Moxifloxacin Apotex 400mg Side effects

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What are the possible side effects of Moxifloxacin Apotex 400mg?

Get emergency medical help if you have signs of an allergic reaction to Moxifloxacin Apotex 400mg: hives, or the first sign of a skin rash; fast heartbeat, difficult breathing; swelling of your face, lips, tongue, or throat.

Moxifloxacin Apotex 400mg may cause swelling or tearing of (rupture) a tendon. Moxifloxacin Apotex 400mg can also have serious effects on your nerves, and may cause permanent nerve damage.

Stop using Moxifloxacin Apotex 400mg 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 Apotex 400mg 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 Apotex 400mg in details

infoA side effect of any drug can be defined as the unwanted or undesired effect produced by the drug. The side effect can be major or in few medications minor that can be ignored. Side effects not only vary from drug to drug, but it also depends on the dose of the drug, the individual sensitivity of the person, brand or company which manufactures it. If side effects overweigh the actual effect of the medicine, it may be difficult to convince the patient to take the drug. Few patients get specific side effects to specific drugs; in that case, a doctor replaces the drug with another. If you feel any side effect and it troubles you, do not forget to share with your healthcare practitioner.

Clinical efficacy trials enrolled over 9,200 Moxifloxacin Apotex 400mg orally and intravenously treated patients, of whom over 8,600 patients received the 400 mg dose. Most adverse events reported in Moxifloxacin Apotex 400mg trials were described as mild to moderate in severity and required no treatment. Moxifloxacin Apotex 400mg 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 Apotex 400mg 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 Apotex 400mg 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 Apotex 400mg 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 Apotex 400mg. 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 Apotex 400mg?

  • Moxifloxacin Apotex 400mg tablets may cause dizziness, drowsiness, light-headedness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Moxifloxacin Apotex 400mg tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Be sure to use Moxifloxacin Apotex 400mg tablets 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.
  • Moxifloxacin Apotex 400mg tablets may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Moxifloxacin Apotex 400mg tablets. 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.
  • Nerve problems in the arms, hands, legs, or feet can happen in people taking Moxifloxacin Apotex 400mg tablets. These nerve problems can happen soon after Moxifloxacin Apotex 400mg tablets is started and may be permanent. Call your doctor right away if you have symptoms or nerve problems (eg, not able to handle heat or cold; decreased sensation of touch; unusual burning, numbness, tingling, pain, or weakness of the arms, hands, legs, or feet).
  • A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.
  • Severe and sometimes fatal effects have rarely happened with Moxifloxacin Apotex 400mg tablets. These have included muscle or joint, kidney, liver, blood, and other problems. Talk with your doctor if you have questions.
  • Moxifloxacin Apotex 400mg tablets only works against bacteria; it does not treat viral infections (eg, the common cold).
  • Do not receive certain live vaccines (oral typhoid vaccine, bacille Calmette-Guérin [BCG] vaccine) while you are taking Moxifloxacin Apotex 400mg tablets. Talk with your doctor before you receive any vaccine.
  • Long-term or repeated use of Moxifloxacin Apotex 400mg tablets 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.
  • Moxifloxacin Apotex 400mg tablets has infrequently caused tendon problems, including tendon rupture. If you experience any unusual pain or swelling in your joints (eg, shoulder, elbow, hand, hip, knee, ankle, foot), contact your doctor right away. Rest and avoid exercise or other physically stressful activity until your doctor tells you otherwise.
  • Diabetes patients - Moxifloxacin Apotex 400mg tablets may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
  • Use Moxifloxacin Apotex 400mg tablets with caution in the ELDERLY; they may be more sensitive to its effects (eg, tendon problems), especially if they take corticosteroids (eg, prednisone). They may also be more sensitive to other effects (eg, irregular heartbeat).
  • PREGNANCY and BREAST-FEEDING: It is not known if Moxifloxacin Apotex 400mg tablets can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of taking Moxifloxacin Apotex 400mg tablets while you are pregnant. It is not known if Moxifloxacin Apotex 400mg tablets is found in breast milk. Do not breast-feed while taking Moxifloxacin Apotex 400mg tablets.

Moxifloxacin Apotex 400mg contraindications

infoContraindication can be described as a special circumstance or a disease or a condition wherein you are not supposed to use the drug or undergo particular treatment as it can harm the patient; at times, it can be dangerous and life threatening as well. When a procedure should not be combined with other procedure or when a medicine cannot be taken with another medicine, it is called Relative contraindication. Contraindications should be taken seriously as they are based on the relative clinical experience of health care providers or from proven research findings.

You should not use this medication if you have a history of myasthenia gravis, or if you are allergic to Moxifloxacin Apotex 400mg or similar antibiotics such as ciprofloxacin (Cipro), gemifloxacin (Factive), levofloxacin (Levaquin), ofloxacin (Floxin), norfloxacin (Noroxin), and others.

Before taking Moxifloxacin Apotex 400mg, 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 Apotex 400mg. These other medicines can make Moxifloxacin Apotex 400mg much less effective when taken at the same time.

Taking Moxifloxacin Apotex 400mg can make your skin more sensitive to sunlight. Avoid exposure to sunlight, sun lamps, or tanning beds.

Moxifloxacin Apotex 400mg 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 Apotex 400mg 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.



  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. ". (accessed September 17, 2018).
  2. HSDB. "Moxifloxacin". (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.". (accessed September 17, 2018).


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Information checked by Dr. Sachin Kumar, MD Pharmacology

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