Periostat Side Effects

Generic Name: doxycycline,doxycycline calcium

Please note - some side effects for Periostat may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Periostat - for the Consumer

Periostat

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Periostat:

Diarrhea; nausea; sensitivity to sunlight; stomach upset.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); bloody stools; chest pain; dark urine; decreased urination; fever, chills, or sore throat; moderate to severe sunburn; red, swollen, blistered, or peeling skin; severe diarrhea; severe or persistent headache; stomach pain or cramps; throat irritation; trouble swallowing; unusual bruising or bleeding; unusual joint pain; unusual tiredness; vaginal irritation or discharge; vision changes; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Periostat Side Effects - for the Professional

Periostat

Adverse Reactions in Clinical Trials of a bioequivalent form of doxycycline hyclate capsules: In clinical trials of adult patients with periodontal disease 213 patients received 20 mg BID over a 9 -12 month period. The most frequent adverse reactions occurring in studies involving treatment with a bioequivalent form of doxycycline hyclate capsules or placebo are listed below:

Adverse Reactions for Tetracyclines: The following adverse reactions have been observed in patients receiving tetracyclines:

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 these patients took medications immediately before going to bed..

Skin: maculopapular and erythematous rashes. Exfoliative dermatitis has been reported but is uncommon. Photosensitivity is discussed above..

Renal toxicity: Rise in BUN has been reported and is apparently dose related..

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.

Side Effects by Body System - for Healthcare Professionals

Gastrointestinal

Gastrointestinal side effects have included nausea, esophageal irritation, ulceration, epigastric burning, diarrhea, upper abdominal pain, abdominal distention, abdominal pain, stomach discomfort, dry mouth, and black, hairy tongue. At least one case of adult tooth staining has been reported. Anorexia, nausea, vomiting, diarrhea, glossitis, dysphagia, enterocolitis, and inflammatory lesions with monilial overgrowth in the anogenital region have been reported with tetracyclines. Rare cases of esophagitis and esophageal ulcerations have been reported in patients receiving capsule and tablet forms of drugs in the tetracycline class.

Numerous cases of esophageal ulceration have been reported. In most of the cases the patients had taken their medication at bedtime, usually without enough liquid. Patients often present with severe retrosternal pain and difficulty swallowing. Ulcerations generally resolve within a week after discontinuation of the medication. One case report describes severe hiccups of 4-day duration associated with esophagitis following the first dose of doxycycline.

Case reports of doxycycline causing Clostridium difficile have also been described.

Dermatologic

Dermatologic side effects have included nail discoloration, phototoxicity, photoallergic reaction, and photo-onycholysis. Photosensitivity, maculopapular and erythematous rashes, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, and exfoliative dermatitis have been reported with tetracyclines.

In a double-blinded study, doxycycline 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 describes scaly erythema and vesicles on the face and neck associated with doxycycline administration. Upon rechallenge, a flare with erythema, itching and burning occurred in the same area.

Another case report was documented in Australian troops treated with doxycycline 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 dosages of doxycycline 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 doxycycline for brucellosis was evaluated for painless brown nail discoloration. Doxycycline 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 one month.

Nervous system

Benign intracranial hypertension resulting in significant 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 doxycycline. The patient also experienced memory dysfunction; she could not remember the events of the afternoon prior to the doxycycline dose 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, CT scan, MRI scan, cerebrospinal fluid, and EEG 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 the doxycycline because of the close relation of the doxycycline dose and the onset of symptoms.

Nervous system side effects have included phrenic nerve paralysis after sclerotherapy, and benign intracranial hypertension (pseudotumor cerebri). Headache, sinus headache, dizziness, drowsiness, amnesia, and paresthesias of body areas exposed to sunlight have been reported.

Hepatic

Hepatic side effects have included increased aspartate aminotransferase. Individual reports of acute hepatocellular injury and cholestatic reactions have been associated with low-dose oral doxycycline. Hepatotoxicity has been reported rarely with tetracyclines.

Metabolic

Metabolic side effects have included increased blood lactate dehydrogenase and increased blood glucose. Hypoglycemia in a nondiabetic patient has been reported.

Genitourinary

Genitourinary side effects have included vaginal candidiasis and vaginal itch.

Other

Other side effects have included fungal infection, influenza, pain, and back pain. The long-term use of tetracyclines has been associated with microscopic brown-black discoloration of the thyroid gland but abnormal thyroid function has not been reported.

Cardiovascular

Cardiovascular side effects have included hypertension and increased blood pressure.

Ocular

Ocular side effects have included diplopia, papilledema, and loss of vision associated with doxycycline-induced benign intracranial hypertension.

Hypersensitivity

Hypersensitivity side effects associated with tetracyclines have included urticaria, angioneurotic edema, anaphylaxis, anaphylactoid purpura, serum sickness, pericarditis, exfoliative dermatitis, and exacerbation of systemic lupus erythematosus.

Hematologic

Hematologic side effects associated with tetracyclines have included hemolytic anemia, thrombocytopenia, neutropenia, and eosinophilia.

Respiratory

Respiratory side effects have included nasopharyngitis, pharyngolaryngeal pain, sinusitis, and nasal congestion.

Psychiatric

Psychiatric side effects have included anxiety.

Renal

Renal side effects associated with tetracyclines have included a dose-related rise in BUN.

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