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Medications for Dry Eye Disease (Keratoconjunctivitis Sicca)

The medications listed below are related to or used in the treatment of this condition.

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Drug name Rating Reviews Activity ? Rx/OTC Pregnancy CSA Alcohol
Rohto Dry-Aid 10 1 review for Rohto Dry-Aid to treat Dry Eye Disease
OTC N N
Generic name:
ocular lubricant ophthalmic
Drug class:
ophthalmic lubricants and irrigations
For consumers:
side effects
TheraTears 10 1 review for TheraTears to treat Dry Eye Disease
OTC N N
Generic name:
ocular lubricant ophthalmic
Drug class:
ophthalmic lubricants and irrigations
For consumers:
side effects
Visine Tears 10 1 review for Visine Tears to treat Dry Eye Disease
OTC N N
Generic name:
ocular lubricant ophthalmic
Drug class:
ophthalmic lubricants and irrigations
For consumers:
side effects
loteprednol 9.8 8 reviews for loteprednol to treat Dry Eye Disease
Rx C N
Generic name:
loteprednol ophthalmic
Brand name:
Eysuvis
Drug class:
ophthalmic steroids
For consumers:
dosage, interactions, side effects
For professionals:
AHFS DI Monograph, Prescribing Information
Eysuvis 9.7 7 reviews for Eysuvis to treat Dry Eye Disease
Rx C N
Generic name:
loteprednol ophthalmic
Drug class:
ophthalmic steroids
For consumers:
dosage, interactions, side effects
For professionals:
Prescribing Information
Bion Tears 9.0 1 review for Bion Tears to treat Dry Eye Disease
OTC N N
Generic name:
ocular lubricant ophthalmic
Drug class:
ophthalmic lubricants and irrigations
For consumers:
side effects
Refresh Liquigel 9.0 1 review for Refresh Liquigel to treat Dry Eye Disease
OTC N N
Generic name:
ocular lubricant ophthalmic
Drug class:
ophthalmic lubricants and irrigations
For consumers:
side effects
Miebo 8.7 14 reviews for Miebo to treat Dry Eye Disease
Rx N
Generic name:
perfluorohexyloctane ophthalmic
Drug class:
ophthalmic anti-inflammatory agents
For consumers:
dosage, side effects
For professionals:
Prescribing Information
perfluorohexyloctane 8.7 14 reviews for perfluorohexyloctane to treat Dry Eye Disease
Rx N
Generic name:
perfluorohexyloctane ophthalmic
Brand name:
Miebo
Drug class:
ophthalmic anti-inflammatory agents
For consumers:
dosage, side effects
For professionals:
AHFS DI Monograph
Lacrisert 8.4 13 reviews for Lacrisert to treat Dry Eye Disease
Rx N N
Generic name:
ocular lubricant ophthalmic
Drug class:
ophthalmic lubricants and irrigations
For consumers:
dosage, side effects
For professionals:
Prescribing Information
Refresh Plus 8.0 1 review for Refresh Plus to treat Dry Eye Disease
OTC N N
Generic name:
ocular lubricant ophthalmic
Drug class:
ophthalmic lubricants and irrigations
For consumers:
side effects
Tyrvaya 8.0 38 reviews for Tyrvaya to treat Dry Eye Disease
Rx C N X
Generic name:
varenicline systemic
Drug class:
cholinergic agonists
For consumers:
dosage, interactions, side effects
For professionals:
Prescribing Information
varenicline 8.0 38 reviews for varenicline to treat Dry Eye Disease
Rx C N X
Generic name:
varenicline systemic
Brand name:
Tyrvaya
Drug class:
cholinergic agonists, smoking cessation agents
For consumers:
dosage, interactions, side effects
For professionals:
AHFS DI Monograph, Prescribing Information
optive 6.7 3 reviews for optive to treat Dry Eye Disease
OTC N N
Generic name:
ocular lubricant ophthalmic
Drug class:
ophthalmic lubricants and irrigations
For consumers:
side effects
Systane Complete 6.7 3 reviews for Systane Complete to treat Dry Eye Disease
OTC N N
Generic name:
ocular lubricant ophthalmic
Drug class:
ophthalmic lubricants and irrigations
For consumers:
side effects
FreshKote 5.8 6 reviews for FreshKote to treat Dry Eye Disease
OTC N N
Generic name:
ocular lubricant ophthalmic
Drug class:
ophthalmic lubricants and irrigations
For consumers:
side effects
Refresh 5.5 2 reviews for Refresh to treat Dry Eye Disease
OTC N N
Generic name:
ocular lubricant ophthalmic
Drug class:
ophthalmic lubricants and irrigations
For consumers:
side effects
Systane Hydration PF 5.4 5 reviews for Systane Hydration PF to treat Dry Eye Disease
OTC N N
Generic name:
ocular lubricant ophthalmic
Drug class:
ophthalmic lubricants and irrigations
For consumers:
side effects
Refresh Tears 5.0 2 reviews for Refresh Tears to treat Dry Eye Disease
OTC N N
Generic name:
ocular lubricant ophthalmic
Drug class:
ophthalmic lubricants and irrigations
For consumers:
side effects
Refresh Optive Mega-3 4.6 5 reviews for Refresh Optive Mega-3 to treat Dry Eye Disease
OTC N N
Generic name:
ocular lubricant ophthalmic
Drug class:
ophthalmic lubricants and irrigations
For consumers:
side effects
Cequa 4.5 32 reviews for Cequa to treat Dry Eye Disease
Rx C N
Generic name:
cyclosporine ophthalmic
Drug class:
miscellaneous ophthalmic agents
For consumers:
dosage, interactions, side effects
For professionals:
Prescribing Information
cyclosporine 4.5 263 reviews for cyclosporine to treat Dry Eye Disease
Rx C N
Generic name:
cyclosporine ophthalmic
Brand names:
Restasis, Cequa, Vevye
Drug class:
miscellaneous ophthalmic agents
For consumers:
dosage, interactions, side effects
For professionals:
AHFS DI Monograph, Prescribing Information
Restasis 4.5 215 reviews for Restasis to treat Dry Eye Disease
Rx C N
Generic name:
cyclosporine ophthalmic
Drug class:
miscellaneous ophthalmic agents
For consumers:
dosage, interactions, side effects
For professionals:
Prescribing Information
Refresh Celluvisc 4.0 1 review for Refresh Celluvisc to treat Dry Eye Disease
OTC N N
Generic name:
ocular lubricant ophthalmic
Drug class:
ophthalmic lubricants and irrigations
For consumers:
side effects
lifitegrast 3.8 303 reviews for lifitegrast to treat Dry Eye Disease
Rx N
Generic name:
lifitegrast ophthalmic
Brand name:
Xiidra
Drug class:
ophthalmic anti-inflammatory agents
For consumers:
dosage, side effects
For professionals:
AHFS DI Monograph, Prescribing Information
Oasis Tears Plus 3.8 6 reviews for Oasis Tears Plus to treat Dry Eye Disease
OTC N N
Generic name:
ocular lubricant ophthalmic
Drug class:
ophthalmic lubricants and irrigations
For consumers:
side effects
Xiidra 3.8 299 reviews for Xiidra to treat Dry Eye Disease
Rx N
Generic name:
lifitegrast ophthalmic
Drug class:
ophthalmic anti-inflammatory agents
For consumers:
dosage, side effects
For professionals:
Prescribing Information
ocular lubricant 3.2 213 reviews for ocular lubricant to treat Dry Eye Disease
Rx/OTC N N
Generic name:
ocular lubricant ophthalmic
Brand names:
Systane, Artificial Tears, Refresh, Systane Ultra, Lacrisert, Refresh Tears, Refresh Liquigel, Systane Balance, TheraTears, FreshKote, Lubricant Eye Drops, Refresh Optive, Refresh Plus, Akwa Tears, GenTeal, Refresh Celluvisc, Refresh Optive Advanced, Refresh Optive Mega-3, Soothe XP, Systane Complete, Altalube, Bion Tears, Clear Eyes Natural Tears Lubricating, Dry Eye Relief, Lacri-Lube S.O.P., Refresh PM, Refresh Relieva, Soothe, Systane Nighttime, Systane Overnight Therapy, Systane Ultra Preservative Free, Advanced Eye Relief Dry Eye, Alcon Tears, Artelac Nighttime, Blink-N-Clean, Blink Contacts, Blink Gel Tears, Blink Tears, Clear Eyes Contact Lens Multi-Action Relief, GenTeal Mild, GenTeal PM, GenTeal Tears Moderate, GenTeal Tears Night-Time, GenTeal Tears Severe, Hypotears, ImproVue, Isopto Tears, Liquitears, Lubrifresh PM, Moisture Drops, Moisture Eyes, Moisture Eyes PM, Oasis Tears, Oasis Tears Plus, Opti-Free Pure Moist Rewetting Drops, optive, optive Sensitive, Puralube, Refresh Contacts, Refresh Digital, Refresh Digital PF, Refresh Endura, Refresh Lacri-Lube, Refresh Relieva PF, Refresh Repair, Regener-Eyes Lite, retaine PM, Rohto Dry-Aid, Soothe Night Time, Sterile Lubricating Tears, Stye Sterile Lubricant, Systane Hydration PF, Tears Again, Tears Naturale, Tears Naturale Forte, Tears Naturale II, Tears Naturale PM, TheraTears Contact Lens, Ultra Fresh, Ultra Fresh PM, Ultra Lubricating Eye Drops, Visine for Contacts, Visine Tears, Viva-Drops
Drug class:
ophthalmic lubricants and irrigations
For consumers:
side effects
Oasis Tears 3.0 9 reviews for Oasis Tears to treat Dry Eye Disease
OTC N N
Generic name:
ocular lubricant ophthalmic
Drug class:
ophthalmic lubricants and irrigations
For consumers:
side effects
Soothe XP 2.8 5 reviews for Soothe XP to treat Dry Eye Disease
OTC N N
Generic name:
ocular lubricant ophthalmic
Drug class:
ophthalmic lubricants and irrigations
For consumers:
side effects
GenTeal PM 2.7 3 reviews for GenTeal PM to treat Dry Eye Disease
OTC N N
Generic name:
ocular lubricant ophthalmic
Drug class:
ophthalmic lubricants and irrigations
For consumers:
side effects
Systane Balance 2.6 9 reviews for Systane Balance to treat Dry Eye Disease
OTC N N
Generic name:
ocular lubricant ophthalmic
Drug class:
ophthalmic lubricants and irrigations
For consumers:
side effects
Systane 2.0 93 reviews for Systane to treat Dry Eye Disease
OTC N N
Generic name:
ocular lubricant ophthalmic
Drug class:
ophthalmic lubricants and irrigations
For consumers:
side effects
Systane Ultra 2.0 26 reviews for Systane Ultra to treat Dry Eye Disease
OTC N N
Generic name:
ocular lubricant ophthalmic
Drug class:
ophthalmic lubricants and irrigations
For consumers:
side effects
Dry Eye Relief 1.0 1 review for Dry Eye Relief to treat Dry Eye Disease
OTC N N
Generic name:
ocular lubricant ophthalmic
Drug class:
ophthalmic lubricants and irrigations
For consumers:
side effects
Lubricant Eye Drops 1.0 3 reviews for Lubricant Eye Drops to treat Dry Eye Disease
OTC N N
Generic name:
ocular lubricant ophthalmic
Drug class:
ophthalmic lubricants and irrigations
For consumers:
side effects
Systane Nighttime 1.0 2 reviews for Systane Nighttime to treat Dry Eye Disease
OTC N N
Generic name:
ocular lubricant ophthalmic
Drug class:
ophthalmic lubricants and irrigations
For consumers:
side effects
Systane Ultra Preservative Free 1.0 4 reviews for Systane Ultra Preservative Free to treat Dry Eye Disease
OTC N N
Generic name:
ocular lubricant ophthalmic
Drug class:
ophthalmic lubricants and irrigations
For consumers:
side effects
Advanced Eye Relief Dry Eye Rate Add review
OTC N N
Generic name:
ocular lubricant ophthalmic
Drug class:
ophthalmic lubricants and irrigations
For consumers:
side effects
Akwa Tears Rate Add review
OTC N N
Generic name:
ocular lubricant ophthalmic
Drug class:
ophthalmic lubricants and irrigations
For consumers:
side effects
Alcon Tears Rate Add review
OTC N N
Generic name:
ocular lubricant ophthalmic
Drug class:
ophthalmic lubricants and irrigations
For consumers:
side effects
Altalube Rate Add review
OTC N N
Generic name:
ocular lubricant ophthalmic
Drug class:
ophthalmic lubricants and irrigations
For consumers:
side effects
Artelac Nighttime Rate Add review
OTC N N
Generic name:
ocular lubricant ophthalmic
Drug class:
ophthalmic lubricants and irrigations
For consumers:
side effects
Artificial Tears Rate Add review
OTC N N
Generic name:
ocular lubricant ophthalmic
Drug class:
ophthalmic lubricants and irrigations
For consumers:
side effects
Blink-N-Clean Rate Add review
OTC N N
Generic name:
ocular lubricant ophthalmic
Drug class:
ophthalmic lubricants and irrigations
For consumers:
side effects
Blink Contacts Rate Add review
OTC N N
Generic name:
ocular lubricant ophthalmic
Drug class:
ophthalmic lubricants and irrigations
For consumers:
side effects
Blink Gel Tears Rate Add review
OTC N N
Generic name:
ocular lubricant ophthalmic
Drug class:
ophthalmic lubricants and irrigations
For consumers:
side effects
Blink Tears Rate Add review
OTC N N
Generic name:
ocular lubricant ophthalmic
Drug class:
ophthalmic lubricants and irrigations
For consumers:
side effects
Cellugel Rate Add review
Rx/OTC N N
Generic name:
hydroxypropyl methylcellulose ophthalmic
Drug class:
ophthalmic lubricants and irrigations
For consumers:
dosage, side effects
Clear Eyes Contact Lens Multi-Action Relief Rate Add review
OTC N N
Generic name:
ocular lubricant ophthalmic
Drug class:
ophthalmic lubricants and irrigations
For consumers:
side effects
Clear Eyes Natural Tears Lubricating Rate Add review
OTC N N
Generic name:
ocular lubricant ophthalmic
Drug class:
ophthalmic lubricants and irrigations
For consumers:
side effects
GenTeal Rate Add review
OTC N N
Generic name:
ocular lubricant ophthalmic
Drug class:
ophthalmic lubricants and irrigations
For consumers:
side effects
GenTeal Mild Rate Add review
OTC N N
Generic name:
ocular lubricant ophthalmic
Drug class:
ophthalmic lubricants and irrigations
For consumers:
side effects
GenTeal Tears Moderate Rate Add review
OTC N N
Generic name:
ocular lubricant ophthalmic
Drug class:
ophthalmic lubricants and irrigations
For consumers:
side effects
GenTeal Tears Night-Time Rate Add review
OTC N N
Generic name:
ocular lubricant ophthalmic
Drug class:
ophthalmic lubricants and irrigations
For consumers:
side effects
GenTeal Tears Severe Rate Add review
OTC N N
Generic name:
ocular lubricant ophthalmic
Drug class:
ophthalmic lubricants and irrigations
For consumers:
side effects
Gonak Hypromellose Rate Add review
Rx/OTC N N
Generic name:
hydroxypropyl methylcellulose ophthalmic
Drug class:
ophthalmic lubricants and irrigations
For consumers:
dosage, side effects
Goniosoft Rate Add review
Rx/OTC N N
Generic name:
hydroxypropyl methylcellulose ophthalmic
Drug class:
ophthalmic lubricants and irrigations
For consumers:
dosage, side effects
Goniosol Rate Add review
Rx/OTC N N
Generic name:
hydroxypropyl methylcellulose ophthalmic
Drug class:
ophthalmic lubricants and irrigations
For consumers:
dosage, side effects
Goniotaire Rate Add review
Rx/OTC N N
Generic name:
hydroxypropyl methylcellulose ophthalmic
Drug class:
ophthalmic lubricants and irrigations
For consumers:
dosage, side effects
Goniovisc Rate Add review
Rx/OTC N N
Generic name:
hydroxypropyl methylcellulose ophthalmic
Drug class:
ophthalmic lubricants and irrigations
For consumers:
dosage, side effects
hydroxypropyl methylcellulose Rate Add review
Rx/OTC N N
Generic name:
hydroxypropyl methylcellulose ophthalmic
Brand names:
Gonak Hypromellose, Goniosol, Cellugel, Goniosoft, Goniotaire, Goniovisc, OcuCoat
Drug class:
ophthalmic lubricants and irrigations
For consumers:
dosage, side effects
Hypotears Rate Add review
OTC N N
Generic name:
ocular lubricant ophthalmic
Drug class:
ophthalmic lubricants and irrigations
For consumers:
side effects
ImproVue Rate Add review
OTC N N
Generic name:
ocular lubricant ophthalmic
Drug class:
ophthalmic lubricants and irrigations
For consumers:
side effects
Isopto Tears Rate Add review
OTC N N
Generic name:
ocular lubricant ophthalmic
Drug class:
ophthalmic lubricants and irrigations
For consumers:
side effects
Lacri-Lube S.O.P. Rate Add review
OTC N N
Generic name:
ocular lubricant ophthalmic
Drug class:
ophthalmic lubricants and irrigations
For consumers:
side effects
Liquitears Rate Add review
OTC N N
Generic name:
ocular lubricant ophthalmic
Drug class:
ophthalmic lubricants and irrigations
For consumers:
side effects
Lubrifresh PM Rate Add review
OTC N N
Generic name:
ocular lubricant ophthalmic
Drug class:
ophthalmic lubricants and irrigations
For consumers:
side effects
Moisture Drops Rate Add review
OTC N N
Generic name:
ocular lubricant ophthalmic
Drug class:
ophthalmic lubricants and irrigations
For consumers:
side effects
Moisture Eyes Rate Add review
OTC N N
Generic name:
ocular lubricant ophthalmic
Drug class:
ophthalmic lubricants and irrigations
For consumers:
side effects
Moisture Eyes PM Rate Add review
OTC N N
Generic name:
ocular lubricant ophthalmic
Drug class:
ophthalmic lubricants and irrigations
For consumers:
side effects
OcuCoat Rate Add review
Rx/OTC N N
Generic name:
hydroxypropyl methylcellulose ophthalmic
Drug class:
ophthalmic lubricants and irrigations
For consumers:
dosage, side effects
Opti-Free Pure Moist Rewetting Drops Rate Add review
OTC N N
Generic name:
ocular lubricant ophthalmic
Drug class:
ophthalmic lubricants and irrigations
For consumers:
side effects
optive Sensitive Rate Add review
OTC N N
Generic name:
ocular lubricant ophthalmic
Drug class:
ophthalmic lubricants and irrigations
For consumers:
side effects
Puralube Rate Add review
OTC N N
Generic name:
ocular lubricant ophthalmic
Drug class:
ophthalmic lubricants and irrigations
For consumers:
side effects
Refresh Contacts Rate Add review
OTC N N
Generic name:
ocular lubricant ophthalmic
Drug class:
ophthalmic lubricants and irrigations
For consumers:
side effects
Refresh Digital Rate Add review
OTC N N
Generic name:
ocular lubricant ophthalmic
Drug class:
ophthalmic lubricants and irrigations
For consumers:
side effects
Refresh Digital PF Rate Add review
OTC N N
Generic name:
ocular lubricant ophthalmic
Drug class:
ophthalmic lubricants and irrigations
For consumers:
side effects
Refresh Endura Rate Add review
OTC N N
Generic name:
ocular lubricant ophthalmic
Drug class:
ophthalmic lubricants and irrigations
For consumers:
side effects
Refresh Lacri-Lube Rate Add review
OTC N N
Generic name:
ocular lubricant ophthalmic
Drug class:
ophthalmic lubricants and irrigations
For consumers:
side effects
Refresh Optive Rate Add review
OTC N N
Generic name:
ocular lubricant ophthalmic
Drug class:
ophthalmic lubricants and irrigations
For consumers:
side effects
Refresh Optive Advanced Rate Add review
OTC N N
Generic name:
ocular lubricant ophthalmic
Drug class:
ophthalmic lubricants and irrigations
For consumers:
side effects
Refresh PM Rate Add review
OTC N N
Generic name:
ocular lubricant ophthalmic
Drug class:
ophthalmic lubricants and irrigations
For consumers:
side effects
Refresh Relieva Rate Add review
OTC N N
Generic name:
ocular lubricant ophthalmic
Drug class:
ophthalmic lubricants and irrigations
For consumers:
side effects
Refresh Relieva PF Rate Add review
OTC N N
Generic name:
ocular lubricant ophthalmic
Drug class:
ophthalmic lubricants and irrigations
For consumers:
side effects
Refresh Repair Rate Add review
OTC N N
Generic name:
ocular lubricant ophthalmic
Drug class:
ophthalmic lubricants and irrigations
For consumers:
side effects
Regener-Eyes Lite Rate Add review
OTC N N
Generic name:
ocular lubricant ophthalmic
Drug class:
ophthalmic lubricants and irrigations
For consumers:
side effects
retaine PM Rate Add review
OTC N N
Generic name:
ocular lubricant ophthalmic
Drug class:
ophthalmic lubricants and irrigations
For consumers:
side effects
Soothe 0.0 1 review for Soothe to treat Dry Eye Disease
OTC N N
Generic name:
ocular lubricant ophthalmic
Drug class:
ophthalmic lubricants and irrigations
For consumers:
side effects
Soothe Night Time Rate Add review
OTC N N
Generic name:
ocular lubricant ophthalmic
Drug class:
ophthalmic lubricants and irrigations
For consumers:
side effects
Sterile Lubricating Tears Rate Add review
OTC N N
Generic name:
ocular lubricant ophthalmic
Drug class:
ophthalmic lubricants and irrigations
For consumers:
side effects
Stye Sterile Lubricant Rate Add review
OTC N N
Generic name:
ocular lubricant ophthalmic
Drug class:
ophthalmic lubricants and irrigations
For consumers:
side effects
Systane Overnight Therapy Rate Add review
OTC N N
Generic name:
ocular lubricant ophthalmic
Drug class:
ophthalmic lubricants and irrigations
For consumers:
side effects
Tears Again Rate Add review
OTC N N
Generic name:
ocular lubricant ophthalmic
Drug class:
ophthalmic lubricants and irrigations
For consumers:
side effects
Tears Naturale Rate Add review
OTC N N
Generic name:
ocular lubricant ophthalmic
Drug class:
ophthalmic lubricants and irrigations
For consumers:
side effects
Tears Naturale Forte Rate Add review
OTC N N
Generic name:
ocular lubricant ophthalmic
Drug class:
ophthalmic lubricants and irrigations
For consumers:
side effects
Tears Naturale II Rate Add review
OTC N N
Generic name:
ocular lubricant ophthalmic
Drug class:
ophthalmic lubricants and irrigations
For consumers:
side effects
Tears Naturale PM Rate Add review
OTC N N
Generic name:
ocular lubricant ophthalmic
Drug class:
ophthalmic lubricants and irrigations
For consumers:
side effects
TheraTears Contact Lens Rate Add review
OTC N N
Generic name:
ocular lubricant ophthalmic
Drug class:
ophthalmic lubricants and irrigations
For consumers:
side effects
Ultra Fresh Rate Add review
OTC N N
Generic name:
ocular lubricant ophthalmic
Drug class:
ophthalmic lubricants and irrigations
For consumers:
side effects
Ultra Fresh PM Rate Add review
OTC N N
Generic name:
ocular lubricant ophthalmic
Drug class:
ophthalmic lubricants and irrigations
For consumers:
side effects
Ultra Lubricating Eye Drops Rate Add review
OTC N N
Generic name:
ocular lubricant ophthalmic
Drug class:
ophthalmic lubricants and irrigations
For consumers:
side effects
Vevye Rate Add review
Rx C N
Generic name:
cyclosporine ophthalmic
Drug class:
miscellaneous ophthalmic agents
For consumers:
dosage, interactions, side effects
For professionals:
Prescribing Information
Visine for Contacts Rate Add review
OTC N N
Generic name:
ocular lubricant ophthalmic
Drug class:
ophthalmic lubricants and irrigations
For consumers:
side effects
Viva-Drops Rate Add review
OTC N N
Generic name:
ocular lubricant ophthalmic
Drug class:
ophthalmic lubricants and irrigations
For consumers:
side effects

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Legend

Rating For ratings, users were asked how effective they found the medicine while considering positive/adverse effects and ease of use (1 = not effective, 10 = most effective).
Activity Activity is based on recent site visitor activity relative to other medications in the list.
Rx Prescription only.
OTC Over-the-counter.
Rx/OTC Prescription or Over-the-counter.
Off-label This medication may not be approved by the FDA for the treatment of this condition.
EUA An Emergency Use Authorization (EUA) allows the FDA to authorize unapproved medical products or unapproved uses of approved medical products to be used in a declared public health emergency when there are no adequate, approved, and available alternatives.
Expanded Access Expanded Access is a potential pathway for a patient with a serious or immediately life-threatening disease or condition to gain access to an investigational medical product (drug, biologic, or medical device) for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available.
Pregnancy Category
A Adequate and well-controlled studies have failed to demonstrate a risk to the fetus in the first trimester of pregnancy (and there is no evidence of risk in later trimesters).
B Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.
C Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use in pregnant women despite potential risks.
D There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use in pregnant women despite potential risks.
X Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use in pregnant women clearly outweigh potential benefits.
N FDA has not classified the drug.
Controlled Substances Act (CSA) Schedule
M The drug has multiple schedules. The schedule may depend on the exact dosage form or strength of the medication.
U CSA Schedule is unknown.
N Is not subject to the Controlled Substances Act.
1 Has a high potential for abuse. Has no currently accepted medical use in treatment in the United States. There is a lack of accepted safety for use under medical supervision.
2 Has a high potential for abuse. Has a currently accepted medical use in treatment in the United States or a currently accepted medical use with severe restrictions. Abuse may lead to severe psychological or physical dependence.
3 Has a potential for abuse less than those in schedules 1 and 2. Has a currently accepted medical use in treatment in the United States. Abuse may lead to moderate or low physical dependence or high psychological dependence.
4 Has a low potential for abuse relative to those in schedule 3. It has a currently accepted medical use in treatment in the United States. Abuse may lead to limited physical dependence or psychological dependence relative to those in schedule 3.
5 Has a low potential for abuse relative to those in schedule 4. Has a currently accepted medical use in treatment in the United States. Abuse may lead to limited physical dependence or psychological dependence relative to those in schedule 4.
Alcohol
X Interacts with Alcohol.

Further information

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