Moxifloxacin Side effects

• Side effects of Moxifloxacin in details
• Moxifloxacin contraindications
• Moxifloxacin reviews

What are the possible side effects of Moxifloxacin?

Get emergency medical help if you have signs of an allergic reaction to Moxifloxacin: hives, or the first sign of a skin rash; fast heartbeat, difficult breathing; swelling of your face, lips, tongue, or throat.

Moxifloxacin may cause swelling or tearing of (rupture) a tendon. Moxifloxacin can also have serious effects on your nerves, and may cause permanent nerve damage.

Stop using Moxifloxacin and call your doctor at once if you have:

• severe stomach pain, diarrhea that is watery or bloody;

• headache with chest pain and severe dizziness, fainting, fast or pounding heartbeats;

• muscle pain or weakness;

• a seizure (convulsions);

• sudden weakness or ill feeling, fever, chills, sore throat, mouth sores, easy bruising or bleeding;

• signs of tendon rupture - sudden pain, swelling, bruising, tenderness, stiffness, movement problems, or a snapping or popping sound in any of your joints (rest the joint until you receive medical care or instructions);

• nerve symptoms - numbness, weakness, tingling, burning, pain, or being more sensitive to temperature, light touch, or the sense of your body position;

• changes in mood or behavior - depression, confusion, hallucinations, paranoia, tremors, feeling restless or anxious, unusual thoughts or behavior, insomnia, nightmares;

• liver problems - upper stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• increased pressure inside the skull - severe headaches, ringing in your ears, vision problems, pain behind your eyes; or

• severe skin reaction - skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common Moxifloxacin side effects may include:

• nausea, constipation, diarrhea;

• dizziness; or

• headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Side effects of Moxifloxacin in details

Clinical efficacy trials enrolled over 9,200 Moxifloxacin orally and intravenously treated patients, of whom over 8,600 patients received the 400 mg dose. Most adverse events reported in Moxifloxacin trials were described as mild to moderate in severity and required no treatment. Moxifloxacin was discontinued due to adverse reactions thought to be drug-related in 2.9% of orally treated patients and 6.3 % of sequentially (intravenous followed by oral) treated patients. The latter studies were conducted in community acquired pneumonia and complicated skin and skin structure infections and complicated intra-abdominal infections with, in general, a sicker patient population compared to the tablet studies.

Adverse reactions, judged by investigators to be at least possibly drug-related, occurring in greater than or equal to 2% of Moxifloxacin treated patients were: nausea (6%), diarrhea (5%), dizziness (2%).

Additional clinically relevant uncommon events, judged by investigators to be at least possibly drug-related, that occurred in greater than or equal to 0.1% and less than 2% of Moxifloxacin treated patients were:

BODY AS A WHOLE: abdominal pain, headache, asthenia, dehydration (secondary to diarrhea or reduced fluid intake), injection site reaction (including phlebitis), malaise, moniliasis, pain, allergic reaction

CARDIOVASCULAR: cardiac arrhythmia (not otherwise specified), tachycardia, palpitation, vasodilation, QT interval prolonged

DIGESTIVE: vomiting, abnormal liver function test (increased transaminases, increased bilirubin), dyspepsia, dry mouth, flatulence, oral moniliasis, constipation, GGTP increased, anorexia, stomatitis, glossitis

HEMIC AND LYMPHATIC: leukopenia, eosinophilia, prothrombin decrease (prothrombin time prolonged/International Normalized Ratio (INR) increased), thrombocythemia

METABOLIC AND NUTRITIONAL: lactic dehydrogenase increased, amylase increased

MUSCULOSKELETAL: arthralgia, myalgia

NERVOUS SYSTEM: insomnia, nervousness, vertigo, somnolence, anxiety, tremor

SKIN/APPENDAGES: rash (maculopapular, purpuric, pustular), pruritus, sweating, urticaria

SPECIAL SENSES: taste perversion

UROGENITAL: vaginal moniliasis, vaginitis

Additional clinically relevant rare events, judged by investigators to be at least possibly drug-related, that occurred in less than 0.1% of Moxifloxacin treated patients were:

abnormal dreams, abnormal vision (visual disturbances temporally associated with CNS symptoms), agitation, amblyopia, amnesia, anemia, aphasia, arthritis, asthma, atrial fibrillation, back pain, chest pain, confusion, convulsions of various clinical manifestations (including grand mal convulsions), depersonalization, depression (potentially culminating in self-endangering behavior), dysphagia, dyspnea, ECG abnormal, emotional lability, face edema, gastritis, gastrointestinal disorder, hallucinations, hyperglycemia, hyperlipidemia, hypertension, hypertonia, hyperuricemia, hypesthesia, hypotension, incoordination, jaundice (predominantly cholestatic), kidney function abnormal, lab test abnormal (not specified), leg pain, paraesthesia, parosmia, pelvic pain, peripheral edema, photosensitivity/phototoxicity reactions, pseudomembranous colitis, prothrombin increase (prothrombin time decreased/International Normalized Ratio (INR) decreased), sleep disorders, speech disorders, supraventricular tachycardia, syncope, taste loss, tendon disorder, thinking abnormal, thrombocytopenia, thromboplastin decrease, tinnitus, tongue discoloration, ventricular tachycardia

Post-Marketing Adverse Event Reports:

Additional adverse events have been reported from worldwide post-marketing experience with Moxifloxacin. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These events, some of them life-threatening, include anaphylactic reaction, anaphylactic shock, angioedema (including laryngeal edema), hepatic failure, including fatal cases, hepatitis (predominantly cholestatic), photosensitivity/phototoxicity reaction (see

What is the most important information I should know about Moxifloxacin?

• Moxifloxacin drops only works against bacteria; it does not treat viral infections (eg, the common cold).
• Long-term or repeated use of Moxifloxacin drops 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.
• Be sure to use Moxifloxacin drops 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.
• Different brands of Moxifloxacin drops are approved for different ages of CHILDREN. Follow the instructions that your doctor has provided. If you have any questions about giving Moxifloxacin drops to your child, check with your doctor or pharmacist.
• Moxifloxacin drops should be used with extreme caution in CHILDREN younger than 1 year old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Moxifloxacin drops while you are pregnant. It is not known if Moxifloxacin drops is found in breast milk. If you are or will be breast-feeding while you use Moxifloxacin drops, check with your doctor. Discuss any possible risks to your baby.

Moxifloxacin contraindications

You should not use this medication if you have a history of myasthenia gravis, or if you are allergic to Moxifloxacin or similar antibiotics such as ciprofloxacin (Cipro), gemifloxacin (Factive), levofloxacin (Levaquin), ofloxacin (Floxin), norfloxacin (Noroxin), and others.

Before taking Moxifloxacin, tell your doctor if you have a heart rhythm disorder, kidney or liver disease, joint problems, a history of seizures, low levels of potassium in your blood (hypokalemia), muscle weakness or trouble breathing, a personal or family history of Long QT syndrome, or if you have ever had an allergic reaction to an antibiotic.

Avoid taking antacids, vitamin or mineral supplements, sucralfate (Carafate), or didanosine (Videx) powder or chewable tablets within 8 hours before or 4 hours after you take Moxifloxacin. These other medicines can make Moxifloxacin much less effective when taken at the same time.

Taking Moxifloxacin can make your skin more sensitive to sunlight. Avoid exposure to sunlight, sun lamps, or tanning beds.

Moxifloxacin may cause swelling or tearing of a tendon (the fiber that connects bones to muscles in the body), especially in the Achilles' tendon of the heel. These effects may be more likely to occur if you are over 60, if you take steroid medication, or if you have had a kidney, heart, or lung transplant. Stop taking Moxifloxacin and call your doctor at once if you have sudden pain, swelling, tenderness, stiffness, or movement problems in any of your joints. Rest the joint until you receive medical care or instructions.

Do not share this medication with another person (especially a child), even if they have the same symptoms you do.

References

1. European Chemicals Agency - ECHA. "1-Cyclopropyl-6-fluoro-1,4-dihydro-8-methoxy-7-[(4aS,7aS)-octahydro-6H-pyrrolo[3,4-b]pyridin-6-yl]-4-oxo-3-quinolinecarboxylic acid: 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. "Moxifloxacin". https://toxnet.nlm.nih.gov/cgi-bin/s... (accessed September 17, 2018).
3. NCIt. "Moxifloxacin: NCI Thesaurus (NCIt) provides reference terminology for many systems. It covers vocabulary for clinical care, translational and basic research, and public information and administrative activities.". https://ncit.nci.nih.gov/ncitbrowser... (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology