Minocycline Hydrochloride Side effects

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What are the possible side effects of Minocycline Hydrochloride?

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:

Diarrhea; dizziness; drowsiness; indigestion; light-headedness; loss of appetite; nausea; sore mouth, throat, or tongue; stomach upset; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); change in the amount of urine produced; decreased hearing; fever, chills, or sore throat; joint pain; muscle pain or weakness; pain, redness, swelling, or white patches in the mouth; rectal or genital irritation; red, swollen, blistered, or peeling skin; redness or swelling of the gums; ringing in the ears; seizures; shortness of breath or wheezing; swollen glands; symptoms of liver problems (eg, yellowing of the skin or eyes; dark urine; pale stools; persistent nausea, stomach pain, or loss of appetite); symptoms of pancreatitis (eg, severe stomach or back pain with or without nausea or vomiting); trouble swallowing; unusual bruising or bleeding; unusual tiredness or weakness; vaginal irritation or discharge.

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.

Side effects of Minocycline Hydrochloride in details

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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.

The following table summarizes selected adverse reactions reported in clinical trials at a rate of ≥1% for Minocycline Hydrochloride extended-release tablets.

Table 2: Selected Treatment-Emergent Adverse Reactions in at least 1% of Clinical Trial Subjects
Adverse Reactions

Minocycline Hydrochloride extended-release tablets

(1 mg/kg)

N = 674 (%)

Placebo

N = 364 (%)

At least one treatment-emergent event

379 (56)

197 (54)

Headache

152 (23)

83 (23)

Fatigue

62 (9)

24 (7)

Dizziness

59 (9)

17 (5)

Pruritus

31 (5)

16 (4)

Malaise

26 (4)

9 (3)

Mood alteration

17 (3)

9 (3)

Somnolence

13 (2)

3 (1)

Urticaria

10 (2)

1 (0)

Tinnitus

10 (2)

5 (1)

Arthralgia

9 (1)

2 (0)

Vertigo

8 (1)

3 (1)

Dry mouth

7 (1)

5 (1)

Myalgia

7 (1)

4 (1)

Postmarketing Experience

Adverse reactions that have been reported with Minocycline Hydrochloride use in a variety of indications include:

Skin and hypersensitivity reactions: fixed drug eruptions, balanitis, erythema multiforme, Stevens-Johnson syndrome, anaphylactoid purpura, photosensitivity, pigmentation of skin and mucous membranes, hypersensitivity reactions, angioneurotic edema, anaphylaxis, DRESS syndrome.

Autoimmune conditions: polyarthralgia, pericarditis, exacerbation of systemic lupus, pulmonary infiltrates with eosinophilia, transient lupus-like syndrome.

Central nervous system: pseudotumor cerebri, bulging fontanels in infants, decreased hearing.

Endocrine: brown-black hygroscopic thyroid discoloration, abnormal thyroid function.

Oncology: thyroid cancer.

Oral: glossitis, dysphagia, tooth discoloration.

Gastrointestinal: enterocolitis, pancreatitis, hepatitis, liver failure.

Renal: reversible acute renal failure.

Hematology: hemolytic anemia, thrombocytopenia, eosinophilia.

Preliminary studies suggest that use of minocycline may have deleterious effects on human spermatogenesis.

What is the most important information I should know about Minocycline Hydrochloride?

Minocycline Hydrochloride contraindications

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This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines or to any of the components of the product formulation.

References

  1. European Chemicals Agency - ECHA. "(4S,4aS,5aR,12aS,Z)-2-[amino(hidroxi)metilene]-4,7-bis(dimetilamino)-10,11,12a-trihidroxi-4a,5,5a,6-tetrahidrotetracene-1,3,12(2H,4H,12aH)-triona: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (accessed September 17, 2018).
  2. HSDB. "MINOCYCLINE". https://toxnet.nlm.nih.gov/cgi-bin/s... (accessed September 17, 2018).
  3. KEGG. "Antiinfectives". http://www.genome.jp/kegg-bin/get_ht... (accessed September 17, 2018).

Reviews

The results of a survey conducted on ndrugs.com for Minocycline Hydrochloride are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Minocycline Hydrochloride. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.

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Information checked by Dr. Sachin Kumar, MD Pharmacology

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