Generic Drugs: Questions & Answers
A generic drug is a medication created to be the same as an already marketed brand-name drug in dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use.
Select a question to see the answer:
- What are generic drugs, and are they as safe and effective as brand name drugs?
- Why do generics often cost less than brand name drugs?
- Why might a generic pill look different than a brand name pill?
- Why is there an expiration date, the tablet looks perfectly fine?
- How does FDA make sure generic drugs are safe and effective?
- What should I do if I think a medication isn’t working or causes a problem?
- Can generic drugs cause different side effects than brand name drugs?
- Are all prescription drugs available as generics?
- How does FDA ensure the quality of generic drugs manufactured outside of the U.S.?
- Why does it seem like there are more problems with generic drugs compared to brand drugs?
- What happens when problems are found on inspections?
- Why are there drug shortages related to generic drugs?
- I’ve read that generic drugs contain “impurities” does that mean they’re unsafe?
- I read that my medication contains nitrosamines. What are nitrosamines?
- What is the FDA’s approval pathway for generic drugs?
- What does “bioequivalence” mean in practical terms?
- Can MedWatch reports lead to regulatory action?
- Does the FDA perform quality testing on generic drugs?
- Do differences in inactive ingredients matter clinically?
- How does FDA detect and address substitutability problems in marketed products?
- How many reports does FDA need before it takes action on quality complaints?
Generic drugs are FDA-approved copies of brand drugs. Generic drugs contain the same active ingredients and must work the same way in the body as the brand drug, and have the same strength, dosage form (tablet, liquid, etc.), and route of administration (taken by mouth, injectable, etc.) as the brand drug, along with the same label information and instructions (with certain exceptions). Generic drugs must meet the same scientific standards for quality as the brand drugs.
Brand drugs are typically more costly to develop than generic drugs because the drug may never have been tested in humans before, and the company developing brand drugs conduct clinical studies to demonstrate the drug’s safety and effectiveness. The necessary studies can take multiple years to complete and may be costly.
Generic drug companies do not need to repeat the costly clinical trials that establish a drug’s safety and effectiveness. Instead, the generic drug manufacturer assures safety and effectiveness by demonstrating that their product is therapeutically equivalent to the brand drug.
FDA generally allows minor differences in appearance between generic and brand drugs, such as in color. These minor differences do not affect how the medicine works.
FDA conducts a rigorous review of generic drugs before approving them to ensure the generic drugs work the same as the brand drug. Every batch of medication sold in the U.S. must meet the same strict quality standards.
After approval, brand and generic drugs are continuously monitored for safety signals that may indicate a potential problem. FDA takes appropriate steps to ensure patient safety if the agency identifies a safety signal.
After a drug’s expiration date, natural chemical changes can occur which can affect the safety and effectiveness of a drug. FDA recommends patients not use drugs after the expiration date.
Even if your tablet looks fine, using medication past its expiration date means you may be getting less of the active ingredient than you need or the drug may no longer be safe and effective.
FDA conducts a rigorous review of generic drugs before approving them to ensure the generic drugs work the same as the brand drug. Every batch of medication sold in the U.S. must meet the same strict quality standards.
After approval, brand and generic drugs are continuously monitored for safety signals that may indicate a potential problem. FDA takes appropriate steps to ensure patient safety if the agency identifies a safety signal.
Talk to your doctor or pharmacist and consider reporting the issue to FDA’s SmartHub. Patients and consumers can report side effects and quality issues to FDA, even if you are not sure the drug caused the problem.
Generic drugs are designed to work the same way as the brand drug, including to be expected to have the same clinical effect and safety profile as the brand drug, but small, allowable differences between the products manufactured by different companies (such as in certain inactive ingredients) can sometimes feel noticeable to patients. If you experience a side effect from a drug, whether brand or generic, you should consult your healthcare provider or pharmacist, and you report any concerns through FDA’s SmartHub.
No. You can look up your drug in FDA’s Orange Book to see if there is a generic version available.
All approved drugs marketed in the U.S. must meet the same quality standards regardless of where they are made. All manufacturers must test their drugs prior to marketing them to ensure they meet these quality standards. FDA inspects facilities around the globe and maintains a quality surveillance program to ensure drug manufacturers comply with FDA’s rigorous quality standards.
Most prescription drugs sold in the U.S. are generic drugs, and due to the much higher volume of use of generic drugs compared to brand drugs, it could appear there are more problems with generic drugs compared to brand drugs.
The vast majority of drugs, whether brand or generic, are safe for use as labeled. FDA takes appropriate action to protect patients when problems are identified.
FDA often finds issues during inspections. Not all of these issues mean there is a problem with the quality of a drug. When inspections identify serious issues that impacts drug quality, FDA takes action to protect patients such as recommend a recall to remove the drug from the market.
FDA has made significant progress in addressing drug shortages in the U.S. in recent years and will continue working to with companies to ensure patients have access to the drugs they need. Visit Drug Shortages for more information.
No. The presence of impurities does not mean a drug is unsafe. Impurities are a natural and expected result of the drug manufacturing process of brand-name and generic drugs. The question is never whether impurities exist, it's whether they are controlled at levels proven to be safe through a drug product’s shelf life.
FDA sets strict limits on the types and levels of impurities that are acceptable in all drug products. Manufacturers must test their products and prove that impurity levels stay within those safe thresholds from the day the drug is made until its expiration date.
Nitrosamines are impurities found in everyday items like water, cured and grilled meats, dairy products and vegetables. Everyone is exposed to small amounts of nitrosamines throughout their life.
Not all nitrosamines cause cancer. Some types of nitrosamines can cause cancer in animals when given in high doses over time. What matters for safety of drugs is:
- Which specific nitrosamine is present
- How much is in the drug
FDA is working with health agencies worldwide to set safe daily recommended limits for nitrosamines in drugs (brand and generic). These recommended limits are set conservatively to keep the cancer risk very low—about 1 in 100,000 people—even after taking the medication daily for 70 years.
Visit Information about Nitrosamine Impurities in Medications for more information about how FDA is addressing nitrosamines in drugs.
Generic manufacturers submit an abbreviated new drug application (ANDA) to the FDA for review. ANDAs must show, among other things, the generic drug is pharmaceutically equivalent and bioequivalent to the brand name drug it references, and the manufacturer can produce the drug consistently and correctly. Generic drugs approved in ANDAs are generally considered therapeutically equivalent to their brand drug counterpart.
Bioequivalence generally means the generic drug delivers the same amount of active ingredient to a patient at the same rate and to the same extent as the brand name drug. This is a key requirement before FDA approves a generic drug.
Yes, MedWatch reports can prompt FDA actions such as updating drug labeling, issuing safety alerts, recommending changes in use, investigating manufacturing problems, or, in some cases, removing a product from the market. Even one detailed report can be critically informative.
FDA’s surveillance program samples drugs based on risk such as a suspected impurity or contaminant. FDA tests the drug’s relevant attributes, for example, identity, potency, dissolution and/or purity. FDA works with manufacturers to correct problems and takes actions to protect patients if a drug does not meet FDA’s standards.
In most cases no, but in a minority of patients, inactive ingredients may affect tolerability or absorption. This is usually minor and uncommon – but worth clinical attention if patients report concerns. FDA will not approve a generic drug if the inactive ingredients of the drug are unsafe for use under the conditions proposed in the drug’s labeling. You can report any suspected quality issues through FDA’s SmartHub.
When a concern arises through various reporting mechanisms, FDA actions depend on:
- The nature and severity of the issue
- Whether patient harm has been identified
- Whether the issue affects safety or effectiveness
- Whether the company corrects the problem
If the issue does not pose an immediate safety risk and corrective steps are taken, products may remain available while oversight continues. If potential issues are identified with respect to a drug’s therapeutic equivalence but the agency has not identified signals related to a problem with the safety of the drug, FDA may modify the drug’s therapeutic equivalence code in the Orange Book to signal that the product may not be therapeutically equivalent to the brand-name drug while the application holder works to address the issue. However, if issues are identified that signal there is a safety risk from a drug, FDA works with the application holder to promptly address these issues and may take other steps as necessary to protect patients, including withdraw approval of the drug.
There is no fixed number of reports that automatically trigger action.
- Seriousness of the reported problem
- Consistency of reports
- Clinical evidence
- Laboratory testing results
- Manufacturing inspection findings
If the issue does not pose an immediate safety risk and corrective steps are taken, products may remain available while oversight continues. If potential issues are identified with respect to a drug’s therapeutic equivalence but the agency has not identified signals related to a problem with the safety of the drug, FDA may modify the drug’s therapeutic equivalence code in the Orange Book to signal that the product may not be therapeutically equivalent to the brand-name drug while the application holder works to address the issue. However, if issues are identified that signal there is a safety risk from a drug, FDA works with the application holder to promptly address these issues and may take other steps as necessary to protect patients, including withdraw approval of the drug.