In line with regulations put in place by the FDA, prescribing information is divided into the Highlights of Prescribing Information, the Table of Contents, and the Full Prescribing Information. The Full Prescribing Information includes the following sections: [2]

• Section 1: Indications and Usage
• Section 2: Dosage and Administration
• Section 3: Dosage Forms and Strengths
• Section 4: Contraindications
• Section 5: Warnings and Precautions
• Section 6: Adverse Reactions
• Section 7: Drug Interactions
• Section 8: Use in Specific Populations
• Section 9: Drug Abuse and Dependence
• Section 10: Overdosage
• Section 11: Description
• Section 12: Clinical Pharmacology
• Section 13: Nonclinical Toxicology
• Section 14: Clinical Studies
• Section 15: References
• Section 16: How Supplied/Storage and Handling
• Section 17: Patient Counseling Information

There’s also rarely a “Recent Major Changes” section that can be added. In this section, new updates are added by the FDA to alert patients of significant new changes or things discovered in post-marketing surveillance.

Learn more about the Full Prescribing Information including the parts of the drug label and what they contain at FDA.gov.

A contraindication refers to a situation where a patient’s medical condition or medical history poses a risk that outweighs the potential benefit of the drug. For example, pregnancy is a common contraindication as drugs may pose theoretical risks to the mother and/or fetus. 

A drug interaction refers to a description of any potential interactions with other medications, drugs, or drug classes, that could lead to an increased frequency or severity of an adverse reaction or decrease the effectiveness of a drug. For example, cyclosporine and gentamicin when taken together can affect kidney function, so they have a drug interaction. This does not mean that the medications can never be taken together, but that they should be used with extreme caution. If a health care provider is prescribing medications that have drug interactions, they may closely monitor the patient by drawing blood and checking labs to make sure there are no significant adverse outcomes. [2]

In addition to talking to your health care provider and pharmacist, there are tools online that can check if there are any interactions between treatments or supplements you are taking. You can access Medscape’s Interaction Checker. Using an online tool like this can help you prepare for a discussion with your health care provider but should not replace the discussion with your provider. Sometimes, health care providers may prescribe something for patients that are contraindicated or have drug-drug interactions due to necessity. In this case, a thorough discussion with your health care provider about what symptoms or side effects to watch for would be beneficial.

Risk means that there is a chance of something happening. Being at risk for something does not mean it will happen; just that it is a possibility. Often information about risk comes from research studies. You may have different characteristics (age, gender, or other health conditions) than the people in the studies, so your risk may be different. For example, a biologic may put one at risk for upper respiratory tract infections. However, if you wear a mask to avoid being exposed to people who are sick, then your risk is lowered and you may not get sick. 

It may be helpful to think of risk as the chance, or likelihood, that you might personally experience a given side effect or adverse event. Talk with your health care provider if you are concerned about your risk. They may be able to help you understand your risk better because they know you and your health history.

You may also consider the risk of not treating your psoriatic disease effectively and what may result from that decision. Not treating your psoriasis may lead to uncontrolled inflammation in the body and an increased risk of developing a comorbidity. Untreated psoriatic arthritis can lead to permanent joint damage in as little as 6 months.

Side effects are unintended results of using a treatment, they can be good or bad. Some can be common while others are rare. It is important to learn more about side effects and how likely you are to experience them.

Before a treatment is made available to the public, it must be researched to show that it is safe and effective. These studies must report side effects that patients develop while they are using the treatment. But it can be hard to determine if the treatment itself caused the person to develop the side effect or if a person would have developed that side effect without using the treatment. This is why you may see a long list of possible side effects even though your likelihood of experiencing a side effect may be low.

In contrast to side effects, adverse events are always "bad", and usually occur less frequently. An adverse reaction is defined by the FDA as an "undesirable effect, reasonably associated with the use of a medicine, for which there is some basis to believe that there is a causal relationship between the medicine and the occurrence of the undesirable effect." [1] Adverse reactions are listed in the prescribing information for that treatment. This section of the prescribing information typically lists the most common serious (including fatal) adverse reactions, including adverse reactions that require pausing, reducing, or stopping treatment. [2]

If you think you have experienced an adverse reaction to your medicine it is important to tell your health care provider immediately, especially if it is serious. You can also report the event through the FDA's MedWatch website or by calling 1-800-FDA-1088.

A boxed warning (sometimes referred to as a “black-box warning”) contains contraindications or warnings about serious adverse reactions that may lead to death or serious injury. These warnings are bolded and surrounded by a single black line (box) and placed prominently at the beginning of the prescribing information for a treatment. [1]

While it's important to consider boxed warnings, these concerns can be added to the package insert for a variety of reasons. Sometimes there are warnings because of an adverse event seen when the drug was tested in psoriatic disease studies. But sometimes boxed warnings are added to psoriatic disease medications because significant adverse events were seen when similar classes of drug were used in other conditions, sometimes at higher doses. Such warnings can also be added when there is not enough data to confirm whether a particularly severe event was due to to the medication itself or happened by chance. 

If a medication you are considering has a boxed warning, it should be taken seriously, but you should also talk to the prescribing health care provider about the warning and how it applies specifically to psoriatic disease.

The following are some questions that you may want to ask your health care provider about your prescribed treatment.

• What are some common side effects of this medication? If a side effect does happen, what should I do? 
• What are the possible long-term risks? How likely is it that I will develop them? Is there anything I can do to reduce the risks?
• Will I need to do tests or bloodwork while taking this treatment? If so, what kind of tests and how often?
• Who do I contact if I experience side effects while taking this treatment?
• Can this medication interact with other medications or supplements I’m currently taking?
• Are there any foods, drinks, or activities I should avoid while taking this medication?
• Is it safe to take this medication if I am pregnant, planning to become pregnant, or breastfeeding?

1. U.S. Food and Drug Administration. (2024, April 1). Frequently Asked Questions about Labeling for Prescription Medicines. FDA. Retrieved October 17, 2024, from https://www.fda.gov/drugs/fdas-labeling-resources-human-prescription-drugs/frequently-asked-questions-about-labeling-prescription-medicines
2. U.S. Food and Drug Administration. (2023, March 29). How Do I Use Prescription Drug Labeling. FDA. Retrieved October 17, 2024, from https://www.fda.gov/about-fda/oncology-center-excellence/how-do-i-use-prescription-drug-labeling