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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. This medicine 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
The following serious and otherwise important adverse drug reactions are discussed in greater detail in other sections of labeling:
- Tendon Effects
- Exacerbation of Myasthenia Gravis
- Hypersensitivity Reactions
- Other Serious and Sometimes Fatal Reactions
- Serious Adverse Reactions with Concomitant Theophylline
- Central Nervous System Effects
- Clostridium difficile-Associated Diarrhea
- Peripheral Neuropathy
- Prolongation of the QT Interval
- Musculoskeletal Disorders in Pediatric Patients
- Development of Drug Resistant Bacteria
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.
During clinical investigations with oral and parenteral Ciprofloxacin, 49,038 patients received courses of the drug.
The most frequently reported adverse reactions, from clinical trials of all formulations, all dosages, all drug-therapy durations, and for all indications of Ciprofloxacin therapy were nausea (2.5%), diarrhea (1.6%), liver function tests abnormal (1.3%), vomiting (1%), and rash (1%).
In randomized, double-blind controlled clinical trials comparing Ciprofloxacin tablets [500 mg two times daily (BID)] to cefuroxime axetil (250 mg to 500 mg BID) and to clarithromycin (500 mg BID) in patients with respiratory tract infections, Ciprofloxacin demonstrated a CNS adverse reaction profile comparable to the control drugs.
Short (6 weeks) and long term (1 year) musculoskeletal and neurological safety of oral/intravenous Ciprofloxacin, was compared to a cephalosporin for treatment of cUTI or pyelonephritis in pediatric patients 1 to 17 years of age (mean age of 6 ± 4 years) in an international multicenter trial. The duration of therapy was 10 to 21 days (mean duration of treatment was 11 days with a range of 1 to 88 days). A total of 335 Ciprofloxacin- and 349 comparator-treated patients were enrolled.
An Independent Pediatric Safety Committee (IPSC) reviewed all cases of musculoskeletal adverse reactions including abnormal gait or abnormal joint exam (baseline or treatment-emergent). Within 6 weeks of treatment initiation, the rates of musculoskeletal adverse reactions were 9.3% (31/335) in the Ciprofloxacin-treated group versus 6% (21/349) in comparator-treated patients. All musculoskeletal adverse reactions occurring by 6 weeks resolved (clinical resolution of signs and symptoms), usually within 30 days of end of treatment. Radiological evaluations were not routinely used to confirm resolution of the adverse reactions. Ciprofloxacin-treated patients were more likely to report more than one adverse reaction and on more than one occasion compared to control patients. The rate of musculoskeletal adverse reactions was consistently higher in the Ciprofloxacin group compared to the control group across all age subgroups. At the end of 1 year, the rate of these adverse reactions reported at any time during that period was 13.7% (46/335) in the Ciprofloxacin-treated group versus 9.5% (33/349) in the comparator-treated patients (Table 7).
The incidence rates of neurological adverse reactions within 6 weeks of treatment initiation were 3% (9/335) in the Ciprofloxacin group versus 2% (7/349) in the comparator group and included dizziness, nervousness, insomnia, and somnolence.
In this trial, the overall incidence rates of adverse reactions within 6 weeks of treatment initiation were 41% (138/335) in the Ciprofloxacin group versus 31% (109/349) in the comparator group. The most frequent adverse reactions were gastrointestinal: 15% (50/335) of Ciprofloxacin patients compared to 9% (31/349) of comparator patients. Serious adverse reactions were seen in 7.5% (25/335) of Ciprofloxacin-treated patients compared to 5.7% (20/349) of control patients. Discontinuation of drug due to an adverse reaction was observed in 3% (10/335) of Ciprofloxacin-treated patients versus 1.4% (5/349) of comparator patients. Other adverse reactions that occurred in at least 1% of Ciprofloxacin patients were diarrhea 4.8%, vomiting 4.8%, abdominal pain 3.3%, dyspepsia 2.7%, nausea 2.7%, fever 2.1%, asthma 1.8% and rash 1.8%.
Short-term safety data for Ciprofloxacin was also collected in a randomized, double-blind clinical trial for the treatment of acute pulmonary exacerbations in cystic fibrosis patients (ages 5 to 17 years). Sixty seven patients received Ciprofloxacin IV 10 mg/kg/dose every 8 hours for one week followed by Ciprofloxacin tablets 20 mg/kg/dose every 12 hours to complete 10 to 21 days treatment and 62 patients received the combination of ceftazidime intravenous 50 mg/kg/dose every 8 hours and tobramycin intravenous 3 mg/kg/dose every 8 hours for a total of 10 to 21 days. Periodic musculoskeletal assessments were conducted by treatment-blinded examiners. Patients were followed for an average of 23 days after completing treatment (range 0 to 93 days). Musculoskeletal adverse reactions were reported in 22% of the patients in the Ciprofloxacin group and 21% in the comparison group. Decreased range of motion was reported in 12% of the subjects in the Ciprofloxacin group and 16% in the comparison group. Arthralgia was reported in 10% of the patients in the Ciprofloxacin group and 11% in the comparison group. Other adverse reactions were similar in nature and frequency between treatment arms. The efficacy of Ciprofloxacin for the treatment of acute pulmonary exacerbations in pediatric cystic fibrosis patients has not been established.
In addition to the adverse reactions reported in pediatric patients in clinical trials, it should be expected that adverse reactions reported in adults during clinical trials or postmarketing experience may also occur in pediatric patients.
The following adverse reactions have been reported from worldwide marketing experience with fluoroquinolones, including Ciprofloxacin. Because these reactions 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 (Table 8).
Adverse Laboratory Changes
Changes in laboratory parameters while on Ciprofloxacin are listed below:
Hepatic –Elevations of ALT (SGPT), AST (SGOT), alkaline phosphatase, LDH, serum bilirubin.
Hematologic–Eosinophilia, leukopenia, decreased blood platelets, elevated blood platelets, pancytopenia.
Renal–Elevations of serum creatinine, BUN, crystalluria, cylindruria, and hematuria have been reported.
Other changes occurring were: elevation of serum gammaglutamyl transferase, elevation of serum amylase, reduction in blood glucose, elevated uric acid, decrease in hemoglobin, anemia, bleeding diathesis, increase in blood monocytes, and leukocytosis.
What is the most important information I should know about Ciprofloxacin?
- Ciprofloxacin may cause drowsiness, dizziness, or light-headedness. These effects may be worse if you take it with alcohol or certain medicines. Use ciprofloxacin with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Tell your doctor or dentist that you take ciprofloxacin before you receive any medical or dental care, emergency care, or surgery.
- Be sure to use ciprofloxacin 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 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 only works against bacteria; it does not treat viral infections (eg, the common cold).
- Before using ciprofloxacin, 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. These nerve problems can happen soon after ciprofloxacin 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 may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
- Ciprofloxacin may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to ciprofloxacin. 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 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 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 using ciprofloxacin while you are pregnant. Ciprofloxacin is found in breast milk. Do not breast-feed while using ciprofloxacin.
Caution should be taken when giving ciprofloxacin to epileptic patients and to those with history of central nervous system (CNS) disorders, myasthenia gravis and glucose-6-phosphate dehydrogenase deficiency. Ciprofloxacin may exacerbate or unmask symptoms of myasthenia gravis. If tendon pain, inflammation or rupture occurs, treatment with ciprofloxacin should be discontinued.
Ciprofloxacin is contraindicated in children, adolescents. It was reported to cause arthralgia and degenerative changes in joints that bear weight in young animals.
Use in pregnancy & lactation: Ciprofloxacin is contraindicated in pregnancy. It is also excreted in breast milk. It should be used in caution when given to breastfeeding mothers as this was found to cause arthropathy in young animals.
- 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-on-ch... (accessed September 18, 2017).
- HSDB. "CIPROFLOXACIN". https://toxnet.nlm.nih.gov/cgi-bin/sis/s... (accessed September 18, 2017).
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.
Information checked by Dr. Sachin Kumar, MD Pharmacology