If this month's refill of a medicine you have taken for years came out of the bottle in a new color and a new shape, with a name on the pharmacy label you do not recognize, read that label against last month's before you swallow anything. Minor differences in appearance, such as color, are generally allowed between a generic and the brand drug, and those differences in appearance do not affect how the medicine works. So a lawful change of maker and a dispensing error can look exactly alike from your kitchen table, even when nobody at the counter mentioned a change. Find out which one you have before you take the next pill.
What two versions of one medicine have to share, and what can differ
Between two versions of one medicine, the active ingredients have to match and the color does not. A generic has to contain the same active ingredients and work the same way in the body as the brand drug, with the same strength, dosage form and route, and it has to meet the same scientific standards for quality. Products with identical amounts of the same active ingredient, in the same dosage form and route, that meet the same standards of strength, quality and purity are known as pharmaceutical equivalents. They do not necessarily contain the same inactive ingredients, and may differ in characteristics such as shape, scoring, packaging, colors, flavors, preservatives and expiration date.
| Feature | Between a generic and the brand |
|---|---|
| Active ingredients | The same |
| Strength | The same |
| Dosage form, such as a tablet or a liquid | The same |
| Route, such as by mouth or by injection | The same |
| Label information and instructions | The same, with certain exceptions |
| Inactive ingredients, including colors, flavors and preservatives | Not necessarily the same |
| Color and shape | Can differ |
| Scoring, packaging and expiration date | Can differ |
The differences named are examples, and products can differ in other ways as well, including, within certain limits, in labeling, so the leaflet with a new version may not read word for word like the old one.
Those differences can cause trouble of their own. When products that differ in these ways are substituted for each other, a new tablet color or shape can confuse patients, and a missing score line can make it impossible to take a partial tablet. If you have been breaking your tablets and the new ones carry a different score line or none, ask the doctor who prescribed them before you break one, because pills are not to be crushed or broken open unless your provider says it is OK.
How to check that what you are holding is the same medicine
Read the pharmacy label first, then look at the pills themselves, because each check can catch something the other misses. Look on the label for your name, the name of the medicine, the dose and how often to take it, and if anything there looks unfamiliar, contact the pharmacy that filled it or the doctor who prescribed it. A pill can look different because it is a generic version or a different brand, and even then, check that it is the same medicine before you take it.
Next, ask about an unfamiliar name, because one medicine can carry a brand name and a generic name. Ask the pharmacist whether yours goes by any other name, and what its brand and generic names are. If you have bought the medicine before, compare the shape, color, size, markings and packaging with what you had, and ask about anything that changed.
The pharmacist who filled it is the person to put those questions to. Pharmacists need to know how products that can be substituted for one another differ, including their expiration dates and storage directions, so they can advise patients when one is substituted for another. If the label names a medicine you were never prescribed, or someone else's name, keep the bottle closed and ring the pharmacy that filled it before you take any of it.
You can also look your medicine up in FDA's Orange Book to see whether a generic version is available. In it you will find drug products FDA has approved on the basis of safety and effectiveness, and you can search it by a proprietary name, an active ingredient or an application number. Search under the active ingredient as well as the name on the bottle.
For prescription medicines made by more than one company, the Orange Book also gives therapeutic equivalence evaluations, as a code. Therapeutically equivalent products are pharmaceutical equivalents that FDA expects to have the same clinical effect and safety profile when they are used as their labeling directs. A code beginning with A marks products FDA considers to be therapeutically equivalent to other pharmaceutically equivalent products, and a code beginning with B marks products FDA, at this time, considers not to be. A code can change: when questions arise about a product's equivalence and no sign of a safety problem has been found, FDA may change its code to show that it may not be therapeutically equivalent to the brand-name drug while the maker works on the issue. If the code for your new product begins with B, ask the pharmacy that filled the prescription about the switch.
If your search finds nothing, that is not proof of a problem. A product missing from the Orange Book may still be lawful, safe, effective and therapeutically equivalent to other products, and it may be missing because FDA has not evaluated it. The pharmacist can tell you what the product is.
The rules on when a pharmacy may substitute one product for another are state rules, and the Orange Book does not set them. To contain drug costs, virtually every state has adopted laws or regulations that encourage the substitution of drug products. Ask the pharmacist what your state lets them change without asking you first.
If the new pills feel different after the switch
A different feeling after a switch can be real. Generics are designed to work the same way as the brand drug, with the same expected clinical effect and safety profile, but small, allowable differences between products made by different companies, such as in certain inactive ingredients, can sometimes feel noticeable to patients. Inactive ingredients in most cases make no clinical difference, but in a minority of patients they may affect tolerability or absorption. Such an effect is usually minor and uncommon, and it is worth the attention of the pharmacist or doctor you report it to.
If the new version seems different when you use it, tell the pharmacist who filled it or the doctor who prescribed it, say the pills changed, and contact that doctor about any unusual or bothersome side effects. Note the date the new pills started and what has changed since, and keep the old label beside the new one. You can report a side effect or a quality problem to FDA online as well, through its SmartHub, without being sure the drug caused the problem (see Reporting a side effect that has not gone away).
If one maker's version keeps suiting you worse than another, tell the doctor who prescribed it. When differences such as these are important in the care of a particular patient, it may be appropriate for the prescribing physician to require that a specific product be dispensed as a medical necessity.
In rare cases a coloring or a preservative can cause an allergic reaction in a particular patient. A few hives, itching or a rash are among the symptoms of a mild allergic reaction; if they start after the new pills and nothing else comes with them, get medical help from the doctor who prescribed the medicine, say the pills changed, and ask whether to take the next one. A swollen face, eyes or tongue, difficulty breathing or wheezing, and difficulty swallowing are among the symptoms of anaphylaxis, a severe, whole-body allergic reaction, and hives that come with any of them belong to the same emergency: dial 911 at once, or get to the nearest emergency room, without waiting to see whether the reaction gets worse.
If you have already taken one and it may be the wrong medicine
If you or someone else has already taken a pill that may be the wrong medicine, call 911 if the person who took it is not breathing, and otherwise ring Poison Help at 1-800-222-1222 without waiting for signs of poisoning. Poison Help is the number for someone who has swallowed the wrong medicine or too much medicine, and the line connects you to your local poison center, free and confidential, 24 hours a day. Have the bottle with you when you ring, because its label has important information, and take nothing more by mouth until you have spoken to the Poison Help expert.
The same line takes questions that are not emergencies. If pills have come out of their bottle and you cannot match them to a label, some poison centers can identify pills, and your local pharmacy can help too.
If the physician NicoCares connected you with wrote the prescription, a state-licensed pharmacy prepares and ships it; keep any vial or pen that arrives not matching your prescription unopened and unused until your prescriber or the pharmacy has checked it (see Check a vial or pen that doesn't match your prescription). For a new version that feels different, send your care team a Spruce message; NicoCares emailed you the invitation to that app. No time is set for their replies, so ring the pharmacy that filled it about anything that cannot wait for one, call your regular doctor's office about a mild allergic reaction, and keep to the 911 steps above for the emergency signs.
