Drug Safety Information for CLEOCIN (Clindamycin palmitate hydrochloride)

Safety-related Labeling Changes for CLEOCIN (CLINDAMYCIN PHOSPHATE) Rx Drug: FDA Link

Adverse Drug Reactions for CLEOCIN* (Clindamycin palmitate hydrochloride)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with CLEOCIN
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Diarrhoea*169
2Nausea*113
3Pain*108
4Drug hypersensitivity106
5Rash104
6Dyspnoea85
7Anxiety*85
8Pyrexia83
9Vomiting80
10Fatigue80
11Asthenia72
12Drug ineffective68
13Weight decreased63
14Dizziness62
15Headache*62
16Dehydration61
17Abdominal pain61
18Anaemia60
19Depression58
20Pneumonia56

* This side effect also appears in "Top 10 Side Effects of CLEOCIN " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking CLEOCIN
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Product used for unknown indication628
2Acne*310
3Tooth infection*132
4Rash118
5Tooth abscess*115
6Osteonecrosis111
7Infection111
8Prophylaxis105
9Ill-defined disorder90
10Chronic sinusitis69

*Also a top-10 reason in AskaPatient Review Summary.


Types of Adverse Events for CLEOCIN

Total Reports Filed with FDA: 12418


Number of FDA Adverse Event Reports by Patient Age for CLEOCIN

Total Reports Filed with FDA: 12418*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Clindamycin palmitate hydrochloride (Clindamicina, Cleocin, Clindamicin)

Charts are based on 12418 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

Click to go back to search results and CLEOCIN Reviews and Review Summary .

Historical Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.