Unapproved Drugs: 7 Medications That Initially Missed FDA Review
Did you know some drugs that aren’t approved by the FDA are still on the market? These unapproved FDA drugs were grandfathered onto the market ages ago. Here’s how.
carbinoxamine
Used for Allergic Conjunctivitis, Allergic Rhinitis, Hives, Skin Allergy
Used for Allergic Conjunctivitis, Allergic Rhinitis, Hives, Skin Allergy
Carbinoxamine maleate, also known by its brand name Ryvent, is a prescription antihistamine used to treat many symptoms of allergies and allergic reactions, such as rash, hives, itching, and sneezing. It's FDA approved for adults and children ages 2 years and older. It comes as a tablet and liquid that are taken by mouth up to 4 times per day on an empty stomach. Side effects include sleepiness, dizziness, and stomach pain.
What is Carbinoxamine?
What is Carbinoxamine used for?
- Seasonal and year-round allergies
- Eye inflammation from airborne allergens or food
- Vasomotor (non-allergic) rhinitis
- Mild skin symptoms of hives and angioedema
- Dermatographism (condition with raised welts or hives caused by light scratching or pressure)
- Severe allergic reaction when used together with epinephrine
- Allergic reactions to blood or plasma products
How Carbinoxamine works
Carbinoxamine is an antihistamine. It blocks a natural chemical in your body called histamine, which is responsible for many allergy symptoms. By blocking histamine in your stomach, blood vessels, and lungs, it helps relieve symptoms like itching, sneezing, and rash.
Drug facts
| Common Brands | Ryvent |
|---|---|
| Drug Class | Antihistamine |
| Controlled Substance Classification | Not a controlled medication |
| Generic Status | Lower-cost generic available |
| Availability | Prescription only |
Side effects of Carbinoxamine
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
- Sleepiness
- Dizziness
- Trouble with coordination or movement
- Stomach pain or discomfort
- Thick mucus in the lungs
Less Common Side Effects
- Skin sensitivity to light
- Chills
- Dry mouth, nose, or throat
- Low blood pressure
- Headache
- Fast heartbeat
- Tiredness
- Confusion
- Irritability
- Trouble sleeping
- Blurry vision
- Nausea
- Vomiting
- Trouble urinating
Carbinoxamine serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Serious allergic reaction: rash, hives, itchiness, shortness of breath, chest tightness; swelling of lips, tongue, face, or eyes
The following Carbinoxamine side effects have also been reported
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Incidence not known
Blurred vision
chills
confusion
decrease in the frequency of urination
decrease in urine volume
difficult or painful urination
difficulty in passing urine (dribbling)
difficulty with swallowing
dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
fast, irregular, pounding, or racing heartbeat or pulse
hives or welts, itching, skin rash
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
redness of the skin
sweating
tightness in the chest
unusual tiredness or weakness
Get emergency help immediately if any of the following symptoms of overdose occur:
Symptoms of overdose
Agitation
difficulty with sleeping
disorientation
dizziness
drowsiness to profound coma
feeling of warmth
fixed and enlarged pupils
headache
lethargy
lightheadedness
loss of appetite
redness of the face, neck, arms, and occasionally, upper chest
seeing, hearing, or feeling things that are not there
seizures
tightness of the chest
trouble breathing
vomiting
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Incidence not known
Back, leg, or stomach pains
black, tarry stools
bleeding gums
blood in the urine or stools
blurred vision
burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
chills
confusion
continuing ringing or buzzing or other unexplained noise in the ears
cough or hoarseness
dark urine
difficulty breathing
difficulty having a bowel movement (stool)
dizziness or lightheadedness
double vision
dry mouth, nose, and throat
feeling excited
feeling of constant movement of self or surroundings
fever with or without chills
general body swelling
general feeling of tiredness or weakness
headache
hearing loss
increased sensitivity of the skin to sunlight
loss of appetite
lower back or side pain
nosebleeds
pale skin
pinpoint red spots on the skin
redness or other discoloration of the skin
restlessness
seeing double
seizures
sensation of spinning
severe sunburn
shakiness in the legs, arms, hands, or feet
sores, ulcers, or white spots on the lips or in the mouth
trembling or shaking of the hands or feet
trouble sleeping
unusual bleeding or bruising
yellowing of the eyes or skin
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Get your GoodRx coupon
$50.65
GoodRx discount
$14.11
Pros and cons of Carbinoxamine
Pros
- Treats many symptoms of allergies and allergic reactions
- Comes as tablets and a flavored liquid
- Safe for children as young as 2 years old
- Can be taken as needed or on a regular schedule, depending on your condition
Cons
- Need to take 3 to 4 times per day
- Commonly causes sleepiness and dizziness
- Interacts with many medications
- Can worsen certain medical conditions including glaucoma, stomach ulcers, and urinary problems
Pharmacist tips for Carbinoxamine
- Take carbinoxamine with or without food, but it's best if you take it on an empty stomach with a full glass of water.
- Carbinoxamine can be taken as needed. But if you have symptoms on a daily basis, taking it regularly might give you the most relief. Ask your prescriber about the best way for you to take this medication.
- For the liquid: Store carbinoxamine liquid at room temperature. Use a medication dosing cup or oral syringe to measure the dose. If you need one, ask your pharmacy. Avoid household spoons because they might not be accurate and could lead you to take the wrong dose.
- Carbinoxamine can make you sleepy, dizzy, and lose your balance. Don't drive until you know how this medication affects you. Also, avoid drinking alcohol because it can worsen these side effects.
- Carbinoxamine can interact with other medications, such as tricyclic antidepressants, monoamine oxidase inhibitors (MAOIs), and other medications that make you sleepy. Tell your prescriber about all the medications you take before starting carbinoxamine.
- Avoid taking other antihistamines while taking carbinoxamine. Many over-the-counter (OTC) products contain antihistamines, and taking more than one can raise your risk of antihistamine overdose, which can lead to serious side effects like heart problems, seizures, or even death.
- Carbinoxamine isn't recommended while breastfeeding because it can cause serious harm to children under 2 years old. Let your prescriber know if you're breastfeeding. They can help figure out a safer alternative for you to use.
- Store carbinoxamine up and away from children and pets. That way, they're less likely to reach it and accidentally take the medication. If you think your child accidentally took the medication, call a Poison Control Center right away at 1-800-222-1222.
Risks and warnings for Carbinoxamine
Carbinoxamine can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Death in young children
- Risk factors: Children under 2 years old
Children under 2 years old should never take carbinoxamine since deaths have been reported in this age group. So keeping this medication away from young children is very important for their safety. It's also important to avoid breastfeeding since the medication likely passes into breastmilk which can cause serious harm to young children. If your child under 2 accidentally takes the medication, call a Poison Control Center right away at 1-800-222-1222. For children under age 2, discuss safer treatment options with your child's pediatrician.
Sleepiness
- Risk factors: Alcohol | Taking other medications that cause sleepiness | Older adults
Carbinoxamine can make you sleepy, which can affect your ability to focus, think, or react. This side effect is more likely to happen or be more intense if you're an older adult, drink alcohol while taking carbinoxamine, or take other medications that cause sleepiness (e.g., opioids, benzodiazepines). Don't drive or operate machinery until you know how this medication affects you. It's best to avoid alcohol while taking carbinoxamine. Talk to your prescriber about possible interactions with other medications and how to manage them.
Worsening of medical conditions
Make sure your care team knows about all of your medical conditions before starting carbinoxamine. Though this medication is an antihistamine, it also has anticholinergic effects, which can worsen the symptoms of many conditions. These conditions include glaucoma, hyperthyroidism, heart disease, high blood pressure, stomach ulcers, trouble urinating, and an enlarged prostate.
Carbinoxamine dosage
The average cost for 60 tablets of 4mg of Carbinoxamine is $14.11 with a free GoodRx coupon. This is 72.14% off the average retail price of $50.65. 
Ml of oral solution
Ml of oral solution| Dosage | Quantity | Price as low as | Price per unit |
|---|---|---|---|
| 4mg/5ml | 120 ml | $30.28 | $0.25 |
Interactions between Carbinoxamine and other drugs
Carbinoxamine may interact with certain medications or supplements. Always let your doctor and pharmacist know about any other medications or supplements (including prescribed and over-the-counter medications, vitamins, and dietary or herbal supplements) that you are currently taking. The list below does not include all possible drug interactions with Carbinoxamine. Please note that only the generic name of each medication is listed below.
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. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Calcium Oxybate
- Furazolidone
- Iproniazid
- Isocarboxazid
- Linezolid
- Magnesium Oxybate
- Methylene Blue
- Moclobemide
- Pargyline
- Phenelzine
- Potassium Oxybate
- Procarbazine
- Rasagiline
- Selegiline
- Sodium Oxybate
- Tranylcypromine
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Alfentanil
- Alprazolam
- Amifampridine
- Amobarbital
- Anileridine
- Benzhydrocodone
- Bromazepam
- Bromopride
- Buprenorphine
- Bupropion
- Buspirone
- Butabarbital
- Butorphanol
- Cannabidiol
- Cetirizine
- Chloral Hydrate
- Chlordiazepoxide
- Chlorpromazine
- Clobazam
- Clonazepam
- Clorazepate
- Clozapine
- Codeine
- Dexmedetomidine
- Diacetylmorphine
- Diazepam
- Difenoxin
- Dihydrocodeine
- Diphenhydramine
- Diphenoxylate
- Donepezil
- Doxylamine
- Esketamine
- Estazolam
- Eszopiclone
- Ethchlorvynol
- Ethylmorphine
- Fentanyl
- Flibanserin
- Flurazepam
- Fospropofol
- Gabapentin
- Gabapentin Enacarbil
- Glucagon
- Glycopyrrolate
- Glycopyrronium Tosylate
- Halazepam
- Hydrocodone
- Hydromorphone
- Hydroxyzine
- Ketamine
- Ketazolam
- Ketobemidone
- Lemborexant
- Levocetirizine
- Levorphanol
- Lofexidine
- Lorazepam
- Loxapine
- Meperidine
- Meprobamate
- Methacholine
- Methadone
- Methotrimeprazine
- Metoclopramide
- Midazolam
- Morphine
- Morphine Sulfate Liposome
- Nalbuphine
- Nicomorphine
- Nitrazepam
- Opium
- Opium Alkaloids
- Oxazepam
- Oxycodone
- Oxymorphone
- Papaveretum
- Paregoric
- Pentobarbital
- Periciazine
- Phenobarbital
- Piritramide
- Pitolisant
- Prazepam
- Pregabalin
- Promethazine
- Propofol
- Propoxyphene
- Quazepam
- Quetiapine
- Ramelteon
- Remifentanil
- Remimazolam
- Revefenacin
- Scopolamine
- Secobarbital
- Secretin Human
- Sufentanil
- Tapentadol
- Temazepam
- Thioridazine
- Tilidine
- Tiotropium
- Topiramate
- Tramadol
- Trazodone
- Triazolam
- Zaleplon
- Zolpidem
- Zopiclone
How much does Carbinoxamine cost?
To access savings, use a GoodRx coupon and pay just a fraction of the retail price.
Carbinoxamine (generic)
$14.11
Carbinoxamine contraindications
Contraindications are specific health conditions or situations in which a person should not take a medication due to safety concerns. If you have any of the following conditions or if any of the following apply to you, let your healthcare provider know because Carbinoxamine will not be safe for you to take.
- Children under age 2
- Currently breastfeeding
- Taking a monoamine oxidase inhibitor (MAOIs), such as phenelzine (Nardil), tranylcypromine (Parnate), and selegiline (Eldepryl)
What are alternatives to Carbinoxamine?
There are a number of medications that your doctor can prescribe in place of Carbinoxamine. Compare a few possible alternatives below.
News about Carbinoxamine
