(ciprofloxacin injection)
The following serious and otherwise important adverse drug reactions are discussed in greater detail in other sections of labeling:
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.
Adult Patients
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 clinical trials the following adverse reactions were reported in greater than 1% of patients treated with intravenous ciprofloxacin: nausea, diarrhea, central nervous system disturbance, local intravenous site reactions, liver function tests abnormal, eosinophilia, headache, restlessness, and rash. Local intravenous site reactions are more frequent if the infusion time is 30 minutes or less. These may appear as local skin reactions that resolve rapidly upon completion of the infusion. Subsequent intravenous administration is not contraindicated unless the reactions recur or worsen.
| System Organ Class | Adverse Reactions |
| Body as a Whole | Abdominal Pain/Discomfort Pain |
| Cardiovascular | Cardiopulmonary Arrest Myocardial Infarction Tachycardia Syncope Hypertension Angina Pectoris Vasodilation |
| Central Nervous System | Restlessness Seizures (including Status Epilepticus) Paranoia Psychosis (toxic) Depression (potentially culminating in self-injurious behavior, such as suicidal ideations/thoughts and attempted or completed suicide) Phobia Depersonalization Manic Reaction Unresponsiveness Ataxia Hallucinations Dizziness Paresthesia Tremor Insomnia Nightmares Irritability Malaise Abnormal Gait Migraine |
| Gastrointestinal | Ileus Gastrointestinal Bleeding Pancreatitis Hepatic Necrosis Intestinal Perforation Dyspepsia Constipation Oral Ulceration Mouth Dryness Anorexia Flatulence Hepatitis |
| Hemic/Lymphatic | Agranulocytosis Prolongation of Prothrombin Time Petechia |
| Metabolic/Nutritional | Hyperglycemia Hypoglycemia |
| Musculoskeletal | Arthralgia Joint Stiffness Muscle Weakness |
| Renal/Urogenital | Renal Failure Interstitial Nephritis Hemorrhagic Cystitis Renal Calculi Frequent Urination Gynecomastia Crystalluria Cylindruria Hematuria Albuminuria |
| Respiratory | Respiratory Arrest Dyspnea Laryngeal Edema Hemoptysis Bronchospasm |
| System Organ Class | Adverse Reactions |
| Skin/Hypersensitivity | Allergic Reactions Anaphylactic Reactions including life-threatening anaphylactic shock Erythema Multiforme/Stevens-Johnson Syndrome Exfoliative Dermatitis Toxic Epidermal Necrolysis Vasculitis Angioedema Extremities Purpura Fever Pruritus Urticaria Increased Perspiration Erythema Nodosum Thrombophlebitis Burning Photosensitivity/Phototoxicity Reaction |
| Special Senses | Decreased Visual Acuity Blurred Vision Disturbed Vision (diplopia, chromatopsia, and photopsia) Anosmia Hearing Loss Tinnitus Nystagmus Bad Taste |
In several instances, nausea, vomiting, tremor, irritability, or palpitation were judged by investigators to be related to elevated serum levels of theophylline possibly as a result of drug interaction with ciprofloxacin.
In randomized, double-blind controlled clinical trials comparing ciprofloxacin (Intravenous and Intravenous/Oral sequential) with intravenous beta-lactam control antibiotics, the CNS adverse reaction profile of ciprofloxacin was comparable to that of the control drugs.
Pediatric Patients
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 6).
1. Included: arthralgia, abnormal gait, abnormal joint exam, joint sprains, leg pain, back pain, arthrosis, bone pain, pain, myalgia, arm pain, and decreased range of motion in a joint (knee, elbow, ankle, hip, wrist, and shoulder) | ||
2. The study was designed to demonstrate that the arthropathy rate for the ciprofloxacin group did not exceed that of the control group by more than + 6%. At both the 6 week and 1 year evaluations, the 95% confidence interval indicated that it could not be concluded that the ciprofloxacin group had findings comparable to the control group. | ||
| Ciprofloxacin | Comparator | |
| All Patients (within 6 weeks) | 31/335 (9.3%) | 21/349 (6%) |
| 95% Confidence Interval2 | (-0.8%, +7.2%) | |
| Age Group | ||
| 12 months to 24 months | 1/36 (2.8%) | 0/41 |
| 2 years to <6 years | 5/124 (4%) | 3/118 (2.5%) |
| 6 years to <12 years | 18/143 (12.6%) | 12/153 (7.8%) |
| 12 years to 17 years | 7/32(21.9%) | 6/37 (16.2%) |
| All Patients (within 1 year) | 46/335 (13.7%) | 33/349 (9.5%) |
| 95% Confidence Interval2 | (-0.6%, +9.1%) | |
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 events 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, doubleblind clinical trial for the treatment of acute pulmonary exacerbations in cystic fibrosis patients (ages 5 to 17 years). Sixty-seven patients received ciprofloxacin 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 7).
| System Organ Class | Adverse Reactions |
| Cardiovascular | QT prolongation Torsade de Pointes Vasculitis and ventricular arrhythmia |
| Central Nervous System | Hypertonia Myasthenia Exacerbation of myasthenia gravis Peripheral neuropathy Polyneuropathy Twitching |
| Gastrointestinal | Pseudomembranous colitis |
| Hemic/Lymphatic | Pancytopenia (life threatening or fatal outcome) Methemoglobinemia |
| Hepatobiliary | Hepatic failure (including fatal cases) |
| Infections and Infestations | Candidiasis (oral, gastrointestinal, vaginal) |
| Investigations | Prothrombin time prolongation or decrease Cholesterol elevation (serum) Potassium elevation (serum) |
| Musculoskeletal | Myalgia Myoclonus Tendinitis Tendon rupture |
| Psychiatric Disorders | Agitation Confusion Delirium |
| Skin/Hypersensitivity | Acute generalized exanthematous pustulosis (AGEP) Fixed eruption Serum sickness-like reaction |
| Special Senses | Anosmia Hyperesthesia Hypesthesia Nystagmus Taste loss |
Changes in laboratory parameters while on ciprofloxacin therapy are listed below:
Other changes occurring were: decreased leukocyte count, elevated atypical lymphocyte count, immature WBCs, elevated serum calcium, elevation of serum gamma-glutamyl transpeptidase (gGT), decreased BUN, decreased uric acid, decreased total serum protein, decreased serum albumin, decreased serum potassium, elevated serum potassium, elevated serum cholesterol. Other changes occurring during administration of ciprofloxacin were: elevation of serum amylase, decrease of blood glucose, pancytopenia, leukocytosis, elevated sedimentation rate, change in serum phenytoin, decreased prothrombin time, hemolytic anemia, and bleeding diathesis.
This Medication Guide has been approved by the U.S. Food and Drug Administration. |
| MEDICATION GUIDE CIPROFLOXACIN (sip-row-FLOX-a-sin) INJECTION, USP (in 5% Dextrose Injection) (ciprofloxacin) for intravenous infusion |
| Read this Medication Guide before you start taking ciprofloxacin and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment. |
What is the most important information I should know about ciprofloxacin? Ciprofloxacin, a fluoroquinolone antibacterial medicine, can cause serious side effects. Some of these serious side effects can happen at the same time and could result in death.If you get any of the following serious side effects while you take ciprofloxacin, you should stop taking ciprofloxacin immediately and get medical help right away. 1. Tendon rupture or swelling of the tendon (tendinitis).
2. Changes in sensation and possible nerve damage (Peripheral Neuropathy). Damage to the nerves in arms, hands, legs, or feet can happen in people who take fluoroquinolones, including ciprofloxacin. Stop taking ciprofloxacin immediately and talk to your healthcare provider right away if you get any of the following symptoms of peripheral neuropathy in your arms, hands, legs, or feet:
3. Central Nervous System (CNS) effects. Mental health problems and seizures have been reported in people who take fluoroquinolone antibacterial medicines, including ciprofloxacin. Tell your healthcare provider if you have a history of seizures before you start taking ciprofloxacin. CNS side effects may happen as soon as after taking the first dose of ciprofloxacin. Stop taking ciprofloxacin immediately and talk to your healthcare provider right away if you get any of these side effects, or other changes in mood or behavior:
4. Worsening of myasthenia gravis (a problem that causes muscle weakness). Fluoroquinolones like ciprofloxacin may cause worsening of myasthenia gravis symptoms, including muscle weakness and breathing problems. Tell your healthcare provider if you have a history of myasthenia gravis before you start taking ciprofloxacin. Call your healthcare provider right away if you have any worsening muscle weakness or breathing problems. |
| What is ciprofloxacin? Ciprofloxacin is a fluoroquinolone antibacterial medicine used in adults age 18 years and older to treat certain infections caused by certain germs called bacteria. These bacterial infections include:
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| Who should not take ciprofloxacin? Do not take ciprofloxacin if you:
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| What should I tell my healthcare provider before taking ciprofloxacin? Before you take ciprofloxacin, tell your healthcare provider about all your medical conditions, including if you:
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. |
How should I take ciprofloxacin?
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What should I avoid while taking ciprofloxacin?
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What are the possible side effects of ciprofloxacin? Ciprofloxacin may cause serious side effects, including:
These are not all the possible side effects of ciprofloxacin. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. |
| Keep ciprofloxacin and all medicines out of the reach of children. |
| General Information about the safe and effective use of ciprofloxacin. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use ciprofloxacin for a condition for which it is not prescribed. Do not give ciprofloxacin to other people, even if they have the same symptoms that you have. It may harm them. This Medication Guide summarizes the most important information about ciprofloxacin. If you would like more information about ciprofloxacin, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about ciprofloxacin that is written for healthcare professionals. |
| What are the ingredients in ciprofloxacin? Ciprofloxacin Injection, USP (in 5% Dextrose Injection):
Brands listed are the trademarks of their respective owners. Hospira Distributed by Hospira, Inc., Lake Forest, IL 60045 USA Revised: August 2022 |
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