Oracea

Indication

ORACEA is indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients. No meaningful effect was demonstrated for generalized erythema (redness) of rosacea.

Limitations of Use

This formulation of doxycycline has not been evaluated in the treatment or prevention of infections. ORACEA should not be used for treating bacterial infections, providing antibacterial prophylaxis, or reducing the numbers or eliminating microorganisms associated with any bacterial disease. To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, ORACEA should be used only as indicated.

Efficacy of ORACEA beyond 16 weeks and safety beyond 9 months have not been established.

ORACEA has not been evaluated for the treatment of the erythematous, telangiectatic, or ocular components of rosacea.

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In controlled clinical trials of adult subjects with mild to moderate rosacea, 537 subjects received ORACEA or placebo over a 16-week period. The following table summarizes selected adverse reactions that occurred in the clinical trials at a rate of ≥ 1% for the active arm:

Table 1: Incidence (%) of Selected Adverse Reactions in Clinical Trials of ORACEA (n=269) vs. Placebo (n=268)

Note: Percentages based on total number of study participants in each treatment group.

The following adverse reactions have been observed in patients receiving tetracyclines at higher, antimicrobial doses:

Gastrointestinal: anorexia, nausea, vomiting, diarrhea, glossitis, dysphagia, enterocolitis, and inflammatory lesions (with vaginal candidiasis) in the anogenital region. Hepatotoxicity has been reported rarely. Rare instances of esophagitis and esophageal ulcerations have been reported in patients receiving the capsule forms of the drugs in the tetracycline-class. Most of the patients experiencing esophagitis and/or esophageal ulceration took their medication immediately before lying down [see DOSAGE AND ADMINISTRATION].

Skin: maculopapular and erythematous rashes. Exfoliative dermatitis has been reported but is uncommon. Photosensitivity is discussed above [see WARNINGS AND PRECAUTIONS].

Renal toxicity: Rise in BUN has been reported and is apparently dose-related [see WARNINGS AND PRECAUTIONS]. Hypersensitivity reactions: urticaria, angioneurotic edema, anaphylaxis, anaphylactoid purpura, serum sickness, pericarditis, and exacerbation of systemic lupus erythematosus. Blood: Hemolytic anemia, thrombocytopenia, neutropenia, and eosinophilia have been reported.

Postmarketing Experience

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The following adverse reactions have been identified during post approval use of ORACEA.

• Nervous system: Pseudotumor cerebri (benign intracranial hypertension), headache.

Read the entire FDA prescribing information for Oracea (Doxycycline)

Tell your doctor about all the medications you take including prescription and non-prescription medications, vitamins, and herbal supplements. Especially tell your doctor if you take:

• anticoagulants, or blood thinners
• penicillin antibiotics such as amoxicillin (Moxatag) and ampicillin
• antacids containing aluminum, calcium, magnesium, or iron
• bismuth subsalicylate (Pepto-Bismol)
• barbiturates such as phenobarbital (Donnatal)
• carbamazepine (Tegretol)
• phenytoin (Dilantin)
• methoxyflurane (Penthrane)
• oral contraceptives

This is not a complete list of doxycycline drug interactions.  Ask your doctor or pharmacist for more information.

Storage

Oral

Tight, light-resistant containers at 15–30°C.1

• It is used to treat rosacea.

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• To gain the most benefit, do not miss doses.
• Keep taking Oracea (doxycycline capsules (rosacea)) as you have been told by your doctor or other health care provider, even if you feel well.
• Some drugs may need to be taken with food or on an empty stomach. For some drugs it does not matter. Check with your pharmacist about how to take this medicine.
• Drink lots of noncaffeine liquids unless told to drink less liquid by your doctor.
• Do not take bismuth (Pepto-Bismol®), calcium, iron, magnesium, zinc, multivitamins with minerals, colestipol, cholestyramine, didanosine, or antacids within 2 hours of Oracea.
• Take with a full glass of water.
• Do not lie down for at least 30 minutes after taking this medicine.
• Swallow whole. Do not chew, break, or crush.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• Signs of a pancreas problem (pancreatitis) like very bad stomach pain, very bad back pain, or very bad upset stomach or throwing up.
• Chest pain.
• Not able to pass urine or change in how much urine is passed.
• Fever or chills.
• Sore throat.
• Throat irritation.
• Trouble swallowing.
• Any unexplained bruising or bleeding.
• Joint pain.
• Feeling very tired or weak.
• Vaginal itching or discharge.
• It is common to have diarrhea when taking Oracea. Rarely, a very bad form of diarrhea called Clostridium difficile (C diff)–associated diarrhea (CDAD) may occur. Sometimes, this has led to a deadly bowel problem (colitis). CDAD may happen while you are taking this medicine or within a few months after you stop taking it. Call your doctor right away if you have stomach pain or cramps, very loose or watery stools, or bloody stools. Do not try to treat loose stools without first checking with your doctor.
• Raised pressure in the brain has happened with Oracea. Most of the time, this will go back to normal after this medicine is stopped. Sometimes, loss of eyesight may happen and may not go away even after Oracea is stopped. Call your doctor right away if you have a headache or eyesight problems like blurred eyesight, seeing double, or loss of eyesight.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take Oracea or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Oracea (doxycycline capsules (rosacea)). This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

General Dosing Information

One Oracea Capsule (40 mg) should be taken once daily in the morning on an empty stomach, preferably at least one hour prior to or two hours after meals.

Administration of adequate amounts of fluid along with the capsules is recommended to wash down the capsule to reduce the risk of esophageal irritation and ulceration [see Adverse Reactions (6)].

Important Considerations for Dosing Regimen

The dosage of Oracea differs from that of doxycycline used to treat infections. Exceeding the recommended dosage may result in an increased incidence of side effects including the development of resistant organisms.

Oracea (doxycycline, USP) Capsules 40 mg are hard gelatin capsule shells filled with two types of doxycycline beads (30 mg immediate release and 10 mg delayed release) that together provide a dose of 40 mg of anhydrous doxycycline (C22H24N2O8).

The structural formula of doxycycline, USP is:

with an empirical formula of C22H24N2O8•H2O and a molecular weight of 462.46. The chemical designation for doxycycline is 2-Naphthacenecar-boxamide,4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-, [4S-(4α, 4aα, 5α, 5aα, 6α,12aα)]-, monohydrate. It is very slightly soluble in water.

Inert ingredients in the formulation are: hypromellose, iron oxide red, iron oxide yellow, methacrylic acid copolymer, polyethylene glycol, Polysorbate 80, sugar spheres, talc, titanium dioxide, and triethyl citrate. Active ingredients: Each capsule contains doxycycline, USP in an amount equivalent to 40 mg of anhydrous doxycycline.

Oracea (beige opaque capsule imprinted with “GLD 40”) containing doxycycline, USP in an amount equivalent to 40 mg of anhydrous doxycycline.

Bottle of 30 (NDC 0299-3822-30).

Storage:

All products are to be stored at controlled room temperatures of 15°C - 30°C (59°F - 86°F) and dispensed in tight, light-resistant containers (USP).

Keep out of reach of children.

See FDA-approved patient labeling (Patient Information)

Patients taking Oracea Capsules 40 mg should receive the following information and instructions:

• It is recommended that Oracea not be used by individuals of either gender who are attempting to conceive a child
• It is recommended that Oracea not be used by pregnant or breast feeding women
• Patients should be advised that pseudomembranous colitis can occur with doxycycline therapy. If patients develop watery or bloody stools, they should seek medical attention.
• Patients should be advised that pseudotumor cerebri can occur with doxycycline therapy. If patients experience headache or blurred vision they should seek medical attention.
• Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines, including doxycycline. Patients should minimize or avoid exposure to natural or artificial sunlight (tanning beds or UVA/B treatment) while using doxycycline. If patients need to be outdoors while using doxycycline, they should wear loose-fitting clothes that protect skin from sun exposure and discuss other sun protection measures with their physician. Treatment should be discontinued at the first evidence of sunburn.
• Concurrent use of doxycycline may render oral contraceptives less effective.
• Autoimmune syndromes, including drug-induced lupus-like syndrome, autoimmune hepatitis, vasculitis and serum sickness have been observed with tetracycline-class drugs, including doxycycline. Symptoms may be manifested by arthralgia, fever, rash and malaise. Patients who experience such symptoms should be cautioned to stop the drug immediately and seek medical help.
• Patients should be counseled about discoloration of skin, scars, teeth or gums that can arise from doxycycline therapy.
• Take Oracea exactly as directed. Increasing doses beyond 40 mg every morning may increase the likelihood that bacteria will develop resistance and will not be treatable by other antibacterial drugs in the future.

PATIENT INFORMATION
Oracea (Or-RAY-sha)
(doxycycline)
capsules

Read this Patient Information before you start taking Oracea and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or treatment.

What is Oracea?
Oracea is a tetracycline-class medicine. Oracea is a prescription medicine used in adults to treat only pimples or bumps (papules and pustules) caused by a condition called rosacea. Oracea does not lessen redness caused by rosacea.
Oracea should not be used for the treatment or prevention of infections.
It is not known if Oracea is:
• effective for use for longer than 16 weeks.
• safe for use longer than 9 months.
• safe and effective in children. Oracea should not be used in infants and children less than 8 years of age because it may cause stained teeth in infants and children.

Who should not take Oracea?
Do not take Oracea if you are allergic to doxycycline or other medicines in the tetracycline-class. Ask your doctor or pharmacist for a list of these medicines if you are not sure.

What should I tell my doctor before taking Oracea?
Before you take Oracea tell your doctor if you:
• have kidney problems.
• have liver problems.
• have diarrhea or watery stools.
• have vision problems.
• have had surgery on your stomach (gastric surgery).
• have or had a yeast or fungal infection in your mouth or vagina.
• have any other medical condition.
• are pregnant or plan to become pregnant. Oracea may harm your unborn baby. Taking Oracea while you are pregnant may cause serious side effects on the growth of bone and teeth of your baby. Stop taking Oracea and call your doctor right away if you become pregnant while taking Oracea.
• are breastfeeding or plan to breastfeed. Oracea can pass into your breast milk and may harm your baby. Talk to your doctor about the best way to feed your baby if you take Oracea. You and your doctor should decide if you will take Oracea or breastfeed. You should not do both.

You should not take Oracea if you are a male with a female sexual partner who plans to become pregnant at any time while you are being treated with Oracea.

Tell your doctor about all of the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Oracea and other medicines can affect each other causing serious side effects.

Especially tell your doctor if you take:
• birth control pills. Oracea may reduce the effectiveness of birth control pills. Talk to your doctor about what types of birth control you can use to prevent pregnancy while taking Oracea.
• a blood thinner medicine.
• a penicillin (antibacterial medicine).
• proton pump inhibitors or antacids that contain aluminum, calcium, or magnesium.
• products containing iron or bismuth subsalicylate.
• a medicine taken by mouth that contains isotretinoin or acitretin.
• a medicine to treat seizures, such as carbamazepineor or phenytoin.

Ask your doctor or pharmacist for a full list of these medicines, if you are not sure.

Know the medicines you take. Keep a list of your medicines and show it to your doctor and pharmacist when you get a new medicine.

How should I take Oracea?
• Take Oracea exactly as prescribed by your doctor. Taking more than your prescribed dose may increase your chance of side effects, including the chance that bacteria will become resistant to Oracea.
• Take Oracea 1 time a day in the morning on an empty stomach.
• You should take Oracea at least one hour before or two hours after a meal.
• Take Oracea with enough fluid to completely swallow the capsule and to lower your risk of getting irritation or ulcer in your esophagus. Your esophagus is the tube that connects your mouth to your stomach.
• If you took too much Oracea call your doctor right away.
• Your doctor may do blood tests during treatment with Oracea to check for side effects.

What should I avoid while taking Oracea?
Avoid sunlight or artificial sunlight, such as a tanning booth or sunlamp. You could get severe sunburn. Use sunscreen and wear clothes that cover your skin while out in sunlight.

What are the possible side effects of Oracea?
Oracea may cause serious side effects, including:
• Harm to an unborn baby. See “What should I tell my doctor before taking Oracea?”
• Permanent teeth discoloration. Oracea may permanently turn a baby or child's teeth yellow-grey-brown during tooth development. Oracea should not be used during tooth development. Tooth development happens in the last half of pregnancy, and from birth to 8 years of age. See “What should I tell my doctor before taking Oracea?”
• Intestine infection (pseudomembranous colitis). Pseudomembranous colitis can happen with most antibiotics, including Oracea. Call your doctor right away if you get diarrhea or bloody stools.
• Immune system reactions including a lupus-like syndrome, hepatitis,
and inflammation of blood or lymph vessels (vasculitis). Stop taking Oracea and tell your doctor right away if you get joint pain, fever, rash, or body weakness.
• Discoloration (hyperpigmentation). Oracea can cause darkening of your skin, scars, teeth, gums, nails, and whites of your eyes.
• Benign intracranial hypertension, also called pseudotumor cerebri. This is a condition where there is high pressure in the fluid around the brain. This swelling may lead to vision changes and permanent vision loss. Stop taking Oracea and tell your doctor right away if you have blurred vision, vision loss, or unusual headaches.

The most common side effects of Oracea include:

• soreness in the nose and throat
• sinus infection
• fungus infection
• flu-like symptoms
• diarrhea
• stomach (abdominal) bloating or pain
• high blood pressure (hypertension)
• change in certain blood tests


Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Oracea. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Galderma Laboratories, L.P. at 1-866-735-4137.

How should I store Oracea?
• Store Oracea at room temperature between 59°F to 86°F (15°C to 30°C).
• Keep Oracea in a tightly closed container.
• Keep Oracea inside container and out of light.

Keep Oracea and all medicine out of the reach of children.

General information about Oracea
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not take Oracea for a condition for which it was not prescribed. Do not give Oracea to other people, even if they have the same symptoms you have. It may harm them.

This Patient Information leaflet summarizes the most important information about Oracea. If you would like more information, talk with your doctor. You can also ask your doctor or pharmacist for information that is written for health professionals.

What are the ingredients in Oracea?
Active ingredient: doxycycline
Inactive ingredients: hypromellose, iron oxide red, iron oxide yellow, methacrylic acid copolymer, polyethylene glycol, Polysorbate 80, sugar spheres, talc, titanium dioxide, and triethyl citrate.

This Patient Information has been approved by the U.S. Food and Drug Administration.

Marketed by:
GALDERMA LABORATORIES, L.P.
Fort Worth, Texas 76177 USA

All trademarks are the property of their respective owners.
P52631-0

Oracea (doxycycline) is used to treat blemishes, bumps, and acne-like lesions caused by rosacea in adults. It works by reducing skin inflammation caused by rosacea.

Oracea is a tetracycline antibiotic. Tetracyclines are often used to treat infections, however this formulation has not been evaluated in the treatment or prevention of infections.

Oracea may also be used for other purposes not listed in this medication guide.

You should not take Oracea if you are allergic to doxycycline or to other tetracycline antibiotics such as demeclocycline, minocycline, tetracycline, or tigecycline.

To make sure Oracea is safe for you, tell your doctor if you have ever had:

• liver disease;

• kidney disease;

• asthma or sulfite allergy;

• increased pressure inside your skull; or

• if you also take isotretinoin, seizure medicine, or a blood thinner such as warfarin (Coumadin).

Taking Oracea during pregnancy may affect tooth and bone development in the unborn baby. Taking doxycycline during the last half of pregnancy can cause permanent tooth discoloration later in the baby's life. Tell your doctor if you are pregnant or if you become pregnant while using this medicine.

Oracea can make birth control pills less effective. Ask your doctor about using a non-hormonal birth control (condom, diaphragm with spermicide) to prevent pregnancy.

Doxycycline can pass into breast milk and may affect bone and tooth development in a nursing infant. Do not breast-feed while you are taking this medicine.

Children should not use Oracea. This medicine can cause permanent yellowing or graying of the teeth in children younger than 8 years old.

Children should use doxycycline only in cases of severe or life-threatening conditions such as anthrax or Rocky Mountain spotted fever. The benefit of treating a serious condition may outweigh any risks to the child's tooth development.

Other drugs may interact with doxycycline, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Applies to doxycycline: injectable powder for injection, oral capsule, oral delayed release capsule, oral delayed release tablet, oral kit, oral powder for reconstitution, oral syrup, oral tablet, oral and topical kit

Nervous system

Very common (10% or more): Headache (up to 26%)
Common (1% to 10%): Sinus headache
Rare (0.01% to 0.1%): Bulging fontanels (in infants), benign intracranial hypertension (pseudotumor cerebri [symptoms include blurred vision, scotomata, diplopia]), tinnitus
Frequency not reported: Hypoesthesia, increased intracranial pressure, paresthesia, somnolence, stupor, taste loss, drowsiness, amnesia, paresthesias of body areas exposed to sunlight, phrenic nerve paralysis after sclerotherapy
Postmarketing reports: Pseudotumor cerebri, headache, dizziness[Ref]

Benign intracranial hypertension resulting in permanent loss of vision has been reported.

A 70-year-old female patient with no significant medical history suddenly developed a severe headache followed by vomiting about 15 minutes after the initial dose of this drug. The patient also experienced memory dysfunction; she could not remember the events of the afternoon prior to the dose of this drug and could not retain the information after she was reminded. The incident lasted about 30 minutes and she was transported to the hospital for further evaluation. No further cause, such as intoxication or trauma, could be elicited. Once at the hospital, the patient was able to remember the events of the afternoon and could retain new information, but amnesia regarding the events of the 30 minutes following the onset of the headache persisted. The patient's laboratory results, computerized tomography scan, MRI scan, cerebrospinal fluid, and electroencephalogram showed no pathology. When the patient was discharged 2 days later, the amnesia for the 30 minutes continued. After elimination of other symptomatic causes, the amnesia was concluded to be due to this drug because of the close relation of the dose and the onset of symptoms.[Ref]

Other

Very common (10% or more): Common cold (up to 22%), influenza symptoms (up to 11%)
Common (1% to 10%): Injury/accidental injury, pain, infection, fungal infection, influenza
Rare (0.01% to 0.1%): Candida infection/candidiasis, flushing, retrosternal pain
Frequency not reported: Malaise, overgrowth of nonsusceptible organisms (superinfection)
Postmarketing reports: Asthenia[Ref]

Gastrointestinal

Very common (10% or more): Nausea (up to 13.4%)
Common (1% to 10%): Nausea/vomiting, toothache, tooth disorder, dyspepsia, diarrhea, periodontal abscess, acid indigestion, upper abdominal pain, abdominal distention, abdominal pain, stomach discomfort, dry mouth
Uncommon (0.1% to 1%): Gum pain, heartburn/gastritis
Rare (less than 0.1%): Glossitis, dysphagia, enterocolitis, inflammatory lesions (with candidal/monilial overgrowth) in the anogenital region, esophagitis, esophageal ulcerations, pancreatitis, pseudomembranous colitis, Clostridium difficile colitis, stomatitis
Frequency not reported: Clostridium difficile-associated diarrhea, esophageal irritation, ulceration, epigastric burning, black hairy tongue, tooth discoloration/adult tooth staining, vomiting, enamel hypoplasia, staphylococcal enterocolitis
Postmarketing reports: Bloody diarrhea, colitis, constipation, superficial tooth discoloration[Ref]

Numerous cases of esophageal ulceration have been reported. In most cases, the patients had taken their medication at bedtime, usually without enough liquid. Patients often presented with severe retrosternal pain and difficulty swallowing. Ulcerations generally resolved within a week after discontinuing the drug. In 1 case report, severe hiccups of 4-day duration associated with esophagitis followed the first dose of this drug.

Esophagitis and esophageal ulcerations have been reported in patients taking the capsule or tablet formulations of tetracycline-class antibiotics. Most of these patients took the drug immediately before going to bed.[Ref]

Musculoskeletal

Common (1% to 10%): Joint pain/arthralgia, back pain/back ache
Uncommon (0.1% to 1%): Muscle pain/myalgia[Ref]

Respiratory

Common (1% to 10%): Nasopharyngitis, sore throat, sinus congestion, coughing, sinusitis, bronchitis, nasal congestion, pharyngolaryngeal pain
Frequency not reported: Bronchospasm

Dermatologic

Common (1% to 10%): Rash (including maculopapular rash, erythematous rash), photosensitivity reaction/dermatitis
Rare (0.01% to 0.1%): Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis, photoonycholysis, drug reaction with eosinophilia and systemic symptoms (DRESS)
Frequency not reported: Nail discoloration, phototoxicity, photoallergic reaction, morbilliform rash, onycholysis, pustular rash
Postmarketing reports: Pruritus, urticaria

Tetracyclines:
-Frequency not reported: Hyperpigmentation[Ref]

In a double-blinded study, this drug was found to be more phototoxic than minocycline and demeclocycline. Paresthesias of the body areas exposed to sunlight may be early signs of sunburn reactions.

A case report of a possible photoallergic reaction described scaly erythema and vesicles on the face and neck associated with administration of this drug. Upon rechallenge, a flare with erythema, itching, and burning occurred in the same area.

Another case report was documented in Australian troops treated with 100 mg daily for malaria prophylaxis while on deployment in East Timor, a group of islands within the Malaysian archipelago located close to the equator. Of the 135 troops, 22 exhibited phototoxic reactions to low doses of this drug that resembled severe sunburn with erythematous plaques on the sun-exposed areas. The troops used a sunscreen containing oxybenzone.

An 11-year-old boy treated with this drug for brucellosis was evaluated for painless brown nail discoloration. This drug was initiated for brucellosis but stopped when the boy developed photosensitivity, but 15 days after the initiation of therapy brown nail discoloration developed. Other than the brown discoloration, the boy's physical condition was normal and the discoloration disappeared within 1 month.[Ref]

Genitourinary

Common (1% to 10%): Menstrual cramps, bacterial vaginitis, vulvovaginal mycotic infection
Uncommon (0.1% to 1%): Vaginal infection
Frequency not reported: Vaginal itch, vaginitis
Postmarketing reports: Vaginal candidiasis/moniliasis, anogenital moniliasis[Ref]

Cardiovascular

Common (1% to 10%): Hypertension, increased blood pressure
Frequency not reported: Phlebitis (with IV administration)

Hepatic

Common (1% to 10%): Increased AST
Rare (0.01% to 0.1%): Abnormal hepatic function, hepatic failure, hepatitis, hepatotoxicity, jaundice
Frequency not reported: Acute hepatocellular injury, cholestatic reactions, cholestatic hepatitis, fatty liver degeneration, transient increases in liver function tests[Ref]

Metabolic

Hypoglycemia in a nondiabetic patient has been reported.[Ref]

Common (1% to 10%): Increased blood LDH, increased blood glucose
Rare (0.01% to 0.1%): Decreased appetite, porphyria
Frequency not reported: Hypoglycemia, anorexia[Ref]

Psychiatric

Common (1% to 10%): Anxiety
Frequency not reported: Confusion, depression, hallucination

Hypersensitivity

Common (1% to 10%): Anaphylactic reaction (including angioedema, exacerbation of systemic lupus erythematosus, pericarditis, hypersensitivity, serum sickness, Henoch-Schonlein purpura, hypotension, dyspnea, tachycardia, peripheral edema, urticaria)
Frequency not reported: Hypersensitivity reactions (including urticaria, angioneurotic edema, anaphylactic shock, anaphylaxis, anaphylactoid reactions, anaphylactoid purpura, serum sickness, hypotension, pericarditis, exacerbation of systemic lupus erythematosus, dyspnea, peripheral edema, tachycardia)
Postmarketing reports: Mild allergic reactions[Ref]

Hematologic

Rare (0.01% to 0.1%): Hemolytic anemia, thrombocytopenia, neutropenia, eosinophilia
Frequency not reported: Increased prothrombin time, leukopenia, thrombocytopenic purpura[Ref]

Renal

Rare (0.01% to 0.1%): Increased BUN/blood urea (dose-related)
Frequency not reported: Acute renal failure[Ref]

Endocrine

The long-term use of tetracyclines has been associated with microscopic brown-black discoloration of the thyroid gland; abnormal thyroid function has not been reported.[Ref]

Rare (0.01% to 0.1%): Microscopic brown-black discoloration of the thyroid gland[Ref]

Ocular

Frequency not reported: Diplopia, papilledema, loss of vision (associated with drug-induced benign intracranial hypertension), conjunctivitis, periorbital edema[Ref]

Immunologic

Tetracyclines:
-Frequency not reported: Autoimmune syndromes

Some side effects of Oracea may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.