Brodspec Side Effects
Generic Name: tetracycline
Note: This document contains side effect information about tetracycline. Some of the dosage forms listed on this page may not apply to the brand name Brodspec.
For the Consumer
Applies to tetracycline: capsule, capsule extended release, powder for suspension, syrup, tablet, tablet delayed release, tablet extended release
Side effects requiring immediate medical attention
Along with its needed effects, tetracycline (the active ingredient contained in Brodspec) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor as soon as possible if any of the following side effects occur while taking tetracycline:
For all tetracyclines
- Increased sensitivity of skin to sunlight (rare with minocycline)
- Abdominal pain
- bulging fontanel (soft spot on head) of infants
- loss of appetite
- nausea and vomiting
- visual changes
- yellowing skin
For demeclocycline only
- Greatly increased frequency of urination or amount of urine
- increased thirst
- unusual tiredness or weakness
For minocycline only
- Pigmentation (darker color or discoloration) of skin and mucous membranes
Side effects not requiring immediate medical attention
Some side effects of tetracycline may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.
Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
For all tetracyclines
- Cramps or burning of the stomach
- Itching of the rectal or genital (sex organ) areas
- sore mouth or tongue
For minocycline only
- Dizziness, light-headedness, or unsteadiness
In some patients tetracyclines may cause the tongue to become darkened or discolored. This effect is only temporary and will go away when you Stop taking tetracycline.
For Healthcare Professionals
Applies to tetracycline: compounding powder, oral capsule, oral suspension, oral tablet
Gastrointestinal side effects have included anogenital lesions with monilial overgrowth, anorexia, black hairy tongue, dysphagia, enamel hypoplasia, enterocolitis, epigastric distress, diarrhea, glossitis, nausea, permanent tooth discoloration, and vomiting. Rarely, esophageal ulceration has been reported with oral tablets and capsules.[Ref]
There have been several cases of esophageal ulcers associated with oral tetracycline therapy. In each case, the patient had taken the medication just before bedtime with only small amounts of liquid and reported severe retrosternal pain and painful swallowing shortly thereafter. The ulcers resolved spontaneously after discontinuation of tetracycline therapy. To minimize esophageal irritation, patients should be advised to avoid taking tetracycline just before retiring and to take the medication with plenty of water.
Oral ulcers have also occurred in a patient who gargled with a tetracycline solution made by emptying the contents of a 250 mg capsule into water.[Ref]
Renal side effects generally occurred in patients with preexisting renal disease and have been the result of accumulation of tetracycline (the active ingredient contained in Brodspec) Increases in BUN commonly occur because of tetracycline's anti-anabolic effect but do not necessarily indicate renal dysfunction.
Fanconi's syndrome is characterized by renal glycosuria, phosphaturia, aminoaciduria, and acidosis with or without proteinuria and rickets. It is associated with the ingestion of outdated or degraded tetracycline. Additionally, previous formulations of tetracycline contained citric acid which may contribute to metabolic acidosis; however, current formulations of the drug do not. Patients generally require hospitalization with intravenous medication to correct the accompanying metabolic abnormalities. Most cases resolve over time after discontinuation of tetracycline without permanent sequelae. Patients should be instructed to discard any unused portions of tetracycline at the end of therapy and to never use tetracycline remaining from a previous prescription.[Ref]
Renal side effects have included increased BUN and Fanconi's syndrome. In patients with preexisting renal impairment, tetracycline may cause azotemia, hyperphosphatemia, and acidosis. Patients with dehydration are particularly vulnerable.[Ref]
Dermatologic side effects have included exfoliative dermatitis, maculopapular and erythematous rashes, nail discoloration, onycholysis, and photosensitivity.[Ref]
Tetracycline (the active ingredient contained in Brodspec) deposits into calcium-rich developing osseous tissue thereby causing the discoloration of permanent teeth, decreased rate of enamel growth, and a decrease in linear skeletal growth rate.[Ref]
Musculoskeletal side effects have included adult tooth discoloration, enamel hypoplasia, and a decrease in linear skeletal growth rate. Tetracycline should not be administered to pregnant women or children less than 12 years of age.[Ref]
There have been several cases of benign intracranial hypertension (pseudotumor cerebri) associated with tetracycline (the active ingredient contained in Brodspec) therapy. In most cases, the patient was female and was prescribed tetracycline to treat acne. Symptoms commonly occurring in these cases consisted of severe headaches, nausea, and blurred vision. Physical examination revealed papilledema in all cases, and several had significantly increased pressure on lumbar puncture. All patients recovered over time after discontinuation of tetracycline therapy. The mechanism for development of increased intracranial pressure is unknown.[Ref]
At least two cases of tetracycline-induced hemolytic anemia have been reported. In both cases, the anemia resolved over time after discontinuation of the medication and reoccurred 1 to 2 years later following another course of tetracycline therapy. The mechanism for development of hemolytic anemia is unknown.[Ref]
Hypersensitivity side effects have included urticaria, angioneurotic edema, anaphylaxis, anaphylactoid purpura, exacerbation of systemic lupus erythematosus, hypersensitivity myocarditis, and serum sickness-like reactions (fever, rash, arthralgia).[Ref]
Hepatic side effects have included increased liver enzyme levels, hepatotoxicity, liver failure, and bile duct paucity with prolonged cholestasis. These may be dose-related.[Ref]
Other side effects have included superinfection due to overgrowth of resistant organisms. The long-term use of tetracyclines has been associated with microscopic brown-black discoloration of the thyroid gland; however, abnormal thyroid function has not been reported.[Ref]
Metabolic side effects have included azotemia, hyperphosphatemia, and metabolic acidosis. Increases in serum BUN levels may occur as a result of the anti-anabolic action of tetracycline (the active ingredient contained in Brodspec) and not necessarily indicate renal disease.[Ref]
These metabolic side effects have occurred more commonly in the presence of preexisting renal disease, and occur as a result of the accumulation of tetracycline.[Ref]
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3. Channer KS, Hollanders D "Tetracycline-induced oesophageal ulceration." Br Med J 282 (1981): 1359-60
4. Khera DC, Herschman BR, Sosa F "Tetracycline-induced esophageal ulcers." Postgrad Med J 68 (1980): 113-5
5. Hinton NA "The effect of oral tetracycline HCl and doxycycline on the intestinal flora." Curr Ther Res Clin Exp 12 (1970): 341-52
6. Reddy J "Tetracycline antibiotics should be avoided in patients with renal disease." N Z Med J 94 (1981): 396
7. Tannenberg AM "Tetracycline and rises in urea nitrogen." JAMA 221 (1972): 713
8. Sulkowski SR, Haserick JR "Simulated systemic lupus erythematosus from degraded tetracycline." JAMA 189 (1964): 152-4
9. George CR, Evans RA "Tetracycline toxicity in renal failure." Med J Aust 06/12/71 (1971): 1271-3
10. Jick H, Slone D, Shapiro S, et al "Tetracycline and drug-attributed rises in blood urea nitrogen: a report from the Boston Collaborative Drug Surveillance Program." JAMA 220 (1972): 377-9
11. Shils ME "Renal disease and the metabolic effects of tetracycline." Ann Intern Med 58 (1963): 389-408
12. Brown CB "Tetracycline and renal function." Br Med J 4 (1971): 428
13. "Product Information. Achromycin (tetracycline)." Lederle Laboratories, Wayne, NJ.
14. Vassileva SG, Mateev G, Parish LC "Antimicrobial photosensitive reactions." Arch Intern Med 158 (1998): 1993-2000
15. Douglas AC "The deposition of tetracycline in human nails and teeth: a complication of long-term treatment." Br J Dis Chest 57 (1963): 44-7
16. Bevelander G "The effect of tetracycline on mineralization and growth." Adv Oral Biol 7 (1964): 205-23
17. Witkop CJ, Wolf RO "Hypoplasia and intrinsic staining of enamel following tetracycline therapy." JAMA 185 (1963): 1008-11
18. Walters BN, Gubbay SS "Tetracycline and benign intracranial hypertension: report of five cases." Br Med J 282 (1981): 19-20
19. Lee AG "Pseudotumor cerebri after treatment with tetracycline and isotretinoin for acne." Cutis 55 (1995): 165-8
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21. Mazza JJ, Kryda MD "Tetracycline-induced hemolytic anemia." J Am Acad Dermatol 2 (1980): 506-8
22. Kounis GN, Kouni SA, Chiladakis JA, Kounis NG "Comment: Mesalamine-Associated Hypersensitivity Myocarditis in Ulcerative Colitis and the Kounis Syndrome (February)." Ann Pharmacother 43 (2009): 393-4
23. Grossman ER, Walchek A, Freedman H, Flanagan C "Tetracyclines and permanent teeth: the relation between dose and tooth color." Pediatrics 47 (1971): 567-70
24. Frimpter GW, Timpanelli AE, Eisenmenger WJ, et al "Reversible fanconi syndrome caused by degraded tetracycline." JAMA 184 (1963): 111-3
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Some side effects may not be reported. You may report them to the FDA.
More about Brodspec (tetracycline)
- During Pregnancy or Breastfeeding
- Dosage Information
- Drug Interactions
- En Español
- Drug class: tetracyclines
- FDA Alerts (1)