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
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.
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?
- Tell your doctor or dentist that you take Minocycline Hydrochloride before you receive any medical or dental care, emergency care, or surgery.
- Minocycline Hydrochloride may cause drowsiness, dizziness, or light-headedness. These effects may be worse if you take it with alcohol or certain medicines. Use Minocycline Hydrochloride with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Minocycline Hydrochloride only works against bacteria; it does not treat viral infections (eg, the common cold).
- Be sure to use Minocycline Hydrochloride for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.
- Long-term or repeated use of Minocycline Hydrochloride may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this.
- Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
- Minocycline Hydrochloride may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Minocycline Hydrochloride. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
- Mild diarrhea is common with antibiotic use. However, a more serious form of diarrhea (pseudomembranous colitis) may rarely occur. This may develop while you use the antibiotic or within several months after you stop using it. Contact your doctor right away if stomach pain or cramps, severe diarrhea, or bloody stools occur. Do not treat diarrhea without first checking with your doctor.
- A very bad and sometimes deadly reaction has happened with Minocycline Hydrochloride. Most of the time, this reaction has signs like fever, rash, or swollen glands with problems in body organs like the liver, kidney, blood, heart, muscles and joints, or lungs. Discuss any questions or concerns with your doctor.
- Raised pressure in the brain has happened with Minocycline Hydrochloride. Most of the time, this problem will go back to normal after Minocycline Hydrochloride is stopped. Sometimes, vision loss may happen and may not go away even after Minocycline Hydrochloride is stopped. Call your doctor right away if you have a headache or vision problems (eg, blurred vision, double vision, vision loss).
- Hormonal birth control (eg, birth control pills) may not work as well while you are using Minocycline Hydrochloride. To prevent pregnancy, use an extra form of birth control (eg, condoms).
- Minocycline Hydrochloride may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Minocycline Hydrochloride.
- Lab tests may be performed while you use Minocycline Hydrochloride. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Minocycline Hydrochloride should not be used in CHILDREN younger than 8 years old unless other medicines cannot be used or have not worked. Using Minocycline Hydrochloride in CHILDREN younger than 8 years old or in women during the last half of pregnancy may cause a permanent change in the tooth coloring of the child. Discuss any questions or concerns with the doctor.
- PREGNANCY and BREAST-FEEDING: Minocycline Hydrochloride may cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Minocycline Hydrochloride while you are pregnant. Minocycline Hydrochloride is found in breast milk. Do not breast-feed while taking Minocycline Hydrochloride.
Minocycline Hydrochloride contraindications
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
- 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).
- HSDB. "MINOCYCLINE". https://toxnet.nlm.nih.gov/cgi-bin/s... (accessed September 17, 2018).
- 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.User reports
Consumer reported side effects
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Information checked by Dr. Sachin Kumar, MD Pharmacology