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What are the possible side effects of Rocephin?
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur:
- Black, tarry stools
- chest pain
- painful or difficult urination
- shortness of breath
- sore throat
- sores, ulcers, or white spots on the lips or in the mouth
- swollen glands
- unusual bleeding or bruising
- unusual tiredness or weakness
- Abdominal or stomach cramps or tenderness
- back, leg, or stomach pains
- bleeding gums
- blood in the urine or stools
- bloody nose
- bluish color
- changes in skin color
- clay-colored stools
- cough or hoarseness
- dark urine
- diarrhea, watery and severe, which may also be bloody
- difficulty with breathing
- difficulty with swallowing
- fast, irregular, pounding, or racing heartbeat or pulse
- feeling of discomfort
- feeling of warmth
- fever with or without chills
- general body swelling
- general feeling of tiredness or weakness
- increased sweating
- increased thirst
- inflammation of the joints
- loss of appetite
- lower back or side pain
- muscle aches
- nausea or vomiting
- noisy breathing
- pale skin
- pinpoint red spots on the skin
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- redness of the face, neck, arms, and occasionally, upper chest
- shortness of breath
- skin rash
- swelling of the foot or leg
- swollen lymph glands
- tightness in the chest
- troubled breathing with exertion
- unpleasant breath odor
- unusual weight loss
- vomiting of blood
- watery or bloody diarrhea
- yellowing of the eyes or skin
- Blistering, peeling, or loosening of the skin
- chest pain
- coughing up blood
- decrease in the amount of urine
- excessive muscle tone
- increased menstrual flow or vaginal bleeding
- muscle stiffness, tension, or tightness
- prolonged bleeding from cuts
- red irritated eyes
- red or black, tarry stools
- red or dark brown urine
- red skin lesions, often with a purple center
- skin rash with a general disease
- trouble sitting still
- unpleasant breath odor
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
- Acid or sour stomach
- change in taste
- excess air or gas in the stomach or intestines
- full feeling
- itching of the vagina or genital area
- loss of taste
- pain during sexual intercourse
- passing gas
- stomach discomfort, upset, or pain
- thick, white vaginal discharge with no odor or with a mild odor
- Hives or welts
- redness, swelling, or soreness of the tongue
- swelling or inflammation of the mouth
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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Side effects of Rocephin in details
Rocephin is generally well tolerated. In clinical trials, the following adverse reactions, which were considered to be related to Rocephin therapy or of uncertain etiology, were observed:
LOCAL REACTIONS—pain, induration and tenderness was 1% overall. Phlebitis was reported in <1% after IV administration. The incidence of warmth, tightness or induration was 17% (3/17) after IM administration of 350 mg/mL and 5% (1/20) after IM administration of 250 mg/mL.
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS—injection site pain (0.6%).
HYPERSENSITIVITY—rash (1.7%). Less frequently reported (<1%) were pruritus, fever or chills.
INFECTIONS AND INFESTATIONS—genital fungal infection (0.1%).
HEMATOLOGIC—eosinophilia (6%), thrombocytosis (5.1%) and leukopenia (2.1%). Less frequently reported (<1%) were anemia, hemolytic anemia, neutropenia, lymphopenia, thrombocytopenia and prolongation of the prothrombin time.
BLOOD AND LYMPHATIC DISORDERS—granulocytopenia (0.9%), coagulopathy (0.4%).
GASTROINTESTINAL—diarrhea/loose stools (2.7%). Less frequently reported (<1%) were nausea or vomiting, and dysgeusia. The onset of pseudomembranous colitis symptoms may occur during or after antibacterial treatment.
HEPATIC—elevations of aspartate aminotransferase (AST) (3.1%) or alanine aminotransferase (ALT) (3.3%). Less frequently reported (<1%) were elevations of alkaline phosphatase and bilirubin.
RENAL—elevations of the BUN (1.2%). Less frequently reported (<1%) were elevations of creatinine and the presence of casts in the urine.
CENTRAL NERVOUS SYSTEM—headache or dizziness were reported occasionally (<1%).
GENITOURINARY—moniliasis or vaginitis were reported occasionally (<1%).
MISCELLANEOUS—diaphoresis and flushing were reported occasionally (<1%).
INVESTIGATIONS—blood creatinine increased (0.6%).
Other rarely observed adverse reactions (<0.1%) include abdominal pain, agranulocytosis, allergic pneumonitis, anaphylaxis, basophilia, biliary lithiasis, bronchospasm, colitis, dyspepsia, epistaxis, flatulence, gallbladder sludge, glycosuria, hematuria, jaundice, leukocytosis, lymphocytosis, monocytosis, nephrolithiasis, palpitations, a decrease in the prothrombin time, renal precipitations, seizures, and serum sickness.
In addition to the adverse reactions reported during clinical trials, the following adverse experiences have been reported during clinical practice in patients treated with Rocephin. Data are generally insufficient to allow an estimate of incidence or to establish causation.
A small number of cases of fatal outcomes in which a crystalline material was observed in the lungs and kidneys at autopsy have been reported in neonates receiving Rocephin and calcium-containing fluids. In some of these cases, the same intravenous infusion line was used for both Rocephin and calcium-containing fluids and in some a precipitate was observed in the intravenous infusion line. At least one fatality has been reported in a neonate in whom Rocephin and calcium-containing fluids were administered at different time points via different intravenous lines; no crystalline material was observed at autopsy in this neonate. There have been no similar reports in patients other than neonates.
GASTROINTESTINAL – pancreatitis, stomatitis and glossitis.
GENITOURINARY – oliguria, ureteric obstruction, post-renal acute renal failure.
DERMATOLOGIC – exanthema, allergic dermatitis, urticaria, edema; acute generalized exanthematous pustulosis (AGEP) and isolated cases of severe cutaneous adverse reactions (erythema multiforme, Stevens-Johnson syndrome or Lyell's syndrome/toxic epidermal necrolysis) have been reported.
HEMATOLOGICAL CHANGES - Isolated cases of agranulocytosis (< 500/mm3) have been reported, most of them after 10 days of treatment and following total doses of 20 g or more.
NERVOUS SYSTEM DISORDERS - convulsion
OTHER, Adverse Reactions - symptomatic precipitation of Rocephin calcium salt in the gallbladder, kernicterus, oliguria, and anaphylactic or anaphylactoid reactions.
Cephalosporin Class Adverse Reactions
In addition to the adverse reactions listed above which have been observed in patients treated with Rocephin, the following adverse reactions and altered laboratory test results have been reported for cephalosporin class antibiotics:
Adverse Reactions: Allergic reactions, drug fever, serum sickness-like reaction, renal dysfunction, toxic nephropathy, reversible hyperactivity, hypertonia, hepatic dysfunction including cholestasis, aplastic anemia, hemorrhage, and superinfection.
Altered Laboratory Tests: Positive direct Coombs' test, false-positive test for urinary glucose, and elevated LDH.
Several cephalosporins have been implicated in triggering seizures, particularly in patients with renal impairment when the dosage was not reduced. If seizures associated with drug therapy occur, the drug should be discontinued. Anticonvulsant therapy can be given if clinically indicated.
What is the most important information I should know about Rocephin?
- 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.
- Rocephin only works against bacteria; it does not treat viral infections (eg, the common cold).
- A severe and sometimes fatal type of anemia (hemolytic anemia) has been reported in patients using cephalosporin antibiotics, including Rocephin. Discuss any questions or concerns with your doctor. Contact your doctor right away if you experience unusual tiredness or weakness, unusually pale skin, dizziness, fever or chills, severe back or stomach pain, or yellowing of the eyes or skin.
- Be sure to use Rocephin 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 Rocephin 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.
- Rocephin may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Rocephin.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Rocephin while you are pregnant. Rocephin is found in breast milk. If you are or will be breast-feeding while you use Rocephin, check with your doctor. Discuss any possible risks to your baby.
Hypersensitivity: Hypersensitivity to Rocephin, any of excipients of Rocephin or to any other cephalosporin. Patients with previous hypersensitivity reactions to penicillin and other β-lactam agents may be at greater risk of hypersensitivity to Rocephin.
Lidocaine: It must be excluded before IM injection of Rocephin when lidocaine solution is used as a solvent. Rocephin solutions containing lidocaine should never be administered IV.
Premature Neonates: Rocephin is contraindicated in premature neonates up to postmenstrual age of 41 weeks (gestational age + chronological age).
Hyperbilirubinemic Newborns: Should not be treated with Rocephin. In vitro studies have shown that Rocephin can displace bilirubin from its binding to serum albumin, leading to a possible risk of bilirubin encephalopathy in these patients.
Neonates and Calcium-Containing IV Solutions: Rocephin is contraindicated in neonates (≤28 days) if they require (or are expected to require) treatment with calcium-containing IV solutions, including continuous calcium-containing infusions eg, parenteral nutrition because of the risk of precipitation of ceftriaxone-calcium.
A small number of cases of fatal outcomes in which a crystalline material was observed in the lungs and kidneys at autopsy have been reported in neonates receiving Rocephin and calcium-containing fluids. In some of these cases, the same IV infusion line was used for both Rocephin and calcium-containing fluids and in some a precipitate was observed in the IV infusion line. At least 1 fatality has been reported in a neonate in whom Rocephin and calcium-containing fluids were administered at different time points via different intravenous lines; no crystalline material was observed at autopsy in this neonate. There have been no similar reports in patients other than neonates.
ReviewsThe results of a survey conducted on nDrugs.com for Rocephin 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 Rocephin. 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.
Consumer reported side effectsNo survey data has been collected yet