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Doribax Side Effects

Generic Name: doripenem

Please note - some side effects for Doribax may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Doribax - for the Consumer

Doribax

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Doribax:

Headache; mild diarrhea; nausea.

Seek medical attention right away if any of these SEVERE side effects occur when using Doribax:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody stools; chest pain; pain, swelling, or redness at the injection site; red, swollen, blistered, or peeling skin; seizures; severe diarrhea; severe stomach cramps or pain; shortness of breath; unusual tiredness or weakness; unusual vaginal odor, itching, or discharge.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Doribax Side Effects - for the Professional

Doribax

The following adverse reactions are discussed in greater detail in other sections of labeling:

Adverse Reactions from Clinical Trials

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be compared directly to rates from clinical trials of another drug and may not reflect rates observed in practice.

During clinical investigations, 853 adult patients were treated with Doribax® IV (500 mg administered over 1 hour every 8 hours) in the three comparative phase 3 clinical studies; in some patients, parenteral therapy was followed by a switch to an oral antimicrobial. [see Clinical Studies (14)] The median age of patients treated with Doribax® was 54 years (range 18–90) in the comparative cUTI study and 46 years (range 18–94) in the pooled comparative cIAI studies. There was a female predominance (62%) in the comparative cUTI study and a male predominance (63%) in the pooled cIAI studies. The patients treated with Doribax® were predominantly Caucasian (77%) in the three pooled phase 3 studies.

The most common adverse reactions (≥ 5%) observed in the Doribax® phase 3 clinical trials were headache, nausea, diarrhea, rash and phlebitis. During clinical trials, adverse drug reactions that led to Doribax® discontinuation were nausea (0.2%), vulvomycotic infection (0.1%) and rash (0.1%).

Adverse reactions due to Doribax® 500 mg administered every 8 hours that occurred at a rate ≥ 1 % in either indication are listed in Table 4. Hypersensitivity reactions related to intravenous study drug and C. difficile colitis occurred at a rate of less than 1% in the three controlled phase 3 clinical trials.

Table 4: Adverse Reactions* with Incidence Rates (%) of ≥1% and Adverse Events† Having Clinically Important Differences in Frequency by Indication in the Three Controlled, Comparative Doribax® Phase 3 Clinical Trials
Complicated Urinary Tract
Infections (one trial)		 Complicated Intra-Abdominal
Infections (two trials)
System organ class Doribax®
500 mg administered every 8 hours
(n =376 )		 Levofloxacin
250 mg administered IV every 24 hours
(n = 372)		 Doribax®
500 mg administered every 8 hours
(n = 477)		 Meropenem
1 g administered every 8 hours
(n = 469)
*
An adverse drug reaction was defined as an undesirable effect, reasonably associated with the use of Doribax® that may occur as part of its pharmacological action or may be unpredictable in its occurrence.
†
An adverse event refers to any untoward medical event associated with the use of the drug in humans, whether or not considered drug-related.
‡
includes reactions reported as alanine aminotransferase increased, aspartate aminotransferase increased, hepatic enzyme increased, and transaminases increased
Nervous system disorders
Headache 16 15 4 5
Vascular disorders
Phlebitis 4 4 8 6
Gastro-intestinal disorders
Nausea 4 6 12 9
Diarrhea 6 10 11 11
Blood and Lymphatic System Disorders
Anemia† 2 1 10 5
Renal and Urinary Disorders
Renal impairment/Renal failure† <1 0 1 <1
Skin and subcutaneous disorders
Pruritus <1 1 3 2
Rash 1 1 5 2
Investigations
Hepatic enzyme elevation‡ 2 3 1 3
Infection and Infestations
Oral candidiasis 1 0 1 2
Vulvomycotic infection 2 1 1 <1

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of doripenem. Because these reactions were reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

 
Anaphylaxis
 
Neutropenia
 
Leukopenia
 
Thrombocytopenia
 
Toxic epidermal necrolysis, Stevens-Johnson Syndrome

The following treatment-emergent adverse events (known to occur with beta-lactams including carbapenems) have been reported voluntarily during post-approval use of Doribax®. They are included due to their seriousness, although it is not possible to estimate their frequency and causality has not been established:

 
Interstitial pneumonia
 
Seizure
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Side Effects by Body System - for Healthcare Professionals

General

The safety report of doripenem is based on 853 adult patients receiving the indicated dosing regimen during three phase 3 clinical trials. The most common side effects (5% or greater) reported with doripenem were headache, nausea, diarrhea, rash, and phlebitis. During clinical studies, side effects leading to discontinuations were nausea (0.2%), rash (0.1%), and vulvomycotic infection (0.1%).

Gastrointestinal

Gastrointestinal side effects have included nausea (4% to 12%), diarrhea (6% to 11%), and Clostridium difficile colitis (less than 1%).

Hypersensitivity

Hypersensitivity side effects have included rash (1% to 5%; includes reactions reported as allergic and bullous dermatitis, urticaria, and erythema multiforme) and serious hypersensitivity reactions (less than 1%). Anaphylaxis, Stevens-Johnson syndrome, and toxic epidermal necrolysis have been reported during postmarketing experience.

Nervous system

Nervous system side effects have included headache (4% to 16%). Seizure has been reported during postmarketing experience.

Hematologic

Hematologic side effects have included anemia (2% to 10%), regardless of causality. Neutropenia, leukopenia, and thrombocytopenia have been reported during postmarketing experience.

Cardiovascular

Cardiovascular side effects have included phlebitis (4% to 8%).

Dermatologic

Dermatologic side effects have included pruritus (less than 1% to 3%) and rash (1% to 5%; includes reactions reported as erythema and macular/papular eruptions).

Immunologic

Immunologic side effects have included vulvomycotic infection (1% to 2%) and oral candidiasis (1%).

Hepatic

Hepatic side effects have included elevated hepatic enzymes (1% to 2%), including reactions reported as elevated alanine transaminase, elevated aspartate transaminase, and elevated transaminases.

Respiratory

Respiratory side effects have included pneumonitis when doripenem was administered via inhalation. Interstitial pneumonia has been reported during postmarketing experience.

Renal

Renal side effects have included renal impairment/renal failure (1% or less), regardless of causality.

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