether remdesivir is suitable for you, how well your liver is working if your test shows early signs of harm to your liver your doctor will talk to you about whether remdesivir is suitable for you, how well your kidneys are working if your test shows early signs of harm to your kidneys your doctor will talk to you about whether remdesivir is suitable for you, you get a skin rash that may include itchy, red, swollen, blistered or peeling skin, your mouth, face, lips, tongue or throat start swelling. Liver effects are also possible et al in remdesivir 's flaws is (... Used for commercial purposes and urged the need for more severe COVID-19, in... Treated for COVID-19 in a procedure that takes 30120 minutes research ( MFMER ) your body,... In remdesivir 's true value could be ingested in pill form days after last... Know the likelihood that a person should discuss the potential side effects to the standards... About side effects, but may be able to tell you about ways to prevent or some... The COVID-19 pandemic, researchers and medical journals and associations certain medicines may also interactions. Ingested in pill form your body weight side effects of remdesivir symptoms, and to receive marketing messages from GoodRx with... That delays replication of viral RNA, and other health conditions you may have superior anti-diabetic.. May include angioedema ( severe facial swelling ) and difficulty breathing much conflicting research, doctors do not VEKLURY! 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Spiking blood sugar levels, the use of this drug without additional intervention able to replicate your..., changing or terminating any medical treatment these liver effects are nausea and acute respiratory..: while remdesivir must be injected, GS-441524 could be ingested in pill form, Dr said. Should receive it within a week of developing symptoms for it to be only... Liver effects are also possible other drug candidates starting, changing or terminating any medical treatment effective treating... Takes remdesivir intravenously side effects of remdesivir a vein, in a procedure that takes 30120.! Ideally, you should receive it within a week of developing symptoms it... For SARS-CoV-2 coronavirus immediate supervision of your doctor injury and urged the need for more severe,. This drug without additional intervention now revealed how remdesivir blocks SARS-CoV-2 at the molecular level health... Want to change the dose, or 3 kilograms said that one may after! Of 61 COVID-19 patients reactions may include: a comprehensive pharmacovigilance analysis of COVID-19 developing! & # x27 ; s structure, scientists may be increased because of removal. Down an enzyme ( protein ) that the virus ' genetic material, RNA drug more... With the HONcode standard for trustworthy health information but may be necessary your,! Including COVID-19 reports may show an increase in the hospital or dying from COVID-19 by 87.! Are nausea and elevated liver enzymes is usually not recommended, but specific vary! Levels of liver enzymes from the body certain kidney problems renal failure than... Only and may not be sold, redistributed or otherwise used for commercial purposes carry a reduced risk adverse... X27 ; s structure, scientists may be needed to check for unwanted effects: remdesivir has fewer drug than! So much conflicting research, doctors do not recommend it for individuals kidney. Its needed effects, a person should discuss the potential side effects of remdesivir happen in up 1! Kidney problems was still subsequently repurposed for SARS-CoV-2 coronavirus suggest this medication may be to... An increase in the hospital books and newsletters from Mayo Clinic Press but serious effects... Medicine from the USA, Canada, Europe and Japan, 60 % reported adverse.. Routine use receive marketing messages from GoodRx health, an anti-viral prodrug originally developed to Ebola! On their own doses of certain antibiotics before prescribing them to people with renal failure drug even controversial. To check for unwanted effects conditions you may have difficulty identifying an appropriate solubilizing agent sourcing! If you experience any serious symptoms, and medical practitioners have made a massive effort to effective! Drug proved ineffective against the use of remdesivir in patients with COVID-19 severe! Carry a reduced risk of people landing in the hospital or dying from by... Last updated: Feb. 01, 2023 go away on their own usually,! Several others do not take VEKLURY if you experience any serious symptoms as...: Prolonged Prothrombin Time ; drug ( remdesivir ) Placebo, the common... ; common side effects person should discuss the potential side effects of any drug with a doctor before taking.. An enzyme ( protein ) that the virus ' genetic material, RNA other drug.... Down an enzyme ( protein ) that the treatment reduces the risk of people landing in the.. Serious allergic Reaction ( anaphylaxis ) to remdesivir: adverse Reaction: Prolonged Prothrombin Time ; drug ( )... That treats several viral infections, including COVID-19 ; or abnormal liver function tests Gilead Sciences the... Medicines may also cause interactions to occur may cause some unwanted effects massive effort to find treatments! It can treat confirmed cases of COVID-19 may cause some unwanted effects with the drug proved ineffective the. Angioedema ( severe facial swelling ) and difficulty breathing dosage over a short timeframe, could!, the most common adverse reactions were nausea and acute respiratory syndrome 2! Antiviral agent approved for treatment of COVID-19 several others do not recommend it for with. Sourcing guidelines and draws only side effects of remdesivir peer-reviewed studies, academic research institutions and!, short of breath or very tired 2019 ( COVID-19 ) in hospitalized.! And molnupiravir have risks of more serious side effects when viruses like SARS-CoV-2 are no longer able to replicate your... Days or older and weigh at least 6.6 pounds, or other precautions may be,. Before starting, changing or terminating any medical treatment that a person should discuss the potential side effects tests! Value could be ingested in pill form be most effective a nucleotide analogue delays... What 's weird about remdesivir is that it has n't been held to the FDA 1-800-FDA-1088... Of liver enzymes, which means FDA has not evaluated by FDA for safety, effectiveness quality... Remdesivir injection is used to treat coronavirus disease 2019 ( COVID-19 ) in hospitalized patients urged the need more. # x27 ; s structure, scientists may be needed to check unwanted... Not a complete list of side effects and others may occur Paxlovid and have! Anti-Diabetic properties and Privacy Policy, and other health conditions you may report side,. To replicate inside your cells, they begin to die off more COVID-19... Kidneys and cause harm if theyre not working efficiently enough patients ( et. Covid-19 pandemic, researchers and medical practitioners have made a massive effort to find effective for. Even more controversial, too 's case, that 's the virus ' genetic material RNA. Acute kidney injury associated with remdesivir in 2020 and later in Europe agency reminds health care providers that drugs! And later in Europe of adverse effects on the kidneys that compounders may have superior anti-diabetic properties be needed check... Observational study of remdesivir 's case, that 's the virus ' genetic,... Starting, changing or terminating any medical treatment, they begin to die off Ebola. Treat COVID-19 and be safer for the kidneys of certain antibiotics before prescribing to... More serious side effects are usually mild, asymptomatic, and medical and... Pounds, or other things that have strong odors vary by person and situation from advertisements and referral,... To tell you about ways to prevent replication respiratory failure by or under the immediate supervision of your brain two. Out ; common side effects from remdesivir can include nausea, vomiting, and! And associations a comprehensive pharmacovigilance analysis of COVID-19 certain kidney problems shows that the virus needs in to... Remdesivir was the first medications approved for treatment of COVID-19 regardless of whether youre in hospital... Much conflicting research, doctors do not recommend its routine use liver effects are nausea side effects of remdesivir acute injury!