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What are the possible side effects of Ciprofloxacin?
Get emergency medical help if you have signs of an allergic reaction to Ciprofloxacin: hives, or the first sign of a skin rash; fast heartbeat, difficult breathing; swelling of your face, lips, tongue, or throat.
Ciprofloxacin may cause swelling or tearing of (rupture) a tendon. Ciprofloxacin can also have serious effects on your nerves, and may cause permanent nerve damage.
Stop using Ciprofloxacin 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);
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 Ciprofloxacin side effects may include:
nausea, vomiting, diarrhea;
abnormal liver function tests.
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 Ciprofloxacin in details
Serious and Otherwise Important Adverse Reactions
The following serious and otherwise important adverse drug reactions are discussed in greater detail in other sections of labeling:
- Tendon Effects
- Hypersensitivity Reactions
- Other Serious and Sometimes Fatal Reactions
- Central Nervous System Effects
- Clostridium difficile-Associated Diarrhea
- Peripheral Neuropathy
- Development of Drug Resistant Bacteria
Crystalluria and cylindruria have been reported with quinolones, including Ciprofloxacin. Therefore, adequate hydration of patients receiving Ciprofloxacin (Ciprofloxacin hcl) should be maintained to prevent the formation of highly concentrated urine.
Clinical Trial 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 data described below reflect exposure to Ciprofloxacin (Ciprofloxacin hcl) in 524 patients in one clinical trial. The population studied had a mean age of 39 years (approximately 93.4% of the population were < 65 years of age), 100% were female, 77% were Caucasian and 7.4% were Black. Patients received Ciprofloxacin (Ciprofloxacin hcl) 500 mg once daily for 3 days. Patients were followed for approximately 5 weeks after the end of study drug dosing.
Discontinuation of Ciprofloxacin (Ciprofloxacin hcl) occurred in 1.4% of patients. Each of the discontinuations were for a different adverse reactions. Refer to Table 1.
The most common adverse reactions ( ≥ 2%) were fungal infection, nasopharyngitis, headache, and micturition urgency.
Table 1: Adverse reactions (regardless of relationship to study drug) occurring in ≥ 1% of Ciprofloxacin (Ciprofloxacin hcl) -treated patients (500 mg once daily for 3 days) during the entire study period compared to Ciprofloxacin-immediate release tablets (250 mg twice daily for 3 days)
|Adverse Reaction||Ciprofloxacin||Ciprofloxacin-immediate release tablets|
|Urinary tract infection||10.8||9.8|
|Upper respiratory tract infection||1.4||2.9|
The incidence of adverse events (regardless of relationship to study drug) reported for at least 1% of patients treated with Ciprofloxacin (Ciprofloxacin hcl) during study drug treatment and up to 3 days after study drug was headache (1.5%).
Less common reactions, occurring at any time during the study in less than 1% of Ciprofloxacin (Ciprofloxacin hcl) -treated patients were:
- Cardiac Disorders: ventricular bigeminy.
- Immune System Disorders: hypersensitivity.
- Gastrointestinal Disorders: abdominal pain, nausea, diarrhea, dyspepsia, aggravated irritable bowel syndrome, lower abdominal pain, vomiting.
- General Disorders: suprapubic pain, fatigue, pain, rigors, tenderness.
- Infections and Infestations: urinary tract infection, fungal vaginosis, bacterial vaginitis, vaginal candidiasis, vaginal infection, vaginitis.
- Investigations: blood bilirubin increased, alanine aminotransferase increased, abdominal aortic bruit, aspartate aminotransferase increased, body temperature increased.
- Musculoskeletal and Connective Tissue Disorders: joint swelling, muscle spasms, night cramps.
- Nervous System Disorders: headache, dizziness, disturbance in attention, paresthesia.
- Renal and Urinary Disorders: micturition urgency, dysuria, urinary frequency, abnormal urine odor, hematuria.
- Reproductive System and Breast Disorders: female genital pruritus.
- Respiratory, Thoracic, and Mediastinal Disorders: dyspnea.
- Skin/Subcutaneous Tissue Disorders: rash, photosensitivity/ phototoxicity reaction, pruritus, urticaria.
Adverse Reactions Reported with Other Systemic Formulations of Ciprofloxacin
In addition, to the adverse reactions reported with Ciprofloxacin (Ciprofloxacin hcl), the following adverse reactions have been reported during clinical trials and from worldwide post-marketing experience with other systemic formulations of Ciprofloxacin (includes all dosages and indications).
Because these reactions have been reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or a causal relationship to drug exposure. Abnormal gait, achiness, acidosis, agitation, agranulocytosis, allergic reactions (ranging from urticaria to anaphylactic reactions), amylase increase, anemia, angina pectoris, angioedema, anosmia, anxiety, arrhythmia, arthralgia, ataxia, atrial flutter, bleeding diathesis, blurred vision, bronchospasm, C. difficile associated diarrhea, candidiasis (cutaneous, oral), candiduria, cardiac murmur, cardiopulmonary arrest, cardiovascular collapse, cerebral thrombosis, chills, cholestatic jaundice, chromatopsia, confusion, convulsion, delirium, depression, diplopia, drowsiness, dysphagia, dyspnea, edema (conjunctivae, face, hands, laryngeal, lips, lower extremities, neck, pulmonary), epistaxis, erythema multiforme, erythema nodosum, exfoliative dermatitis, fever, fixed eruptions, flushing, gastrointestinal bleeding, gout (flare up), grand mal convulsion, gynecomastia, hallucinations, hearing loss, hematuria, hemolytic anemia, hemoptysis, hemorrhagic cystitis, hepatic failure (including fatal cases), hepatic necrosis, hepatitis, hiccup, hyperesthesia, hyperpigmentation, hypertension, hypertonia, hypoesthesia, hypotension, ileus, insomnia, interstitial nephritis, intestinal perforation, jaundice, joint stiffness, lethargy, lightheadedness, lipase increase, lymphadenopathy, malaise, manic reaction, marrow depression, migraine, moniliasis (oral, gastrointestinal, vaginal), mouth dryness, myalgia, myasthenia, myasthenia gravis (possible exacerbation), myocardial infarction, myoclonus, nephritis, nightmares, nystagmus, oral ulceration, pain (arm, back, breast, chest, epigastric, eye, extremities, foot, jaw, neck, oral mucosa), palpitation, pancreatitis, pancytopenia, paranoia, paresthesia, peripheral neuropathy, perspiration (increased), petechia, phlebitis, phobia, photosensitivity/phototoxicity reaction pleural effusion, polyuria, postural hypotension, prothrombin time prolongation, pseudomembranous colitis (the onset of symptoms may occur during or after antimicrobial treatment), pulmonary embolism, purpura, renal calculi, renal failure, respiratory arrest, respiratory distress, restlessness, serum sickness-like reaction, Stevens-Johnson syndrome, sweating, syncope, tachycardia, taste loss, tendonitis, tendon rupture, tinnitus, torsade de pointes, toxic epidermal necrolysis, toxic psychosis, tremor, twitching, unresponsiveness, urethral bleeding, urinary retention, urination (frequent), vaginal pruritus, vasculitis, ventricular ectopy, vesicles, visual acuity (decreased), visual disturbances (flashing lights, change in color perception, overbrightness of lights), weakness.
The following adverse laboratory changes, in alphabetical order, regardless of incidence or relationship to drug, have been reported in patients given Ciprofloxacin (includes all formulations, all dosages, all drug-therapy durations, and all indications):
Decreases in blood glucose, BUN, hematocrit, hemoglobin, leukocyte counts, platelet counts, prothrombin time, serum albumin, serum potassium, total serum protein, uric acid.
Increases in alkaline phosphatase, ALT (SGPT), AST (SGOT), atypical lymphocyte counts, blood glucose, blood monocytes, BUN, cholesterol, eosinophils counts, LDH, platelet counts, prothrombin time, sedimentation rate, serum amylase, serum bilirubin, serum calcium, serum cholesterol, serum creatinine phosphokinase, serum creatinine, serum gamma-glutamyl transpeptidase (GGT), serum potassium, serum theophylline (in patients receiving theophylline concomitantly), serum triglycerides, uric acid.
Others: albuminuria, change in serum phenytoin, crystalluria, cylindruria, immature WBCs, leukocytosis, methemaglobinemia, pancytopenia.
What is the most important information I should know about Ciprofloxacin?
- Ciprofloxacin suspension may cause drowsiness, dizziness, or light-headedness. These effects may be worse if you take it with alcohol or certain medicines. Use Ciprofloxacin suspension with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Be sure to use Ciprofloxacin suspension 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 Ciprofloxacin suspension 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.
- Ciprofloxacin suspension only works against bacteria; it does not treat viral infections (eg, the common cold).
- Before using Ciprofloxacin suspension, tell your doctor if you take a medicine that contains caffeine or you consume large amounts of food or drink that contain caffeine (eg, coffee, tea, cocoa, cola, chocolate).
- Tell your doctor right away if you experience pain or swelling of a tendon or weakness or loss of use of a joint area. Rest the area and avoid exercise until further instruction from your doctor.
- Nerve problems in the arms, hands, legs, or feet can happen in people taking Ciprofloxacin suspension. These nerve problems can happen soon after Ciprofloxacin suspension 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).
- Diabetes patients - Ciprofloxacin suspension may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
- Ciprofloxacin suspension may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Ciprofloxacin suspension. 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.
- Use Ciprofloxacin suspension 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).
- Ciprofloxacin suspension should be used with extreme caution in CHILDREN younger than 18 years old; they may be more sensitive to its effects, especially joint and tendon problems.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of taking Ciprofloxacin suspension while you are pregnant. Ciprofloxacin suspension is found in breast milk. Do not breast-feed while taking Ciprofloxacin suspension.
You should not use this medication if you are taking tizanidine (Zanaflex), if you have a history of myasthenia gravis, or if you are allergic to Ciprofloxacin or similar antibiotics such as gemifloxacin (Factive), levofloxacin (Levaquin), moxifloxacin (Avelox), norfloxacin (Noroxin), and others.
Before taking Ciprofloxacin, tell your doctor if you have a heart rhythm disorder, kidney or liver disease, joint problems, diabetes, muscle weakness or trouble breathing, a condition called pseudotumor cerebri, a history of seizures, a history of head injury or brain tumor, low levels of potassium in your blood, a personal or family history of Long QT syndrome, or if you have ever had an allergic reaction to an antibiotic.
Do not take Ciprofloxacin with dairy products such as milk or yogurt, or with calcium-fortified juice.
Avoid taking antacids, vitamin or mineral supplements, sucralfate (Carafate), or didanosine (Videx) powder or chewable tablets within 6 hours before or 2 hours after you take Ciprofloxacin.
Ciprofloxacin 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. Stop taking Ciprofloxacin 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.
- DailyMed. "CIPROFLOXACIN; DEXAMETHASONE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- DTP/NCI. "ciprofloxacin: The NCI Development Therapeutics Program (DTP) provides services and resources to the academic and private-sector research communities worldwide to facilitate the discovery and development of new cancer therapeutic agents.". https://dtp.cancer.gov/dtpstandard/s... (accessed September 17, 2018).
- European Chemicals Agency - ECHA. "1-Cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl): 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).
ReviewsThe results of a survey conducted on ndrugs.com for Ciprofloxacin 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 Ciprofloxacin. 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.
1 consumer reported side effectsDid you experience side effects while taking Ciprofloxacin drug?
According to the report by ndrugs.com, the below mentioned statistics discuss the number of people who experienced side effects after taking Ciprofloxacin drug. Every drug produces at least minor unwanted effects, which we call side effects. The side effects can be bothersome, or they can be minor so patients do not know they are experiencing them. The side effects of the drug depend on the individual, severity of disease, symptom, and associated conditions in the patient. The most deciding factor is the drug dosage. The higher the dosage, the higher the therapeutic result, and the more side effects. Every patient need not have the same intensity of side effect. When the side effects are greater, immediately consult your health care provider.
|No side effects||1||100.0%|
|its hard to find. have been to so many chemists all in vain|
Information checked by Dr. Sachin Kumar, MD Pharmacology