Ocudox Side Effects

Generic Name: doxycycline

Note: This page contains side effects data for the generic drug doxycycline. It is possible that some of the dosage forms included below may not apply to the brand name Ocudox.

It is possible that some side effects of Ocudox may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to doxycycline: oral capsule, oral capsule delayed release, oral capsule extended release, oral powder for suspension, oral syrup, oral tablet, oral tablet delayed release

Other dosage forms:

As well as its needed effects, doxycycline (the active ingredient contained in Ocudox) may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking doxycycline, check with your doctor immediately:

Incidence not known
  • Abdominal or stomach tenderness
  • bloating
  • clay-colored stools
  • cough
  • dark urine
  • decreased appetite
  • diarrhea
  • diarrhea, watery and severe, which may also be bloody
  • difficulty with swallowing
  • dizziness
  • fast heartbeat
  • feeling of discomfort
  • fever
  • headache
  • hives, itching, puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • hives or welts
  • increased thirst
  • inflammation of the joints
  • itching
  • joint or muscle pain
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • loss of appetite
  • nausea and vomiting
  • numbness or tingling of the face, hands, or feet
  • pain
  • rash
  • redness and soreness of the eyes
  • redness of the skin
  • shortness of breath
  • sore throat
  • sores in the mouth
  • stomach cramps
  • stomach pain or tenderness
  • swelling of the feet or lower legs
  • swollen lymph glands
  • tightness in the chest
  • unusual tiredness or weakness
  • unusual weight loss
  • wheezing
  • yellow eyes or skin

Some doxycycline side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

Incidence not known
  • Back, leg, or stomach pains
  • black, tarry stools
  • bleeding gums
  • blood in the urine or stools
  • blurred vision
  • bulging soft spot on the head of an infant
  • change in the ability to see colors, especially blue or yellow
  • chest pain, discomfort, or burning
  • chills
  • cracks in the skin
  • decrease in vision
  • difficulty breathing
  • discoloration of the thyroid glands
  • double vision
  • general body swelling
  • heartburn
  • increased sensitivity of the skin to sunlight
  • loss of heat from the body
  • lower back or side pain
  • nosebleeds
  • pain or burning in the throat
  • pain with swallowing
  • painful or difficult urination
  • pale skin
  • pinpoint red spots on the skin
  • rash with flat lesions or small raised lesions on the skin
  • red, swollen skin
  • redness or other discoloration of the skin
  • redness, swelling, or soreness of the tongue
  • scaly skin
  • severe nausea
  • severe stomach pain
  • severe sunburn
  • sores, ulcers, or white spots on the lips or tongue or inside the mouth
  • unusual bleeding or bruising
  • vomiting blood

For Healthcare Professionals

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

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 active ingredient contained in Ocudox) 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.[Ref]

Very common (10% or more): Headache (up to 26%)
Frequency not reported: Sinus headache, dizziness, drowsiness, amnesia, paresthesias of body areas exposed to sunlight, phrenic nerve paralysis after sclerotherapy
Postmarketing reports: Pseudotumor cerebri (benign intracranial hypertension), headache

Tetracyclines:
Frequency not reported: Bulging fontanels in infants, benign intracranial hypertension (pseudotumor cerebri) in adults[Ref]

Gastrointestinal

Very common (10% or more): Nausea (up to 13.4%)
Common (1% to 10%): Vomiting (8.1%), toothache (7%), tooth disorder (6%), dyspepsia (6%), diarrhea (up to 6%), periodontal abscess (4%), acid indigestion (4%), upper abdominal pain (2%), abdominal distention (1%), abdominal pain (1%), stomach discomfort (1%), dry mouth (1%)
Uncommon (0.1% to 1%): Gum pain (less than 1%)
Rare (less than 0.1%): Adult tooth staining (at least 1 case)
Frequency not reported: Clostridium difficile associated diarrhea, esophageal irritation, ulceration, epigastric burning, black hairy tongue

Tetracyclines:
Frequency not reported: Nausea, vomiting, diarrhea, glossitis, dysphagia, enterocolitis, inflammatory lesions (with monilial overgrowth) in the anogenital region, esophagitis, esophageal ulcerations[Ref]

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.

Esophagitis and esophageal ulcerations have been reported in patients receiving capsule and tablet formulations of tetracycline-class drugs. Most took medication immediately before going to bed.[Ref]

Other

Very common (10% or more): Common cold (22%), influenza symptoms (11%)
Common (1% to 10%): Injury (5%), pain (up to 4%), back pain (up to 3%), back ache (2%), infection (2%), fungal infection (2%), influenza (2%)
Frequency not reported: Possible overgrowth of nonsusceptible organisms (superinfection)

Tetracyclines:
Frequency not reported: Microscopic brown-black discoloration of the thyroid gland[Ref]

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]

Musculoskeletal

Common (1% to 10%): Joint pain (6%), muscle pain (1%)

Respiratory

Common (1% to 10%): Nasopharyngitis (5%), sore throat (5%), sinus congestion (5%), coughing (4%), sinus headache (up to 4%), sinusitis (3%), bronchitis (3%), nasal congestion (2%), pharyngolaryngeal pain (1%)

Dermatologic

Common (1% to 10%): Rash (4%)
Frequency not reported: Nail discoloration, phototoxicity, photoallergic reaction, photo-onycholysis

Tetracyclines:
Frequency not reported: Photosensitivity, maculopapular and erythematous rashes, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis, hyperpigmentation[Ref]

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.[Ref]

Genitourinary

Common (1% to 10%): Menstrual cramp (4%), bacterial vaginitis (3.3%), vulvovaginal mycotic infection (2%)
Frequency not reported: Vaginal itch

Tetracyclines:
Frequency not reported: Vaginal candidiasis[Ref]

Cardiovascular

Common (1% to 10%): Hypertension (3%), increased blood pressure (2%)

Hepatic

Common (1% to 10%): Increased aspartate aminotransferase (2%)
Frequency not reported: Acute hepatocellular injury, cholestatic reactions

Tetracyclines:
Frequency not reported: Hepatotoxicity[Ref]

Metabolic

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

Common (1% to 10%): Increased blood lactate dehydrogenase (2%), increased blood glucose (1%)
Frequency not reported: Hypoglycemia

Tetracyclines:
Frequency not reported: Anorexia[Ref]

Psychiatric

Common (1% to 10%): Anxiety (2%)

Hypersensitivity

Tetracyclines:
Frequency not reported: Hypersensitivity reactions (including urticaria, angioneurotic edema, anaphylaxis, anaphylactoid purpura, serum sickness, pericarditis, exacerbation of systemic lupus erythematosus, drug rash with eosinophilia and systemic symptoms [DRESS])[Ref]

Hematologic

Tetracyclines:
Frequency not reported: Hemolytic anemia, thrombocytopenia, neutropenia, eosinophilia[Ref]

Ocular

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

Renal

Tetracyclines:
Frequency not reported: Dose-related rise in BUN[Ref]

Immunologic

Tetracyclines:
Frequency not reported: Autoimmune syndromes

References

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2. Digre KB "Not so benign intracranial hypertension." BMJ 326 (2003): 613-4

3. Kirse DJ, Suen JY, Stern SJ "Phrenic nerve paralysis after doxycycline sclerotherapy for chylous fistula." Otolaryngol Head Neck Surg 116 (1997): 680-3

4. Del Rosso JQ, Webster GF, Jackson M, et al. "Two randomized phase III clinical trials evaluating anti-inflammatory dose doxycycline (40-mg doxycycline, USP capsules) administered once daily for treatment of rosacea." J Am Acad Dermatol 56 (2007): 791-802

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8. Friedman DI, Gordon LK, Egan RA, et al. "Doxycycline and intracranial hypertension." Neurology 62 (2004): 2297-9

9. "Product Information. Adoxa (doxycycline)." Doak Dermatologics Division, Fairfield, NJ.

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11. Akhyani M, Ehsani AH, Ghiasi M, Jafari AK "Comparison of efficacy of azithromycin vs. doxycycline in the treatment of rosacea: a randomized open clinical trial." Int J Dermatol 47 (2008): 284-8

12. Tzianetas I, Habal F, Keystone JS "Short report: severe hiccups secondary to doxycycline-induced esophagitis during treatment of malaria." Am J Trop Med Hyg 54 (1996): 203-4

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15. Grochenig HP, Tilg H, Vogetseder W "Clinical challenges and images in GI. Pill esophagitis." Gastroenterology 131 (2006): 996, 1365

16. de Vries HJ, Smelov V, Middelburg JG, Pleijster J, Speksnijder AG, Morre SA "Delayed microbial cure of lymphogranuloma venereum proctitis with doxycycline treatment." Clin Infect Dis 48 (2009): e53-6

17. Freedman DO "Clinical practice. Malaria prevention in short-term travelers." N Engl J Med 359 (2008): 603-12

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19. Ramsakal A, Mangat L "Images in clinical medicine. Lingua villosa nigra." N Engl J Med 357 (2007): 2388

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22. "Product Information. Oracea (doxycycline)." Collagenex Pharmaceuticals, Newtown, PA.

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24. Nelson R, Parker SR "Doxycycline-induced staining of adult teeth: the first reported case." Arch Dermatol 142 (2006): 1081-2

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30. Hasanjani Roushan MR, Mohraz M, Hajiahmadi M, Ramzani A, Valayati AA "Efficacy of Gentamicin plus Doxycycline versus Streptomycin plus Doxycycline in the Treatment of Brucellosis in Humans." Clin Infect Dis 42 (2006): 1075-80

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33. Frost P, Weinstein GD, Gomez EC "Phototoxic potential of minocycline and doxycycline." Arch Dermatol 105 (1972): 681-3

34. Lim DS, Murphy GM "High-level ultraviolet A photoprotection is needed to prevent doxycycline phototoxicity: lessons learned in East Timor." Br J Dermatol 149 (2003): 213-4

35. Tanaka N, Kawada A, Ohnishi Y, Hiruma M, Tajima S, Akiyama M, Ishibashi A "Photosensitivity due to doxycycline hydrochloride with an unusual flare." Contact Dermatitis 37 (1997): 93-4

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37. Curley RK, Verbov JL "Stevens-Johnson syndrome due to tetracyclines: a case report (doxycycline) and review of the literature." Clin Exp Dermatol 12 (1987): 124-5

38. Lewis-Jones MS, Evans S, Thompson CM "Erythema multiforme occurring in association with lupus erythematosus during therapy with doxycycline." Clin Exp Dermatol 13 (1988): 245-7

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40. Bjornsson E, Lindberg J, Olsson R "Liver reactions to oral low-dose tetracyclines." Scand J Gastroenterol 32 (1997): 390-5

41. Basaria S, Braga M, Moore WT "Doxycycline-induced hypoglycemia in a nondiabetic young man." South Med J 95 (2002): 1353-4

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