Do not take any prescription medication, including Plaquenil or hydroxychloroquine, unless your doctor advises that you do so.
For information about COVID-19 and its treatment recommendations, view our COVID-19 hub.
Plaquenil is a brand-name prescription drug. It’s approved by the Food and Drug Administration (FDA) for the following purposes.
- Treating lupus. With lupus, the immune system attacks healthy tissues throughout the body. This leads to inflammation that can affect joints, muscles, skin, and other organs. Doctors can prescribe Plaquenil for systemic lupus erythematosus or long-term discoid lupus erythematosus in adults.
- Treating rheumatoid arthritis (RA). With RA, the immune system attacks your joints, typically in your wrists, hands, and knees. This leads to inflammation that can cause joint stiffness and pain. Doctors can prescribe Plaquenil for RA in adults.
- Treating or helping prevent malaria. Malaria is caused by a parasite that typically spreads to a person through a mosquito bite. This can lead to symptoms such as fever or chills. Doctors can prescribe Plaquenil for this use in adults and children of any age who weigh at least 31 kilograms (kg), which is about 68 pounds (lb).
For details about these conditions and how the drug treats them, see the “Plaquenil: Uses” section below.
The following table provides key facts about Plaquenil.
Finding a healthcare professional
Plaquenil is a brand-name medication. It contains the active drug hydroxychloroquine, which also comes in a generic form. A generic is an identical copy of the active drug found in a brand-name medication.
The Food and Drug Administration (FDA) ensures that generic drugs are as safe and effective as their original drug. Generics tend to be less expensive than brand-name drugs.
If you’d like to know about the generic version of Plaquenil, ask your doctor or pharmacist. They can tell you if the generic medication comes in forms and strengths recommended for your condition.
As with most drugs, it’s possible to have side effects with Plaquenil. These can include some mild side effects, but also some serious ones.
To learn more about Plaquenil’s side effects, talk with your doctor or pharmacist. They may also provide information about managing certain side effects of this drug.
Keep in mind that Plaquenil was approved by the Food and Drug Administration (FDA) in 1955. At that time, the process for approving medications was not as thorough as it is today. As a result, details about Plaquenil’s side effects weren’t collected until after the drug became available for the public to use. For this reason, it isn’t known for certain whether the side effects below occurred in clinical studies.
Note: The FDA tracks side effects of drugs it has approved. If you would like to notify the FDA about a side effect you’ve had with Plaquenil, you can do so through MedWatch.
Mild and serious side effects
Mild and serious side effects of Plaquenil are listed below. This article does not include all of Plaquenil’s possible side effects.
Mild side effects
Mild side effects* of Plaquenil may include:
- hair loss
- irritability or nervousness
- ringing in the ears
- weight loss
- digestive problems, such as abdominal pain, nausea, vomiting, or diarrhea
- allergic reaction†
* This is not a complete list of Plaquenil’s mild side effects. To learn about other mild side effects of this drug, ask your doctor or pharmacist. Or you can view the drug’s prescribing information.
† To learn more about allergic reaction, see below. An allergic reaction is possible after taking Plaquenil. However, it’s not clear whether this side effect occurred in clinical studies.
Serious side effects
Serious side effects of Plaquenil may include:
- ear problems, such as hearing loss
- eye side effects, such as retinal toxicity (damage to the retina, which is the layer of tissue lining the back of your eye)
- liver problems, such as liver failure
- low blood sugar level
- mental health problems, such as depression, mood changes, or suicidal thoughts and behaviors
- muscle problems, such as muscle pain or weakness
- nerve problems, such as nerve damage
- sleep problems, such as nightmares
- heart problems, such as cardiomyopathy (muscle damage in the heart)
- serious skin reactions, such as Stevens-Johnsons syndrome
- blood disorders, such as low levels of blood cells
- severe allergic reaction*
* To learn more about allergic reaction, see below. An allergic reaction is possible after taking Plaquenil. However, it’s not clear whether this side effect occurred in clinical studies.
Most times, mild side effects of a drug go away within a few days or a couple of weeks. Talk with your doctor or pharmacist if any side effects become severe or don’t go away.
Serious side effects from Plaquenil aren’t common, but they are possible. If you have serious side effects, call your doctor right away. However, if you’re having a medical emergency or your symptoms feel life threatening, call 911 or your local emergency number.
If you know someone at immediate risk of self-harm, suicide, or hurting another person:
- Ask the tough question: “Are you considering suicide?”
- Listen to the person without judgment.
- Call 911 or the local emergency number, or text TALK to 741741 to communicate with a trained crisis counselor.
- Stay with the person until professional help arrives.
- Try to remove any weapons, medications, or other potentially harmful objects.
If you or someone you know is having thoughts of suicide, a prevention hotline can help. The National Suicide
Prevention Lifeline is available 24 hours per day at 800-273-8255. During a crisis, people who are hard of hearing can use their preferred relay service or dial 711 then 800-273-8255.
As with most drugs, some people can have an allergic reaction after taking Plaquenil. A more severe allergic reaction is rare but possible.
It’s not clear whether this allergic reaction occurred in clinical studies.
Possible symptoms of mild and serious allergic reactions are listed in the table below.
|Mild allergic reaction symptoms||Serious allergic reaction symptoms|
|• flushing||• swelling under your skin, possibly in your hands, feet, lips, or eyelids|
|• rash||• swelling in your throat or mouth|
|• itching||• trouble breathing|
If you have an allergic reaction to Plaquenil, call your doctor right away. This is important to do because the reaction could become severe.
However, if you’re having a medical emergency or your symptoms feel life threatening, call 911 or your local emergency number.
Below, you’ll find dosages that are commonly recommended for Plaquenil. However, you should take the dosage your doctor prescribes for you. They’ll recommend the dosage that’s best for your needs.
The dosage of Plaquenil that your doctor prescribes will depend on factors such as:
- your age
- any health conditions you have
- the condition you’re using Plaquenil to treat and the severity of the condition
- the side effects you may have
Plaquenil’s forms and strengths
Plaquenil is available as follows.
- Form: oral tablet
- Strength: 200 milligrams (mg)
Plaquenil’s recommended dosage
Recommended dosages for Plaquenil in adults and children are described below.
Plaquenil is approved for these uses in adults:
Plaquenil’s recommended dosages for these uses are described below.
|lupus treatment||• 200 mg once or twice daily, or
• 400 mg once daily
|RA treatment||• starting dosage: 400 mg to 600 mg once daily or as divided doses taken twice daily
• maintenance dosage: 200 mg once or twice daily, or 400 mg once daily
|malaria treatment||800 mg taken once, followed by 400 mg taken at 6 hours, 24 hours, and 48 hours after the first dose|
|malaria prevention||400 mg once weekly, starting 2 weeks before travel and ending 4 weeks after travel|
Plaquenil is approved to treat or help prevent malaria in children. Doctors can prescribe the drug for children of any age who weigh at least 31 kilograms (kg), which is about 68 pounds (lb).
Recommended dosages for Plaquenil in children are described below. These dosages are based on a child’s weight in kg. One kg is about 2.2 lb.
|malaria treatment||13 mg/kg taken once, followed by 6.5 mg/kg taken at 6 hours, 24 hours, and 48 hours after the first dose|
|malaria prevention||6.5 mg/kg once weekly, starting 2 weeks before travel and ending 4 weeks after travel|
Below are some things to consider about Plaquenil’s dosage.
- Missing a dose. What you’ll do about a missed dose likely depends on the reason you’re taking Plaquenil. If you miss a dose of the drug, talk with your doctor or pharmacist. They’ll recommend what to do about a missed dose of Plaquenil. View these medication reminder options to help avoid missing doses. You could also set an alarm, use a timer, or download a reminder app on your phone.
- Length of treatment. Doctors typically prescribe Plaquenil as a long-term treatment for lupus or RA. You’ll likely take it long term if you and your doctor feel it’s safe and effective for your condition. However, Plaquenil is usually prescribed short term for treating or helping prevent malaria.
Prescription drugs, such as Plaquenil, are approved by the Food and Drug Administration (FDA) to treat certain conditions. Doctors sometimes prescribe drugs off-label for other conditions. With off-label use, doctors prescribe a drug for a purpose other than what it’s approved for.
Using Plaquenil for lupus
The FDA has approved Plaquenil to treat lupus in adults.
Doctors can prescribe Plaquenil for specific types of lupus in adults. Below are the types of lupus Plaquenil may be used to treat, along with symptoms of each.
|Type of lupus||Symptoms|
|systemic lupus erythematosus||• fever
• hair loss
• butterfly rash across the cheeks and nose
|long-term discoid lupus erythematosus||• skin peeling
• discolored skin
Using Plaquenil for rheumatoid arthritis
The FDA has approved Plaquenil to treat rheumatoid arthritis (RA) in adults. This includes acute RA (flare-ups of RA symptoms) and chronic RA (RA symptoms that lead to long-term effects, such as joint damage).
With RA, the immune system attacks your joints, typically in your wrists, hands, and knees. This leads to inflammation that can cause joint stiffness and pain.
Other symptoms of RA can include:
Using Plaquenil for malaria
The FDA has approved Plaquenil to treat or help prevent malaria. Doctors can prescribe Plaquenil for this use in adults and children of any age who weigh at least 31 kilograms (kg), which is about 68 pounds (lb).
Malaria is caused by a parasite, and it typically spreads to a person through a mosquito bite. It’s common in tropical regions of the world. Malaria can cause symptoms such as:
Plaquenil’s limitations of use
The manufacturer of Plaquenil has noted some limitations of the drug’s use. These are situations in which treatment with the drug may not be recommended.
Doctors aren’t likely to prescribe Plaquenil for certain types of malaria. For example, they won’t prescribe the drug for malaria caused by an unknown parasite. They also won’t prescribe it for the types of malaria that don’t typically improve after treatment with Plaquenil. Additionally, doctors won’t prescribe Plaquenil to treat severe malaria. Your doctor will advise whether Plaquenil is the right medication for you.
Taking Plaquenil with other drugs
Your doctor can recommend the combination of drugs that’s right for you.
Using Plaquenil in children
The FDA has approved Plaquenil to treat or help prevent malaria in certain children. Specifically, doctors can prescribe the drug for children of any age who weigh at least 31 kg (about 68 lb).
For details about this condition, see the “Using Plaquenil for malaria” section above.
Finding a healthcare professional for Plaquenil
If you’re interested in taking Plaquenil, you can find a doctor who might prescribe it by searching here. You can prepare for your appointment by viewing Healthgrades’ appointment guide for lupus or rheumatoid arthritis.
Here are some common questions about Plaquenil and brief answers to them. If you’d like to know more about these topics, ask your doctor.
Does Plaquenil cause weight gain?
However, weight loss has been reported since the drug became available for use.
To learn more about weight gain and Plaquenil, talk with your doctor. They can suggest ways to reach or maintain a weight that is healthy for you while taking the drug.
Will I have side effects when stopping Plaquenil?
Side effects aren’t likely to happen when stopping Plaquenil.
If you’d like to stop Plaquenil treatment, talk with your doctor. If they tell you it’s safe to stop, they can recommend other ways to manage your symptoms. For example, they may prescribe a different treatment for your condition.
Is Plaquenil a steroid?
No, Plaquenil is not a steroid.
Instead, Plaquenil belongs to a class of drugs called antimalarials. The drug is used to treat and help prevent malaria. In addition, Plaquenil is also approved to treat lupus and rheumatoid arthritis.
To learn more about how the drug is used for these conditions, see the “Plaquenil: Uses” section below.
Do doctors prescribe Plaquenil for arthritis?
Plaquenil is not approved to treat osteoarthritis (OA), which is commonly called arthritis. However, doctors sometimes prescribe the drug off-label for this condition. With off-label use, doctors prescribe a drug for a purpose other than what it’s approved for.
Plaquenil isn’t approved to treat OA, but it is approved for rheumatoid arthritis (RA).
Both OA and RA cause inflammation that leads to joint stiffness and pain. OA happens because of wear and tear on your bones or joints over time. However, RA happens when your immune system attacks your joints. (For more information about RA, see “Plaquenil: Uses” above.)
If you have arthritis and are interested in taking Plaquenil, talk with your doctor. They can recommend whether Plaquenil is the right treatment for you.
Your doctor will recommend how you should take Plaquenil. It’s important that you take the drug exactly as your doctor instructs.
Plaquenil comes as an oral tablet. You’ll take the drug by swallowing it.
Questions about taking Plaquenil
Here’s a list of common questions related to taking Plaquenil.
- When should I take Plaquenil? When you’ll take Plaquenil depends on the reason you’re taking the drug. For treating lupus orrheumatoid arthritis, you’ll likely take Plaquenil once or twice a day. Taking Plaquenil around the same time of day helps keep a steady level of it in your body. This helps the medication work effectively. For treating malaria, you’ll take several doses of Plaquenil within 48 hours. To help prevent malaria, you’ll take the drug once each week. (For exact details, see the “Plaquenil: Dosage” section above.) View these medication reminder options to help avoid missing doses of Plaquenil. You could also set an alarm, use a timer, or download a reminder app on your phone.
- Is there a best time of day to take Plaquenil? No, there isn’t a best time of day to take Plaquenil. You can take the drug any time of day. Because Plaquenil is taken with food, you may find it easiest to take the drug with a meal.
- Do I need to take Plaquenil with food? Yes, you’ll take Plaquenil with food or milk.
- Can Plaquenil be chewed, split, or crushed? No, you should not chew, split, or crush Plaquenil tablets. You’ll swallow the tablets whole.
As with other medications, prices for Plaquenil may vary. The drug’s price will depend on factors such as:
Cost considerations for Plaquenil
Here’s a list of things to consider when looking into the cost of Plaquenil.
- Option for a 90-day supply. For some drugs, it’s possible to get a 90-day supply. If this option is approved by your insurance company, it can help lower the cost of the drug. It can also help you avoid frequent trips to your pharmacy. If you’d like to learn more about this option, ask your doctor, pharmacist, or insurance company.
- Need for prior authorization. Before insurance coverage for Plaquenil is approved, your insurance company may require prior authorization. In this case, your doctor and insurance company will communicate about your prescription for Plaquenil. Then, the insurance company will decide if the drug will be covered. To find out if you need prior authorization for Plaquenil, contact your insurance company.
- Possible cost assistance options. Financial assistance to help lower the cost of Plaquenil may be available. Visit the Medicine Assistance Tool site to learn about possible programs to help reduce the drug’s cost. Also, check out this article to learn about ways to save on prescription drugs.
- Use of a mail-order pharmacy. Plaquenil may be dispensed through mail-order pharmacies. Getting your prescription through a mail-order pharmacy could lower its cost. It can also allow you to get the drug without leaving home. To find out more about this option, check with your doctor, pharmacist, or insurance company.
- Availability of a generic form. Plaquenil comes in a generic form called hydroxychloroquine. A generic drug is an exact copy of the active drug in a brand-name medication. Generics are typically less expensive than brand-name drugs. If your doctor prescribes Plaquenil, but you want to know about taking hydroxychloroquine, talk with your doctor about which option might be better for you. Also, check your insurance plan because it might cover just one form or the other.
There aren’t any known interactions between Plaquenil and alcohol.
However, both Plaquenil and alcohol may cause liver damage. So drinking alcohol while taking Plaquenil could increase your risk of this side effect.
If you drink alcohol, talk with your doctor. They can recommend an amount of alcohol that’s safe for you to consume while taking the drug.
Plaquenil is approved for the uses below:
To learn more about these conditions, see the “Plaquenil: Uses” section above.
Plaquenil belongs to a drug class called antimalarials. The way it works in the body to help prevent malaria or treat malaria, lupus, or RA isn’t completely understood. However, it’s thought the drug may work by affecting certain processes in the immune system.
If you have questions about how Plaquenil works for your condition, talk with your doctor or pharmacist.
How long does Plaquenil take to start working?
How long Plaquenil takes to start working depends on the reason you’re taking the drug. For lupus or RA, it may take several weeks to notice your symptoms ease. However, for malaria, Plaquenil will start to treat or help prevent the condition right away.
Talk with your doctor or pharmacist about what to expect with Plaquenil treatment.
Plaquenil may interact with other medications. It’s not known to interact with herbs, supplements, or foods.
Different interactions can cause different effects. Some interactions can interfere with a drug’s effectiveness. Others can increase a drug’s side effects or cause them to be severe.
If any of the interactions listed below might pertain to you, talk with your doctor. They can tell you what you need to do to avoid the interaction.
- Plaquenil and certain other medications. Because Plaquenil may interact with the following drugs, your doctor may recommend that you don’t take it with these drugs. Examples include:
- seizure drugs, such as carbamazepine (Tegretol)
- antacids, such as aluminum/magnesium hydroxide (Maalox)
- diabetes drugs, such as insulin
- other antimalarial drugs
- abnormal heart rhythm drugs, including digoxin (Lanoxin)
- certain mood disorder drugs, such as quetiapine (Seroquel, Seroquel XR) and haloperidol
- the antibiotics rifampin (Rimactane) and ampicillin
- the organ transplant rejection drug cyclosporine (Gengraf, Neoral)
- the rheumatoid arthritis drug methotrexate (Trexall)
- the stomach ulcer drug cimetidine (Tagamet HB)
- the anti-worm drug praziquantel (Biltricide)
- the tricyclic antidepressant drug amitriptyline
- Plaquenil and herbs and supplements. No herbs or supplements are known to interact with Plaquenil. However, to be safe, check with your doctor or pharmacist before taking any of these products with Plaquenil.
- Plaquenil and foods. No foods are known to interact with Plaquenil. If you have questions about eating certain foods with Plaquenil, talk with your doctor or pharmacist.
For information about drug-condition interactions, see the “Plaquenil: Precautions” section below.
Doctors may prescribe drugs other than Plaquenil for your condition. Certain drugs may work better for you than others.
Plaquenil is used to treat lupus, rheumatoid arthritis (RA), and malaria. Here’s a summary of other drugs that doctors sometimes prescribe for RA. And here’s information about treatment options for lupus.
For more information about alternatives to Plaquenil, ask your doctor. They can tell you about other medications that could be prescribed for your condition.
It’s not known whether Plaquenil is safe to take during pregnancy.
If you’re pregnant or planning to become pregnant while taking Plaquenil, talk with your doctor. They can recommend whether it’s safe for you to take the drug.
If you do take Plaquenil during pregnancy, consider enrolling in the drug’s pregnancy registry. Registries collect information about the safety of a drug when taken during pregnancy. To learn more, talk with your doctor or call 877-311-8972.
Plaquenil and birth control needs
Doctors aren’t sure whether it’s safe to take Plaquenil during pregnancy. Talk with your doctor about your birth control needs with Plaquenil if you’re sexually active and you or your partner can become pregnant. Your doctor can recommend if you should use birth control with this medication.
It’s not known whether Plaquenil is safe to take while breastfeeding.
A small amount of Plaquenil does pass into breast milk. However, no side effects have been reported in children breastfed by a person who took the drug.
If you’re breastfeeding or planning to breastfeed while taking Plaquenil, talk with your doctor. They can advise whether it’s safe for you to take the drug during this time.
Tell your doctor about your health history before starting treatment with Plaquenil. Your doctor may not recommend this medication if you have certain factors affecting your health or specific medical conditions. These situations are considered drug-condition interactions.
These factors and conditions include those listed below.
- Psoriasis or porphyria. If you have psoriasis or porphyria, taking Plaquenil could worsen your condition. Talk with your doctor about whether Plaquenil is safe for you to take.
- Liver problems. If you have liver problems, such as liver failure, talk with your doctor before taking Plaquenil. They may give you a lower dose of the drug than usual.
- Low levels of electrolytes in the blood. Before taking Plaquenil, tell your doctor if you have low levels of the electrolytes potassium or magnesium. These conditions could increase your risk of certain heart problems with Plaquenil. Your doctor will likely give you treatments to increase your levels of potassium or magnesium before you start Plaquenil.
- Eye problems. In rare cases, Plaquenil may cause serious eye problems. If you have eye problems, such as macular degeneration, you may have a higher risk of eye side effects with Plaquenil. Talk with your doctor about whether Plaquenil is a safe treatment option for you.
- Heart problems. Plaquenil may cause heart problems, such as abnormal heart rhythm. Your risk of this side effect may be higher if you already have heart problems before taking the drug. Your doctor can recommend whether it’s safe to take Plaquenil.
- Kidney problems. Kidney problems can increase your risk of certain eye side effects with Plaquenil. This includes retinal toxicity (damage to the retina, which is the layer of tissue lining the back of your eye). Before taking Plaquenil, tell your doctor if you have kidney problems such as kidney failure. They can advise whether it’s safe for you to take Plaquenil. Your doctor may also prescribe you a lower dosage of the drug than usual.
- Mental health conditions. Although rare, Plaquenil may cause mental health problems, such as depression, mood changes, or suicidal thoughts and behaviors. Before taking Plaquenil, tell your doctor if you have any mental health conditions. They can tell you if Plaquenil is safe to take.
- Low level of certain blood cells. Plaquenil can cause a low level of white blood cells, red blood cells, or platelets. Before taking Plaquenil, your doctor may check the levels of these blood cells. If you have low levels before starting treatment with Plaquenil, your doctor can advise whether the drug is right for you.
- Glucose-6-phosphate dehydrogenase (G6PD) deficiency. Before taking Plaquenil, tell your doctor if you have G6PD deficiency. (G6PD is a protein that helps your red blood cells function correctly.) If you have this condition, Plaquenil could cause your red blood cells to burst. Your doctor will advise if Plaquenil is safe for you to take.
- Allergic reaction. Your doctor will likely not prescribe Plaquenil if you’ve had an allergic reaction to it or any of its ingredients. To find out about other treatment options, talk with your doctor.
- Pregnancy. It isn’t known whether Plaquenil is safe to take during pregnancy. If you’d like more information about taking Plaquenil while pregnant, view the “Plaquenil: Taking while pregnant” section above.
- Breastfeeding. It’s not known whether Plaquenil is safe to take while breastfeeding. If you’d like more information about taking Plaquenil while breastfeeding, view the “Plaquenil: Taking while breastfeeding” section above.
To learn more about effects of Plaquenil that could be harmful, see the “Plaquenil: Side effects” section above.
Serious effects can occur if you use more than the recommended dosage of Plaquenil. Do not use more Plaquenil than your doctor recommends.
In rare cases, an overdose with Plaquenil can be life threatening and may lead to a coma.
Symptoms of overdose
Symptoms that an overdose could cause include:
- low blood pressure
- low level of potassium in the blood
- depression (slowing) of the central nervous system
- vision problems, such as temporary blindness
- heart problems, such as abnormal heart rhythm
What to do in case of overdose
Call your doctor if you think you’ve taken too much of this drug. Also, you can call the American Association of Poison Control Centers at 800-222-1222 or use its online tool. However, if your symptoms are severe, call 911 or your local emergency number. Or go to the nearest emergency room right away.
Here’s some information about Plaquenil’s expiration date, as well as how to store and dispose of the drug.
- Expiration. Your pharmacist will add an expiration date to the label on Plaquenil’s bottle. This date is usually 1 year from the date the medication was dispensed to you. Expiration dates help ensure that a medication is effective during a period of time. The Food and Drug Administration (FDA) advises that you avoid using expired drugs. If you have an unused medication and it’s past the drug’s expiration date, talk with your pharmacist. They can let you know whether you might still be able to use the medication.
- Storage. Many factors determine how long a medication remains good to use. These factors include how and where you store the drug. Plaquenil tablets should be stored at room temperature up to 86°F (30°C). The drug can temporarily be stored at temperatures between 59°F and 86°F (15°C and 30°C), such as when traveling. Avoid storing it in areas where it could get damp or wet, such as bathrooms. The medication should be kept away from light in a tightly sealed container.
- Disposal. It’s important to safely dispose of Plaquenil if you no longer need to take it and have unused medication. Doing so helps prevent others, including children and pets, from accidentally taking the drug. It also helps avoid causing harm to the environment. Ask your pharmacist for information about disposing of Plaquenil. Also, check out this page for several tips on safe medication disposal.
If you have questions about Plaquenil, talk with your doctor. They can help advise you on whether Plaquenil could be a good treatment option for you.
Here’s a list of questions you may want to ask your doctor:
- How is Plaquenil different from other treatment options for my condition?
- Does my Plaquenil dosage affect my risk of side effects from the drug?
- Will my hearing be affected by Plaquenil?
Your doctor may also tell you about other treatment options for your condition. You may find this article helpful in learning about alternative drugs for rheumatoid arthritis (RA). And view our selection of videos on RA.
Disclaimer: Healthgrades 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.