Periostat Side Effects

Generic Name: doxycycline

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 at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

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; 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.

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

Gastrointestinal

Gastrointestinal side effects have included nausea, esophageal irritation, ulceration, epigastric burning, and black, hairy tongue. At least one case of adult tooth staining has been reported. Other gastrointestinal side effects associated with tetracyclines have included anorexia, vomiting, diarrhea, glossitis, dysphagia, enterocolitis, and inflammatory lesions with monilial overgrowth in the anogenital region.

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.

Genitourinary

Genitourinary side effects have included vaginal candidiasis and vaginal itch.

Hypersensitivity

Hypersensitivity reactions have included urticaria, angioneurotic edema, anaphylaxis, anaphylactoid purpura, serum sickness, pericarditis, exfoliative dermatitis, and exacerbation of systemic lupus erythematosus.

Dermatologic

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 photo sensitivity, 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.

Dermatologic side effects have included photosensitivity, maculopapular and erythematous rashes, exfoliative dermatitis, nail discoloration, and photo-onycholysis.

There is a case report of doxycycline induced nail discoloration.

Other

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.

Hematologic

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

Nervous system

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 intracranial hypertension (pseudotumor cerebri). Headache, dizziness, drowsiness, and amnesia have also been reported.

Hepatic

Hepatic side effects have included individual reports of acute hepatocellular injury and cholestatic reactions associated with low-dose oral doxycycline.

Metabolic

Metabolic side effects have included hypoglycemia in a nondiabetic patient.

Renal

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

Ocular

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

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